Composition, disintegrative properties, and labeling compliance of commercially available taurine and carnitine dietary products.

PubMed

Bragg, Rebecca R; Freeman, Lisa M; Fascetti, Andrea J; Yu, Zengshou

2009-01-15

To test the quality, disintegration properties, and compliance with labeling regulations for representative commercially available taurine and carnitine dietary products. Evaluation study. 11 commercially available taurine and 10 commercially available carnitine products. For each product, the amount of taurine or carnitine was determined and compared with the label claim. All products were evaluated for concentrations of mercury, arsenic, and selenium. Disintegration properties of 5 taurine and 8 carnitine products were determined in vitro. Labels were evaluated for compliance with FDA guidelines. 10 of 11 taurine and 10 of 10 carnitine products were within 10% of the stated label claim. Three of 11 taurine and 6 of 10 carnitine products were within 5% of the stated label claim. The median percentage difference between laboratory analysis and label claim was -5.7% (range, -26.3% to 2.5%) for taurine and 3.6% (range, -2.6% to 8.8%) for carnitine. No substantial amount of contamination with mercury, arsenic, or selenium was found in any of the products. During disintegration testing, 1 of 5 taurine products and 5 of 8 carnitine products did not disintegrate within 45 minutes during at least 1 test. Disintegration time for those that did disintegrate ranged from 1.7 to 37.0 minutes. All product labels conformed with FDA regulations. Taurine and carnitine products evaluated in this study closely adhered to manufacturer claims and labeling guidelines. However, disintegration testing suggested high variability in some products, possibly limiting uptake and use by animals that receive them.

9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2010 CFR

2010-01-01

... labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with... nutrient content claims in § 381.413; and (3) The product for which the claim is made is labeled in accordance with § 381.409. (b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may...

9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2013 CFR

2013-01-01

... labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with... nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317.309. (b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may...

9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2010 CFR

2010-01-01

... labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with... nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317.309. (b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may...

9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2013 CFR

2013-01-01

... labeling of the product if: (1) The claim uses one of the terms defined in this section in accordance with... nutrient content claims in § 381.413; and (3) The product for which the claim is made is labeled in accordance with § 381.409. (b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may...

Health claims and other health-related statements in the labeling and advertising of alcohol beverages (99R-199P). Final rule, Treasury decision.

PubMed

2003-03-03

TTB is amending the regulations to prohibit the appearance on labels or in advertisements of any health-related statement, including a specific health claim, that is untrue in any particular or tends to create a misleading impression. A specific health claim on a label or in an advertisement is considered misleading unless the claim is truthful and adequately substantiated by scientific evidence; properly detailed and qualified with respect to the categories of individuals to whom the claim applies; adequately discloses the health risks associated with both moderate and heavier levels of alcohol consumption; and outlines the categories of individuals for whom any levels of alcohol consumption may cause health risks. In addition, TTB will consult with the Food and Drug Administration (FDA), as needed, on the use of specific health claims on labels. If FDA determines that a specific health claim is a drug claim that is not in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act, TTB will not approve the use of such statement on a label. Health-related statements that are not specific health claims or health-related directional statements will be evaluated on a case-by-case basis to determine if they tend to mislead consumers. The final rule provides that health-related directional statements (statements that direct or refer consumers to a third party or other source for information regarding the effects on health of alcohol consumption) will be presumed misleading unless those statements include a brief disclaimer advising consumers that the statement should not encourage consumption of alcohol for health reasons, or some other appropriate disclaimer to avoid misleading consumers. TTB believes that the final regulations will ensure that labels and advertisements do not contain statements or claims that would tend to mislead the consumer about the significant health consequences of alcohol consumption.

9 CFR 317.369 - Labeling applications for nutrient content claims.

Code of Federal Regulations, 2014 CFR

2014-01-01

... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

9 CFR 317.369 - Labeling applications for nutrient content claims.

Code of Federal Regulations, 2013 CFR

2013-01-01

... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

9 CFR 381.469 - Labeling applications for nutrient content claims.

Code of Federal Regulations, 2013 CFR

2013-01-01

... AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

9 CFR 317.369 - Labeling applications for nutrient content claims.

Code of Federal Regulations, 2012 CFR

2012-01-01

... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

9 CFR 317.369 - Labeling applications for nutrient content claims.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AND VOLUNTARY INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

9 CFR 381.469 - Labeling applications for nutrient content claims.

Code of Federal Regulations, 2012 CFR

2012-01-01

... AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

9 CFR 381.469 - Labeling applications for nutrient content claims.

Code of Federal Regulations, 2014 CFR

2014-01-01

... AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

9 CFR 381.469 - Labeling applications for nutrient content claims.

Code of Federal Regulations, 2011 CFR

2011-01-01

... AND VOLUNTARY INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling... of the food component characterized by the claim is of importance in human nutrition by virtue of its... intake of nutrients that have beneficial and negative consequences in the total diet. If the claim is...

Consumers’ Exposure to Nutrition and Health Claims on Pre-Packed Foods: Use of Sales Weighting for Assessing the Food Supply in Slovenia

PubMed Central

Pravst, Igor; Kušar, Anita

2015-01-01

Insights into the use of health-related information on foods are important for planning studies about the effects of such information on the consumer’s understanding, purchasing, and consumption of foods, and also support further food policy decisions. We tested the use of sales data for weighting consumers’ exposure to health-related labeling information in the Slovenian food supply. Food labeling data were collected from 6342 pre-packed foods available in four different food stores in Slovenia. Consumers’ exposure was calculated as the percentage of available food products with particular food information in the food category. In addition, 12-month sales data were used to calculate sales weighted exposure as a percentage of sold food products with certain food information in the food category. The consumer’s in-store and sales-weighted exposure to nutrition claims was 37% and 45%, respectively. Exposure to health claims was much lower (13%, 11% when sales-weighted). Health claims were mainly found in the form of general non-specific claims or function claims, while children’s development and reduction of disease risk claims were present on only 0.1% and 0.2% of the investigated foods, respectively. Sales data were found very useful for establishing a reliable estimation of consumers’ exposure to information provided on food labels. The high penetration of health-related information on food labels indicates that careful regulation of this area is appropriate. Further studies should focus on assessing the nutritional quality of foods labeled with nutrition and health claims, and understanding the importance of such labeling techniques for consumers’ food preferences and choices. PMID:26569301

Consumers' Exposure to Nutrition and Health Claims on Pre-Packed Foods: Use of Sales Weighting for Assessing the Food Supply in Slovenia.

PubMed

Pravst, Igor; Kušar, Anita

2015-11-12

Insights into the use of health-related information on foods are important for planning studies about the effects of such information on the consumer's understanding, purchasing, and consumption of foods, and also support further food policy decisions. We tested the use of sales data for weighting consumers' exposure to health-related labeling information in the Slovenian food supply. Food labeling data were collected from 6342 pre-packed foods available in four different food stores in Slovenia. Consumers' exposure was calculated as the percentage of available food products with particular food information in the food category. In addition, 12-month sales data were used to calculate sales weighted exposure as a percentage of sold food products with certain food information in the food category. The consumer's in-store and sales-weighted exposure to nutrition claims was 37% and 45%, respectively. Exposure to health claims was much lower (13%, 11% when sales-weighted). Health claims were mainly found in the form of general non-specific claims or function claims, while children's development and reduction of disease risk claims were present on only 0.1% and 0.2% of the investigated foods, respectively. Sales data were found very useful for establishing a reliable estimation of consumers' exposure to information provided on food labels. The high penetration of health-related information on food labels indicates that careful regulation of this area is appropriate. Further studies should focus on assessing the nutritional quality of foods labeled with nutrition and health claims, and understanding the importance of such labeling techniques for consumers' food preferences and choices.

A Critical Review of the Marketing Claims of Infant Formula Products in the United States.

PubMed

Belamarich, Peter F; Bochner, Risa E; Racine, Andrew D

2016-05-01

A highly competitive infant formula market has resulted in direct-to-consumer marketing intended to promote the sale of modified formulas that claim to ameliorate common infant feeding problems. The claims associated with these marketing campaigns are not evaluated with reference to clinical evidence by the Food and Drug Administration. We aimed to describe the language of claims made on formula labels and compare it with the evidence in systematic reviews. Of the 22 product labels we identified, 13 product labels included claims about colic and gastrointestinal symptoms. There is insufficient evidence to support the claims that removing or reducing lactose, using hydrolyzed or soy protein or adding pre-/probiotics to formula benefits infants with fussiness, gas, or colic yet claims like "soy for fussiness and gas" encourage parents who perceive their infants to be fussy to purchase modified formula. Increased regulation of infant formula claims is warranted. © The Author(s) 2015.

78 FR 52199 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-22

... Request; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims... review and clearance. Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular... in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With...

Patient-reported outcomes to support medical product labeling claims: FDA perspective.

PubMed

Patrick, Donald L; Burke, Laurie B; Powers, John H; Scott, Jane A; Rock, Edwin P; Dawisha, Sahar; O'Neill, Robert; Kennedy, Dianne L

2007-01-01

This article concerns development and use of patient-reported outcomes (PROs) in clinical trials to evaluate medical products. A PRO is any report coming directly from patients, without interpretation by physicians or others, about how they function or feel in relation to a health condition and its therapy. PRO instruments are used to measure these patient reports. PROs provide a unique perspective on medical therapy, because some effects of a health condition and its therapy are known only to patients. Properly developed and evaluated PRO instruments also have the potential to provide more sensitive and specific measurements of the effects of medical therapies, thereby increasing the efficiency of clinical trials that attempt to measure the meaningful treatment benefits of those therapies. Poorly developed and evaluated instruments may provide misleading conclusions or data that cannot be used to support product labeling claims. We review selected major challenges from Food and Drug Administration's perspective in using PRO instruments, measures, and end points to support treatment benefit claims in product labeling. These challenges highlight the need for sponsors to formulate desired labeling claim(s) prospectively, to acquire and document information needed to support these claim(s), and to identify existing instruments or develop new and more appropriate PRO instruments for evaluating treatment benefit in the defined population in which they will seek claims.

Australian consumers are sceptical about but influenced by claims about fat on food labels.

PubMed

Chan, C; Patch, C; Williams, P

2005-01-01

To explore the beliefs and attitudes of Australian consumers to claims about fat made on the labels of packaged food. Content analysis of transcripts from focus group discussions. A total of 26 female and 10 male participants aged 20-80 y, recruited by advertisement into six focus groups, stratified by age, sex and health status. Awareness of claims about fat was high in this sample of Australians and participants admitted that they influenced their purchase decisions. The most preferred form of claim was 'X% fat free'. Claims were considered most useful on foods that were high in fat. There was considerable scepticism about all nutrient claims, and consumers preferred to check claims about fat against the values in the nutrition information panel. Many claims were seen as advertising that could be misleading, deceptive or confusing. While claims about fat might prompt product trial, factors such as price, taste, naturalness, as well as other nutritional factors, also influenced purchase decisions. Some consumers believe low fat claims encourage over consumption of foods. Changes to regulations governing nutrition claims on food labels should be made to enhance their credibility and support their role in assisting consumers to make healthier food choices.

Origins of the prohibition against off-label promotion.

PubMed

Coleman, Terry S

2014-01-01

The statute and regulations administered by the Food and Drug Administration ("FDA") do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the government has collected billions of dollars in penalties for such "off-label" promotion. The statutory interpretations and regulatory provisions relied on by the government to take enforcement action against off-label promotion are the incidental by-products of initiatives undertaken by FDA through administrative action and litigation early in its implementation of the Federal Food, Drug, and Cosmetic Act. The actions were designed to obtain FDA authority over therapeutic claims made in advertising, even though Congress had assigned authority over advertising to the Federal Trade Commission, and to establish a prescription-only drug system, even though FDA lacked statutory authority for such a system. The principal purpose of both efforts was to prevent inappropriate self-medication. This article describes the history of those strategies, including expansion of the definition of the term "labeling" to encompass matter that was initially regarded as advertising; creation of the rule that the labeling of drugs must have adequate directions for all "intended" uses; and construction of the prescription-only drug system in a manner that allowed FDA to use the statutory requirement for labeling to have "adequate directions for use" to prohibit the off-label promotion of prescription drugs.

Comparison of the nutritional content of products, with and without nutrient claims, targeted at children in Brazil.

PubMed

Rodrigues, Vanessa Mello; Rayner, Mike; Fernandes, Ana Carolina; de Oliveira, Renata Carvalho; Proença, Rossana Pacheco da Costa; Fiates, Giovanna Medeiros Rataichesck

2016-06-01

Many children's food products highlight positive attributes on their front-of-package labels in the form of nutrient claims. This cross-sectional study investigated all retailed packaged foods (n 5620) in a major Brazilian supermarket, in order to identify the availability of products targeted at children, and to compare the nutritional content of products with and without nutrient claims on labels. Data on energy, carbohydrate, protein, fibre, Na and total and SFA content, along with the presence and type of nutrient claims, were obtained in-store from labels of all products. Products targeted at children were identified, divided into eight food groups and compared for their nutritional content per 100 g/ml and the presence of nutrient claims using the Mann-Whitney U test (P<0·05). Of the 535 food products targeted at children (9·5 % of all products), 270 (50·5 %) displayed nutrient claims on their labels. Children's products with nutrient claims had either a similar or worse nutritional content than their counterparts without nutrient claims. The major differences among groups were found in Group 8 (e.g. sauces and ready meals), in which children's products bearing nutrient claims had higher energy, carbohydrate, Na and total and SFA content per 100 g/ml than products without nutrient claims (P<0·05). This suggests that, to prevent misleading parents who are seeking healthier products for their children, the regulation on the use of nutrient claims should be revised, so that only products with appropriate nutrient profiles are allowed to display them.

9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2012 CFR

2012-01-01

... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to..., and cholesterol in a product may only be made on the label or in labeling of products if: (1) The...

9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2012 CFR

2012-01-01

... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to..., and cholesterol in a product may only be made on the label or in labeling of products if: (1) The...

9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2011 CFR

2011-01-01

... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to... level of fat, fatty acid, and cholesterol in a product may only be made on the label or in labeling of...

9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2011 CFR

2011-01-01

... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. Link to... level of fat, fatty acid, and cholesterol in a product may only be made on the label or in labeling of...

Effects of alternative label formats on choice of high- and low-sodium products in a New Zealand population sample.

PubMed

McLean, Rachael; Hoek, Janet; Hedderley, Duncan

2012-05-01

Dietary sodium reduction is a cost-effective public health intervention to reduce chronic disease. In response to calls for further research into front-of-pack labelling systems, we examined how alternative sodium nutrition label formats and nutrition claims influenced consumers' choice behaviour and whether consumers with or without a diagnosis of hypertension differed in their choice patterns. An anonymous online experiment in which participants viewed ten choice sets featuring three fictitious brands of baked beans with varied label formats and nutritional profiles (high and low sodium) and indicated which brand in each set they would purchase if shopping for this product. Participants were recruited from New Zealand's largest online nationwide research panel. Five hundred people with self-reported hypertension and 191 people without hypertension aged 18 to 79 years. The addition of a front-of-pack label increased both groups' ability to discriminate between products with high and low sodium, while the Traffic Light label enabled better identification of the high-sodium product. Both front-of-pack formats enhanced discrimination in the presence of a reduced salt claim, but the Traffic Light label also performed better than the Percentage Daily Intake label in moderating the effect of the claim for the high-sodium product. Front-of-pack labels, particularly those with simple visual cues, enhance consumers' ability to discriminate between high- and low-sodium products, even when those products feature nutrition claims.

76 FR 6319 - Designation of Biobased Items for Federal Procurement

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-04

... to have retroactive effect, and does not involve administrative appeals. D. Executive Order 13132... at: http://www.biopreferred.gov . * * * (b) Advertising, labeling and marketing claims. Manufacturers and vendors are reminded that their advertising, labeling, and other marketing claims, including...

Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness.

PubMed

Boyce, Richard D; Horn, John R; Hassanzadeh, Oktie; Waard, Anita de; Schneider, Jodi; Luciano, Joanne S; Rastegar-Mojarad, Majid; Liakata, Maria

2013-01-26

Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug's efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File - Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market.

Dynamic enhancement of drug product labels to support drug safety, efficacy, and effectiveness

PubMed Central

2013-01-01

Out-of-date or incomplete drug product labeling information may increase the risk of otherwise preventable adverse drug events. In recognition of these concerns, the United States Federal Drug Administration (FDA) requires drug product labels to include specific information. Unfortunately, several studies have found that drug product labeling fails to keep current with the scientific literature. We present a novel approach to addressing this issue. The primary goal of this novel approach is to better meet the information needs of persons who consult the drug product label for information on a drug’s efficacy, effectiveness, and safety. Using FDA product label regulations as a guide, the approach links drug claims present in drug information sources available on the Semantic Web with specific product label sections. Here we report on pilot work that establishes the baseline performance characteristics of a proof-of-concept system implementing the novel approach. Claims from three drug information sources were linked to the Clinical Studies, Drug Interactions, and Clinical Pharmacology sections of the labels for drug products that contain one of 29 psychotropic drugs. The resulting Linked Data set maps 409 efficacy/effectiveness study results, 784 drug-drug interactions, and 112 metabolic pathway assertions derived from three clinically-oriented drug information sources (ClinicalTrials.gov, the National Drug File – Reference Terminology, and the Drug Interaction Knowledge Base) to the sections of 1,102 product labels. Proof-of-concept web pages were created for all 1,102 drug product labels that demonstrate one possible approach to presenting information that dynamically enhances drug product labeling. We found that approximately one in five efficacy/effectiveness claims were relevant to the Clinical Studies section of a psychotropic drug product, with most relevant claims providing new information. We also identified several cases where all of the drug-drug interaction claims linked to the Drug Interactions section for a drug were potentially novel. The baseline performance characteristics of the proof-of-concept will enable further technical and user-centered research on robust methods for scaling the approach to the many thousands of product labels currently on the market. PMID:23351881

LCA-Based Product Claims

EPA Science Inventory

Product environmental claims include a wide range of marketing claims, labels, declarations, statements and reports that are generally intended to distinguish a product as environmentally friendly or ‘green’. They differ from organizational environmental claims in the...

78 FR 23271 - Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-18

... Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims AGENCY: Food and Drug Administration... solicits comments on the information collection associated with the guidance ``Hypertension Indication... labeling for outcome claims for drugs that are indicated to treat hypertension. DATES: Submit either...

Health claim evidence requirements in Japan.

PubMed

Yamada, Kazuhiko; Sato-Mito, Natsuko; Nagata, Junichi; Umegaki, Keizo

2008-06-01

In the early 1980s the Japanese scientific academy defined a functional food as a food having a tertiary or physiologically active function. The current Japanese "Food with Health Claims" include 2 categories. For the first category, "Food with Nutrient Function Claims," the label may be freely used if a product satisfies the standard for the minimum and maximum levels per daily portion usually consumed. The second category is defined as "Food for Specified Health Uses" (FOSHU). FOSHU foods are those that contain dietary ingredients that have beneficial effects on the physiological functions of the human body, maintain and promote health, and improve health-related conditions. Health claims on these foods correspond to the category of "other" function claims of the Codex Alimentarius. However, claims of disease-risk reduction are not currently allowed under FOSHU with an exception for calcium and folic acid. Manufacturers can emphasize the characteristics of their products and promote sales by labeling or claims. Therefore, the labeling should be clear and correct and avoid any chance of misinterpretation. The labeling of health claims on foods should always be based on scientific evidence. Any manufacturer who applies to the government for approval under the FOSHU code for its product must tabulate both published available publications and internal reports on the effectiveness of the product and/or its ingredients and provide a summary of each available publication or report. The tabulation must include in vitro metabolic and biochemical studies, in vivo studies, and randomized controlled trials on Japanese people. The overall philosophy of the Ministry is to maintain and improve the health status of people and to prevent chronic noncommunicable diseases through an approach that involves a well-balanced diet as well as through the use of "health foods" including "Food with Health Claims."

75 FR 13547 - Agency Information Collection Activities; Proposed Collection: Comment Request: Guidance for...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-22

... Entitled Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims AGENCY: Food and Drug... guidance ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims,'' which is intended to... hypertension. DATES: Submit written or electronic comments on the collection of information by May 21, 2010...

9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2014 CFR

2014-01-01

... broccoli in this meal is high in vitamin C”). (c) “Good Source” claims. (1) The terms “good source... that nutrient (excluding total carbohydrate) in § 317.309(c), may only be made on the label or in... defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product...

9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2012 CFR

2012-01-01

... broccoli in this meal is high in vitamin C”). (c) “Good Source” claims. (1) The terms “good source... that nutrient (excluding total carbohydrate) in § 381.409(c), may only be made on the label or in... defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product...

9 CFR 317.354 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2012 CFR

2012-01-01

... broccoli in this meal is high in vitamin C”). (c) “Good Source” claims. (1) The terms “good source... that nutrient (excluding total carbohydrate) in § 317.309(c), may only be made on the label or in... defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product...

9 CFR 381.454 - Nutrient content claims for “good source,” “high,” and “more.”

Code of Federal Regulations, 2014 CFR

2014-01-01

... broccoli in this meal is high in vitamin C”). (c) “Good Source” claims. (1) The terms “good source... that nutrient (excluding total carbohydrate) in § 381.409(c), may only be made on the label or in... defined in paragraph (c)(1) of this section may be used on the label or in labeling of a meal-type product...

Nutrition labelling: purpose, scientific issues and challenges.

PubMed

Van den Wijngaart, Annoek W E M

2002-01-01

Nutrition labels describe the nutrient content of a food and are intended to guide the consumer in food selection. The nutrition information provided must be selected on the basis of consistency with dietary recommendations. Selection of the specific nutrients or food components to be listed should further take into account label space, the analytical feasibility of measuring the particular nutritional component within the food matrix, and the relative costs of such analyses. Nutrition information provided on labels should be truthful and not mislead consumers. At the same time, labelling regulations should provide incentives to manufacturers to develop products that promote public health and assist consumers in following dietary recommendations. It is likely that in many countries, there would be some segments of the population that would benefit from information about the composition of foods. In these cases, countries should consider the need to provide for appropriate labelling and its presentation relative to existing guidelines and approaches. As nutrition-labelling efforts have evolved, different approaches and legal requirements have been established. These create difficulties in developing and harmonizing nutrition information listings, which have broad international applications. For these reasons, the Codex Guidelines on Nutrition Labeling play an important role to provide guidance to member countries when they want to develop or update their national regulations and to encourage harmonization of national standards with international standards. These Guidelines are based on the principle that no food should be described or presented in a manner that is false, misleading or deceptive. The Guidelines include provisions for voluntary nutrient declaration, calculation and presentation of nutrient information. The Guidelines on Claims establish general principles to be followed and leave the definition of specific claims to national regulations. Definitions are provided for a number of claims (nutrient content, comparative claims, nutrient function claims) as well as general requirements concerning consumer information in relation with claims. Nutrition labelling by itself cannot solve nutrition problems. It should be seen as one of the elements of nutrition policy and should be envisaged in the larger perspective of consumer education, which in its turn is part of an overall development policy. Exchange of information at the regional and subregional level is important, as each country can learn from the experience of others and regional co-ordination and co-operation can be developed.

Korean consumers' perceptions of health/functional food claims according to the strength of scientific evidence

PubMed Central

Kim, Ji Yeon; Kang, Eun Jin; Kwon, Oran

2010-01-01

In this study, we investigated that consumers could differentiate between levels of claims and clarify how a visual aid influences consumer understanding of the different claim levels. We interviewed 2,000 consumers in 13 shopping malls on their perception of and confidence in different levels of health claims using seven point scales. The average confidence scores given by participants were 4.17 for the probable level and 4.07 for the possible level; the score for the probable level was significantly higher than that for the possible level (P < 0.05). Scores for confidence in claims after reading labels with and without a visual aid were 5.27 and 4.43, respectively; the score for labeling with a visual aid was significantly higher than for labeling without a visual aid (P < 0.01). Our results provide compelling evidence that providing health claims with qualifying language differentiating levels of scientific evidence can help consumers understand the strength of scientific evidence behind those claims. Moreover, when a visual aid was included, consumers perceived the scientific levels more clearly and had greater confidence in their meanings than when a visual aid was not included. Although this result suggests that consumers react differently to different claim levels, it is not yet clear whether consumers understand the variations in the degree of scientific support. PMID:21103090

Naturally good: Front-of-package claims as message cues.

PubMed

Skubisz, Christine

2017-01-01

Excess bodyweight is a significant public health problem in the United States, increasing the risk of adverse health conditions including hypertension, diabetes, heart disease, stroke, and cancer. Americans are consuming more calories than their bodies need each day and making purchasing decisions using heuristic cues, rather than caloric information. A recent trend in food and beverage labeling is the placement of a natural claim on a product's package. Unfortunately, the United States has not established clear requirements for natural claims and manufacturers are using this term liberally. Using models of information processing as a framework, the goal of this study was to predict the effects of natural claims on message processing and evaluations. It was predicted that natural claims would be perceived as heuristics for healthfulness. A 6 (product) x 2 (claim) experimental design was carried out. Support for the prediction that natural labeled products are evaluated as more healthful was found. Despite the fact that natural products contained the same number of calories as their regular counterparts, participants estimated that natural products contained 18% fewer calories. Implications of these findings for food labeling and public health are discussed. Copyright © 2016 Elsevier Ltd. All rights reserved.

21 CFR 101.71 - Health claims: claims not authorized.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Health claims: claims not authorized. 101.71 Section 101.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.71 Health...

21 CFR 101.71 - Health claims: claims not authorized.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Health claims: claims not authorized. 101.71 Section 101.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.71 Health...

Scenario-Testing: Decision Rules for Evaluating Conflicting Probabilistic Claims.

ERIC Educational Resources Information Center

Dudczak, Craig A.; Baker, David

Evaluators of argument are frequently confronted by conflicting claims. While these claims are usually based on probabilities, they are often resolved with the accepted claim treated as though it were "true," while the rejected claim is treated as though it were "false." Scenario testing is the label applied to a set of…

21 CFR 101.71 - Health claims: claims not authorized.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Health claims: claims not authorized. 101.71 Section 101.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.71 Health...

Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union

PubMed Central

2014-01-01

Background Metastatic castration-resistant prostate cancer (mCRPC) and its treatment significantly affect health-related quality of life (HRQOL). Our objectives were to evaluate and compare patient-reported outcome (PRO) claims granted by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for 5 recently approved mCRPC treatments and to examine key characteristics, development, and measurement properties of the PRO measures supporting these claims against current regulatory standards. Methods Five products approved for treatment of mCRPC by the FDA and the EMA (2010–2013) were examined: enzalutamide, abiraterone, sipuleucel-T, cabazitaxel, and radium Ra 223 dichloride. United States (US) drug approval packages and European Public Assessment Reports were reviewed. PRO claims in the US labels and European Summaries of Product Characteristics and supporting measures were identified. For PRO measures supporting claims, a targeted literature review was conducted to identify information on key characteristics and measurement properties; this information was compared against FDA PRO guidance criteria. Results Nine PRO “claims” were granted across 4 of 5 products reviewed. The EMA granted more claims (7 claims—4 for pain, 3 for HRQOL) than the FDA (2 claims, both for pain). The Brief Pain Inventory–Short Form (BPI-SF) worst pain item supported most pain claims and was the only measure supporting US claims. EMA pain claims were supported by BPI-SF worst pain (n = 2) and average pain (n = 1) items and the McGill Pain Questionnaire Present Pain Intensity component (n = 1). EMA HRQOL claims were supported by the Functional Assessment of Cancer Therapy–Prostate Module (n = 2) and the EuroQol 5 Dimensions with visual analogue scale (n = 1). Pain and prostate cancer–specific HRQOL measures supporting claims met US regulatory standards for construct validity, reliability, and responsiveness; these properties were strongest for the BPI-SF worst pain item. Only the BPI-SF worst pain item has documented content validity in mCRPC. Conclusions PRO label claims were commonly granted across the mCRPC products reviewed. Among the measures reviewed, only the BPI-SF worst pain item supported US label claims. The BPI-SF worst pain item is recommended for pain assessment for the evaluation of new mCRPC treatments. PMID:24989428

78 FR 47154 - Food Labeling; Gluten-Free Labeling of Foods

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-05

...The Food and Drug Administration (FDA or we) is issuing a final rule to define the term ``gluten-free'' for voluntary use in the labeling of foods. The final rule defines the term ``gluten-free'' to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim ``no gluten,'' ``free of gluten,'' or ``without gluten'' in its labeling and fails to meet the requirements for a ``gluten-free'' claim will be deemed to be misbranded. In addition, a food whose labeling includes the term ``wheat'' in the ingredient list or in a separate ``Contains wheat'' statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim ``gluten-free'' will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a ``gluten-free'' claim. Establishing a definition of the term ``gluten-free'' and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

21 CFR 101.91 - Gluten-free labeling of food.

Code of Federal Regulations, 2014 CFR

2014-04-01

... that has not been processed to remove gluten (e.g., wheat flour); or (3) An ingredient that is derived... is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). (b) Requirements. (1) A food that... Nutrient Content Claims nor Health Claims § 101.91 Gluten-free labeling of food. (a) Definitions. (1) The...

Simvastatin prescribing patterns before and after FDA dosing restrictions: a retrospective analysis of a large healthcare claims database.

PubMed

Tuchscherer, Rhianna M; Nair, Kavita; Ghushchyan, Vahram; Saseen, Joseph J

2015-02-01

Muscle-related events, or myopathies, are a commonly reported adverse event associated with statin use. In June 2011, the US FDA released a Drug Safety Communication that provided updated product labeling with dosing restrictions for simvastatin to minimize the risk of myopathies. Our objective was to describe prescribing patterns of simvastatin in combination with medications known to increase the risk of myopathies following updated product labeling dosing restrictions in June 2011. A retrospective observational analysis was carried out, in which administrative claims data were utilized to identify prescribing patterns of simvastatin in combination with calcium channel blockers (CCBs) and other pre-specified drug therapies. Prescribing patterns were analyzed on a monthly basis 24 months prior to and 9 months following product label changes. Incidence of muscle-related events was also analyzed. In June 2011, a total of 60% of patients with overlapping simvastatin-CCB claims and 94% of patients with overlapping simvastatin-non-CCB claims were prescribed an against-label combination. As of March 2012, a total of 41% and 93% of patients continued to be prescribed against-label simvastatin-CCB and simvastatin-non-CCB combinations, respectively. The most commonly prescribed dose of simvastatin was 20 mg (39%). Against-label combinations were most commonly prescribed at a simvastatin dose of 40 mg (56%). Amlodipine was the most commonly prescribed CCB in combination with simvastatin (70%) and the most common CCB prescribed against-label (67%). Despite improvements in prescribing practices, many patients are still exposed to potentially harmful simvastatin combinations. Aggressive changes in simvastatin prescribing systems and processes are needed to improve compliance with FDA labeling to improve medication and patient safety.

16 CFR 260.11 - Ozone-safe and ozone-friendly claims.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Ozone-safe and ozone-friendly claims. 260.11... THE USE OF ENVIRONMENTAL MARKETING CLAIMS § 260.11 Ozone-safe and ozone-friendly claims. It is... friendly to, the ozone layer or the atmosphere. Example 1: A product is labeled “ozone-friendly.” The claim...

16 CFR 260.11 - Ozone-safe and ozone-friendly claims.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Ozone-safe and ozone-friendly claims. 260.11... THE USE OF ENVIRONMENTAL MARKETING CLAIMS § 260.11 Ozone-safe and ozone-friendly claims. It is... friendly to, the ozone layer or the atmosphere. Example 1: A product is labeled “ozone-friendly.” The claim...

Australian and New Zealand Fish Oil Products in 2016 Meet Label Omega-3 Claims and Are Not Oxidized.

PubMed

Nichols, Peter D; Dogan, Lalen; Sinclair, Andrew

2016-11-05

We provide new fish oil product results to assist industry in Australia and New Zealand and, ultimately, consumers in understanding the high product quality assurance protocols in place, together with the high product quality that has been determined by both industry and independent laboratories. Fish oil capsule products common to Australia and New Zealand were purchased in May 2016 in Richmond, Victoria, Australia. Products were from two groups; five standard fish oil products and five fish oil concentrates. Noting Therapeutic Goods Administration (TGA) requirement for use of standard methods, for all analyses undertaken a laboratory was selected that met the TGA criteria, including with accreditation. Total n -3 content exceeded the label-claimed content for all 10 products, with supplements containing on average 124% of the claimed content (range 115%-136%); eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) content averaged 109% of the label claim (range 99%-119%). All 10 products (100%) similarly met the international recommended peroxide value (PV) level. Anisidine value (pAV) met the international recommended level for eight of the 10 products, with two products known to contain flavorings that interfere with the pAV test. When accredited laboratories and standard protocols are used, Australian and New Zealand fish oil products have been shown to clearly meet their label claims for EPA + DHA content, and are not oxidized.

Australian and New Zealand Fish Oil Products in 2016 Meet Label Omega-3 Claims and Are Not Oxidized

PubMed Central

Nichols, Peter D.; Dogan, Lalen; Sinclair, Andrew

2016-01-01

We provide new fish oil product results to assist industry in Australia and New Zealand and, ultimately, consumers in understanding the high product quality assurance protocols in place, together with the high product quality that has been determined by both industry and independent laboratories. Fish oil capsule products common to Australia and New Zealand were purchased in May 2016 in Richmond, Victoria, Australia. Products were from two groups; five standard fish oil products and five fish oil concentrates. Noting Therapeutic Goods Administration (TGA) requirement for use of standard methods, for all analyses undertaken a laboratory was selected that met the TGA criteria, including with accreditation. Total n-3 content exceeded the label-claimed content for all 10 products, with supplements containing on average 124% of the claimed content (range 115%–136%); eicosapentaenoic acid and docosahexaenoic acid (EPA + DHA) content averaged 109% of the label claim (range 99%–119%). All 10 products (100%) similarly met the international recommended peroxide value (PV) level. Anisidine value (pAV) met the international recommended level for eight of the 10 products, with two products known to contain flavorings that interfere with the pAV test. When accredited laboratories and standard protocols are used, Australian and New Zealand fish oil products have been shown to clearly meet their label claims for EPA + DHA content, and are not oxidized. PMID:27827947

9 CFR 317.360 - Nutrient content claims for calorie content.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrient content claims for calorie content. 317.360 Section 317.360 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.360 Nutrient content claims for calorie content. (a) General requirements. A claim about the...

FDA: polyurethane condom carries "extremely misleading" label. Federal agency allows distribution for public health's sake.

PubMed

1995-02-01

The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.

7 CFR 3201.6 - Providing product information to Federal agencies.

Code of Federal Regulations, 2013 CFR

2013-01-01

... Web site will provide information as to the availability, relative price, biobased content... marketing claims. Manufacturers and vendors are reminded that their advertising, labeling, and other marketing claims, including claims regarding health and environmental benefits of the product, must conform...

Unwarranted claims of drug efficacy in pharmaceutical sales visits: are drugs approved on the basis of surrogate outcomes promoted appropriately?

PubMed

Habibi, Roojin; Lexchin, Joel; Mintzes, Barbara; Holbrook, Anne

2017-11-01

This study compares physicians' recall of the claims of benefits on cardiovascular disease and diabetes made by pharmaceutical sales representatives for drugs approved on the basis of a surrogate outcome, i.e., an off-label claim, compared with those approved on the basis of a serious morbidity or mortality (clinical) outcome. Physicians in primary care practices in Montreal, Vancouver, Sacramento and Toulouse, who saw sales representatives as part of their usual practice and served a non-referral population, were contacted in blocks of 25 from a randomized list of all physicians practising in the relevant metropolitan area. We compared how frequently physicians reported that sales reps made claims of serious morbidity or mortality (clinically meaningful) benefits for drugs approved on the basis of surrogate outcomes vs. drugs approved on the basis of clinical outcomes. There were 448 promotions for 58 unique brand name cardiovascular and diabetes drugs. Claims of clinically meaningful benefit were reported in 156 (45%) of the 347 promotions for surrogate outcome drugs, constituting unwarranted efficacy claims, i.e., off-label promotion. Claims of clinical benefit were reported in 72 of the 101 promotions (71%) for drugs approved on the basis of clinical outcomes, adjusted OR = 0.3 (95% CI 0.2, 0.6), P < 0.001. Claims of efficacy made in sales visit promotions for drugs approved only on the basis of surrogate outcomes extended beyond the regulator-approved efficacy information for the product in almost half of promotions. Unapproved claims of drug efficacy constitute a form of off-label promotion and merit greater attention from regulators. © 2017 The British Pharmacological Society.

Liability for Diagnosing Malingering.

PubMed

Weiss, Kenneth J; Van Dell, Landon

2017-09-01

Malingering is a medical diagnosis, but not a psychiatric disorder. The label imputes that an evaluee has intentionally engaged in false behavior or statements. By diagnosing malingering, psychiatrists pass judgment on truthfulness. Evaluees taking exception to the label may claim that the professional has committed defamation of character (libel or slander) when the diagnosis is wrong and costs the claimant money or benefits. Clinicians may counter by claiming immunity or that the diagnosis was made in good faith. This problem has come into focus in military and veterans' contexts, where diagnoses become thresholds for benefits. Through historical and literary examples, case law, and military/veterans' claims of disability and entitlement, the authors examine the potency of the malingering label and the potential liability for professionals and institutions of making this diagnosis. © 2017 American Academy of Psychiatry and the Law.

9 CFR 317.309 - Nutrition label content.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrition label content. 317.309... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.309 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

9 CFR 317.309 - Nutrition label content.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition label content. 317.309... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.309 Nutrition... only through a weight-control program qualify for nutrition claims. (3) The declaration of nutrient and...

9 CFR 317.309 - Nutrition label content.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition label content. 317.309... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.309 Nutrition... only through a weight-control program qualify for nutrition claims. (3) The declaration of nutrient and...

9 CFR 317.309 - Nutrition label content.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Nutrition label content. 317.309... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.309 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

21 CFR 101.82 - Health claims: Soy protein and risk of coronary heart disease (CHD).

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Health claims: Soy protein and risk of coronary... HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.82 Health claims: Soy protein and risk of coronary heart disease (CHD). (a...

21 CFR 101.65 - Implied nutrient content claims and related label statements.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., physiological, pathological, or other condition, where the claim identifies the special diet of which the food... certain amount (e.g., “high in oat bran”) are implied nutrient content claims and must comply with... the ingredient or type of preparation. If a more specific level is claimed (e.g., “high in ___), that...

21 CFR 101.65 - Implied nutrient content claims and related label statements.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., physiological, pathological, or other condition, where the claim identifies the special diet of which the food... certain amount (e.g., “high in oat bran”) are implied nutrient content claims and must comply with... the ingredient or type of preparation. If a more specific level is claimed (e.g., “high in ___), that...

21 CFR 101.65 - Implied nutrient content claims and related label statements.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., physiological, pathological, or other condition, where the claim identifies the special diet of which the food... certain amount (e.g., “high in oat bran”) are implied nutrient content claims and must comply with... the ingredient or type of preparation. If a more specific level is claimed (e.g., “high in ___), that...

21 CFR 101.13 - general principles.

Code of Federal Regulations, 2010 CFR

1996-04-01

... content claims FOOD AND DRUGS FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--CONTINUED FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions Sec. 101.13 Nutrient content claims... supplements). (b) A claim that expressly or implicitly characterizes the level of a nutrient (nutrient content...

PRN 96-4: Label Statements Involving Product Efficacy and Potential for Harm to Property

EPA Pesticide Factsheets

This notice explains EPA procedures in approving pesticide labels that include claims relating to the efficacy of agricultural pesticides and provides a warning to growers regarding reliance on label statements regarding pesticide efficacy.

16 CFR 460.21 - Government claims.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 16 Commercial Practices 1 2012-01-01 2012-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

16 CFR 460.21 - Government claims.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

16 CFR 460.21 - Government claims.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

16 CFR 460.21 - Government claims.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 16 Commercial Practices 1 2014-01-01 2014-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

16 CFR 460.21 - Government claims.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 16 Commercial Practices 1 2013-01-01 2013-01-01 false Government claims. 460.21 Section 460.21 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.21 Government claims. Do not say or imply that a government agency uses, certifies...

38 CFR 20.1500 - Rule 1500. Expedited Claims Adjudication Initiative.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Claims Adjudication Initiative. 20.1500 Section 20.1500 Pensions, Bonuses, and Veterans' Relief... Adjudication Initiative-Pilot Program § 20.1500 Rule 1500. Expedited Claims Adjudication Initiative. (a) Purpose. The Expedited Claims Adjudication Initiative is a pilot program designed to streamline the claims...

9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be... fat. (iv) A synonym for “___ percent fat free” is “___ percent lean.” (c) Fatty acid content claims...

9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be.... (iv) A synonym for “___ percent fat free” is “___ percent lean.” (c) Fatty acid content claims. (1...

Do Health Claims and Front-of-Pack Labels Lead to a Positivity Bias in Unhealthy Foods?

PubMed Central

Talati, Zenobia; Pettigrew, Simone; Dixon, Helen; Neal, Bruce; Ball, Kylie; Hughes, Clare

2016-01-01

Health claims and front-of-pack labels (FoPLs) may lead consumers to hold more positive attitudes and show a greater willingness to buy food products, regardless of their actual healthiness. A potential negative consequence of this positivity bias is the increased consumption of unhealthy foods. This study investigated whether a positivity bias would occur in unhealthy variations of four products (cookies, corn flakes, pizzas and yoghurts) that featured different health claim conditions (no claim, nutrient claim, general level health claim, and higher level health claim) and FoPL conditions (no FoPL, the Daily Intake Guide (DIG), Multiple Traffic Lights (MTL), and the Health Star Rating (HSR)). Positivity bias was assessed via measures of perceived healthiness, global evaluations (incorporating taste, quality, convenience, etc.) and willingness to buy. On the whole, health claims did not produce a positivity bias, while FoPLs did, with the DIG being the most likely to elicit this bias. The HSR most frequently led to lower ratings of unhealthy foods than the DIG and MTL, suggesting that this FoPL has the lowest risk of creating an inaccurate positivity bias in unhealthy foods. PMID:27918426

Serum potassium monitoring for users of ethinyl estradiol/drospirenone taking medications predisposing to hyperkalemia: physician compliance and survey of knowledge and attitudes.

PubMed

Mona Eng, Patricia; Seeger, John D; Loughlin, Jeanne; Oh, Kelly; Walker, Alexander M

2007-02-01

Yasmin-28 [ethinyl estradiol 0.03 mg/drospirenone 3 mg (EE/DRSP)] contains drospirenone, a progestin component that possesses antimineralocorticoid activity with a potassium-sparing diuretic effect similar to that in spironolactone. Product labeling recommends potassium monitoring in the first month of use for women concurrently receiving medication that may increase serum potassium. We evaluated compliance with this recommendation by measuring monitoring around the date of oral contraceptive (OC) initiation in women who received EE/DRSP while being treated with medications predisposing to hyperkalemia and in similar women who received other OCs. Because preliminary analyses indicated incomplete compliance, we surveyed physicians who prescribed EE/DRSP to women receiving drugs predisposing to hyperkalemia on their knowledge and attitudes with regard to the recommendation. We conducted this study using data from the Ingenix Research Datamart, which includes insurance claims for reimbursement for medical services and prescription medications for approximately 8,000,000 members of a large nationally dispersed health plan. We used claims for pharmacy dispensings of prescription medications to identify all women aged 10-59 years old who initiated EE/DRSP or other OCs during the first 3 years of EE/DRSP availability (July 2001 to June 2004). The frequency of potassium monitoring was measured by identifying claims for serum potassium tests. We conducted a telephone survey of 58 physicians who had prescribed EE/DRSP up to June 2003 to women who received concomitant hyperkalemic drugs. Although potassium monitoring was generally more frequent among EE/DRSP initiators receiving concomitant hyperkalemic drugs than among other OC initiators receiving similar medications, only 40% of 466 EE/DRSP initiators with concurrent hyperkalemic treatment had potassium tests. More than 98% of surveyed physicians were aware of the potassium-sparing property of EE/DRSP. Compared with physicians whose patients had potassium tests, physicians of patients without such tests were more likely to disagree with the recommendation for users of angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, heparin and nonsteroidal anti-inflammatory drugs. Patient barriers and health plan restrictions were other factors possibly contributing to noncompliance. This study demonstrates incomplete physician compliance with a labeling recommendation of potassium monitoring for initiators of EE/DRSP receiving concomitant therapy predisposing to hyperkalemia. The limited compliance was likely due to a combination of selective physician acceptance of the recommendations and specific patient and health plan barriers to testing.

Food label usage and reported difficulty with following a gluten-free diet among individuals in the USA with coeliac disease and those with noncoeliac gluten sensitivity.

PubMed

Verrill, L; Zhang, Y; Kane, R

2013-10-01

Individuals with coeliac disease (CD) and those with noncoeliac gluten sensitivity (GS) have reported difficulty following a gluten-free diet (GFD); however, few studies have explored the link between the food label, gluten-free (GF) claims and the difficulty associated with following a GFD. The present study surveyed adults with CD (n = 1,583) and adults with GS (n = 797) about their reported difficulty following a GFD, including assessing the role of food labels and GF claims, as well as other factors known to contribute to this difficulty. A two-sample t-test and chi-squared tests for equality of means or proportions were used for the descriptive data and ordinal logistic regression (OLR) was used to model associations. On average, individuals with GS reported slightly more difficulty following the GFD than did participants with CD. According to the OLR results, reading the food label often was significantly associated with less reported difficulty following a GFD, whereas consuming packaged processed foods and looking for GF claims more often were significantly associated with more reported difficulty for both respondent groups. Individuals with GS may rely more heavily on the GF claim for information about a product's gluten content. Individuals with CD, on the other hand, may be more experienced food label readers and may rely more on the ingredient list for finding GF foods. More studies are needed aiming to understand the role of the food label in facilitating consumers' ability to follow a GFD. Published 2013. This article is a U.S. Government work and is in the public domain in the USA.

The role of health-related claims and health-related symbols in consumer behaviour: Design and conceptual framework of the CLYMBOL project and initial results.

PubMed

Hieke, S; Kuljanic, N; Wills, J M; Pravst, I; Kaur, A; Raats, M M; van Trijp, H C M; Verbeke, W; Grunert, K G

2015-03-01

Health claims and symbols are potential aids to help consumers identify foods that are healthier options. However, little is known as to how health claims and symbols are used by consumers in real-world shopping situations, thus making the science-based formulation of new labelling policies and the evaluation of existing ones difficult. The objective of the European Union-funded project R ole of health-related   CLaims   and   sYMBOLs   in consumer behaviour (CLYMBOL) is to determine how health-related information provided through claims and symbols, in their context, can affect consumer understanding, purchase and consumption. To do this, a wide range of qualitative and quantitative consumer research methods are being used, including product sampling, sorting studies ( i.e. how consumers categorise claims and symbols according to concepts such as familiarity and relevance), cross-country surveys, eye-tracking ( i.e. what consumers look at and for how long), laboratory and in-store experiments, structured interviews, as well as analysis of population panel data. EU Member States differ with regard to their history of use and regulation of health claims and symbols prior to the harmonisation of 2006. Findings to date indicate the need for more structured and harmonised research on the effects of health claims and symbols on consumer behaviour, particularly taking into account country-wide differences and individual characteristics such as motivation and ability to process health-related information. Based on the studies within CLYMBOL, implications and recommendations for stakeholders such as policymakers will be provided.

Regulatory science requirements of labeling of genetically modified food.

PubMed

Moghissi, A Alan; Jaeger, Lisa M; Shafei, Dania; Bloom, Lindsey L

2018-05-01

This paper provides an overview of the evolution of food labeling in the USA. It briefly describes the three phases of agricultural development consisting of naturally occurring, cross-bred, and genetically engineered, edited or modified crops, otherwise known as Genetically Modified Organisms (GMO). It uses the Best Available Regulatory Science (BARS) and Metrics for Evaluation of Regulatory Science Claims (MERSC) to evaluate the scientific validity of claims applicable to GMO and the Best Available Public Information (BAPI) to evaluate the pronouncements by public media and others. Subsequently claims on health risk, ecological risk, consumer choice, and corporate greed are evaluated based on BARS/MERSC and BAPI. The paper concludes by suggesting that labeling of food containing GMO should consider the consumer's choice, such as the food used by those who desire kosher and halal food. Furthermore, the consumer choice is already met by the exclusion of GMO in organic food.

Dietary supplement labeling and advertising claims: are clinical studies on the full product required?

PubMed

Villafranco, John E; Bond, Katie

2009-01-01

Whether labeling and advertising claims for multi-ingredient dietary supplements may be based on the testing of individual, key ingredients--rather than the actual product--has caused a good deal of confusion. This confusion stems from the dearth of case law and the open-endedness of Federal Trade Commission (FTC) and Food and Drug Administration (FDA) guidance on this issue. Nevertheless, the relevant regulatory guidance, case law and self-regulatory case law--when assessed together--indicate that the law allows and even protects "key ingredient claims" (i.e., claims based on efficacy testing of key ingredients in the absence of full product testing). This article provides an overview of the relevant substantiation requirements for dietary supplement claims and then reviews FTC's and FDA's guidance on key ingredient claims; relevant case law; use of key ingredient claims in the advertising of other consumer products; and the National Advertising Division of the Better Business Bureau, Inc.'s (NAD's) approach to evaluating key ingredient claims for dietary supplements. This article concludes that key ingredient claims--provided they are presented in a truthful and non-deceptive manner--are permissible, and should be upheld in litigation and cases subject to industry self-regulation. This article further concludes that the NAD's approach to key ingredient claims provides practical guidance for crafting and substantiating dietary supplement key ingredient claims.

21 CFR 101.14 - Health claims: general requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Health claims: general requirements. 101.14 Section 101.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.14 Health claims: general...

21 CFR 101.14 - Health claims: general requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Health claims: general requirements. 101.14 Section 101.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.14 Health claims: general...

21 CFR 101.70 - Petitions for health claims.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

21 CFR 101.14 - Health claims: general requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Health claims: general requirements. 101.14 Section 101.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.14 Health claims: general...

21 CFR 101.70 - Petitions for health claims.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

21 CFR 101.70 - Petitions for health claims.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

21 CFR 101.14 - Health claims: general requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Health claims: general requirements. 101.14 Section 101.14 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.14 Health claims: general...

21 CFR 101.70 - Petitions for health claims.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

21 CFR 101.70 - Petitions for health claims.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Petitions for health claims. 101.70 Section 101.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.70 Petitions for...

Anticonvulsant use after formulary status change for brand-name second-generation anticonvulsants.

PubMed

Patel, Hemal; Toe, Diana C; Burke, Shawn; Rasu, Rafia S

2010-08-01

Anticonvulsant medications are commonly used for off-label indications. However, managed care organizations can restrict utilization of medication to indicated uses only. To evaluate the pattern of off-label use of second-generation anticonvulsants after implementing a formulary change. We did a retrospective analysis of an administrative pharmacy claims database for a managed care plan with more than 1 million members continuously enrolled during 2004-2005. The study evaluated off-label use and explored pharmacy utilization patterns (by physician specialty, region, plan type, age, sex, copayment) across the study population following the formulary change. A total of 10,185 patients had at least 1 pharmacy claim (total of 137,638 claims) for a second-generation anticonvulsant during the study period. Most members were female (68%), and 4.9% were <18 years old. A total of 3986 of 4698 patients (84.8%) and 4600 of 5487 patients (83.8%) had anticonvulsants prescribed for off-label use in 2004 and 2005, respectively (P = .162). The off-label usage pattern varied for individual anticonvulsants in 2004 and 2005 (P <.050), which may have been because of the change to nonpreferred coverage. Primary care physicians accounted for 41.3% of the prescribing of second-generation anticonvulsants for off-label uses, followed by neurologists (9.4%), psychiatrists (2.8%), and other (46.5%). The coverage change resulted in cost savings for the plan of $0.16 per member per month. The off-label usage pattern varied for individual anticonvulsants in 2004 and 2005. Future considerations for controlling off-label use may include requiring prior authorization and provider education.

Influence of Food Labels on Adolescent Diet.

ERIC Educational Resources Information Center

Misra, Ranjita

2002-01-01

Provides information on food nutrition labels and discusses the benefits of adolescents' using them to plan healthy diets. Suggests that teachers and educators should encourage appropriate label reading education for adolescents to promote healthy eating practices. Provides definitions of nutrient content claims. (SG)

Americans and Palestinians judge spontaneous facial expressions of emotion.

PubMed

Kayyal, Mary H; Russell, James A

2013-10-01

The claim that certain emotions are universally recognized from facial expressions is based primarily on the study of expressions that were posed. The current study was of spontaneous facial expressions shown by aborigines in Papua New Guinea (Ekman, 1980); 17 faces claimed to convey one (or, in the case of blends, two) basic emotions and five faces claimed to show other universal feelings. For each face, participants rated the degree to which each of the 12 predicted emotions or feelings was conveyed. The modal choice for English-speaking Americans (n = 60), English-speaking Palestinians (n = 60), and Arabic-speaking Palestinians (n = 44) was the predicted label for only 4, 5, and 4, respectively, of the 17 faces for basic emotions, and for only 2, 2, and 2, respectively, of the 5 faces for other feelings. Observers endorsed the predicted emotion or feeling moderately often (65%, 55%, and 44%), but also denied it moderately often (35%, 45%, and 56%). They also endorsed more than one (or, for blends, two) label(s) in each face-on average, 2.3, 2.3, and 1.5 of basic emotions and 2.6, 2.2, and 1.5 of other feelings. There were both similarities and differences across culture and language, but the emotional meaning of a facial expression is not well captured by the predicted label(s) or, indeed, by any single label.

Ingredient Consistency of Commercially Available Polyphenol and Tocopherol Nutraceuticals

PubMed Central

Remsberg, Connie M.; Good, Renee L.; Davies, Neal M.

2010-01-01

Label claims of vitamin E succinate and polyphenolic nutraceuticals are assessed. A validated HPLC method was utilized to assess vitamin E succinate products. Three novel LC/MS methods were used to assess the polyphenols, pterostilbene, phloretin, and myricetin, in dietary supplements. The amount of vitamin E succinate varied from 0-130% of the stated label content with two products containing vitamin E acetate rather than vitamin E succinate. Expected polyphenols were found in 7 of the 8 supplement products. None of the polyphenol supplements contained content within 100-120% of label claims. The present study indicates a lack of uniformity in nutraceutical products. PMID:27721342

Consumer attitudes and understanding of low-sodium claims on food: an analysis of healthy and hypertensive individuals.

PubMed

Wong, Christina L; Arcand, JoAnne; Mendoza, Julio; Henson, Spencer J; Qi, Ying; Lou, Wendy; L'Abbé, Mary R

2013-06-01

Sodium-related claims on food labels should facilitate lower-sodium food choices; however, consumer attitudes and understanding of such claims are unknown. We evaluated consumer attitudes and understanding of different types of sodium claims and the effect of having hypertension on responses to such claims. Canadian consumers (n = 506), with and without hypertension, completed an online survey that contained a randomized mock-package experiment, which tested 4 packages that differed only by the claims they carried as follows: 3 sodium claims (disease risk reduction, function, and nutrient-content claims) and a tastes-great claim (control). Participants answered the same questions on attitudes and understanding of claims after seeing each package. Food packages with any sodium claim resulted in more positive attitudes toward the claim and the product healthfulness than did packages with the taste control claim, although all mock packages were identical nutritionally. Having hypertension increased ratings related to product healthfulness and purchase intentions, but there was no difference in reported understanding between hypertensives and normotensives. In general, participants attributed additional health benefits to low-sodium products beyond the well-established relation of sodium and hypertension. Sodium claims have the potential to facilitate lower-sodium food choices. However, we caution that consumers do not seem to differentiate between different types of claims, but the nutritional profiles of foods that carry different sodium claims can potentially differ greatly in the current labeling environment. Additional educational efforts are needed to ensure that consumers do not attribute inappropriate health benefits to foods with low-sodium claims. This trial was registered at clinicaltrials.gov as NCT01764724.

What's in a name: the Vermont Genetically Engineered Food Labeling Act

PubMed Central

McPherson, Malia J.

2014-01-01

On May 8, 2014, Vermont passed the Vermont Genetically Engineered Food Labeling Act (Act) requiring labels on certain genetically engineered foods. Once the bill takes effect July 1, 2016, all Vermont-retailed foods with more than 0.9% of their total weight in genetically modified ingredients must be labeled with language stating, “may be partially produced with genetic engineering.” As genetically engineered food are considered scientifically equivalent to their traditional counterparts and are not subject to federal labeling by the FDA, the Act presents several legal questions. Several of the legal questions have been raised in a recent lawsuit filed by the Grocery Manufactures Association that claims the Act violates the First Amendment, Supremacy Clause, and Commerce Clause. This paper will discuss why the Second Circuit could strike down the Act as unconstitutional as to each claim. PMID:27774175

9 CFR 381.409 - Nutrition label content.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... that are available only through a weight-control program qualify for nutrition claims. (3) The...

9 CFR 381.409 - Nutrition label content.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... that are available only through a weight-control program qualify for nutrition claims. (3) The...

16 CFR 460.22 - Tax claims.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Tax claims. 460.22 Section 460.22 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.22 Tax claims. Do not say or imply that your product qualifies for a tax benefit unless it is true. ...

21 CFR 101.74 - Health claims: sodium and hypertension.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Health claims: sodium and hypertension. 101.74 Section 101.74 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.74 Health...

21 CFR 101.74 - Health claims: sodium and hypertension.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Health claims: sodium and hypertension. 101.74 Section 101.74 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Health Claims § 101.74 Health...

21 CFR 101.67 - Use of nutrient content claims for butter.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Use of nutrient content claims for butter. 101.67 Section 101.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content Claims § 101...

21 CFR 101.67 - Use of nutrient content claims for butter.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Use of nutrient content claims for butter. 101.67 Section 101.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content Claims § 101...

16 CFR 460.22 - Tax claims.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Tax claims. 460.22 Section 460.22 Commercial Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.22 Tax claims. Do not say or imply that your product qualifies for a tax benefit unless it is true. ...

21 CFR 101.67 - Use of nutrient content claims for butter.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Use of nutrient content claims for butter. 101.67 Section 101.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content Claims § 101...

21 CFR 101.67 - Use of nutrient content claims for butter.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Use of nutrient content claims for butter. 101.67 Section 101.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content Claims § 101...

9 CFR 381.409 - Nutrition label content.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

9 CFR 381.409 - Nutrition label content.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Nutrition label content. 381.409... INSPECTION AND CERTIFICATION POULTRY PRODUCTS INSPECTION REGULATIONS Nutrition Labeling § 381.409 Nutrition... program qualify for nutrition claims. (3) The declaration of nutrient and food component content shall be...

75 FR 37816 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-30

... Request; Guidance for Industry Entitled Hypertension Indication: Drug Labeling for Cardiovascular Outcome... control number 0910-new and title Guidance for Industry entitled ``Hypertension Indication: Drug Labeling... Industry entitled ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims''--21 CFR 201...

The role of health-related claims and health-related symbols in consumer behaviour: Design and conceptual framework of the CLYMBOL project and initial results

PubMed Central

Hieke, S; Kuljanic, N; Wills, J M; Pravst, I; Kaur, A; Raats, M M; van Trijp, H C M; Verbeke, W; Grunert, K G

2015-01-01

Health claims and symbols are potential aids to help consumers identify foods that are healthier options. However, little is known as to how health claims and symbols are used by consumers in real-world shopping situations, thus making the science-based formulation of new labelling policies and the evaluation of existing ones difficult. The objective of the European Union-funded project Role of health-related CLaims and sYMBOLs in consumer behaviour (CLYMBOL) is to determine how health-related information provided through claims and symbols, in their context, can affect consumer understanding, purchase and consumption. To do this, a wide range of qualitative and quantitative consumer research methods are being used, including product sampling, sorting studies (i.e. how consumers categorise claims and symbols according to concepts such as familiarity and relevance), cross-country surveys, eye-tracking (i.e. what consumers look at and for how long), laboratory and in-store experiments, structured interviews, as well as analysis of population panel data. EU Member States differ with regard to their history of use and regulation of health claims and symbols prior to the harmonisation of 2006. Findings to date indicate the need for more structured and harmonised research on the effects of health claims and symbols on consumer behaviour, particularly taking into account country-wide differences and individual characteristics such as motivation and ability to process health-related information. Based on the studies within CLYMBOL, implications and recommendations for stakeholders such as policymakers will be provided. PMID:25750587

Persistent use of against-label statin-fibrate combinations from 2003-2009 despite United States Food and Drug Administration dose restrictions.

PubMed

Alford, Julie C; Saseen, Joseph J; Allen, Richard R; Nair, Kavita V

2012-07-01

To describe the prevalence of prescribing against-label statin-fibrate combination therapy. Retrospective cohort study. Medstat MarketScan Commercial Claims and Encounter database. Adults (aged 18-89 yrs) who were prescribed statin-fibrate combination therapy between January 1, 2003, and June 30, 2009, had pharmacy claims demonstrating two or more concurrently filled prescriptions for a statin and a fibrate, and had continuous insurance enrollment for at least 12 months. Claims data were used to identify patients with dyslipidemia based on International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis codes. National Drug Codes were used to describe concurrent statin-fibrate combination therapy. The primary outcome was recent use of against-label statin-fibrate combination therapy, defined as use during the last 18 months (January 1, 2008-June 30, 2009) of the study period. Patients were stratified according to statin and dosage to identify against-label combination use (e.g., simvastatin > 10 mg/day with gemfibrozil). Within the recent-use period, 131,394 patients were prescribed concurrent statin-fibrate combination therapy; of these patients, 13,420 (10.2%) had against-label therapy. Simvastatin-gemfibrozil accounted for 8978 (66.9%) of all against-label combinations. Of all 9877 simvastatin-gemfibrozil combinations prescribed in the recent-use period (both on-label and against-label use), 8978 (90.9%) were against label. The secondary outcome was prevalence of against-label statin-fibrate combination therapy on an annual basis: 15.5% in 2003, 18.7% in 2004, 9.1% in 2005, 8.3% in 2006, 9.2% in 2007, and 9.8% in 2008. Against-label statin-fibrate combination therapy continues to be prescribed despite established United States Food and Drug Administration (FDA) dose restrictions. Nearly every time the simvastatin-gemfibrozil combination was prescribed, it was against label because simvastatin exceeded the maximum dose restriction. Updated simvastatin labeling in June 2011 includes additional maximum dose restrictions and new contraindications, which include gemfibrozil. Different approaches in clinical practice are needed to ensure adherence with the revised FDA labeling. © 2012 Pharmacotherapy Publications, Inc. All rights reserved.

Oncology patient-reported claims: maximising the chance for success.

PubMed

Kitchen, H; Rofail, D; Caron, M; Emery, M-P

2011-01-01

To review Patient Reported Outcome (PRO) labelling claims achieved in oncology in Europe and in the United States and consider the benefits, and challenges faced. PROLabels database was searched to identify oncology products with PRO labelling approved in Europe since 1995 or in the United States since 1998. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) websites and guidance documents were reviewed. PUBMED was searched for articles on PRO claims in oncology. Among all oncology products approved, 22 were identified with PRO claims; 10 in the United States, 7 in Europe, and 5 in both. The language used in the labelling was limited to benefit (e.g. "…resulted in symptom benefits by significantly prolonging time to deterioration in cough, dyspnoea, and pain, versus placebo") and equivalence (e.g. "no statistical differences were observed between treatment groups for global QoL"). Seven products used a validated HRQoL tool; two used symptom tools; two used both; seven used single-item symptom measures (one was unknown). The following emerged as likely reasons for success: ensuring systematic PRO data collection; clear rationale for pre-specified endpoints; adequately powered trials to detect differences and clinically significant changes; adjusting for multiplicity; developing an a priori statistical analysis plan including primary and subgroup analyses, dealing with missing data, pooling multiple-site data; establishing clinical versus statistical significance; interpreting failure to detect change. End-stage patient drop-out rates and cessation of trials due to exceptional therapeutic benefit pose significant challenges to demonstrating treatment PRO improvement. PRO labelling claims demonstrate treatment impact and the trade-off between efficacy and side effects ultimately facilitating product differentiation. Reliable and valid instruments specific to the desired language, claim, and target population are required. Practical considerations include rationale for study endpoints, transparency in assumptions, and attention to subtle variations in data.

Oncology patient-reported claims: maximising the chance for success

PubMed Central

Kitchen, H; Rofail, D; Caron, M; Emery, M-P

2011-01-01

Objectives/purpose: To review Patient Reported Outcome (PRO) labelling claims achieved in oncology in Europe and in the United States and consider the benefits, and challenges faced. Methods: PROLabels database was searched to identify oncology products with PRO labelling approved in Europe since 1995 or in the United States since 1998. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) websites and guidance documents were reviewed. PUBMED was searched for articles on PRO claims in oncology. Results: Among all oncology products approved, 22 were identified with PRO claims; 10 in the United States, 7 in Europe, and 5 in both. The language used in the labelling was limited to benefit (e.g. “…resulted in symptom benefits by significantly prolonging time to deterioration in cough, dyspnoea, and pain, versus placebo”) and equivalence (e.g. “no statistical differences were observed between treatment groups for global QoL”). Seven products used a validated HRQoL tool; two used symptom tools; two used both; seven used single-item symptom measures (one was unknown). The following emerged as likely reasons for success: ensuring systematic PRO data collection; clear rationale for pre-specified endpoints; adequately powered trials to detect differences and clinically significant changes; adjusting for multiplicity; developing an a priori statistical analysis plan including primary and subgroup analyses, dealing with missing data, pooling multiple-site data; establishing clinical versus statistical significance; interpreting failure to detect change. End-stage patient drop-out rates and cessation of trials due to exceptional therapeutic benefit pose significant challenges to demonstrating treatment PRO improvement. Conclusions: PRO labelling claims demonstrate treatment impact and the trade-off between efficacy and side effects ultimately facilitating product differentiation. Reliable and valid instruments specific to the desired language, claim, and target population are required. Practical considerations include rationale for study endpoints, transparency in assumptions, and attention to subtle variations in data. PMID:22276055

Focus on Food Labeling. An FDA Consumer Special Report.

ERIC Educational Resources Information Center

Food and Drug Administration (DHHS/PHS), Washington, DC.

This special issue is designed for those who want to know all they can about the new federal requirements for nutrition information on food labels. Nine articles are included. "Good Reading for Good Eating" (Paula Kurtzweil) addresses mandatory nutrition labeling, the nutrition panel, nutrient content and health claims, and ingredient…

9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2013 CFR

2013-01-01

... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be...

9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2013 CFR

2013-01-01

... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be...

9 CFR 381.462 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2014 CFR

2014-01-01

... acids, and cholesterol content. 381.462 Section 381.462 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 381.462 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be...

9 CFR 317.362 - Nutrient content claims for fat, fatty acids, and cholesterol content.

Code of Federal Regulations, 2014 CFR

2014-01-01

... acids, and cholesterol content. 317.362 Section 317.362 Animals and Animal Products FOOD SAFETY AND... Nutrition Labeling § 317.362 Nutrient content claims for fat, fatty acids, and cholesterol content. (a) General requirements. A claim about the level of fat, fatty acid, and cholesterol in a product may only be...

9 CFR 317.380 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2010 CFR

2010-01-01

... other comparative claims. A product purporting to be “reduced calorie” or otherwise containing fewer... bears another comparative calorie claim in compliance with the applicable provisions in this subpart. (2...

9 CFR 317.380 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2014 CFR

2014-01-01

... other comparative claims. A product purporting to be “reduced calorie” or otherwise containing fewer... bears another comparative calorie claim in compliance with the applicable provisions in this subpart. (2...

Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier.

PubMed

Revicki, Dennis A; Gnanasakthy, Ari; Weinfurt, Kevin

2007-05-01

The Food and Drug Administration (FDA) and European Medicines Agency (EMEA) are willing to consider including information on patient reported outcomes (PROs) in product labeling and advertising. Pharmaceutical industry researchers must provide sufficient evidence supporting PRO benefit before an approval may be granted. This report describes the purpose and content of a PRO Evidence Dossier, which consists of important information supporting PRO claims. The dossier should be completed by pharmaceutical industry or other researchers to document the planning of the PRO assessment strategy, psychometric evidence, desired target labeling statements, and the clinical trial evidence of PRO benefits. The systematic reporting and documentation of information on the rationale for including PROs, rationale for the selection of specific PRO instruments, evidence on the psychometric qualities of the PRO measures, and guidelines for interpreting PRO findings will facilitate achieving a PRO labeling or promotional claim. Combining all the relevant information into a single document will facilitate the review and evaluation process for clinical and regulatory reviewers. The PRO Evidence Dossier may also be helpful to industry and academic researchers in identifying further information that will need to be developed to support the clinical development program and the PRO endpoints.

Are foods with fat-related claims useful for weight management?

PubMed

Schermel, Alyssa; Wong, Christina L; L'Abbé, Mary R

2016-01-01

Many consumers believe that foods labelled with fat claims (e.g. low fat) are lower in calories than comparable regular foods and are therefore helpful for weight management. However, it is unknown whether such foods are actually lower in calories. Our aims were to determine 1) the relative proportion of foods carrying fat claims among various food categories within the Canadian marketplace; and 2) whether foods with fat claims are actually lower in calories than comparable foods without claims. The Food Label Information Program 2010, a database of Canadian foods developed at the University of Toronto, was used to compare the calorie content of products with and without fat claims within a given food subcategory, as defined by Schedule M of the Food and Drug Regulations. Median differences of 25% or greater were deemed nutritionally significant, as that is the minimum difference required for comparative claims such as "reduced" and "lower" in the Food and Drug Regulations. Fat claims were present on up to 68% of products in a given food subcategory. Products with fat claims were not significantly lower in both fat and calories compared to comparable products without fat claims in more than half of the subcategories (24 out of 40) analyzed. Conversely, in 16 subcategories, foods with fat claims were at least 25% lower in calories; however, for many of these foods, the absolute difference in calories was small, i.e., for 9 of the 16 subcategories, the absolute difference between foods with and without fat claims was <50 calories, even though the relative percent difference was high. This research suggests that foods with fat claims may be misleading consumers and undermining their efforts to manage body weight or prevent obesity. Copyright © 2015 Elsevier Ltd. All rights reserved.

The ban on "off-label" pharmaceutical promotion: constitutionally permissible prophylaxis against false or misleading commercial speech?

PubMed

Greenwood, Kate

2011-01-01

Critics of the Food & Drug Administration's ban on off-label promotion often claim that it violates the First Amendment because it suppresses pharmaceutical manufacturers' truthful speech about their legal--and beneficial--products. Characterizing the ban on off-label promotion in this way has more than rhetorical significance. Bans on truthful, non-misleading speech elicit special skepticism because of the belief that they "usually rest solely on the offensive assumption that the public will respond 'irrationally' to the truth." The legislative history of the provisions of the Food Drug and Cosmetic Act that underlie the ban on off-label promotion, however, reveals that Congress was concerned that physicians were responding rationally to false and misleading promotional claims. In this Article, I explore the doctrinal questions raised by conceiving of the ban on off-label promotion not as a ban on "truthful speech to physicians" but instead as a prophylaxis against false and misleading pharmaceutical promotion. I review the evidence that false and misleading claims were commonplace before the ban's adoption and persist today, along with the enforcement challenges the FDA confronted at that time and would confront were the ban lifted, and conclude the government likely could develop the factual record necessary to establish that Congress' rejection of an after-the-fact case-by-case approach to combating false and misleading prescription drug promotion is constitutional.

Toddler drinks, formulas, and milks: Labeling practices and policy implications.

PubMed

Pomeranz, Jennifer L; Romo Palafox, Maria J; Harris, Jennifer L

2018-04-01

Toddler drinks are a growing category of drinks marketed for young children 9-36 months old. Medical experts do not recommend them, and public health experts raise concerns about misleading labeling practices. In the U.S., the toddler drink category includes two types of products: transition formulas, marketed for infants and toddlers 9-24 months; and toddler milks, for children 12-36 months old. The objective of this study was to evaluate toddler drink labeling practices in light of U.S. food labeling policy and international labeling recommendations. In January 2017, we conducted legal research on U.S. food label laws and regulations; collected and evaluated toddler drink packages, including nutrition labels and claims; and compared toddler drink labels with the same brand's infant formula labels. We found that the U.S. has a regulatory structure for food labels and distinct policies for infant formula, but no laws specific to toddler drinks. Toddler drink labels utilized various terms and images to identify products and intended users; made multiple health and nutrition claims; and some stated there was scientific or expert support for the product. Compared to the same manufacturer's infant formula labels, most toddler drink labels utilized similar colors, branding, logos, and graphics. Toddler drink labels may confuse consumers about their nutrition and health benefits and the appropriateness of these products for young children. To support healthy toddler diets and well-informed decision-making by caregivers, the FDA can provide guidance or propose regulations clarifying permissible toddler drink labels and manufacturers should end inappropriate labeling practices. Copyright © 2018 Elsevier Inc. All rights reserved.

16 CFR 460.20 - R-value per inch claims.

Code of Federal Regulations, 2014 CFR

2014-01-01

... HOME INSULATION § 460.20 R-value per inch claims. In labels, fact sheets, ads, or other promotional... here, you can petition to amend the order. (b) You can do this if actual test results prove that the R...

16 CFR 460.20 - R-value per inch claims.

Code of Federal Regulations, 2012 CFR

2012-01-01

... HOME INSULATION § 460.20 R-value per inch claims. In labels, fact sheets, ads, or other promotional... here, you can petition to amend the order. (b) You can do this if actual test results prove that the R...

16 CFR 460.20 - R-value per inch claims.

Code of Federal Regulations, 2013 CFR

2013-01-01

... HOME INSULATION § 460.20 R-value per inch claims. In labels, fact sheets, ads, or other promotional... here, you can petition to amend the order. (b) You can do this if actual test results prove that the R...

16 CFR 460.20 - R-value per inch claims.

Code of Federal Regulations, 2011 CFR

2011-01-01

... HOME INSULATION § 460.20 R-value per inch claims. In labels, fact sheets, ads, or other promotional... here, you can petition to amend the order. (b) You can do this if actual test results prove that the R...

27 CFR 13.1 - Scope of part.

Code of Federal Regulations, 2014 CFR

2014-04-01

... OF THE TREASURY ALCOHOL LABELING PROCEEDINGS Scope and Construction of Regulations § 13.1 Scope of... process in this part does not apply to organic claims on alcohol beverage labels. See § 13.101. [T.D. ATF...

27 CFR 13.1 - Scope of part.

Code of Federal Regulations, 2012 CFR

2012-04-01

... OF THE TREASURY LIQUORS LABELING PROCEEDINGS Scope and Construction of Regulations § 13.1 Scope of... process in this part does not apply to organic claims on alcohol beverage labels. See § 13.101. [T.D. ATF...

27 CFR 13.1 - Scope of part.

Code of Federal Regulations, 2011 CFR

2011-04-01

... OF THE TREASURY LIQUORS LABELING PROCEEDINGS Scope and Construction of Regulations § 13.1 Scope of... process in this part does not apply to organic claims on alcohol beverage labels. See § 13.101. [T.D. ATF...

Banning front-of-package food labels: first Amendment constraints on public health policy.

PubMed

Lytton, Timothy D

2011-06-01

In recent months, the FDA has begun a crackdown on misleading nutrition and health claims on the front of food packages by issuing warning letters to manufacturers and promising to develop stricter regulatory standards. Leading nutrition policy experts Marion Nestle and David Ludwig have called for an even tougher approach: a ban on all nutrition and health claims on the front of food packages. Nestle and Ludwig argue that most of these claims are scientifically unsound and misleading to consumers and that eliminating them would 'aid educational efforts to encourage the public to eat whole or minimally processed foods and to read the ingredients list on processed foods'. Nestle and Ludwig are right to raise concerns about consumer protection and public health when it comes to front-of-package food labels, but an outright ban on front-of-package nutrition and health claims would violate the First Amendment. As nutrition policy experts develop efforts to regulate front-of-package nutrition and health claims, they should be mindful of First Amendment constraints on government regulation of commercial speech.

Labeling of trans fatty acid content in food, regulations and limits-the FDA view.

PubMed

Moss, Julie

2006-05-01

With the scientific evidence associating trans fatty acid (TFA) intake with an increased risk of coronary heart disease (CHD), the U.S. Food and Drug Administration (FDA) issued a final rule that requires the declaration of the amount of TFA present in foods, including dietary supplements, on the nutrition label by January 1, 2006. The addition of TFA to the nutrition label will lead to the prevention of 600 to 1200 cases of CHD and 240-480 deaths each year saving Dollars 900 million to Dollars 1.8 billion per year in medical costs, lost productivity, and pain and suffering. For the purpose of nutrition labeling, TFA are defined as the sum of all unsaturated fatty acids that contain one or more isolated (i.e. non-conjugated) double bonds in a trans configuration. There are many issues that FDA has yet to resolve: (1) defining nutrient content claims for "free" and "reduced" levels of trans fat, (2) placing limits on the amount of TFA in conjunction with saturated fat limits for nutrient content claims, health claims, and disclosure and disqualifying levels, (3) a daily value, and (4) a possible footnote or disclosure statement to enhance consumer understanding of cholesterol raising lipids. FDA issued an Advanced Notice of Proposed Rulemaking (ANPR) requesting comments on the unresolved issues. FDA will also be conducting consumer research to determine consumer understanding of various TFA labeling possibilities. Comments to the ANPR, results of consumer research and current science will be used by FDA to resolve these issues and to determine future rulemaking for TFA labeling.

21 CFR 105.66 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) “Reduced calorie” foods and other comparative calorie claims. A food purporting to be “reduced calorie” or... comparative calorie claim in compliance with part 101 of this chapter and this section. (2) Paragraph (e)(1...

21 CFR 105.66 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) “Reduced calorie” foods and other comparative calorie claims. A food purporting to be “reduced calorie” or... comparative calorie claim in compliance with part 101 of this chapter and this section. (2) Paragraph (e)(1...

21 CFR 101.10 - Nutrition labeling of restaurant foods.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Nutrition labeling of restaurant foods. 101.10... restaurant foods. Nutrition labeling in accordance with § 101.9 shall be provided upon request for any restaurant food or meal for which a nutrient content claim (as defined in § 101.13 or in subpart D of this...

Determinants of escalating costs in low risk workers' compensation claims.

PubMed

Bernacki, Edward J; Yuspeh, Larry; Tao, Xuguang

2007-07-01

To identify and quantify attributes that lead to unanticipated cost escalation in workers' compensation claims. We constructed four claim categories: low initial reserve/low cost, migrated catastrophic (low initial reserve/high cost), high initial reserve/low cost, and catastrophic (high initial reserve/high cost). To assess the attributes associated with the increased cost of migrated catastrophic claims, we analyzed 36,329 Louisiana workers' compensation claims in the four categories over a 5-year period. In the 729 claims initially thought to be low-cost claims (migrated catastrophic), the most significant predictors for cost escalation were attorney involvement and claim duration, followed by low back disorder, married/single/divorced status, male gender, small company size, high premium, reporting delays, and older age. These injuries accounted for 2% of all claims but 32.3% of the costs. Accelerated escalation of costs occurred late in the claim cycle (2 years). Certain attributes, particularly attorney involvement and claim duration, are associated with unanticipated cost escalation in a small number of claims that drastically affect overall losses. The results of this study suggest that these cases may be identified and addressed before rapid escalation occurs.

16 CFR 260.2 - Scope of guides.

Code of Federal Regulations, 2010 CFR

2010-01-01

... through any other means, including marketing through digital or electronic means, such as the Internet or... ENVIRONMENTAL MARKETING CLAIMS § 260.2 Scope of guides. (a) These guides apply to environmental claims included in labeling, advertising, promotional materials and all other forms of marketing, whether asserted...

16 CFR 260.2 - Scope of guides.

Code of Federal Regulations, 2011 CFR

2011-01-01

... through any other means, including marketing through digital or electronic means, such as the Internet or... ENVIRONMENTAL MARKETING CLAIMS § 260.2 Scope of guides. (a) These guides apply to environmental claims included in labeling, advertising, promotional materials and all other forms of marketing, whether asserted...

Is dentistry a profession? Part 1. Professionalism defined.

PubMed

Welie, Jos V M

2004-09-01

Individual dentists and organized dentistry alike invariably claim to be (members of) a profession. This label is cherished because it suggests special social, moral and political status. However, almost every self-respecting occupation nowadays claims to be a profession. Hence, the question arises as to what exactly is meant when dentists claim to be professionals and, more important, whether they can justifiably lay claim to this label. Rather than reviewing the manifold and divergent discussions in the literature about professionalism, the author proposes--in this first of 3 consecutive articles--a definition of the term "profession" that is based on the literal origins of the word. Next, it is argued that a profession arises out of a social contract between the public and a service occupation that professes to give priority to the existential needs of the people served. In the second article, the author deduces several professional responsibilities. The third and final article examines whether and to what extent dentistry fulfills these responsibilities and outlines some future challenges.

Effectiveness of Bed Bug Pesticides

EPA Pesticide Factsheets

Before EPA allows a bed bug claim on a label, the product must be supported by data showing it will kill bed bugs when applied according to the label. Also consider factors such as extent of infestation, site preparation, and insect life stages.

Health claims in the labelling and marketing of food products:

PubMed Central

Asp, Nils-Georg; Bryngelsson, Susanne

2007-01-01

Since 1990 certain health claims in the labelling and marketing of food products have been allowed in Sweden within the food sector's Code of Practice. The rules were developed in close dialogue with the authorities. The legal basis was a decision by the authorities not to apply the medicinal products’ legislation to “foods normally found on the dinner table” provided the rules defined in the Code were followed. The Code of Practice lists nine well-established diet–health relationships eligible for generic disease risk reduction claims in two steps and general rules regarding nutrient function claims. Since 2001, there has also been the possibility for using “product-specific physiological claims (PFP)”, subject to premarketing evaluation of the scientific dossier supporting the claim. The scientific documentation has been approved for 10 products with PFP, and another 15 products have been found to fulfil the Code's criteria for “low glycaemic index”. In the third edition of the Code, active since 2004, conditions in terms of nutritional composition were set, i.e. “nutrient profiles”, with a general reference to the Swedish National Food Administration's regulation on the use of a particular symbol, i.e. the keyhole symbol. Applying the Swedish Code of practice has provided experience useful in the implementation of the European Regulation on nutrition and health claims made on foods, effective from 2007.

38 CFR 3.161 - Expedited Claims Adjudication Initiative-Pilot Program.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Adjudication Initiative-Pilot Program. 3.161 Section 3.161 Pensions, Bonuses, and Veterans' Relief DEPARTMENT... Claims § 3.161 Expedited Claims Adjudication Initiative—Pilot Program. Rules pertaining to the Expedited Claims Adjudication Initiative Pilot Program are set forth in part 20, subpart P, of this chapter...

Effects of Categorical Labels on Similarity Judgments: A Critical Evaluation of a Critical Analysis--Comment on Noles and Gelman (2012)

ERIC Educational Resources Information Center

Sloutsky, Vladimir M.; Fisher, Anna V.

2012-01-01

Noles and Gelman (2012) attempt to critically reevaluate the claim that linguistic labels affect children's judgments of visual similarity. They report results of an experiment that used a modified version of Sloutsky and Fisher's (2004) task and conclude that "labels do not generally affect children's perceptual similarity judgments; rather,…

Effects of Categorical Labels on Similarity Judgments: A Critical Analysis of Similarity-Based Approaches

ERIC Educational Resources Information Center

Noles, Nicholaus S.; Gelman, Susan A.

2012-01-01

Our goal in the present study was to evaluate the claim that category labels affect children's judgments of visual similarity. We presented preschool children with discriminable and identical sets of animal pictures and asked them to make perceptual judgments in the presence or absence of labels. Our findings indicate that children who are asked…

Homosexuality and scientific evidence: On suspect anecdotes, antiquated data, and broad generalizations.

PubMed

Kinney, Robert L

2015-11-01

The American Psychiatric Association and the American Psychological Association have suggested for many years now that there is significant empirical evidence supporting the claim that homosexuality is a normal variant of human sexual orientation as opposed to a mental disorder. This paper summarizes and analyzes that purported scientific evidence and explains that much (if not all) of the evidence is irrelevant and does not support the homosexuality-is-not-a-mental-disorder claim. As a result of their deficiencies and arbitrariness, the credibility those two groups that are typically deemed authoritative and trustworthy is called into question. Lay summary: At one time, homosexuality was considered to be mentally disordered. Since the 1970s, however, major medical associations in the U.S. have labeled homosexuality as a normal counterpart of heterosexuality. Those medical associations have proposed that their homosexuality-is-normal claim is based on "scientific evidence." This article critically reviews that "scientific evidence" and finds that much of their literature does not support the claim that homosexuality is normal. This article suggests that instead of supporting their claim with scientific evidence, those major medical associations arbitrarily label homosexuality as normal.

The impact of Wyeth v. Levine on FDA regulation of prescription drugs.

PubMed

Ausness, Richard C

2010-01-01

In Wyeth v. Levine, decided in March, 2009, the United States Supreme Court concluded that the plaintiff's failure to warn claim against the makers of the drug Phenergan was not impliedly preempted by the Food, Drug and Cosmetic Act. In doing so, the Court rejected the argument of the U.S. Food and Drug Administration (FDA) that tort claims of this nature stand as an obstacle to federal regulatory objectives. This Article evaluates the Court's opinion in Wyeth and examines that decision's impact on subsequent litigation in the area of prescription drug labeling. The Article first discusses the preemption doctrine and its application to state law tort claims against product manufacturers. It then reviews the history of implied preemption of tort claims against manufacturers of FDA-approved prescription drugs prior to Wyeth and then discusses the Wyeth decisions in the Vermont Supreme Court and the United States Supreme Court. Finally, the Article evaluates some of the prescription drug preemption cases that have been decided in the lower federal courts since Wyeth and suggests that these courts are now reluctant to preempt failure to warn claims unless a manufacturer affirmatively seeks permission from FDA to change a drug's labeling.

Homosexuality and scientific evidence: On suspect anecdotes, antiquated data, and broad generalizations

PubMed Central

Kinney, Robert L.

2015-01-01

The American Psychiatric Association and the American Psychological Association have suggested for many years now that there is significant empirical evidence supporting the claim that homosexuality is a normal variant of human sexual orientation as opposed to a mental disorder. This paper summarizes and analyzes that purported scientific evidence and explains that much (if not all) of the evidence is irrelevant and does not support the homosexuality-is-not-a-mental-disorder claim. As a result of their deficiencies and arbitrariness, the credibility those two groups that are typically deemed authoritative and trustworthy is called into question. Lay summary: At one time, homosexuality was considered to be mentally disordered. Since the 1970s, however, major medical associations in the U.S. have labeled homosexuality as a normal counterpart of heterosexuality. Those medical associations have proposed that their homosexuality-is-normal claim is based on “scientific evidence.” This article critically reviews that “scientific evidence” and finds that much of their literature does not support the claim that homosexuality is normal. This article suggests that instead of supporting their claim with scientific evidence, those major medical associations arbitrarily label homosexuality as normal. PMID:26997677

The role of nutrition labels and advertising claims in altering consumers' evaluation and choice.

PubMed

Bialkova, Svetlana; Sasse, Lena; Fenko, Anna

2016-01-01

Despite policy efforts, consumers' well-informed healthful choice is a challenge. Due to increasing number of benefit claims advertising taste or health front of pack (FOP), consumers face the dilemma to trade taste for health. To understand the mechanisms underlying food evaluation, this study investigates the health-pleasure trade-off and its effect on consumers' choice. 240 EU consumers took part in a taste experiment, after being presented with the product FOP. Half of the products carried a nutrition label FOP, respectively, reduced fat for potato chips, reduced sugar for cereal bars. Further, one third of the products carried health benefit claim, one third taste benefit claim, and one third no additional claim FOP. Attention to information and its effect on experienced taste, health perception and the buying intention were measured. The results show that the message displayed FOP altered consumers evaluation and choice. The effectiveness of the FOP message further depended on consumers' health motivation and the healthfulness perception of carrier products. The outcomes are summarized in a framework of health-pleasure trade-off. Current findings call for the establishment of standards to avoid the use of misleading information FOP. Copyright © 2015 Elsevier Ltd. All rights reserved.

76 FR 49707 - Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease; Reopening of the...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-11

...; (8) allow for the use of the health claim on phytosterol ester-containing dietary supplements (esterified with food- grade fatty acids) but not on nonesterified phytosterol-containing dietary supplements... regarding the cholesterol- lowering efficacy of nonesterified phytosterols in dietary supplements. FDA did...

9 CFR 381.480 - Label statements relating to usefulness in reducing or maintaining body weight.

Code of Federal Regulations, 2014 CFR

2014-01-01

... criteria set forth for such foods in § 381.460. (d) “Reduced calorie” foods and other comparative claims. A... misleading, and the product is labeled “low calorie” or “reduced calorie” or bears another comparative...

78 FR 76841 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-19

...; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims AGENCY... announcing that a collection of information entitled ``Guidance for Industry on Hypertension Indication: Drug... information entitled ``Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular...

Interpretive front-of-pack nutrition labels. Comparing competing recommendations.

PubMed

Maubach, Ninya; Hoek, Janet; Mather, Damien

2014-11-01

Many stakeholders support introducing an interpretive front-of-pack (FOP) nutrition label, but disagree over the form it should take. In late 2012, an expert working group established by the New Zealand government recommended the adoption of an untested summary rating system: a Star label. This study used a best-worst scaling choice experiment to estimate how labels featuring the new Star rating, the Multiple Traffic Light (MTL), Daily Intake Guide (DIG), and a no-FOP control affected consumers' choice behaviours and product perceptions. Nutrient-content and health claims were included in the design. We also assessed whether respondents who used more or less information during the choice tasks differed in their selection patterns. Overall, while respondents made broadly similar choices with respect to the MTL and Star labels, the MTL format had a significantly greater impact on depressing preference as a food's nutritional profile became less healthy. Health claims increased rankings of less nutritious options, though this effect was less pronounced when the products featured an MTL. Further, respondents were best able to differentiate products' healthiness with MTL labels. The proposed summary Stars system had less effect on choice patterns than an MTL label and our findings highlight the need for policy makers to ensure that decisions to introduce FOP labels are underpinned by robust research evidence. These results suggest that the proposed summary Stars system will have less effect on shifting food choice patterns than interpretive FOP nutrition label featuring traffic light ratings. Copyright © 2014 Elsevier Ltd. All rights reserved.

Children and adolescents' attitudes towards sugar reduction in dairy products.

PubMed

Yoo, Hye-Jong; Machín, Leandro; Arrúa, Alejandra; Antúnez, Lucía; Vidal, Leticia; Giménez, Ana; Curutchet, María Rosa; Ares, Gastón

2017-04-01

The development of strategies to reduce sugar intake of children and adolescents has been deemed necessary to cope with the global obesity epidemic. In this context, the aims of the present work were to study attitudes towards sugar reduction in three dairy products of children and adolescents of two income levels and to assess if these attitudes were modulated by the inclusion of the traffic light system on labels. A total of 646 children and adolescents from three primary/secondary schools in Montevideo (Uruguay) participated in the study. A total of twelve labels were designed following a full factorial design with three variables: dairy product (3 levels: yogurt, chocolate-flavoured milk and vanilla milk dessert), sugar reduction claim (2 levels: absent and present "20% less sugar") and traffic light system (2 levels: absent and present). Children had to evaluate their expected liking of the labels and to answer a check-all-that-apply question composed of terms related to tastiness, healthfulness and fun. Sugar claim significantly increased children and adolescents' expected liking scores (p=0.01), suggesting they had a positive attitude towards sugar reduction in the evaluated dairy products. However, the influence of sugar reduction claim on hedonic expectations and healthfulness perception was modulated by the inclusion of the traffic-light system on labels (p=0.01). This front-of-pack nutrition labelling scheme increased their unhealthfulness perception of products with high sugar content and could potentially discourage their consumption. Age and income modulated the influence of these strategies on hedonic and healthfulness perception (p<0.05). Copyright © 2017 Elsevier Ltd. All rights reserved.

Content Analysis of Trends in Print Magazine Tobacco Advertisements.

PubMed

Banerjee, Smita; Shuk, Elyse; Greene, Kathryn; Ostroff, Jamie

2015-07-01

To provide a descriptive and comparative content analysis of tobacco print magazine ads, with a focus on rhetorical and persuasive themes. Print tobacco ads for cigarettes, cigars, e-cigarettes, moist snuff, and snus (N = 171) were content analyzed for the physical composition/ad format (e.g., size of ad, image, setting, branding, warning label) and the content of the ad (e.g., rhetorical themes, persuasive themes). The theme of pathos (that elicits an emotional response) was most frequently utilized for cigarette (61%), cigar (50%), and moist snuff (50%) ads, and the theme of logos (use of logic or facts to support position) was most frequently used for e-cigarette (85%) ads. Additionally, comparative claims were most frequently used for snus (e.g., "spit-free," "smoke-free") and e-cigarette ads (e.g., "no tobacco smoke, only vapor," "no odor, no ash"). Comparative claims were also used in cigarette ads, primarily to highlight availability in different flavors (e.g., "bold," "menthol"). This study has implications for tobacco product marketing regulation, particularly around limiting tobacco advertising in publications with a large youth readership and prohibiting false or misleading labels, labeling, and advertising for tobacco products, such as modified risk (unless approved by the FDA) or therapeutic claims.

The impact of implementation of the Canadian regulatory requirements on the quality of natural health products: the glucosamine case.

PubMed

Aghazadeh-Habashi, Ali; Duke, John; Jamali, Fakhreddin

2014-01-01

We investigated whether the recent implementation of the regulatory requirements for the entry to the Canadian market of natural products has resulted in improved quality of the available glucosamine products. Eleven available products, of which 8 had been tested in 2002 (7 had contained substantially lower than the label claim of the active ingredient), and a European pharmaceutical grade tablet were assayed for their glucosamine content. The potassium and sodium contents of the products were also tested. Nine of the 11 Canadian products and the European tablet had more than 91% of the label claim of the active ingredient, hence, met the criterion. Two products contained 71 and 78% label claim. The electrolyte contents were very variable but constituted only a small fraction of the daily requirements. Most tested glucosamine products passed the Health Canada requirements. This improvement is likely due to the publicity regarding the low quality of the products in the past and also a result, at least in part, of the introduction of the new regulatory requirements. The sub-standard quality of a few tested products is still of concern.

16 CFR 260.9 - Free-of claims.

Code of Federal Regulations, 2014 CFR

2014-01-01

... intentionally to the product. Example 1: A package of t-shirts is labeled “Shirts made with a chlorine-free bleaching process.” The shirts, however, are bleached with a process that releases a reduced, but still... substantiated claim, however, that the shirts were “bleached with a process that releases 50% less of the...

16 CFR 260.9 - Free-of claims.

Code of Federal Regulations, 2013 CFR

2013-01-01

... intentionally to the product. Example 1: A package of t-shirts is labeled “Shirts made with a chlorine-free bleaching process.” The shirts, however, are bleached with a process that releases a reduced, but still... substantiated claim, however, that the shirts were “bleached with a process that releases 50% less of the...

10 CFR 782.5 - Contents of communication initiating claim.

Code of Federal Regulations, 2012 CFR

2012-01-01

... patents or other right to make the claim. (10) If it is available to claimant, a copy of the Patent Office... 782.5 Energy DEPARTMENT OF ENERGY CLAIMS FOR PATENT AND COPYRIGHT INFRINGEMENT Requirements and Procedures § 782.5 Contents of communication initiating claim. (a) Requirements for claim. A patent or...

10 CFR 782.5 - Contents of communication initiating claim.

Code of Federal Regulations, 2014 CFR

2014-01-01

... patents or other right to make the claim. (10) If it is available to claimant, a copy of the Patent Office... 782.5 Energy DEPARTMENT OF ENERGY CLAIMS FOR PATENT AND COPYRIGHT INFRINGEMENT Requirements and Procedures § 782.5 Contents of communication initiating claim. (a) Requirements for claim. A patent or...

10 CFR 782.5 - Contents of communication initiating claim.

Code of Federal Regulations, 2013 CFR

2013-01-01

... patents or other right to make the claim. (10) If it is available to claimant, a copy of the Patent Office... 782.5 Energy DEPARTMENT OF ENERGY CLAIMS FOR PATENT AND COPYRIGHT INFRINGEMENT Requirements and Procedures § 782.5 Contents of communication initiating claim. (a) Requirements for claim. A patent or...

21 CFR 101.56 - Nutrient content claims for “light” or “lite.”

Code of Federal Regulations, 2013 CFR

2013-04-01

...) Quantitative information comparing the level of calories and fat content in the product per labeled serving... information panel, the quantitative information may be located elsewhere on the information panel in... sauce); and (B) Quantitative information comparing the level of sodium per labeled serving size with...

21 CFR 101.56 - Nutrient content claims for “light” or “lite.”

Code of Federal Regulations, 2011 CFR

2011-04-01

...) Quantitative information comparing the level of calories and fat content in the product per labeled serving... information panel, the quantitative information may be located elsewhere on the information panel in... sauce); and (B) Quantitative information comparing the level of sodium per labeled serving size with...

21 CFR 101.56 - Nutrient content claims for “light” or “lite.”

Code of Federal Regulations, 2014 CFR

2014-04-01

...) Quantitative information comparing the level of calories and fat content in the product per labeled serving... information panel, the quantitative information may be located elsewhere on the information panel in... sauce); and (B) Quantitative information comparing the level of sodium per labeled serving size with...

21 CFR 101.56 - Nutrient content claims for “light” or “lite.”

Code of Federal Regulations, 2012 CFR

2012-04-01

...) Quantitative information comparing the level of calories and fat content in the product per labeled serving... information panel, the quantitative information may be located elsewhere on the information panel in... sauce); and (B) Quantitative information comparing the level of sodium per labeled serving size with...

21 CFR 101.56 - Nutrient content claims for “light” or “lite.”

Code of Federal Regulations, 2010 CFR

2010-04-01

...) Quantitative information comparing the level of calories and fat content in the product per labeled serving... information panel, the quantitative information may be located elsewhere on the information panel in... sauce); and (B) Quantitative information comparing the level of sodium per labeled serving size with...

9 CFR 317.363 - Nutrient content claims for “healthy.”

Code of Federal Regulations, 2013 CFR

2013-01-01

... more than 60 milligrams (mg) of cholesterol per reference amount customarily consumed, per labeled... than 12 ounces (oz) per serving (container), shall not contain more than 90 mg of cholesterol per labeled serving size; and (ii) Single-ingredient, raw products may meet the cholesterol criterion for...

9 CFR 317.363 - Nutrient content claims for “healthy.”

Code of Federal Regulations, 2012 CFR

2012-01-01

... more than 60 milligrams (mg) of cholesterol per reference amount customarily consumed, per labeled... than 12 ounces (oz) per serving (container), shall not contain more than 90 mg of cholesterol per labeled serving size; and (ii) Single-ingredient, raw products may meet the cholesterol criterion for...

9 CFR 317.363 - Nutrient content claims for “healthy.”

Code of Federal Regulations, 2014 CFR

2014-01-01

... more than 60 milligrams (mg) of cholesterol per reference amount customarily consumed, per labeled... than 12 ounces (oz) per serving (container), shall not contain more than 90 mg of cholesterol per labeled serving size; and (ii) Single-ingredient, raw products may meet the cholesterol criterion for...

21 CFR 201.128 - Meaning of “intended uses”.

Code of Federal Regulations, 2010 CFR

2010-04-01

... the distribution of the article. This objective intent may, for example, be shown by labeling claims....128 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED..., and 201.122 refer to the objective intent of the persons legally responsible for the labeling of drugs...

Vitamin-Fortified Snack Food May Lead Consumers to Make Poor Dietary Decisions.

PubMed

Verrill, Linda; Wood, Dallas; Cates, Sheryl; Lando, Amy; Zhang, Yuanting

2017-03-01

The US Food and Drug Administration's (FDA's) fortification policy discourages the fortification of certain foods, including sugars and snack foods such as cookies, candies, cakes, chips, and carbonated beverages, yet manufacturers sometimes add vitamins and minerals to snack foods. To assess whether vitamin-fortified snack foods affect consumers' information-seeking, purchase decisions, and product-related health perceptions. For this experimental study, participants were randomly assigned to study conditions to compare products that varied in product type, nutrition profile, and fortification and nutrient claim status. Data were collected via an online consumer panel. US adults aged 18 years and older were randomly selected from Research Now's e-panel online household panel. Data were collected during fall 2014 (N=5,076). Participants were randomly assigned to one of 24 conditions: two products (vegetable chip/potato chip), two nutrition profiles (healthier/less healthy), two fortification scenarios (not fortified/fortified), and three nutrient claim conditions (two no claim/one with claim). The design was not balanced; claims were not shown on products that were not vitamin fortified. Outcome measures were information-seeking (viewed the Nutrition Facts label), purchase decisions, perception of product healthfulness, and correct selection of product with the healthier nutrient profile. Logistic regression was used to test all models. Analyses was adjusted for general label use, consumes product, health status, age, sex, level of education, presence of children in the household, and race/ethnicity. When the snack food carried a nutrient claim for vitamin fortification, participants were 1) less likely to look for nutrition information on the Nutrition Facts label, 2) more likely to select the product for purchase, 3) more likely to perceive the product as healthier, and 4) less likely to correctly choose the healthier product. Snack foods that have been vitamin-fortified may cause consumers to make poor dietary decisions. Copyright © 2017 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

The effect of extrinsic attributes on liking of cottage cheese.

PubMed

Hubbard, E M; Jervis, S M; Drake, M A

2016-01-01

Preference mapping studies with cottage cheese have demonstrated that cottage cheese liking is influenced by flavor, texture, curd size, and dressing content. However, extrinsic factors such as package, label claims, and brand name may also influence liking and have not been studied. The objective of this study was to evaluate the role of package attributes and brand on the liking of cottage cheese. A conjoint survey with Kano analysis (n=460) was conducted to explore the effect of extrinsic attributes (brand, label claim, milkfat content, and price) on liking. Following the survey, 150 consumers evaluated intrinsic attributes of 7 cottage cheeses with and without brand information in a 2-d crossover design. Results were evaluated by 2-way ANOVA and multivariate analyses. Milkfat content and price had the highest influence on liking by conjoint analysis. Cottage cheese with 2% milkfat and a low price was preferred. Specific label claims such as "excellent source of calcium (>10%)" were more attractive to consumers than "low sodium" or "extra creamy." Branding influenced overall liking and purchase intent for cottage cheeses to differing degrees. For national brands, acceptance scores were enhanced in the presence of the brand. An all-natural claim was more appealing than organic by conjoint analysis and this result was also confirmed with consumer acceptance testing. Findings from this study can help manufacturers, as well as food marketers, better target their products and brands with attributes that drive consumer choice. Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

21 CFR 101.65 - Implied nutrient content claims and related label statements.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., physiological, pathological, or other condition, where the claim identifies the special diet of which the food... that is useful in creating a diet that is consistent with dietary recommendations if: (i) The food... must contain... (A) A raw fruit or vegetable Low fat as defined in § 101.62(b)(2) Low saturated fat as...

PRN 94-7: Label Improvement Program for the Revision of Use Directions for Commensal Rodenticides and Statement of the Agency's Policies on the Use of Rodenticide Bait Stations

EPA Pesticide Factsheets

This Notice requires registrants of certain pesticide products claimed to control commensal rodents and registered under FIFRA to revise the labeling of such products to bear certain statements concerning tamper-resistant bait stations.

76 FR 52862 - Time for Payment of Certain Excise Taxes, and Quarterly Excise Tax Payments for Small Alcohol...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-24

... 40 Cigars and cigarettes, Claims, Electronic fund transfers, Excise taxes, Labeling, Packaging and... that are not required to pay taxes through electronic funds transfer (EFT), this first payment period..., Electronic funds transfers, Excise taxes, Exports, Food additives, Fruit juices, Labeling, Liquors, Packaging...

9 CFR 381.463 - Nutrient content claims for “healthy.”

Code of Federal Regulations, 2013 CFR

2013-01-01

... milligrams (mg) of cholesterol per reference amount customarily consumed, per labeled serving size, and, only... ounces (oz) per serving (container), shall not contain more than 90 mg of cholesterol per labeled serving size; and (ii) Single-ingredient, raw products may meet the cholesterol criterion for “extra lean” in...

9 CFR 381.463 - Nutrient content claims for “healthy.”

Code of Federal Regulations, 2012 CFR

2012-01-01

... milligrams (mg) of cholesterol per reference amount customarily consumed, per labeled serving size, and, only... ounces (oz) per serving (container), shall not contain more than 90 mg of cholesterol per labeled serving size; and (ii) Single-ingredient, raw products may meet the cholesterol criterion for “extra lean” in...

9 CFR 381.463 - Nutrient content claims for “healthy.”

Code of Federal Regulations, 2014 CFR

2014-01-01

... milligrams (mg) of cholesterol per reference amount customarily consumed, per labeled serving size, and, only... ounces (oz) per serving (container), shall not contain more than 90 mg of cholesterol per labeled serving size; and (ii) Single-ingredient, raw products may meet the cholesterol criterion for “extra lean” in...

21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

Code of Federal Regulations, 2010 CFR

2010-04-01

... an exhaustive review of labeling claims made for drugs marketed under new-drug and antibiotic drug... classification in lieu of the Academy's classification. (d) For new drugs and antibiotics, supplements to provide... purchaser or prescriber is not misled by being left unaware through the sponsor's silence that a basic...

Repeat workers' compensation claims: risk factors, costs and work disability

PubMed Central

2011-01-01

Background The objective of our study was to describe factors associated with repeat workers' compensation claims and to compare the work disability arising in workers with single and multiple compensation claims. Methods All initial injury claims lodged by persons of working age during a five year period (1996 to 2000) and any repeat claims were extracted from workers' compensation administrative data in the state of Victoria, Australia. Groups of workers with single and multiple claims were identified. Descriptive analysis of claims by affliction, bodily location, industry segment, occupation, employer and workplace was undertaken. Survival analysis determined the impact of these variables on the time between the claims. The economic impact and duration of work incapacity associated with initial and repeat claims was compared between groups. Results 37% of persons with an initial claim lodged a second claim. This group contained a significantly greater proportion of males, were younger and more likely to be employed in manual occupations and high-risk industries than those with single claims. 78% of repeat claims were for a second injury. Duration between the claims was shortest when the working conditions had not changed. The initial claims of repeat claimants resulted in significantly (p < 0.001) lower costs and work disability than the repeat claims. Conclusions A substantial proportion of injured workers experience a second occupational injury or disease. These workers pose a greater economic burden than those with single claims, and also experience a substantially greater cumulative period of work disability. There is potential to reduce the social, health and economic burden of workplace injury by enacting prevention programs targeted at these workers. PMID:21696637

Comorbidity ascertainment from the ESRD Medical Evidence Report and Medicare claims around dialysis initiation: a comparison using US Renal Data System data.

PubMed

Krishnan, Mahesh; Weinhandl, Eric D; Jackson, Scott; Gilbertson, David T; Lacson, Eduardo

2015-11-01

The end-stage renal disease Medical Evidence Report serves as a source of comorbid condition data for risk adjustment of quality metrics. We sought to compare comorbid condition data in the Medical Evidence Report around dialysis therapy initiation with diagnosis codes in Medicare claims. Observational cohort study using US Renal Data System data. Medicare-enrolled elderly (≥66 years) patients who initiated maintenance dialysis therapy July 1 to December 31, 2007, 2008, or 2009. 12 comorbid conditions ascertained from claims during the 6 months before dialysis therapy initiation, the Medical Evidence Report, and claims during the 3 months after dialysis therapy initiation. None. Comorbid condition prevalence according to claims before dialysis therapy initiation generally exceeded prevalence according to the Medical Evidence Report. The κ statistics for comorbid condition designations other than diabetes ranged from 0.06 to 0.43. Discordance of designations was associated with age, race, sex, and end-stage renal disease Network. During 23,930 patient-years of follow-up from 4 to 12 months after dialysis therapy initiation (8,930 deaths), designations from claims during the 3 months after initiation better discriminated risk of death than designations from the Medical Evidence Report (C statistics of 0.674 vs 0.616). Between the Medical Evidence Report and claims, standardized mortality ratios changed by >10% for more than half the dialysis facilities. Neither the Medical Evidence Report nor diagnosis codes in claims constitute a gold standard of comorbid condition data; results may not apply to nonelderly patients or patients without Medicare coverage. Discordance of comorbid condition designations from the Medical Evidence Report and claims around dialysis therapy initiation was substantial and significantly associated with patient characteristics, including location. These patterns may engender bias in risk-adjusted quality metrics. In lieu of the Medical Evidence Report, claims during the 3 months after dialysis therapy initiation may constitute a useful source of comorbid condition data. Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

The Effect of Energy Labelling on Menus and a Social Marketing Campaign on Food-Purchasing Behaviours of University Students.

PubMed

Roy, Rajshri; Beattie-Bowers, Jack; Ang, Siew Min; Colagiuri, Stephen; Allman-Farinelli, Margaret

2016-08-05

This study assessed the impact of kilojoule (kJ) labelling alone or accompanied by a social marketing campaign on food sales and selection of less energy-dense meals by young adults from a university food outlet. There were two kJ labelling intervention phases each of five weeks: (1) kJ labelling alone (2) kJ labels with marketing materials ("8700 kJ campaign"). Food sales of labelled items were tracked during each intervention and five weeks after. Food sales during interventions were also compared with historical sales of foods in the same 10-week period in the previous year. A sub sample of young adults (n = 713; aged 19-24) were surveyed during both the interventions to assess awareness, influence, sentiment and anticipated future impact of kJ labels and the social marketing campaign respectively. There were no differences in sales between the kJ labelling with social marketing and the 5-weeks of labelling before and after. The percentage sale of chicken Caesar burger (3580 kJ, P = 0.01), steak and chips (4000 kJ, P = 0.02) and the grill burger (5500 kJ, P = 0.00) were lower in the year with menu labelling and social marketing campaign. Only 30 % students were initially aware of the kJ labels on the menu but 75 % of students were accepting of kJ labelling, after they were made aware. Respondents viewing the marketing campaign elements and then using kJ values on the menu selected meals with a lower mean energy content; constituting a reduction of 978 kJ (p < 0.01) even though the majority claimed that the 8700 kJ campaign would not impact their food choices. Point-of-purchase energy labelling may be an effective method to encourage better food choices when eating out among young adults. However, further efforts to increase awareness and provide education about energy requirements to prevent weight gain will be needed.

20 CFR 416.922 - When you have two or more unrelated impairments-initial claims.

Code of Federal Regulations, 2010 CFR

2010-04-01

... impairments-initial claims. 416.922 Section 416.922 Employees' Benefits SOCIAL SECURITY ADMINISTRATION... of Disability § 416.922 When you have two or more unrelated impairments—initial claims. (a) Unrelated severe impairments. We cannot combine two or more unrelated severe impairments to meet the 12-month...

The motivational and informational basis of attitudes toward foods with health claims.

PubMed

Žeželj, Iris; Milošević, Jasna; Stojanović, Žaklina; Ognjanov, Galjina

2012-12-01

This research explored the effects of food choice motives, nutritional knowledge, and the use of food labels, on attitude toward food with health claims. Food with health claims was chosen as a relatively novel category of products designed to be beneficial for health. We identified eight motives served by food in general, and tested if they serve as motivations to positively evaluate functional food. Questionnaire was administered on nationally representative samples of 3085 respondents from six Western Balkan countries. We proposed two structural models relating an extensive list of eight and, alternatively, restricted list of three food-choice motives (health, mood and sensory appeal) to attitude toward functional food. We also expected the indirect association between the health motive and attitude, through nutritional knowledge and use of food labels. The results revealed highly positive, although undifferentiated attitude toward functional food, with no significant differences between the countries. The restricted model provided a better fit then the exhaustive model; the health motive was proven to have indirect influence on attitude through knowledge and label use. The implications of these findings for functional approach to attitudes, understanding the demand for functional food and overcoming barriers to dietary change are discussed. Copyright © 2012 Elsevier Ltd. All rights reserved.

Content Analysis of Trends in Print Magazine Tobacco Advertisements

PubMed Central

Banerjee, Smita; Shuk, Elyse; Greene, Kathryn; Ostroff, Jamie

2015-01-01

Objectives To provide a descriptive and comparative content analysis of tobacco print magazine ads, with a focus on rhetorical and persuasive themes. Methods Print tobacco ads for cigarettes, cigars, e-cigarettes, moist snuff, and snus (N = 171) were content analyzed for the physical composition/ad format (e.g., size of ad, image, setting, branding, warning label) and the content of the ad (e.g., rhetorical themes, persuasive themes). Results The theme of pathos (that elicits an emotional response) was most frequently utilized for cigarette (61%), cigar (50%), and moist snuff (50%) ads, and the theme of logos (use of logic or facts to support position) was most frequently used for e-cigarette (85%) ads. Additionally, comparative claims were most frequently used for snus (e.g., “spit-free,” “smoke-free”) and e-cigarette ads (e.g., “no tobacco smoke, only vapor,” “no odor, no ash”). Comparative claims were also used in cigarette ads, primarily to highlight availability in different flavors (e.g., “bold,” “menthol”). Conclusions This study has implications for tobacco product marketing regulation, particularly around limiting tobacco advertising in publications with a large youth readership and prohibiting false or misleading labels, labeling, and advertising for tobacco products, such as modified risk (unless approved by the FDA) or therapeutic claims. PMID:26236763

32 CFR 1633.2 - Claim for other than Class 1-A.

Code of Federal Regulations, 2011 CFR

2011-07-01

... initial determination of claims for all administrative classifications are made by area office compensated... local board to consider the claim. (e) The initial determination of a judgmental classification is made... ADMINISTRATION OF CLASSIFICATION § 1633.2 Claim for other than Class 1-A. (a) Any registrant who has received an...

Characterization of Breakfast Cereals Available in the Mexican Market: Sodium and Sugar Content.

PubMed

Nieto, Claudia; Rincon-Gallardo Patiño, Sofia; Tolentino-Mayo, Lizbeth; Carriedo, Angela; Barquera, Simón

2017-08-16

Preschool Mexican children consume 7% of their total energy intake from processed breakfast cereals. This study characterized the nutritional quality and labelling (claims and Guideline Daily Amount (GDA)) of the packaged breakfast cereals available in the Mexican market. Photographs of all breakfast cereals available in the 9 main food retail chains in the country were taken. The nutrition quality of cereals was assessed using the United Kingdom Nutrient Profiling Model (UKNPM). Claims were classified using the International Network for Food and Obesity/non-communicable Diseases Research, Monitoring and Action Support (INFORMAS) taxonomy and the GDA was defined according to the Mexican regulation, NOM-051. Overall, a total of 371 different breakfast cereals were analysed. The nutritional profile showed that 68.7% were classified as "less healthy". GDAs and claims were displayed more frequently on the "less healthy" cereals. Breakfast cereals within the "less healthy" category had significantly higher content of energy, sugar and sodium ( p < 0.001). Most of the claims were displayed in the "less healthy" cereals ( n = 313). This study has shown that there is a lack of consistency between the labelling on the front of the pack and the nutritional quality of breakfast cereals.

The Basis of Structure/Function Claims of Nutraceuticals.

PubMed

Borchers, Andrea T; Keen, Carl L; Gershwin, M Eric

2016-12-01

In the United States, as in most of the world, there are large numbers of nutraceuticals that are sold and which people take to boost their immune response. There are, in addition, almost an equal number of products sold to reduce allergies. However, very few consumers, and indeed physicians, are aware of what a structure/function claim is. Structure/function claims are labeling claims that can be used to describe the potential effects of a dietary ingredient or similar substance on the structure or function of the human body. This category of claims was created by legislation contained in the Dietary Supplement Health and Education Act. The intent was to supply consumers with reasonably substantiated information that would allow them to make educated choices about their diet and health. They were not intended to have the same weight and substantiation as the claims made for conventional prescription pharmaceuticals. Rather, they were proposed to fill the gap between consumer desire for over-the-counter supplements and foods, and rigorous and generally more potent and potentially "toxic" prescription medications. The legally mandated disclaimer, stating that the U.S. Food and Drug Administration has not evaluated the structure/function claim, often leads to misinterpretation. While there should be a biologic premise underlying the claim, there is not an absolute requirement for a conventional rigorous placebo-controlled dose response trial. While this may not be the clinical standard that a typical scientific oriented society might desire, it reflects the attempts of the FDA to find common grounds and to allow consumers to use products that are generally considered as safe based on historical use and biologic comparisons. The logic of, indeed need for, structure/function claims is straightforward; however, of equal importance is that nutraceuticals should be properly labeled, have accuracy in their ingredients, be free of contamination, be safe, and have a reasonable body of data that supports their efficacy.

Sunscreen sun protection factor claim based on in vivo interlaboratory variability.

PubMed

Miksa, S; Lutz, D; Guy, C; Delamour, E

2016-12-01

The SPF (sun protection factor) is the best known reference in the world for expressing UVB protection. The SPF is used for labelling purposes for consumer guidance. The determination of the SPF is often accomplished using an in vivo method that has been standardized. Only one in vivo SPF value from one laboratory is required for claiming an SPF value. The aim of this study was to determine the relevance of the in vivo SPF value in terms of interlaboratory variability for claiming purposes and to determine whether some minimum number of different in vivo SPF values from different laboratories would improve the reliability of the final SPF claimed. A large population of 44 different commercially available sunscreen formulations from the European market has been investigated, covering various product types. The majority of the SPF values claimed ranged from 15 to 50+. For each product, at least three different in vivo SPF values tested in different laboratories have been gathered, and a variety of statistical analyses have been performed. For each SPF category from the average of all samples, the minimum and maximum in vivo-measured SPF values from the different laboratories would lead to labels claiming different levels of SPF for the same product. Indeed, with coefficients of variation for in vivo SPF determinations that exceed 50% in some cases, as an example, the same product could in reality be claimed to be SPF 30, SPF 50 or SPF 50+. In this study, the authors demonstrated that using only one in vivo SPF value from one laboratory may actually challenge the reliability of the final SPF claim significantly. To reduce the consumer health risk by ensuring the reliability of the SPF claim, an average from at least 3 (ideally 4) different in vivo SPF values should be compulsory. © 2016 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

US Dietary Supplement Labeling Rules and the Possibility of Medical Cost Reduction.

PubMed

Amagase, Harunobu

2015-01-01

US dietary supplements classified as foods are regulated under the Dietary Supplement Health and Education Act (DSHEA) and other rules. After the DSHEA established in 1994, the supplement market grew by about 4 times and reached $32 billion as of 2012. One of the major reasons for this market expansion is that consumers can recognize functions of the supplements by the structure/function (S/F) claims. S/F claims must not be false or misleading, and must be based upon reliable scientific evidence, especially clinical studies. At the same time, disclaimers must be shown on the package, which are "These statements have not been evaluated by the Food and Drug Administration (FDA). These products are not intended to diagnose, treat, cure or prevent any disease." Both the FDA and Federal Trade Commission (FTC) are responsible for label claims and advertisement of dietary supplements. S/F claims are not medical claims, but these may have impact on people's mindset to be healthier. Recent research shows utilizing dietary supplements in 4 major areas with 10 popular ingredients could hypothetically reduce medical costs by over $50 billion in the US in the period of 2013-2020. Predicted fewer health problems and reduced medical cost information will further increase awareness of supplement usage and thus may raise quality of life. These may reduce the medical cost significantly, if the products are used appropriately with sufficient consumer education.

Nutritional quality of packaged foods targeted at children in Brazil: which ones should be eligible to bear nutrient claims?

PubMed

Rodrigues, V M; Rayner, M; Fernandes, A C; de Oliveira, R C; Proença, R P C; Fiates, G M R

2017-01-01

This study aimed to assess the nutritional quality of food products marketed at children, with and without nutrient claims, using two different approaches. Analyses were performed based on a data set with food composition and labelling data from every packaged food marketed at children sold in a major Brazilian supermarket (n=535). Foods were classified as 'healthier' and 'less healthy' according to the UK/Ofcom nutrient profile model and to the NOVA classification based on the level of food processing. Pearson's χ 2 test was used to compare proportions between models. Agreement was assessed using Cohen's κ-statistic (P<0.05). The NOVA model was stricter than the UK/Ofcom model, classifying more products as 'less healthy' (91.4%) compared with the nutrient profile-based model (75.0%; P<0.001). Agreement between models was 79.4% (k=0.30), because 72.9% (n=390) of products were categorised as 'less healthy' by both models, and 6.5% (n=35) as 'healthier'. Half of the food products marketed at children from the database (270; 50.5%) bore nutrient claims. From these products with nutrient claims, 95.9% (92.8-98.0) were classified as 'less healthy' by the NOVA model, whereas this percentage was 74.1% (68.4-79.2) according to the UK/Ofcom model (P<0.05). The high number of foods with low nutritional quality being marketed at children via product packaging and nutrient claims should be of concern to policy makers wanting to improve children's diets and to tackle childhood obesity. The implementation of nutritional quality criteria to ensure that foods targeted at children should be eligible to bear nutrient claims on their labels could avoid a situation where claims mask the overall nutritional status of a food.

Development of functional agricultural products utilizing the new health claim labeling system in Japan.

PubMed

Maeda-Yamamoto, Mari; Ohtani, Toshio

2018-04-01

In April 2015, Consumer Affairs Agency of Japan launched a new food labeling system known as "Foods with Function Claims (FFC)." Under this system, the food industry independently evaluates scientific evidence on foods and describes their functional properties. As of May 23, 2017, 1023 FFC containing 8 fresh foods have been launched. Meanwhile, to clarify the health-promoting effects of agricultural products, National Agriculture and Food Research Organization (NARO) implemented the "Research Project on Development of Agricultural Products" and demonstrated the risk reduction of osteoporosis of β-cryptoxanthin rich Satsuma mandarins and the anti-allergic effect of the O-methylated catechin rich tea cultivar Benifuuki. These foods were subsequently released as FFC. Moreover, NARO elucidated the health-promoting effects of various functional agricultural products (β-glucan rich barley, β-conglycinin rich soybean, quercetin rich onion, etc.) and a healthy boxed lunch. This review focuses on new food labeling system or research examining functional aspects of agricultural products.

Enhancing antimicrobial stewardship by strengthening the veterinary drug regulatory framework

PubMed Central

Mehrotra, M; Li, X-Z; Ireland, MJ

2017-01-01

Antimicrobial resistance is a major and growing public health threat. Recently, Health Canada introduced multiple regulatory changes to strengthen the oversight of antimicrobial drugs for veterinary use. These changes aim specifically at increasing control over importation of veterinary drugs and active pharmaceutical ingredients, mandatory reporting of antimicrobial sales data from manufacturers, importers and compounders and facilitating access to low risk veterinary health products. Additional policy changes under existing authorities are also being made to enhance veterinary supervision of antimicrobial use and to remove production claims for food animals from labels of medically important antimicrobial drugs. These important interlinked initiatives are aimed towards enhancing antimicrobial stewardship in Canada to preserve the effectiveness of existing antimicrobials and to protect the health of Canadians. PMID:29770050

Stability of Commercially Available Macular Carotenoid Supplements in Oil and Powder Formulations

PubMed Central

Phelan, David

2017-01-01

We previously identified that the concentration of zeaxanthin in some commercially available carotenoid supplements did not agree with the product’s label claim. The conclusion of this previous work was that more quality assurance was needed to guarantee concordance between actual and declared concentrations of these nutrients i.e., lutein (L) zeaxanthin (Z) and meso-zeaxanthin (MZ) in commercially available supplements. Since this publication, we performed further analyses using different commercially available macular carotenoid supplements. Three capsules from one batch of eight products were analysed at two different time points. The results have been alarming. All of the powder filled products (n = 3) analysed failed to comply with their label claim (L: 19–74%; Z: 57–73%; MZ: 83–97%); however, the oil filled soft gel products (n = 5) met or were above their label claim (L: 98–122%; Z: 117–162%; MZ: 97–319%). We also identified that the carotenoid content of the oil filled capsules were stable over time (e.g., L average percentage change: −1.7%), but the powder filled supplements degraded over time (e.g., L average percentage change: −17.2%). These data are consistent with our previous work, and emphasize the importance of using carotenoid interventions in oil based formulas rather than powder filled formulas. PMID:29039801

38 CFR 20.1501 - Rule 1501. Definitions.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) BOARD OF VETERANS' APPEALS: RULES OF PRACTICE Expedited Claims Adjudication Initiative-Pilot...: (a) Initiative means the Expedited Claims Adjudication Initiative as promulgated by this subpart. (b) Participant means any eligible claimant who elects to participate in the Initiative by executing, with his or...

Declaration of nutrition information on and nutritional quality of Thai ready-to-eat packaged food products.

PubMed

Pongutta, Suladda; Chongwatpol, Pitipa; Tantayapirak, Parwin; Vandevijvere, Stefanie

2018-06-01

The present study assessed the nutrition information displayed on ready-to-eat packaged foods and the nutritional quality of those food products in Thailand. In March 2015, the nutrition information panels and nutrition and health claims on ready-to-eat packaged foods were collected from the biggest store of each of the twelve major retailers, using protocols developed by the International Network for Food and Obesity/Non-communicable Diseases Research, Monitoring and Action Support (INFORMAS). The Thai Nutrient Profile Model was used to classify food products according to their nutritional quality as 'healthier' or 'less healthy'. In total, information from 7205 food products was collected across five broad food categories. Out of those products, 5707 (79·2 %), 2536 (35·2 %) and 1487 (20·6 %) carried a nutrition facts panel, a Guideline Daily Amount (GDA) label and health-related claims, respectively. Only 4691 (65·1 %) and 2484 (34·5 %) of the products that displayed the nutrition facts or a GDA label, respectively, followed the guidelines of the Thai Food and Drug Administration. In total, 4689 products (65·1 %) could be classified according to the Thai Nutrient Profile Model, of which 432 products (9·2 %) were classified as healthier. Moreover, among the 1487 products carrying health-related claims, 1219 (82·0 %) were classified as less healthy. Allowing less healthy food products to carry claims could mislead consumers and result in overconsumption of ready-to-eat food products. The findings suggest effective policies should be implemented to increase the relative availability of healthier ready-to-eat packaged foods, as well as to improve the provision of nutrition information on labels in Thailand.

Are Front of Pack Claims Indicators of Nutrition Quality? Evidence from 2 Product Categories.

PubMed

Schaefer, Debra; Hooker, Neal H; Stanton, John L

2016-01-01

American grocery shoppers face an array of front of pack (FOP) nutrition and health claims when making food selections. Such systems have been categorized as summary or nutrient specific. Either type should help consumers make judgments about the nutrition quality of a product. This research tests if the type or quantity of FOP claims are indeed good indicators of objective nutrition quality. Claim and nutrition information from more than 2200 breakfast cereals and prepared meals launched between 2006 and 2010 were analyzed using binary and multinomial logistic regression models. Results suggest that no type or number of front of pack claims could distinguish "healthy" foods. However, some types and frequencies of FOP claims were significant predictors of higher or lower levels of certain key nutrients. Given the complex and crowded label environment in which these FOP claims reside, one may be concerned that such cues are not closely related to objective measures of nutrition quality. © 2015 Institute of Food Technologists®

Characterization of Breakfast Cereals Available in the Mexican Market: Sodium and Sugar Content

PubMed Central

Rincon-Gallardo Patiño, Sofia; Tolentino-Mayo, Lizbeth; Carriedo, Angela

2017-01-01

Preschool Mexican children consume 7% of their total energy intake from processed breakfast cereals. This study characterized the nutritional quality and labelling (claims and Guideline Daily Amount (GDA)) of the packaged breakfast cereals available in the Mexican market. Photographs of all breakfast cereals available in the 9 main food retail chains in the country were taken. The nutrition quality of cereals was assessed using the United Kingdom Nutrient Profiling Model (UKNPM). Claims were classified using the International Network for Food and Obesity/non-communicable Diseases Research, Monitoring and Action Support (INFORMAS) taxonomy and the GDA was defined according to the Mexican regulation, NOM-051. Overall, a total of 371 different breakfast cereals were analysed. The nutritional profile showed that 68.7% were classified as “less healthy”. GDAs and claims were displayed more frequently on the “less healthy” cereals. Breakfast cereals within the “less healthy” category had significantly higher content of energy, sugar and sodium (p < 0.001). Most of the claims were displayed in the “less healthy” cereals (n = 313). This study has shown that there is a lack of consistency between the labelling on the front of the pack and the nutritional quality of breakfast cereals. PMID:28813010

Nutrition marketing on processed food packages in Canada: 2010 Food Label Information Program.

PubMed

Schermel, Alyssa; Emrich, Teri E; Arcand, JoAnne; Wong, Christina L; L'Abbé, Mary R

2013-06-01

The current study describes the frequency of use of different forms of nutrition marketing in Canada and the nutrients and conditions that are the focus of nutrition marketing messages. Prepackaged foods with a Nutrition Facts table (N = 10,487) were collected between March 2010 and April 2011 from outlets of the 3 largest grocery chains in Canada and 1 major western Canadian grocery retailer. The nutrition marketing information collected included nutrient content claims, disease risk reduction claims, and front-of-pack nutrition rating systems (FOPS). We found that nutrition marketing was present on 48.1% of Canadian food packages, with nutrient content claims being the most common information (45.5%), followed by FOPS on 18.9% of packages. Disease risk reduction claims were made least frequently (1.7%). The marketing messages used most often related to total fat and trans fat (15.6% and 15.5% of nutrient content claims, respectively). Limiting total and trans fats is a current public health priority, as recommended by Health Canada and the World Health Organization. However, other nutrients that are also recommended to be limited, including saturated fats, sodium, and added sugars, were not nearly as prominent on food labels. Thus, greater emphasis should be placed by the food industry on these other important nutrients. Repeated data collection in the coming years will allow us to track longitudinal changes in nutrition marketing messages over time as food marketing, public health, and consumer priorities evolve.

Motives Underlying Food Choice for Children and Perception of Nutritional Information Among Low-Income Mothers in a Latin American Country.

PubMed

Machín, Leandro; Giménez, Ana; Curutchet, María Rosa; Martínez, Joseline; Ares, Gastón

2016-01-01

The aim of the present study was to investigate the influence of nutritional information on how low-income mothers select food for their children. Five focus groups, each consisting of 5-10 participants, were conducted. Women, older than 18 years, mothers of young children who were beneficiaries of one of the national food stamps programs in Uruguay. Focus group discussions were held around motives underlying food choices for children and perception of labeling systems. Transcripts of the focus group discussions were analyzed using inductive coding. Forty-two women, aged between 18 and 40 years, participated in 5 focus groups. Results showed that low-income mothers do not consider nutritional information when selecting food their children. Traditional nutritional labeling was perceived as complex, difficult to find, and difficult to understand. Participants stressed that they relied on the nutrition claims included on labels for assessing the healthfulness of food products. Semi-directive and directive front-of-pack labels were positively evaluated in terms of ease of interpretation. Participants preferred the traffic light system over other alternatives. Results suggest the need to implement simplified nutritional labeling and to regulate the use of nutrition claims on products targeted at children. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Influence of time orientation on food choice: Case study with cookie labels.

PubMed

Tórtora, Giuliana; Ares, Gastón

2018-04-01

Time orientation can influence health-related behaviors, including food consumption. The aim of the present work was to study the influence of time orientation on food choice, using cookie labels as case study. A choice-conjoint task was designed using labels differing in type of cookie (chocolate chips vs. granola), front-of-pack nutrition information (nutritional warnings vs. Facts Up Front system) and nutritional claim (no claim vs. "0% cholesterol. 0% trans fat"). An online study was conducted, in which 155 participants evaluated 8 pairs of cookie labels and selected the one they would buy if they were in the supermarket. Then, they were asked to complete a consideration of future consequences scale (CFC) adapted to eating habits, as well as a questionnaire about socio-demographic characteristics. Time orientation influenced participants' choices of cookies labels; particularly the importance attached to type of cookie. Participants with greater consideration of future consequences preferred the granola cookies, associated with health, while those who prioritized immediate consequences preferred chocolate chip cookies. In addition, nutritional warnings discouraged choice regardless of participants' time orientation. Results from the present work provide additional evidence of the influence of time preferences on food choices and suggest that strategies to stimulate and generate a more future-oriented perspective on eating habits could contribute to more healthful food choices. Copyright © 2018 Elsevier Ltd. All rights reserved.

Microbiological and molecular characterization of commercially available probiotics containing Bacillus clausii from India and Pakistan.

PubMed

Patrone, Vania; Molinari, Paola; Morelli, Lorenzo

2016-11-21

Probiotics are actively used for treatment of diarrhoea, respiratory infections, and prevention of infectious gastrointestinal diseases. The efficacy of probiotics is due to strain-specific features and the number of viable cells; however, several reports of deviations from the label in the actual content of strains in probiotic products are a matter of concern. Most of the available data on quality focuses on probiotic products containing lactobacilli and/or bifidobacteria, while very few data are available on spore-forming probiotics. The present study evaluates the label claims for spore count and species identification in five commercial probiotic products marketed in India and Pakistan that claim to contain Bacillus clausii: Tufpro, Ecogro, Enterogermina, Entromax, and Ospor. Bacterial enumeration from three batches was done by microbiological plating methods by two independent operators. Species identification was done using PCR amplification and sequence analysis of the 16S rRNA gene, and determination of the total amount of species present in the products was done using PCR-denaturing gradient gel electrophoresis (PCR-DGGE) analysis followed by DNA sequencing of the excised bands. Plate count methods demonstrated poor correlations between quantitative label indications and bacteria recovered from plates for Tufpro, Ecogro, and Ospor. The 16S rRNA analysis performed on bacteria isolated from plate counts showed that only Enterogermina and Ospor contained homogenous B. clausii. PCR-DGGE analysis revealed that only Enterogermina had a homogenous B. clausii population while other products had mixed bacterial populations. In conclusion, the current analysis clearly demonstrates that of the five analysed commercial probiotics, only Enterogermina followed the label claims. Copyright © 2016 Elsevier B.V. All rights reserved.

Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003–2012

PubMed Central

Vilhelmsson, Andreas; Davis, Courtney; Mulinari, Shai

2016-01-01

Background European Union law prohibits companies from marketing drugs off-label. In the United Kingdom—as in some other European countries, but unlike the United States—industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2) shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion. Methods and Findings We conducted structured reviews of rulings by the UK self-regulatory authority, the Prescription Medicines Code of Practice Authority (PMCPA), between 2003 and 2012. There were 74 off-label promotion rulings involving 43 companies and 65 drugs. Nineteen companies were ruled in breach more than once, and ten companies were ruled in breach three or more times over the 10-y period. Drawing on a typology previously developed to analyse US whistleblower complaints, we coded and analysed the apparent strategic goals of each off-label marketing scheme and the practices consistent with those alleged goals. 50% of rulings cited efforts to expand drug use to unapproved indications, and 39% and 38% cited efforts to expand beyond approved disease entities and dosing strategies, respectively. The most frequently described promotional tactic was attempts to influence prescribers (n = 72, 97%), using print material (70/72, 97%), for example, advertisements (21/70, 30%). Although rulings cited prescribers as the prime target of off-label promotion, competing companies lodged the majority of complaints (prescriber: n = 16, 22%, versus companies: n = 42, 57%). Unlike US whistleblower complaints, few UK rulings described practices targeting consumers (n = 3, 4%), payers (n = 2, 3%), or company staff (n = 2, 3%). Eight UK rulings (11%) pertaining to six drugs described promotion of the same drug for the same off-label use as was alleged by whistleblowers in the US. However, while the UK cases typically related to only one or a few claims made in printed material, several complaints in the US alleged multifaceted and covert marketing activities. Because this study is limited to PMCPA rulings and whistleblower-initiated federal cases, it may offer a partial view of exposed off-label marketing. Conclusion The UK self-regulatory system for exposing marketing violations relies largely on complaints from company outsiders, which may explain why most off-label promotion rulings relate to plainly visible promotional activities such as advertising. This contrasts with the US, where Department of Justice investigations and whistleblower testimony have alleged complex off-label marketing campaigns that remain concealed to company outsiders. UK authorities should consider introducing increased incentives and protections for whistleblowers combined with US-style governmental investigations and meaningful sanctions. UK prescribers should be attentive to, and increasingly report, off-label promotion. PMID:26812151

Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012.

PubMed

Vilhelmsson, Andreas; Davis, Courtney; Mulinari, Shai

2016-01-01

European Union law prohibits companies from marketing drugs off-label. In the United Kingdom--as in some other European countries, but unlike the United States--industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to (1) characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and (2) shed light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion. We conducted structured reviews of rulings by the UK self-regulatory authority, the Prescription Medicines Code of Practice Authority (PMCPA), between 2003 and 2012. There were 74 off-label promotion rulings involving 43 companies and 65 drugs. Nineteen companies were ruled in breach more than once, and ten companies were ruled in breach three or more times over the 10-y period. Drawing on a typology previously developed to analyse US whistleblower complaints, we coded and analysed the apparent strategic goals of each off-label marketing scheme and the practices consistent with those alleged goals. 50% of rulings cited efforts to expand drug use to unapproved indications, and 39% and 38% cited efforts to expand beyond approved disease entities and dosing strategies, respectively. The most frequently described promotional tactic was attempts to influence prescribers (n = 72, 97%), using print material (70/72, 97%), for example, advertisements (21/70, 30%). Although rulings cited prescribers as the prime target of off-label promotion, competing companies lodged the majority of complaints (prescriber: n = 16, 22%, versus companies: n = 42, 57%). Unlike US whistleblower complaints, few UK rulings described practices targeting consumers (n = 3, 4%), payers (n = 2, 3%), or company staff (n = 2, 3%). Eight UK rulings (11%) pertaining to six drugs described promotion of the same drug for the same off-label use as was alleged by whistleblowers in the US. However, while the UK cases typically related to only one or a few claims made in printed material, several complaints in the US alleged multifaceted and covert marketing activities. Because this study is limited to PMCPA rulings and whistleblower-initiated federal cases, it may offer a partial view of exposed off-label marketing. The UK self-regulatory system for exposing marketing violations relies largely on complaints from company outsiders, which may explain why most off-label promotion rulings relate to plainly visible promotional activities such as advertising. This contrasts with the US, where Department of Justice investigations and whistleblower testimony have alleged complex off-label marketing campaigns that remain concealed to company outsiders. UK authorities should consider introducing increased incentives and protections for whistleblowers combined with US-style governmental investigations and meaningful sanctions. UK prescribers should be attentive to, and increasingly report, off-label promotion.

Natural products and the athlete: facts and folklore.

PubMed

Barron, R L; Vanscoy, G J

1993-05-01

To contrast scientific facts with suggested manufacturers' claims regarding food supplements (natural products) marketed for enhanced athletic prowess. A MEDLINE search was performed to obtain documentation supporting the claims of natural-product manufacturers. In addition, several references pertaining to pharmacognosy, natural products, herbs, pharmacy practice, and sports medicine were reviewed. Claims were obtained from promotional advertisements in bodybuilding magazines, product labels, and fact sheets for sales representatives in nutrition and health-food stores. We reviewed all of the clinical trials, published between 1966 and 1992, relative to the manufacturers' claims regarding these products. Pertinent human and/or animal studies supporting each natural product were compared with the manufacturers' claims. We found that there was no published scientific evidence to support the promotional claims for a large proportion of the products (8/19, 42 percent). Only 4 of 19 products (21 percent) were associated with any documented human clinical trials supporting their promotional claims. Six of 19 agents (32 percent) had some scientific documentation to support their promotional claims; however, these products were judged to be marketed in a misleading manner.

Concordance with prescribing information dosage recommendations for dipeptidyl-peptidase-4 inhibitors among type 2 diabetes mellitus patients with moderate to severe chronic kidney disease.

PubMed

Huang, Huan; Shetty, Sharash; Bauer, Elise; Lang, Kathleen

2018-06-01

To estimate the proportion of patients with moderate to severe chronic kidney disease (CKD) whose initial dipeptidyl-peptidase-4 inhibitor (DPP4-i) dosage was concordant with prescribing information (label) recommendations in the United States. Adult patients with type 2 diabetes mellitus (T2DM) who initiated a DPP4-i (linagliptin, sitagliptin, saxagliptin) between 1 January 2011 and 30 June 2014 were identified using electronic medical records and administrative claims, with index date being the date of first observed DPP4-i treatment. Patients were required to have chronic kidney disease (CKD) stage 3b, 4 or 5 (estimated Glomerular Filtration Rate [eGFR] value <45 ml/min/1.73 m 2 ) during the 12 month pre-index period. Patients were classified as concordant or not concordant based on whether the first prescribed dose was consistent with label recommendations. Demographics, clinical characteristics, resource use and costs during pre-index were evaluated by DPP4-i concordance status. Of the 492 patients (323 sitagliptin, 57 saxagliptin, 112 linagliptin), 36.2% were prescribed doses that were not concordant with label recommendations (44.9% for sitagliptin, 57.9% for saxagliptin and 0% for linagliptin [which does not require dosage adjustment]). Concordant patients were slightly older (mean age 71 years vs. 68, p = .01) but had similar gender distribution (55% vs. 60% female, p = .31) compared to those who were not concordant. They had lower general health status (Charlson Comorbidity Score 2.6 vs. 2.2, p = .03), and had similar pre-index all-cause total costs ($25,245 vs. $21,972, p = .68) and lower pre-index T2DM-related costs ($1618 vs. $1922, p = .05). More than a third of DPP4-i patients with CKD stage 3b or higher were prescribed doses not concordant with DPP4-i label dosage recommendations.

13 CFR 124.1006 - Can SBA initiate a review of the SDB status of a firm claiming to be an SDB?

Code of Federal Regulations, 2013 CFR

2013-01-01

... SDB status of a firm claiming to be an SDB? 124.1006 Section 124.1006 Business Credit and Assistance... § 124.1006 Can SBA initiate a review of the SDB status of a firm claiming to be an SDB? SBA may initiate an SDB determination on any firm that has been certified to be an SDB by a procuring agency or that...

13 CFR 124.1006 - Can SBA initiate a review of the SDB status of a firm claiming to be an SDB?

Code of Federal Regulations, 2012 CFR

2012-01-01

... SDB status of a firm claiming to be an SDB? 124.1006 Section 124.1006 Business Credit and Assistance... § 124.1006 Can SBA initiate a review of the SDB status of a firm claiming to be an SDB? SBA may initiate an SDB determination on any firm that has been certified to be an SDB by a procuring agency or that...

13 CFR 124.1006 - Can SBA initiate a review of the SDB status of a firm claiming to be an SDB?

Code of Federal Regulations, 2011 CFR

2011-01-01

... SDB status of a firm claiming to be an SDB? 124.1006 Section 124.1006 Business Credit and Assistance... § 124.1006 Can SBA initiate a review of the SDB status of a firm claiming to be an SDB? SBA may initiate an SDB determination on any firm that has been certified to be an SDB by a procuring agency or that...

13 CFR 124.1006 - Can SBA initiate a review of the SDB status of a firm claiming to be an SDB?

Code of Federal Regulations, 2010 CFR

2010-01-01

... SDB status of a firm claiming to be an SDB? 124.1006 Section 124.1006 Business Credit and Assistance... § 124.1006 Can SBA initiate a review of the SDB status of a firm claiming to be an SDB? SBA may initiate an SDB determination on any firm that has been certified to be an SDB by a procuring agency or that...

13 CFR 124.1006 - Can SBA initiate a review of the SDB status of a firm claiming to be an SDB?

Code of Federal Regulations, 2014 CFR

2014-01-01

... SDB status of a firm claiming to be an SDB? 124.1006 Section 124.1006 Business Credit and Assistance... § 124.1006 Can SBA initiate a review of the SDB status of a firm claiming to be an SDB? SBA may initiate an SDB determination on any firm that has been certified to be an SDB by a procuring agency or that...

10 CFR 782.5 - Contents of communication initiating claim.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Contents of communication initiating claim. 782.5 Section 782.5 Energy DEPARTMENT OF ENERGY CLAIMS FOR PATENT AND COPYRIGHT INFRINGEMENT Requirements and... Department of Energy under any of the applicable statutes cited in § 782.3, must be actually communicated to...

10 CFR 782.5 - Contents of communication initiating claim.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Contents of communication initiating claim. 782.5 Section 782.5 Energy DEPARTMENT OF ENERGY CLAIMS FOR PATENT AND COPYRIGHT INFRINGEMENT Requirements and... Department of Energy under any of the applicable statutes cited in § 782.3, must be actually communicated to...

75 FR 44282 - In the Matter of Certain Mobile Telephones and Wireless Communication Devices Featuring Digital...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-28

... review the June 22, 2010, initial determination on claim construction (``ID'') issued by the presiding... question of the legal authority for addressing the issue of claim construction as a matter for summary determination and treating the claim construction ruling as an initial determination under the Commission's...

21 CFR 201.100 - Prescription drugs for human use.

Code of Federal Regulations, 2011 CFR

2011-04-01

..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...

21 CFR 201.100 - Prescription drugs for human use.

Code of Federal Regulations, 2014 CFR

2014-04-01

..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...

21 CFR 201.100 - Prescription drugs for human use.

Code of Federal Regulations, 2012 CFR

2012-04-01

..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...

21 CFR 201.100 - Prescription drugs for human use.

Code of Federal Regulations, 2013 CFR

2013-04-01

..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...

21 CFR 201.100 - Prescription drugs for human use.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., optionally, information relating to quantitative ingredient statements, dosage form, quantity of package... labeling claims for the drug by the National Academy of Sciences/National Research Council (NAS/NRC), Drug...

Consumer attitudes and understanding of cholesterol-lowering claims on food: randomize mock-package experiments with plant sterol and oat fibre claims.

PubMed

Wong, C L; Mendoza, J; Henson, S J; Qi, Y; Lou, W; L'Abbé, M R

2014-08-01

Few studies have examined consumer acceptability or comprehension of cholesterol-lowering claims on food labels. Our objective was to assess consumer attitudes and understanding of cholesterol-lowering claims regarding plant sterols (PS) and oat fibre (OF). We conducted two studies on: (1) PS claims and (2) OF claims. Both studies involved a randomized mock-packaged experiment within an online survey administered to Canadian consumers. In the PS study (n=721), we tested three PS-related claims (disease risk reduction claim, function claim and nutrient content claim) and a 'tastes great' claim (control) on identical margarine containers. Similarly, in the OF study (n=710), we tested three claims related to OF and a 'taste great' claim on identical cereal boxes. In both studies, participants answered the same set of questions on attitudes and understanding of claims after seeing each mock package. All claims that mentioned either PS or OF resulted in more positive attitudes than the taste control claim (P<0.0001), despite all products within each study having the same nutrition profile. How consumers responded to the nutrition claims between the two studies was influenced by contextual factors such as familiarity with the functional food/component and the food product that carried the claim. Permitted nutrition claims are approved based on physiological evidence and are allowed on any food product as long as it meets the associated nutrient criteria. However, it is difficult to generalize attitudes and understanding of claims when they are so highly dependent on contextual factors.

Effect of low-carbohydrate claims on consumer perceptions about food products' healthfulness and helpfulness for weight management.

PubMed

Labiner-Wolfe, Judith; Jordan Lin, Chung-Tung; Verrill, Linda

2010-01-01

Evaluate effect of low-carbohydrate claims on consumer perceptions about food products' healthfulness and helpfulness for weight management. Experiment in which participants were randomly assigned 1 of 12 front-of-package claim conditions on bread or a frozen dinner. Seven of the 12 conditions also included Nutrition Facts (NF) information. Internet. 4,320 members of a national on-line consumer panel. Exposure to images of a food package. Ratings on Likert scales about perceived healthfulness, helpfulness for weight management, and caloric content. Mean ratings by outcome measure, condition, and product were calculated. Ratings were also used as the dependent measure in analysis of variance models. Participants who saw front-of-package-only conditions rated products bearing low-carbohydrate claims as more helpful for weight management and lower in calories than the same products without a claim. Those who saw the bread with low-carbohydrate claims also rated it as more healthful than those who saw no claim. When the NF label was available and products had the same nutrition profile, participants rated products with low-carbohydrate claims the same as those with no claim. Consumers who do not use the NF panel may interpret low-carbohydrate claims to have meaning beyond the scope of the claim itself. Published by Elsevier Inc.

Enhancing masculinity by slandering homosexuals: the role of homophobic epithets in heterosexual gender identity.

PubMed

Carnaghi, Andrea; Maass, Anne; Fasoli, Fabio

2011-12-01

The current studies investigate the effects of homophobic labels on the self-perception of heterosexual males, hypothesizing that when exposed to homophobic epithets, they are motivated to underline their masculinity and claim a distinctly heterosexual identity by taking distance from homosexuals and, to a lesser degree, from women. Heterosexual male participants were subliminally (Study 1) and supraliminally (Study 2) primed either by a homophobic epithet or by a category label, and completed the Traditional Beliefs About Gender and Gender Identity scale. Participants stressed their heterosexual identity, but not their gender distinctiveness, when exposed to homophobic epithets, compared to category labels. Study 2 demonstrated that the relation between the homophobic label and the participants' heterosexual identity was mediated by how negatively they reacted to the antigay label. Heterosexual identity was enhanced in reaction to homophobic labels but not to an equally derogatory label referring to regional identity. Results are discussed within an intergroup framework.

No Evidence against Sketch Reinstatement of Context, Verbal Labels or the Use of Registered Intermediaries for Children with Autism Spectrum Disorder: Response to Henry et al. (2017)

ERIC Educational Resources Information Center

Dando, Coral J.; Ormerod, Thomas C.; Cooper, Penny; Marchant, Ruth; Mattison, Michelle; Milne, Rebecca; Bull, Ray

2018-01-01

Recently, Henry et al. ("J Autism Dev Disord" 8:2348-2362, 2017) found no evidence for the use of Verbal Labels, Sketch Reinstatement of Context and Registered Intermediaries by forensic practitioners when interviewing children with a diagnosis of autism spectrum disorder. We consider their claims, noting the limited ecological validity…

Consumers' knowledge, understanding, and attitudes toward health claims on food labels.

PubMed

Fullmer, S; Geiger, C J; Parent, C R

1991-02-01

The purpose of this study was to assess consumers' knowledge of current fiber recommendations and their attitudes, understanding, and awareness of health claims on breakfast cereal labels. An incidental sample of 241 respondents was drawn from four grocery stores of a local chain in Utah. Data were collected using a computerized interviewing system. The results suggested that consumers with higher education levels had a better understanding of diet-disease-related messages and a more positive attitude toward health messages on food labels. Knowledge of fiber was significantly correlated with positive attitudes toward health messages and understanding of health messages. Overall, attitudes toward placing diet-disease-related messages on food labels were positive. On a scale of 1 through 250, the mean score was 182.5 +/- 37.5 standard deviation (73%). Consumer knowledge of fiber was low. Out of 15 possible points, the mean score for fiber knowledge questions was 8.8 +/- 2.1 (59%). Consumers were more familiar with the role fiber may play in the prevention or treatment of certain diseases or conditions than with sources, classifications, and recommended intakes of fiber. Understanding of health messages was relatively low (45%). Whereas consumer attitudes toward health messages on food labels were positive, consumers (especially less-educated consumers) did not appear to understand the messages well. These results reiterate the concern for public policymakers to exercise caution and ensure that health messages on food labels are responsible and accurate. The results should also remind dietetic practitioners, who are the nutrition experts, of their continual role in providing and ensuring accurate nutrition education to the public.

Microbial status and product labelling of 58 original tattoo inks.

PubMed

Høgsberg, T; Saunte, D M; Frimodt-Møller, N; Serup, J

2013-01-01

European Council resolutions on tattoo ink introduce sterility and preservation of inks to protect customers. Inks used in Denmark are typically purchased over the internet from international suppliers and manufacturers from the US and the UK. In Denmark tattoo inks are regulated and labelled according to REACH as if they were plain chemicals. The objective of this study was to check the microbial product safety of unopened and opened tattoo ink stock bottles. Packaging, labelling, preservation, sterility and contamination with micro-organisms were studied. Physical inspection and culture of bacteria and fungi. Six of 58 unopened stock bottles (10%) were contaminated with bacteria and one of six samples (17%) of previously used stock bottles was contaminated. The bacterial species represented bacteria considered pathogenic in humans as well as non-pathogenic environmental bacteria. Yeast or moulds were detected in none of the samples. A total of 31% of the manufacturers informed only about the brand name. No information about content, sterility, risks or expiry date was indicated on the label. A total of 42% claimed sterility of their inks. A total of 54% labelled a maximum period of durability of typically 2-3 years. The physical sealing was leaking in 28% of the products. The European Council resolutions regarding safety of tattoo inks are not effective. Stock bottles of tattoo ink may contain bacteria pathogenic to humans and environmental bacteria, and packaging, labelling and preservation of inks are of inadequate quality. Claim of sterility can be erroneous. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

The Effects of Prior Beliefs on Student Interactions in Online Debates

ERIC Educational Resources Information Center

Jeong, Allan; Liu, Zhichun

2017-01-01

Because prior beliefs can affect how people argue and respond to controversial claims, in this study we examined how patterns in students' responses posted in online debates were associated with students' initial positions on given claims prior to debate. Students that held initial opposing positions to the claim exhibited the tendency to respond…

[Health claims made about foods: the new European regulation].

PubMed

Baelde, D

2008-01-01

Pursuant to the regulation harmonized relating to labelling, the presentation of the foodstuffs and publicity on them, the health claims made on these products should not be likely to mislead the consumer, must be able to be scientifically substantiated and it cannot be stated nor be evoked a property relating to the prevention, the treatment or the cure of a human disease. The recent publication of the European regulation concerning nutrition and health claims made on foods is a specific text, which supplements this device. The scientific evaluation of health claims allegations is centralized at the European Food Safety Authority and is preliminary to the launching of the food products. The food supplements, defined in the lawful plan in the field of the food right, are also subjected to these provisions.

Internet-ordered viagra (sildenafil citrate) is rarely genuine.

PubMed

Campbell, Neil; Clark, John P; Stecher, Vera J; Goldstein, Irwin

2012-11-01

Counterfeit medication is a growing problem. This study assessed the requirement for prescription, cost, origin, and content of medications sold via the Internet and purporting to be the phosphodiesterase type 5 inhibitor Viagra (sildenafil citrate). Pfizer monitored top search results for the query "buy Viagra" on the two leading Internet search engines in March 2011. Orders were placed from 22 unique Web sites claiming to sell Viagra manufactured by Pfizer. Tablets received were assessed for chemical composition. No Web site examined required a prescription for purchase or a health screening survey; 90% offered illegal "generic Viagra." Cost per tablet ranged from $3.28-$33.00. Shipment origins of purchases were Hong Kong (N = 11), the United States (N = 6), and the United Kingdom (N = 2) as well as Canada, China, and India (N = 1 each). Notably, the four Internet pharmacies claiming to be Canadian did not ship medication from a Canadian address. Of 22 sample tablets examined, 17 (77%) were counterfeit, 4 (18%) were authentic, and 1 (5%) was an illegal generic. Counterfeit tablets were analyzed for sildenafil citrate, the active pharmaceutical ingredient (API) of Viagra, and contents varied between 30% and 50% of the label claim. Counterfeits lacked product information leaflets, including appropriate safety warnings, and genuine Viagra formulations. Internet sites claiming to sell authentic Viagra shipped counterfeit medication 77% of the time; counterfeits usually came from non-U.S. addresses and had 30% to 50% of the labeled API claim. Caution is warranted when purchasing Viagra via the Internet. © 2012 International Society for Sexual Medicine.

"Off Label" Use of FDA-Approved Devices and Digital Breast Tomosynthesis.

PubMed

Kopans, Daniel B

2015-11-01

The purpose of this article is to clarify for radiologists the meaning of U.S. Food and Drug Administration (FDA) approval with respect to Digital Breast Tomosynthesis (DBT). DBT is a major improvement over 2D mammography in the detection of cancers (sensitivity) and the reduction in recalls resulting from screening (specificity). Most imaging systems that have been approved by the FDA are used "off label" for breast imaging. Although the FDA determines which claims a manufacturer can make for a device, physicians may use approved devices, such as DBT, off label to provide better patient care.

Evaluating promotional claims as false or misleading.

PubMed

Brushwood, David B; Knox, Caitlin A; Liu, Wei; Jenkins, Kevin A

2013-11-01

In light of the "false or misleading" standard resulting from the recent legal ruling, it can be concluded that a true claim is one that is both factually and analytically true. Factual truth could be based on the accuracy of the information and the sufficiency of the information. Analytical truth could be based on the scientific foundation for the claim and whether the information within the claim is presented in a balanced way. Regarding the assessment of whether a truthful claim is misleading, the evaluator could consider the relevance, consistency, and context of the information. Standards are important in medication use and medication regulation. Health care professionals who must decide whether a claim is truthful and not misleading will rely on guidance from FDA in determining how to evaluate promotional claims. As the court suggested in the case reviewed here, FDA could take the lead and provide guidance "in differentiating between misleading and false promotion, exaggerations and embellishments, and truthful or non-misleading information." Existing FDA regulations provide a foundation for such guidance. The next step for the agency would be to expand existing guidance to specifically describe how an off-label claim can be identified as either false or misleading.

39 CFR 601.109 - Contract claims and disputes.

Code of Federal Regulations, 2010 CFR

2010-07-01

...: INTELLECTUAL PROPERTY RIGHTS OTHER THAN PATENTS PURCHASING OF PROPERTY AND SERVICES § 601.109 Contract claims... decision on a claim, and even when the supplier does not agree to use ADR, the contracting officer should... issuance of a final decision. (c) Supplier claim initiation. Supplier claims must be submitted in writing...

Nutrition and health claims in products directed at children via television in Spain in 2012.

PubMed

Royo-Bordonada, Miguel Ángel; Bosqued-Estefanía, María José; Damián, Javier; López-Jurado, Lázaro; Moya-Geromini, María Ángeles

2016-01-01

To describe the use of nutrition and health claims in products directed at children via television in Spain and to analyse their nutrient profile. A cross-sectional study of television food advertisements over 7 days in five Spanish television channels popular among children. The products were classified as core, non-core or miscellaneous, and as either healthy or less healthy, according to the United Kingdom Nutrient Profile Model. We registered all claims contained on the product (packaging and labelling) and its advertisement. We calculated the frequency distributions of health and nutrition claims. During the 420hours of broadcasting, 169 food products were identified, 28.5% in the dairy group and 60.9% in the non-core category. A total of 53.3% of products contained nutrition claims and 26.6% contained health claims; 62.2% of the products with claims were less healthy. Low-fat dairy products were the food category containing the highest percentage of health and nutrition claims. Over half of all food products marketed to children via television in Spain made some type of nutrition or health claim. Most of these products were less healthy, which could mislead Spanish consumers. Copyright © 2016 SESPAS. Published by Elsevier Espana. All rights reserved.

Effect of loss control service on reported injury incidence.

PubMed

Nave, Michael E; Veltri, Anthony

2004-01-01

A retrospective analysis evaluated the effectiveness of an insurance carrier's flexible loss control service strategy in reducing workers' compensation policyholders' reported injury and illness claims. To assess the effects of a loss control service strategy on workers' compensation claim frequency rates, on medical-only claim rates, on severity-claim rates, and on claim cost among a group of California employers. Eighty-two small- and medium-sized companies with workers' compensation policies expiring in 1999 were randomly selected from a population of policyholders assigned to loss control consultants for two or more years. Claim performance data were obtained for each company's first expired in-force policy year and its 1999 expired policy year. The retrospective design was combined with a control component based on a randomly selected comparison group of 45 companies whose first policy year with the insurer expired in 1999 and who received safety services from the loss control staff. The flexible loss control consultation service strategy was associated with lower average claim rates and costs. Companies assigned to a loss control consultant for two or more years (the "outcome group") had an average claim rate of 1.24 per $10,000 premium, compared with a rate of 1.62 in the "initial group" and a rate of 1.60 in the "comparison group." The average severity-claim rate of the outcome group was 0.32, compared with the initial-year and comparison-group means of 0.48 and 0.46, respectively. The average medical-only claim rate was 0.92, compared with the initial- and comparison-group means of 1.14 and 1.14. The outcome group's average loss ratio was over 10% lower than that of the initial and comparison groups. Statistical analysis indicated that differences among the groups' claim rates and severity-claim rates were [F=(2,206) 4.938, P=0.008] and [F=(2,206) 8.208, P<0.001], respectively. A loss control service strategy that provides service flexibility and develops partnership between employer and consultant can help reduce the frequency and severity of workers' compensation claims. Barriers to consultation service flexibility, both internal and external, should be identified and removed to enhance service efficacy.

FDA preemption of drug and device labeling: who should decide what goes on a drug label?

PubMed

Valoir, Tamsen; Ghosh, Shubha

2011-01-01

The Supreme Court decided an issue that is critical to consumer health and safety last year. In April 2009, the Supreme Court held that extensive FDA regulation of drugs did not preempt a state law claim that an additional warning on the label was necessary to make the drug reasonably safe for use. Thus, states--and even courts and juries--are now free to cast their vote on what a drug label should say. This is in direct contrast to medical devices, where the federal statute regulating medical devices expressly provides that state regulations are preempted. This Article discusses basic preemption principles and drugs, and explores the policy ramifications of pro- and anti-preemption policy in the healthcare industry.

20 CFR 220.103 - Two or more unrelated impairments-initial claims.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false Two or more unrelated impairments-initial... impairments—initial claims. (a) Unrelated severe impairments. Two or more unrelated severe impairments cannot be combined to meet the 12-month duration test. If the claimant has a severe impairment(s) and then...

The interplay of health claims and taste importance on food consumption and self-reported satiety.

PubMed

Vadiveloo, Maya; Morwitz, Vicki; Chandon, Pierre

2013-12-01

Research has shown that subtle health claims used by food marketers influence pre-intake expectations, but no study has examined how they influence individuals' post-consumption experience of satiety after a complete meal and how this varies according to the value placed on food taste. In two experiments, we assess how labeling a pasta salad as "healthy" or "hearty" influences self-reported satiety, consumption volume, and subsequent consumption of another food. Using MANOVA, Study 1 shows that individuals who report low taste importance consume less-yet feel just as satiated-when a salad is labeled "hearty" rather than "healthy." In contrast, for individuals with higher taste importance, consumption and self-reported satiety are correlated and are both higher when a salad is labeled as "hearty" versus "healthy." Study 2 primes taste importance, rather than measuring it, and replicates these findings for consumption, but not for self-reported satiety. There was no effect on the consumption of other foods in either study. Overall, our findings add to earlier work on the impact of health labels by showing that subtle food descriptions also influence post-intake experiences of satiety, but that the direction of the effects depends on taste importance and on the selection of direct or indirect measures of satiety. Copyright © 2013 Elsevier Ltd. All rights reserved.

Does tobacco industry marketing of 'light' cigarettes give smokers a rationale for postponing quitting?

PubMed

Gilpin, Elizabeth A; Emery, Sherry; White, Martha M; Pierce, John P

2002-01-01

The objective of this analysis was to examine further whether tobacco industry marketing using the labels light and ultra-light is perceived by smokers as a health claim. Smokers might view low tar/nicotine brands of cigarettes as a means to reduce the harm to their health from smoking and postpone quitting. Data were from smokers responding to a large, population-based survey of Californians' smoking behavior, conducted in 1996 (8,582 current smokers). Sixty percent of smokers thought the labels light and ultra-light referred to low tar/nicotine cigarettes, or otherwise implied a health claim. This percentage was higher for smokers of low tar/nicotine brands. Among smokers of regular brands, the more highly addicted, those who were trying unsuccessfully to quit, those who had cut consumption or thought about it, and those with health concerns were more likely to have considered switching. While some of these characteristics also were associated with smokers of low tar/nicotine brands, the associations were not as numerous or as strong. We conclude that some smokers appear to view low tar/nicotine brands as one short-term strategy to reduce the harm to their health from smoking without quitting. By implying reduced tar or nicotine exposure, tobacco industry marketing using the labels light and ultra-light is misleading smokers. The use of such labels should be regulated.

32 CFR 842.6 - Signature on the claim form.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 6 2011-07-01 2011-07-01 false Signature on the claim form. 842.6 Section 842.6 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE CLAIMS AND LITIGATION... signs the claim form in ink using the first name, middle initial, and last name. (a) Claim filed by an...

40 CFR 763.179 - Confidential business information claims.

Code of Federal Regulations, 2011 CFR

2011-07-01

...) TOXIC SUBSTANCES CONTROL ACT ASBESTOS Prohibition of the Manufacture, Importation, Processing, and Distribution in Commerce of Certain Asbestos-Containing Products; Labeling Requirements § 763.179 Confidential... asbestos on human health and the environment? If your answer is yes, explain. ...

21 CFR 807.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES...) Representative sampling of advertisements means typical advertising material that gives the promotional claims... change includes any change or modification in the labeling or advertisements that affects the identity or...

21 CFR 807.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES...) Representative sampling of advertisements means typical advertising material that gives the promotional claims... change includes any change or modification in the labeling or advertisements that affects the identity or...

The influence of weight-of-evidence strategies on audience perceptions of (un)certainty when media cover contested science.

PubMed

Kohl, Patrice Ann; Kim, Soo Yun; Peng, Yilang; Akin, Heather; Koh, Eun Jeong; Howell, Allison; Dunwoody, Sharon

2016-11-01

Controversy in science news accounts attracts audiences and draws attention to important science issues. But sometimes covering multiple sides of a science issue does the audience a disservice. Counterbalancing a truth claim backed by strong scientific support with a poorly backed argument can unnecessarily heighten audience perceptions of uncertainty. At the same time, journalistic norms often constrain reporters to "get both sides of the story" even when there is little debate in the scientific community about which truth claim is most valid. In this study, we look at whether highlighting the way in which experts are arrayed across truth claims-a strategy we label "weight-of-evidence reporting"-can attenuate heightened perceptions of uncertainty that can result from coverage of conflicting claims. The results of our study suggest weight-of-evidence strategies can indeed play a role in reducing some of the uncertainty audiences may perceive when encountering lop-sided truth claims. © The Author(s) 2015.

5 CFR 890.105 - Filing claims for payment or service.

Code of Federal Regulations, 2010 CFR

2010-01-01

... REGULATIONS (CONTINUED) FEDERAL EMPLOYEES HEALTH BENEFITS PROGRAM Administration and General Provisions § 890.105 Filing claims for payment or service. (a) General. (1) Each health benefits carrier resolves claims filed under the plan. All health benefits claims must be submitted initially to the carrier of the...

42 CFR § 512.307 - Subsequent calculations.

Code of Federal Regulations, 2010 CFR

2017-10-01

... (CONTINUED) HEALTH CARE INFRASTRUCTURE AND MODEL PROGRAMS EPISODE PAYMENT MODEL Pricing and Payment § 512.307... the initial NPRA, using claims data and non-claims-based payment data available at that time, to account for final claims run-out, final changes in non-claims-based payment data, and any additional...

20 CFR 405.510 - Claims remanded by a Federal court.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 20 Employees' Benefits 2 2012-04-01 2012-04-01 false Claims remanded by a Federal court. 405.510 Section 405.510 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ADMINISTRATIVE REVIEW PROCESS FOR ADJUDICATING INITIAL DISABILITY CLAIMS Judicial Review § 405.510 Claims remanded by a Federal court. When a...

20 CFR 405.510 - Claims remanded by a Federal court.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Claims remanded by a Federal court. 405.510 Section 405.510 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ADMINISTRATIVE REVIEW PROCESS FOR ADJUDICATING INITIAL DISABILITY CLAIMS Judicial Review § 405.510 Claims remanded by a Federal court. When a...

Chromium picolinate intake and risk of type 2 diabetes: an evidence-based review by the United States Food and Drug Administration.

PubMed

Trumbo, Paula R; Ellwood, Kathleen C

2006-08-01

The labeling of both health claims that meet significant scientific agreement (SSA) and qualified health claims on conventional foods and dietary supplements requires pre-market approval by the US Food and Drug Administration (FDA). Approval by the FDA involves, in part, a thorough review of the scientific evidence to support an SSA or a qualified health claim. This article discusses FDA's evidence-based review of the scientific evidence on the role of chromium picolinate supplements in reducing the risk of type 2 diabetes. Based on this evidence-based review, FDA issued a letter of enforcement discretion for one qualified health claim on chromium picolinate and risk of insulin resistance, a surrogate endpoint for type 2 diabetes. The agency concluded that the relationship between chromium picolinate intake and insulin resistance is highly uncertain.

Adulteration and Counterfeiting of Online Nutraceutical Formulations in the United States: Time for Intervention?

PubMed

Nounou, Mohamed Ismail; Ko, Yamin; Helal, Nada A; Boltz, Jeremy F

2017-10-11

Global prevalence of nutraceuticals is noticeably high. The American market is flooded with nutraceuticals claiming to be of natural origin and sold with a therapeutic claim by major online retail stores such as Amazon and eBay. The objective of this commentary is to highlight the possible problems of online-sold nutraceuticals in the United States with respect to claim, adulterants, and safety. Furthermore, there is a lack of strict regulatory laws governing the sales, manufacturing, marketing, and label claims of nutraceutical formulations currently sold in the U.S. market. Major online retail stores and Internet pharmacies aid the widespread sale of nutraceuticals. Finally, according to the literature, many of these products were found to be either counterfeit or adulterated with active pharmaceutical ingredients (API) and mislabeled as being safe and natural. Therefore, regulatory authorities along with the research community should intervene to draw attention to these products and their possible effects.

Compensation patterns for healthcare workers in British Columbia, Canada.

PubMed

Alamgir, H; Siow, S; Yu, S; Ngan, K; Guzman, J

2009-06-01

This report examines relationships between the acceptance of compensation claims, and employee and workplace characteristics for healthcare workers in British Columbia, Canada to determine suitability of using only accepted claims for occupational epidemiology research. A retrospective cohort of full-time healthcare workers was constructed from an active incident surveillance database. Incidents filed for compensation over a 1-year period were examined for initial claim decision within a 6-month window relative to sub-sector of employment, age, sex, seniority, occupation of workers, and injury category. Compensation costs and duration of time lost for initially accepted claims were also investigated. Multiple logistic regression models with generalised estimating equations (GEEs) were used to calculate adjusted relative odds (ARO) of claims decision accounting for confounding factors and clustering effects. Employees of three health regions in British Columbia filed 2274 work-related claims in a year, of which 1863 (82%) were initially accepted for compensation. Proportion of claims accepted was lowest in community care (79%) and corporate office settings (79%) and highest in long-term care settings (86%). Overall, 46% of claims resulting from allergy/irritation were accepted, in contrast to 98% acceptance of claims from cuts and puncture wounds. Licensed practical nurses had the lowest odds of claims not accepted compared with registered nurses (ARO (95% CI) = 0.55 (0.33 to 0.91)), whereas management/administrative staff had the highest odds (ARO = 2.91 (1.25 to 6.79)) of claims not accepted. A trend was observed with higher seniority of workers associated with lower odds of non-acceptance of claims. Analysis from British Columbia's healthcare sector suggests variation in workers' compensation acceptance exists across sub-sectors, occupations, seniority of workers, and injury categories. The patterns observed, however, were independent of age and sex of workers. Results suggest that when using workers' compensation datasets, local adjudication regulations and factors associated with acceptance of claims should be taken into consideration.

Food labels, autonomy, and the right (not) to know.

PubMed

Bonotti, Matteo

2014-12-01

Food labelling has been overlooked in the emerging body of literature concerning the normative dimensions of food and drink policies. In this paper, I argue that arguments normally advanced in bioethics and medical ethics regarding the "right to know" and the "right not to know" can provide useful normative guidelines for critically assessing existing and proposed food labelling regimes. More specifically, I claim that food labelling ought to respect the legitimate interests and the autonomy of both consumers who seek knowledge about their food in order to make informed dietary choices and consumers who prefer to remain ignorant about the contents and effects of their food in order to avoid the emotional and psychological harm, or more simply the loss of enjoyment, which may result from receiving that information.

Healthfulness and nutritional composition of Canadian prepackaged foods with and without sugar claims.

PubMed

Bernstein, Jodi T; Franco-Arellano, Beatriz; Schermel, Alyssa; Labonté, Marie-Ève; L'Abbé, Mary R

2017-11-01

The objective of this study was to evaluate differences in calories, nutrient content, overall healthfulness, and use of sweetener ingredients between products with and without sugar claims. Consumers assume products with sugar claims are healthier and lower in calories. It is therefore important claims be found on comparatively healthier items. This study is a cross-sectional analysis of the University of Toronto's 2013 Food Label Database. Subcategories where at least 5% of products (and n ≥ 5) carried a sugar claim were included (n = 3048). Differences in median calorie content, nutrient content, and overall healthfulness, using the Food Standards Australia/New Zealand Nutrient Profiling Scoring criterion, between products with and without sugar claims, were determined. Proportion of products with and without claims that had excess free sugar levels (≥10% of calories from free sugar) and that contained sweeteners was also determined. Almost half (48%) of products with sugar claims contained excess free sugar, and a greater proportion contained sweeteners than products without such claims (30% vs 5%, χ 2 = 338.6, p < 0.0001). Overall, products with sugar claims were "healthier" and had lower median calorie, free sugar, total sugar, and sodium contents than products without claims. At the subcategory level, reductions in free sugar contents were not always met with similar reductions in calorie contents. This study highlights concerns with regards to the nutritional composition of products bearing sugar claims. Findings can support educational messaging to assist consumer interpretation of sugar claims and can inform changes in nutrition policies, for example, permitting sugar claims only on products with calorie reductions and without excess free sugar.

Phenotypic plasticity, the Baldwin effect, and the speeding up of evolution: the computational roots of an illusion.

PubMed

Santos, Mauro; Szathmáry, Eörs; Fontanari, José F

2015-04-21

An increasing number of dissident voices claim that the standard neo-Darwinian view of genes as 'leaders' and phenotypes as 'followers' during the process of adaptive evolution should be turned on its head. This idea is older than the rediscovery of Mendel's laws of inheritance, with the turn-of-the-twentieth-century notion eventually labeled as the 'Baldwin effect' as one of the many ways in which the standard neo-Darwinian view can be turned around. A condition for this effect is that environmentally induced variation such as phenotypic plasticity or learning is crucial for the initial establishment of a trait. This gives the additional time for natural selection to act on genetic variation and the adaptive trait can be eventually encoded in the genotype. An influential paper published in the late 1980s claimed the Baldwin effect to happen in computer simulations, and avowed that it was crucial to solve a difficult adaptive task. This generated much excitement among scholars in various disciplines that regard neo-Darwinian accounts to explain the evolutionary emergence of high-order phenotypic traits such as consciousness or language almost hopeless. Here, we use analytical and computational approaches to show that a standard population genetics treatment can easily crack what the scientific community has granted as an unsolvable adaptive problem without learning. Evolutionary psychologists and linguists have invoked the (claimed) Baldwin effect to make wild assertions that should not be taken seriously. What the Baldwin effect needs are plausible case-histories. Copyright © 2015 Elsevier Ltd. All rights reserved.

Impact of Health Labels on Flavor Perception and Emotional Profiling: A Consumer Study on Cheese

PubMed Central

Schouteten, Joachim J.; De Steur, Hans; De Pelsmaeker, Sara; Lagast, Sofie; De Bourdeaudhuij, Ilse; Gellynck, Xavier

2015-01-01

The global increase of cardiovascular diseases is linked to the shift towards unbalanced diets with increasing salt and fat intake. This has led to a growing consumers’ interest in more balanced food products, which explains the growing number of health-related claims on food products (e.g., “low in salt” or “light”). Based on a within-subjects design, consumers (n = 129) evaluated the same cheese product with different labels. Participants rated liking, saltiness and fat flavor intensity before and after consuming four labeled cheeses. Even though the cheese products were identical, inclusion of health labels influenced consumer perceptions. Cheese with a “light” label had a lower overall expected and perceived liking compared to regular cheese. Although cheese with a “salt reduced” label had a lower expected liking compared to regular cheese, no lower liking was found when consumers actually consumed the labeled cheese. All labels also influenced the perceived intensities of the attributes related to these labels, e.g., for example salt intensity for reduced salt label. While emotional profiles of the labeled cheeses differed before tasting, little differences were found when actual tasting these cheeses. In conclusion, this study shows that health-related labels might influence the perceived flavor and emotional profiles of cheese products. PMID:26690211

The positive side of a negative reference: the delay between linguistic processing and common ground

PubMed Central

Noveck, Ira; Rivera, Natalia; Jaume-Guazzini, Francisco

2017-01-01

Interlocutors converge on names to refer to entities. For example, a speaker might refer to a novel looking object as the jellyfish and, once identified, the listener will too. The hypothesized mechanism behind such referential precedents is a subject of debate. The common ground view claims that listeners register the object as well as the identity of the speaker who coined the label. The linguistic view claims that, once established, precedents are treated by listeners like any other linguistic unit, i.e. without needing to keep track of the speaker. To test predictions from each account, we used visual-world eyetracking, which allows observations in real time, during a standard referential communication task. Participants had to select objects based on instructions from two speakers. In the critical condition, listeners sought an object with a negative reference such as not the jellyfish. We aimed to determine the extent to which listeners rely on the linguistic input, common ground or both. We found that initial interpretations were based on linguistic processing only and that common ground considerations do emerge but only after 1000 ms. Our findings support the idea that—at least temporally—linguistic processing can be isolated from common ground. PMID:28386440

48 CFR 1333.206 - Initiation of a claim.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Initiation of a claim. 1333.206 Section 1333.206 Federal Acquisition Regulations System DEPARTMENT OF COMMERCE GENERAL.... Contracting officers shall promptly notify Procurement Counsel and seek legal advice upon receiving a...

Interpreting labels of abuse-deterrent opioid analgesics.

PubMed

Webster, Lynn R

To provide an overview of available abuse-deterrent opioids (ADOs) and the labeling text that describes abuse-deterrent (AD) properties. A nonsystematic review of ADO literature and regulatory documents guiding their development. A critical assessment and discussion of common routes of opioid abuse, AD methods and properties, US Food and Drug Administration (FDA) study requirements to achieve AD labeling, and brief guide to understanding AD labels. The FDA has issued guidance as incentive and direction to industry to develop ADOs as one component of a multi-pronged public-health strategy to combat opioid abuse and misuse. The guidance describes separate categories of premarket and postmarket studies and makes recommendations for claims that may be made based on study findings. Ten ADOs have FDA-approved labeling attesting to AD properties. Available formulations that fail to conform to FDA guidance in study and labeling recommendations cannot be considered ADO. Formulations with AD properties are expected to reduce risk compared to the same agents without AD properties but cannot prevent all abuse and adverse clinical outcomes.

The effect of food label cues on perceptions of quality and purchase intentions among high-involvement consumers with varying levels of nutrition knowledge.

PubMed

Walters, Amber; Long, Marilee

2012-01-01

To determine whether differences in nutrition knowledge affected how women (a high-involvement group) interpreted intrinsic cues (ingredient list) and extrinsic cues ("all natural" label) on food labels. A 2 (intrinsic cue) × 2 (extrinsic cue) × 2 (nutrition knowledge expert vs novice) within-subject factorial design was used. Participants were 106 female college students (61 experts, 45 novices). Dependent variables were perception of product quality and purchase intention. As predicted by the elaboration likelihood model, experts used central route processing to scrutinize intrinsic cues and make judgments about food products. Novices used peripheral route processing to make simple inferences about the extrinsic cues in labels. Consumers' levels of nutrition knowledge influenced their ability to process food labels. The United States Food and Drug Administration should regulate the "all natural" food label, because this claim is likely to mislead most consumers. Copyright © 2012 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

21 CFR 320.25 - Guidelines for the conduct of an in vivo bioavailability study.

Code of Federal Regulations, 2014 CFR

2014-04-01

... physician determines that there is a potential benefit to the patient. (b) Basic design. The basic design of... to or to meet any comparative labeling claims made in relation to the drug product that is the...

21 CFR 320.25 - Guidelines for the conduct of an in vivo bioavailability study.

Code of Federal Regulations, 2012 CFR

2012-04-01

... physician determines that there is a potential benefit to the patient. (b) Basic design. The basic design of... to or to meet any comparative labeling claims made in relation to the drug product that is the...

21 CFR 320.25 - Guidelines for the conduct of an in vivo bioavailability study.

Code of Federal Regulations, 2011 CFR

2011-04-01

... physician determines that there is a potential benefit to the patient. (b) Basic design. The basic design of... to or to meet any comparative labeling claims made in relation to the drug product that is the...

21 CFR 320.25 - Guidelines for the conduct of an in vivo bioavailability study.

Code of Federal Regulations, 2013 CFR

2013-04-01

... physician determines that there is a potential benefit to the patient. (b) Basic design. The basic design of... to or to meet any comparative labeling claims made in relation to the drug product that is the...

40 CFR 350.9 - Initial action by EPA.

Code of Federal Regulations, 2011 CFR

2011-07-01

... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims... determine whether chemical identity information claimed as trade secret is entitled to trade secret... disclosure of trade secret chemical identity or if EPA decides to initiate a determination of the validity of...

40 CFR 350.9 - Initial action by EPA.

Code of Federal Regulations, 2013 CFR

2013-07-01

... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims... determine whether chemical identity information claimed as trade secret is entitled to trade secret... disclosure of trade secret chemical identity or if EPA decides to initiate a determination of the validity of...

40 CFR 350.9 - Initial action by EPA.

Code of Federal Regulations, 2012 CFR

2012-07-01

... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims... determine whether chemical identity information claimed as trade secret is entitled to trade secret... disclosure of trade secret chemical identity or if EPA decides to initiate a determination of the validity of...

40 CFR 350.9 - Initial action by EPA.

Code of Federal Regulations, 2014 CFR

2014-07-01

... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims... determine whether chemical identity information claimed as trade secret is entitled to trade secret... disclosure of trade secret chemical identity or if EPA decides to initiate a determination of the validity of...

40 CFR 350.9 - Initial action by EPA.

Code of Federal Regulations, 2010 CFR

2010-07-01

... RIGHT-TO-KNOW INFORMATION: AND TRADE SECRET DISCLOSURES TO HEALTH PROFESSIONALS Trade Secrecy Claims... determine whether chemical identity information claimed as trade secret is entitled to trade secret... disclosure of trade secret chemical identity or if EPA decides to initiate a determination of the validity of...

Processed foods available in the Pacific Islands

PubMed Central

2013-01-01

Background There is an increasing reliance on processed foods globally, yet food composition tables include minimal information on their nutrient content. The Pacific Islands share common trade links and are heavily reliant on imported foods. The objective was to develop a dataset for the Pacific Islands on nutrient composition of processed foods sold and their sources. Methods Information on the food labels, including country of origin, nutrient content and promotional claims were recorded into a standardised dataset. Data were cleaned, converted to per 100 g data as needed and then checked for anomalies and recording errors. Setting: Five representative countries were selected for data collection, based on their trading patterns: Fiji, Guam, Nauru, New Caledonia, and Samoa. Data were collected in the capitals, in larger stores which import their own foods. Subjects: Processed foods in stores. Results The data from 6041 foods and drinks were recorded. Fifty four countries of origin were identified, with the main provider of food for each Pacific Island country being that with which it was most strongly linked politically. Nutrient data were not provided for 6% of the foods, imported from various countries. Inaccurate labels were found on 132 products. Over one-quarter of the foods included some nutrient or health-related claims. Conclusions The globalisation of the food supply is having considerable impacts on diets in the Pacific Islands. While nutrient labels can be informative for consumers looking for healthier options, difficulties still exist with poor labelling and interpretation can be challenging. PMID:24160249

Consumer and health literacy: The need to better design tobacco-cessation product packaging, labels, and inserts.

PubMed

Weiss, Stephanie M; Smith-Simone, Stephanie Y

2010-03-01

Tobacco-cessation product packaging and instruction materials may not be appropriate for some smokers and may contribute to the underuse and misuse of evidence-based treatments. The dual goals of this project are to analyze literacy levels of Food and Drug Administration (FDA)-approved and non-approved tobacco-cessation product packaging, directions, and claims, and to identify and categorize claims found on product packaging. The Campaign for Tobacco Free Kids (CTFK) maintains the Quitting and Reducing Tobacco Use Inventory of Products (QuiTIP) database, which catalogs products marketed and sold to consumers to reduce or quit use of tobacco products. It also includes all medications approved by the FDA for tobacco cessation as well as a sample of non-approved products such as homeopathic, herbal, nutritional, or dietary supplements commonly marketed as either cessation aids or alternative tobacco/nicotine products. This paper assesses the reading levels required to understand product packaging, labeling, and instructions using the Simple Measure of Gobbledygook (SMOG) and identifies claims on the product package labels using standard qualitative methods. Key findings show that the average reading levels needed to understand instructions for both FDA-approved and non-approved cessation products are above the reading levels recommended to ensure maximum comprehension. Improving the packaging and directions of evidence-based tobacco-cessation products so that they are preferably at or below a fifth-grade reading level, along with using consumer-based design principles to develop packaging, may help smokers take advantage of and correctly use products that will greatly increase their chances of successful quitting. 2010 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

"Organic," "natural," and "additive-free" cigarettes: Comparing the effects of advertising claims and disclaimers on perceptions of harm.

PubMed

Baig, Sabeeh A; Byron, M Justin; Lazard, Allison J; Brewer, Noel T

2018-02-26

The U.S. Tobacco Control Act restricts advertising or labeling that suggests one tobacco product is less harmful than another. We sought to examine how "organic," "natural," and "additive-free" advertising claims and corresponding disclaimers affect perceptions of cigarettes' harm. Participants were a national probability sample of adults in the U.S. (n = 1,114, including 344 smokers). We conducted a 5 (claim) × 2 (disclaimer) between-subjects factorial experiment. Participants viewed a Natural American Spirit cigarettes ad claiming they were "organic," "natural," "additive-free," "light," or "regular;" and with or without a corresponding disclaimer. The outcome was perceived harm of the advertised cigarettes. Among smokers, we also assessed interest in switching within their current brand to cigarettes with this characteristic (e.g., "additive-free"). Claims in the ad had a large effect on perceived harm (Cohen's d = 0.87, 95% CI: 0.47-1.29). Claims of cigarettes being "organic," "natural," or "additive-free" reduced perceived harm from the advertised cigarettes, as compared to "regular" and "light" claims. Disclaimers had a small effect, increasing perceived harm (d = 0.25, 95% CI: 0.08-0.41). The problematic claims also increased smokers' interest in switching. Disclaimers had no effect on smokers' interest in switching. "Organic," "natural," and "additive-free" claims may mislead people into thinking that the advertised cigarettes are less harmful than other cigarettes. Disclaimers did not offset misperceptions of harm created by false claims. The U.S. Food and Drug Administration should restrict the use of these misleading claims in tobacco advertising.

Consumer awareness of salt and sodium reduction and sodium labeling.

PubMed

Kim, M K; Lopetcharat, K; Gerard, P D; Drake, M A

2012-09-01

Reduction of dietary sodium by reduction of sodium in foods is a current industry target. Quantitative information on consumer knowledge of sodium and reduction of dietary sodium is limited. The objectives of this study were to characterize consumer knowledge and awareness of sodium and salt reduction in foods. Consumers (n = 489) participated in a quantitative internet survey designed to gather knowledge and attitudes towards dietary sodium, sodium in foods, and health. Eating habits and food consumption characteristics, knowledge of salt and sodium, and interest in health and wellness were probed. Saltiness believe and sodium knowledge indices were calculated based on correct responses to salt levels in food products. Kano analysis was conducted to determine the role of nutrition labels and satisfaction/dissatisfaction of foods. Consumers were aware of the presence of sodium in "salty" foods, and that sodium was part of salt. People who had a family history of certain diseases associated with a higher intake of dietary sodium did not necessarily have more knowledge of the relationship between sodium intake and a specific disease compared to consumers with no family history. Sodium content on the food label panel did not influence consumer dissatisfaction; however, sodium content did not necessarily increase consumer product satisfaction either. The addition of a healthy nutrient (that is, whole grain, fiber) into a current food product was appealing to consumers. For nutrient labeling, a "reduced" claim was more appealing to consumers than a "free" claim for "unhealthy" nutrients such as fat, sodium, and sugar. This study demonstrated the current state of consumer knowledge on sodium and salt reduction, and consumer perception of the relationship between diets high in sodium and many chronic diseases. Information that may contribute to consumer satisfaction on nutrition panel labeling was also determined. © 2012 Institute of Food Technologists®

32 CFR Appendix D to Part 282 - Processing a Claim

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 2 2010-07-01 2010-07-01 false Processing a Claim D Appendix D to Part 282.... 282, App. D Appendix D to Part 282—Processing a Claim (a) Initial Component Processing. Upon receipt... apply for a waiver. (Paragraph (d) of this Appendix explains which claims qualify and the procedures for...

43 CFR 2650.3-2 - Mining claims.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Mining claims. 2650.3-2 Section 2650.3-2...: Generally § 2650.3-2 Mining claims. (a) Possessory rights. Pursuant to section 22(c) of the Act, on any..., initiated a valid mining claim or location, including millsites, under the general mining laws and recorded...

20 CFR 404.1642 - Processing time standards.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., whichever is earlier. (b) Target levels. The processing time target levels are: (1) 37 days for title II initial claims. (2) 43 days for title XVI initial claims. (c) Threshold levels. The processing time... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Processing time standards. 404.1642 Section...

20 CFR 416.1042 - Processing time standards.

Code of Federal Regulations, 2010 CFR

2010-04-01

..., whichever is earlier. (b) Target levels. The processing time target levels are: (1) 37 days for title II initial claims. (2) 43 days for title XVI initial claims. (c) Threshold levels. The processing time... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Processing time standards. 416.1042 Section...

20 CFR 404.1522 - When you have two or more unrelated impairments-initial claims.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false When you have two or more unrelated impairments-initial claims. 404.1522 Section 404.1522 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL OLD-AGE, SURVIVORS AND DISABILITY INSURANCE (1950- ) Determining Disability and Blindness...

Did Viking discover life on Mars?

NASA Technical Reports Server (NTRS)

Klein, H. P.

1999-01-01

A major argument in the claim that life had been discovered during the Viking mission to Mars is that the results obtained in the Labeled Release (LR) experiment are analogous to those observed with terrestrial microorganisms. This assertion is critically examined and found to be implausible.

Guidance to Registrants: Process for Making Claims Against Emerging Viral Pathogens not on EPA-Registered Disinfectant Labels

EPA Pesticide Factsheets

This guidance proposes to use an organism hierarchy to identify effective products for use with emerging pathogens and to permit registrants to make limited statements against such pathogens. It provides general guidance to interested parties.

Did Viking discover life on Mars?

PubMed

Klein, H P

1999-12-01

A major argument in the claim that life had been discovered during the Viking mission to Mars is that the results obtained in the Labeled Release (LR) experiment are analogous to those observed with terrestrial microorganisms. This assertion is critically examined and found to be implausible.

Waterpipe product packaging and labelling at the 3rd international Hookah Fair; does it comply with Article 11 of the Framework Convention on Tobacco Control?

PubMed

Jawad, Mohammed; Darzi, Andrea; Lotfi, Tamara; Nakkash, Rima; Hawkins, Ben; Akl, Elie A

2017-08-01

We assessed compliance of waterpipe product packaging and labelling with the Framework Convention on Tobacco Control's Article 11. We evaluated samples collected at a trade fair against ten domains: health warning location, size, use of pictorials, use of colour, and packaging information on constituents and emissions. We also evaluated waterpipe accessories (e.g., charcoal) for misleading claims. Ten of 15 tobacco products had health warnings on their principal display areas, covering a median of 22.4 per cent (interquartile range 19.4-27.4 per cent) of those areas. Three had pictorial, in-colour health warnings. We judged all packaging information on constituents and emissions to be misleading. Eight of 13 charcoal products displayed environmentally friendly descriptors and/or claims of reduced harm that we judged to be misleading. Increased compliance with waterpipe tobacco regulation is warranted. An improved policy framework for waterpipe tobacco should also consider regulation of accessories such as charcoal products.

Labelling Polymers and Micellar Nanoparticles via Initiation, Propagation and Termination with ROMP

PubMed Central

Thompson, Matthew P.; Randolph, Lyndsay M.; James, Carrie R.; Davalos, Ashley N.; Hahn, Michael E.

2014-01-01

In this paper we compare and contrast three approaches for labelling polymers with functional groups via ring-opening metathesis polymerization (ROMP). We explored the incorporation of functionality via initiation, termination and propagation employing an array of novel initiators, termination agents and monomers. The goal was to allow the generation of selectively labelled and well-defined polymers that would in turn lead to the formation of labelled nanomaterials. Norbornene analogues, prepared as functionalized monomers for ROMP, included fluorescent dyes (rhodamine, fluorescein, EDANS, and coumarin), quenchers (DABCYL), conjugatable moieties (NHS esters, pentafluorophenyl esters), and protected amines. In addition, a set of symmetrical olefins for terminally labelling polymers, and for the generation of initiators in situ is described. PMID:24855496

Marketing Functional Foods: What Have We Learned? An Examination of the Metamucil, Benefit, and Heartwise Introductions as Cholesterol-Reducing Ready-to-Eat Cereals.

PubMed

Childs, N M

1999-01-01

Health claims, U.S. Food and Drug Administration regulatory actions, and marketing practices are examined in the environment precipitating the introduction of the Nutrition and Labeling Education Act (NLEA) in 1990. The introduction of three psyllium-based products in 1989 and 1990, Procter & Gamble's Metamucil wafers, General Mills' Benefit cereal, and Kellogg's Heartwise cereal, are examined for their use of health claims and marketing tactics in a changing regulatory environment. Inconsistent approval of psyllium-based health claims for drug and food products created a confusing environment in the pre- and early post-NLEA era. This was exacerbated by marketing issues regarding consumer communication and product positioning. Suggestions for marketing products with health positionings in the new NLEA environment are proposed.

The incidence and impact of recurrent workplace injury and disease: a cohort study of WorkSafe Victoria, Australia compensation claims

PubMed Central

Ruseckaite, Rasa; Collie, Alex

2013-01-01

Objective To determine the incidence and impact of recurrent workplace injury and disease over the period 1995–2008. Design Population-based cohort study using data from the state workers’ compensation system database. Setting State of Victoria, Australia. Participants A total of 448 868 workers with an accepted workers’ compensation claim between 1 January 1995 and 31 December 2008 were included into this study. Of them, 135 349 had at least one subsequent claim accepted for a recurrent injury or disease during this period. Main outcome measures Incidence of initial and recurrent injury and disease claims and time lost from work for initial and recurrent injury and disease. Results Over the study period, 448 868 workers lodged 972 281 claims for discrete occurrences of work-related injury or disease. 53.4% of these claims were for recurrent injury or disease. On average, the rates of initial claims dropped by 5.6%, 95% CI (−5.8% to −5.7%) per annum, while the rates of recurrent injuries decreased by 4.1%, 95% CI (−4.2% to −0.4%). In total, workplace injury and disease resulted in 188 978 years of loss in full-time work, with 104 556 of them being for the recurrent injury. Conclusions Recurrent work-related injury and disease is associated with a substantial social and economic impact. There is an opportunity to reduce the social, health and economic burden of workplace injury by enacting secondary prevention programmes targeted at workers who have incurred an initial occupational injury or disease. PMID:23457329

78 FR 9688 - Pesticides; Draft Guidance for Pesticide Registrants on Antimicrobial Pesticide Products With...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-11

... Pesticide Registrants on Antimicrobial Pesticide Products With Mold-Related Label Claims; Notice of... Register issue of December 12, 2012, requesting comments on Guidance for Antimicrobial Pesticide Products... CONTACT: Melba S. Morrow, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental...

7 CFR 1218.53 - Exemption procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... exemption is claimed. (c) A producer who operates under an approved National Organic Program (NOP) (7 CFR part 205) system plan; produces only products that are eligible to be labeled as 100 percent organic... organic farm or organic handling operation certificate provided by a USDA-accredited certifying agent as...

The marketing of testosterone treatments for age-related low testosterone or 'Low T'.

PubMed

Mintzes, Barbara

2018-06-01

To summarize the research evidence on promotion of testosterone for 'Low T', or age-related hypogonadism. Marketing of testosterone for 'Low T' has relied on strategies that are inadequately regulated to prevent off-label promotion, such as unbranded 'disease-awareness' advertising campaigns targeting the general public, sponsored continuing medical education (CME) and ghostwriting. A recent US analysis of television advertising exposure levels versus insurance claims found that both unbranded 'disease-awareness' advertising and branded ads were associated with increased rates of testosterone testing, treatment initiation, and treatment without prior testing. Exposés of sponsored CME and ghostwriting indicate misrepresentation of the research evidence on the sequelae of untreated low testosterone and on treatment efficacy. In the United States, advertising to the general public ceased in 2014 after the Food and Drug Administration changed product labeling to clarify that testosterone is only indicated for pathological hypogonadism. Unbranded 'disease-awareness' advertising to the general public and 'Low T' messages for health professionals have continued elsewhere. The review of the experience of promotion of testosterone for 'Low T' and research evidence on effects of advertising targeting the public highlights the need for improved regulation of unbranded 'disease awareness' advertising to ensure adequate protection of public.

Food claims and nutrition facts of commercial infant foods.

PubMed

Koo, Yu-Chin; Chang, Jung-Su; Chen, Yi Chun

2018-01-01

Composition claim, nutrition claim and health claim are often found on the commercial complementary food packaging. The introduction of complementary foods (CFs) to infants is a turning point in the development of their eating behavior, and their commercial use for Taiwanese infants is growing. In Taiwan, lots of the advertisements for CFs employed health or nutrition claims to promote the products, but the actual nutritional content of these CFs is not clear. The aim of this study was to compare the food claims of commercial complementary food products with their actual nutrition facts. A sample of 363 commercial CFs was collected from websites, local supermarkets, and other food stores, and their nutrition-related claims were classified into composition, nutrition, and health categories. Although the World Health Organization recommends that infants should be exclusively breastfed for the first 6 months, 48.2% of the commercial CFs were targeted at infants younger than 6 months. Therefore, marketing regulations should be implemented to curb early weaning as a result of products targeted at infants younger than 6 months. More than 50% of Taiwanese commercial CFs have high sugar content and more than 20% were high in sodium. Products with health claims, such as "provides good nutrition to children" or "improves appetite," have higher sodium or sugar content than do those without such claims. Moreover, products with calcium or iron content claims did not contain more calcium or iron than products without such claims. Additionally, a significantly greater proportion of the products with "no added sugar" claims were classified as having high sugar content as compared to those without such claims. Parents cannot choose the healthiest food products for their children by simply focusing on food claims. Government should regulate the labeling of nutrition facts and food claims for foods targeted at infants younger than 12 months.

Food claims and nutrition facts of commercial infant foods

PubMed Central

Koo, Yu-Chin; Chang, Jung-Su

2018-01-01

Composition claim, nutrition claim and health claim are often found on the commercial complementary food packaging. The introduction of complementary foods (CFs) to infants is a turning point in the development of their eating behavior, and their commercial use for Taiwanese infants is growing. In Taiwan, lots of the advertisements for CFs employed health or nutrition claims to promote the products, but the actual nutritional content of these CFs is not clear. The aim of this study was to compare the food claims of commercial complementary food products with their actual nutrition facts. A sample of 363 commercial CFs was collected from websites, local supermarkets, and other food stores, and their nutrition-related claims were classified into composition, nutrition, and health categories. Although the World Health Organization recommends that infants should be exclusively breastfed for the first 6 months, 48.2% of the commercial CFs were targeted at infants younger than 6 months. Therefore, marketing regulations should be implemented to curb early weaning as a result of products targeted at infants younger than 6 months. More than 50% of Taiwanese commercial CFs have high sugar content and more than 20% were high in sodium. Products with health claims, such as “provides good nutrition to children” or “improves appetite,” have higher sodium or sugar content than do those without such claims. Moreover, products with calcium or iron content claims did not contain more calcium or iron than products without such claims. Additionally, a significantly greater proportion of the products with “no added sugar” claims were classified as having high sugar content as compared to those without such claims. Parents cannot choose the healthiest food products for their children by simply focusing on food claims. Government should regulate the labeling of nutrition facts and food claims for foods targeted at infants younger than 12 months. PMID:29489848

28 CFR 79.14 - Proof of initial exposure prior to age 21.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Proof of initial exposure prior to age 21. 79.14 Section 79.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CLAIMS UNDER THE RADIATION EXPOSURE COMPENSATION ACT Eligibility Criteria for Claims Relating to Leukemia § 79.14 Proof of...

28 CFR 79.14 - Proof of initial exposure prior to age 21.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 28 Judicial Administration 2 2010-07-01 2010-07-01 false Proof of initial exposure prior to age 21. 79.14 Section 79.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CLAIMS UNDER THE RADIATION EXPOSURE COMPENSATION ACT Eligibility Criteria for Claims Relating to Leukemia § 79.14 Proof of...

28 CFR 79.14 - Proof of initial exposure prior to age 21.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 28 Judicial Administration 2 2013-07-01 2013-07-01 false Proof of initial exposure prior to age 21. 79.14 Section 79.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CLAIMS UNDER THE RADIATION EXPOSURE COMPENSATION ACT Eligibility Criteria for Claims Relating to Leukemia § 79.14 Proof of...

28 CFR 79.14 - Proof of initial exposure prior to age 21.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Proof of initial exposure prior to age 21. 79.14 Section 79.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CLAIMS UNDER THE RADIATION EXPOSURE COMPENSATION ACT Eligibility Criteria for Claims Relating to Leukemia § 79.14 Proof of...

28 CFR 79.14 - Proof of initial exposure prior to age 21.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 28 Judicial Administration 2 2012-07-01 2012-07-01 false Proof of initial exposure prior to age 21. 79.14 Section 79.14 Judicial Administration DEPARTMENT OF JUSTICE (CONTINUED) CLAIMS UNDER THE RADIATION EXPOSURE COMPENSATION ACT Eligibility Criteria for Claims Relating to Leukemia § 79.14 Proof of...

7 CFR 1599.14 - Noncompliance with an agreement.

Code of Federal Regulations, 2010 CFR

2010-01-01

....14 Noncompliance with an agreement. If a participant fails to comply with a term of an agreement, FAS... appropriate, initiate a claim against the participant. FAS may also initiate a claim against a participant if the donated commodities are damaged or lost or the sale proceeds, income, or FAS-provided funds are...

7 CFR 1599.14 - Noncompliance with an agreement.

Code of Federal Regulations, 2011 CFR

2011-01-01

....14 Noncompliance with an agreement. If a participant fails to comply with a term of an agreement, FAS... appropriate, initiate a claim against the participant. FAS may also initiate a claim against a participant if the donated commodities are damaged or lost or the sale proceeds, income, or FAS-provided funds are...

7 CFR 1599.14 - Noncompliance with an agreement.

Code of Federal Regulations, 2012 CFR

2012-01-01

....14 Noncompliance with an agreement. If a participant fails to comply with a term of an agreement, FAS... appropriate, initiate a claim against the participant. FAS may also initiate a claim against a participant if the donated commodities are damaged or lost or the sale proceeds, income, or FAS-provided funds are...

7 CFR 1599.14 - Noncompliance with an agreement.

Code of Federal Regulations, 2013 CFR

2013-01-01

....14 Noncompliance with an agreement. If a participant fails to comply with a term of an agreement, FAS... appropriate, initiate a claim against the participant. FAS may also initiate a claim against a participant if the donated commodities are damaged or lost or the sale proceeds, income, or FAS-provided funds are...

7 CFR 1599.14 - Noncompliance with an agreement.

Code of Federal Regulations, 2014 CFR

2014-01-01

....14 Noncompliance with an agreement. If a participant fails to comply with a term of an agreement, FAS... appropriate, initiate a claim against the participant. FAS may also initiate a claim against a participant if the donated commodities are damaged or lost or the sale proceeds, income, or FAS-provided funds are...

78 FR 75238 - Federal Housing Administration (FHA) Risk Management Initiatives: New Manual Underwriting...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-11

...-AJ07 Federal Housing Administration (FHA) Risk Management Initiatives: New Manual Underwriting... the number of claims. FHA can control costs through risk management practices. The lower costs are a... insurance claim rates and risk of loss to FHA. \\1\\ U.S. Department of Housing and Urban Development, Annual...

Tips on preventing or minimizing construction claims.

PubMed

Kasimer, J H

1981-02-01

With proper planning and use of successful techniques of claims avoidance, recognition, and resolution from the initial stages of the project, a hospital can prevent or minimize construction delays and claims and can complete its new construction in a reasonable atmosphere with a minimum of cost.

Supplemental calcium and risk reduction of hypertension, pregnancy-induced hypertension, and preeclampsia: an evidence-based review by the US Food and Drug Administration.

PubMed

Trumbo, Paula R; Ellwood, Kathleen C

2007-02-01

The labeling of health claims that meet the significant scientific agreement (SSA) standard (authorized health claims) and qualified health claims on conventional foods and dietary supplements requires premarket approval by the US Food and Drug Administration (FDA). FDA conducts an evidence-based review to determine whether there is sufficient evidence to support an authorized or qualified health claim. An evidence-based review was conducted on the human intervention and observational studies evaluating the role of supplemental calcium in reducing the risk of hypertension, pregnancy-induced hypertension, and preeclampsia. This review provides FDA's evaluation of the current scientific evidence on the role of supplemental calcium in reducing the risk of these three end points. Based on this evidence-based review, the agency concluded that the relationship between calcium and risk of hypertension is inconsistent and inconclusive, and the relationship between calcium and risk of pregnancy-induced hypertension and preeclampsia is highly unlikely.

A Pilot Stability Study of Dehydroepiandrosterone Rapid-dissolving Tablets Prepared by Extemporaneous Compounding.

PubMed

Rush, Steven D; Vernak, Charlene; Zhao, Fang

2017-01-01

Dehydroepiandrosterone supplementation is used to treat a variety of conditions. Rapid-dissolving tablets are a relatively novel choice for compounded dehydroepiandrosterone dosage forms. While rapid-dissolving tablets offer ease of administration, there are uncertainties about the physical and chemical stability of the drug and dosage form during preparation and over long-term storage. This study was designed to evaluate the stability of dehydroepiandrosterone rapid-dissolving tablets just after preparation and over six months of storage. The Professional Compounding Centers of America rapid-dissolving tablet mold and base formula were used to prepare 10-mg strength dehydroepiandrosterone rapid-dissolving tablets. The formulation was heated at 100°C to 110°C for 30 minutes, released from the mold, and cooled at room temperature for 30 minutes. The resulting rapid-dissolving tablets were individually packaged in amber blister packs and stored in a stability chamber maintained at 25°C and 60% relative humidity. The stability samples were pulled at pre-determined time points for evaluation, which included visual inspection, tablet weight check, United States Pharmacopeia disintegration test, and stability-indicating high-performance liquid chromatography. The freshly prepared dehydroepiandrosterone rapiddissolving tablets exhibited satisfactory chemical and physical stability. Time 0 samples disintegrated within 40 seconds in water kept at 37°C. The high-performance liquid chromatographic results confirmed that the initial potency was 101.9% of label claim and that there was no chemical degradation from the heating procedure. Over six months of storage, there were no significant changes in visual appearance, physical integrity, or disintegration time for any of the stability samples. The high-performance liquid chromatographic results also indicated that dehydroepiandrosterone rapid-dissolving tablets retained >95% label claim with no detectable degradation products. The dehydroepiandrosterone rapid-dissolving tablets investigated in this pilot study were physically and chemically stable during preparation and over six months of storage at 25°C and 60% relative humidity. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

78 FR 78973 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-27

..., including allowing notifications for food contact substances to become effective and approving food additive petitions, color additive petitions, GRAS affirmation petitions, requests for exemption from regulation as a food additive, and actions on certain food labeling citizen petitions, nutrient content claims...

Guidance to Companies on Referring to Registered Disinfectant Products that Meet the CDC Criteria for Use Against the Ebola Virus

EPA Pesticide Factsheets

There are no EPA-registered products with label claims against the Ebola virus, but enveloped viruses such as Ebola are susceptible to many hospital disinfectants used to disinfect hard, non-porous surfaces. CDC guidance addresses use of such products.

Whole grain gluten-free flat breads

USDA-ARS?s Scientific Manuscript database

The USDA food guide recommends that at least ½ of all the grains eaten should be whole grains. The FDA allows food health claim labels for food containing 51% whole gains and 11 g of dietary fiber. This is the only report demonstrating innovative whole grain gluten free (without yeast or chemicals) ...

Dietary Supplement Ingredient Database (DSID) release 4.0

USDA-ARS?s Scientific Manuscript database

Nearly half of U.S. adults report taking dietary supplements (DS). A single serving of a DS may contain amounts of nutrients or other bioactive compounds that exceed their concentration in foods. During the manufacturing of DS, ingredients may be added in amounts exceeding the label claims in orde...

7 CFR 58.505 - Meaning of words.

Code of Federal Regulations, 2011 CFR

2011-01-01

... contain a culture of harmless lactic acid and flavor producing bacteria, food grade acid, salt, and... (21 CFR 133.129), “Nutrient content claims for fat, fatty acid, and cholesterol content of foods... of approved food grade acids. This product shall be labeled according to the requirements of the Food...

7 CFR 58.505 - Meaning of words.

Code of Federal Regulations, 2013 CFR

2013-01-01

... contain a culture of harmless lactic acid and flavor producing bacteria, food grade acid, salt, and... (21 CFR 133.129), “Nutrient content claims for fat, fatty acid, and cholesterol content of foods... of approved food grade acids. This product shall be labeled according to the requirements of the Food...

7 CFR 58.505 - Meaning of words.

Code of Federal Regulations, 2010 CFR

2010-01-01

... contain a culture of harmless lactic acid and flavor producing bacteria, food grade acid, salt, and... (21 CFR 133.129), “Nutrient content claims for fat, fatty acid, and cholesterol content of foods... of approved food grade acids. This product shall be labeled according to the requirements of the Food...

7 CFR 58.505 - Meaning of words.

Code of Federal Regulations, 2012 CFR

2012-01-01

... contain a culture of harmless lactic acid and flavor producing bacteria, food grade acid, salt, and... (21 CFR 133.129), “Nutrient content claims for fat, fatty acid, and cholesterol content of foods... of approved food grade acids. This product shall be labeled according to the requirements of the Food...

7 CFR 58.505 - Meaning of words.

Code of Federal Regulations, 2014 CFR

2014-01-01

... contain a culture of harmless lactic acid and flavor producing bacteria, food grade acid, salt, and... (21 CFR 133.129), “Nutrient content claims for fat, fatty acid, and cholesterol content of foods... of approved food grade acids. This product shall be labeled according to the requirements of the Food...

A proposal for new keypad design of electronic locks.

PubMed

Trayner, C

1993-10-01

Electronic locks, for which a password is entered on a computer-style keyboard, are described. Certain security problems associated with them are analysed. It is proposed that different labelling of the keyboard keys can reduce this problem. Theoretical figures are provided to support this claim and to aid design.

Ancient whole grain gluten-free flatbreads

USDA-ARS?s Scientific Manuscript database

The USDA food guide recommends that at least ½ of all the grains eaten should be whole grains. The FDA allows food Health Claim labels for food containing 51% whole gains and 11 g of dietary fiber. This is the only report demonstrating innovative ancient whole grain gluten-free (no yeast or chemical...

75 FR 42446 - Agency Information Collection Activities; Proposed Collection; Comment Request; Preparing a Claim...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-21

... approving food additive petitions, color additive petitions, GRAS affirmation petitions, requests for exemption from regulation as a food additive, and actions on certain food labeling citizen petitions... information about the manufacturing and production of FDA-regulated articles. FDA also has eliminated the...

75 FR 59722 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-28

..., including allowing notifications for food contact substances to become effective and approving food additive petitions, color additive petitions and GRAS petition requests for exemption from regulation as a food additive, and actions on certain food labeling citizen petitions, nutrient content claims petitions, and...

Testing consumer perception of nutrient content claims using conjoint analysis.

PubMed

Drewnowski, Adam; Moskowitz, Howard; Reisner, Michele; Krieger, Bert

2010-05-01

The US Food and Drug Administration (FDA) proposes to establish standardized and mandatory criteria upon which front-of-pack (FOP) nutrition labelling must be based. The present study aimed to estimate the relative contribution of declared amounts of different nutrients to the perception of the overall 'healthfulness' of foods by the consumer. Protein, fibre, vitamin A, vitamin C, calcium and iron were nutrients to encourage. Total fat, saturated fat, cholesterol, total and added sugar, and sodium were the nutrients to limit. Two content claims per nutrient used the FDA-approved language. An online consumer panel (n 320) exposed to multiple messages (n 48) rated the healthfulness of each hypothetical food product. Utility functions were constructed using conjoint analysis, based on multiple logistic regression and maximum likelihood estimation. Consumer perception of healthfulness was most strongly driven by the declared presence of protein, fibre, calcium and vitamin C and by the declared total absence of saturated fat and sodium. For this adult panel, total and added sugar had lower utilities and contributed less to the perception of healthfulness. There were major differences between women and men. Conjoint analysis can lead to a better understanding of how consumers process information about the full nutrition profile of a product, and is a powerful tool for the testing of nutrient content claims. Such studies can help the FDA develop science-based criteria for nutrient profiling that underlies FOP and shelf labelling.

14 CFR 1245.202 - Contents of communication initiating claim.

Code of Federal Regulations, 2013 CFR

2013-01-01

... claim for compensation, asserted against the United States as represented by NASA under any of the... within a NASA Center. Claims must be in writing and must include the following: (1) An allegation of... corresponding foreign patents and patent applications and full copies of the same. (11) Pertinent prior art...

20 CFR 405.340 - Deciding a claim without a hearing before an administrative law judge.

Code of Federal Regulations, 2010 CFR

2010-04-01

... administrative law judge. 405.340 Section 405.340 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ADMINISTRATIVE REVIEW PROCESS FOR ADJUDICATING INITIAL DISABILITY CLAIMS Administrative Law Judge Hearing § 405.340 Deciding a claim without a hearing before an administrative law judge. (a) Decision wholly...

42 CFR 401.625 - Effect of CMS claims collection decisions on appeals.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Effect of CMS claims collection decisions on... Compromise § 401.625 Effect of CMS claims collection decisions on appeals. Any action taken under this..., is not an initial determination for purposes of CMS appeal procedures. ...

Cost and effectiveness of biologics for rheumatoid arthritis in a commercially insured population.

PubMed

Curtis, Jeffrey R; Chastek, Benjamin; Becker, Laura; Quach, Caroleen; Harrison, David J; Yun, Huifeng; Joseph, George J; Collier, David H

2015-04-01

Administrative claims contain detailed medication, diagnosis, and procedure data, but the lack of clinical outcomes for rheumatoid arthritis (RA) historically has limited their use in comparative effectiveness research. A claims-based algorithm was developed and validated to estimate effectiveness for RA from data for adherence, dosing, and treatment modifications. To implement the claims-based algorithm in a U.S. managed care database to estimate biologic cost per effectively treated patient. The cohort included patients with RA aged 18-63 years in the Optum Research Database who initiated biologic treatment between January 2007 and December 2010 and were continuously enrolled 6 months before through 12 months after the first claim for the biologic (the index date). Patients were categorized as effectively treated by the claims-based algorithm if they met all of the following 6 criteria in the 12-month post-index period: (1) a medication possession ratio ≥ 80% for subcutaneous biologics, or at least as many infusions as specified in U.S. labeling for intravenous biologics; (2) no increase in biologic dose; (3) no switch in biologics; (4) no new nonbiologic disease-modifying antirheumatic drug; (5) no new or increased oral glucocorticoid treatment; and (6) no more than 1 glucocorticoid injection. Drug costs (all biologics) and administration costs (intravenous biologics) were obtained from allowed amounts on claims. Biologic cost per effectively treated patient was defined as total 1-year biologic cost divided by the number of patients categorized by the algorithm as effectively treated with that index biologic. Sensitivity analysis was conducted to examine the total health care costs per effectively treated patient during the first year of biologic therapy. A total of 5,474 individuals were included in the analysis. The index biologic was categorized as effective by the algorithm for 28.9% of patients overall, including 30.6% for subcutaneous biologics and 22.1% for intravenous biologics. The index biologic was categorized as effective in the first year for 32.7% of etanercept (794/2,425), 32.3% of golimumab (40/124), 30.2% of abatacept (89/295), 27.7% of adalimumab (514/1,857), and 19.0% of infliximab (147/773) patients. Mean 1-year biologic cost per effectively treated patient, as defined in the algorithm, was lowest for etanercept ($43,935), followed by golimumab ($49,589), adalimumab ($52,752), abatacept ($62,300), and infliximab ($101,402). The rank order in the sensitivity analysis was the same, except for golimumab and etanercept.  Using a claims-based algorithm in a large commercial claims database, etanercept was the most effective and had the lowest biologic cost per effectively treated patient with RA.

78 FR 33106 - Certain Automated Media Library Devices; Decision to Modify In Part a Remand Initial...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-03

... of infringement of certain claims of U.S. Patent No. 6,328,766 (``the '766 patent'') and U.S. Patent... investigation with respect to claims 6 and 11 of the '766 patent and claims 8, 11 and 17-19 of the '581 patent... Respondents with respect to any of the asserted patent claims. On August 20, 2012, the Commission determined...

The evolution of nutritional information and communication about food and beverages the last 50 years

PubMed

Quirós-Villegas, Deyanira; Estévez-Martínez, Isabel; Perales-García, Aránzazu; Urrialde, Rafael

2017-10-15

Nutritional information directed to consumers has evolved in some key aspects such as nutritional parameters, qualitative characteristics of the product and the necessary requirements for their communication. To provide a general overview of legislative developments in nutrition communication in the last 50 years. Literature review of available literature and European and Spanish Regulations. The main changes have occurred on the two key regulations. Regulation 1924/2006 covering for the first times in Europe the characteristics that must be declared by foods and beverages to make certain nutritional claims and their commercial communications. Additionally, Regulation 432/2012 provides a positive list of health claims. On the other hand, Regulation 1169/2011 offers an updated view of the information provided to the consumer, the compulsory and voluntary aspects of it and its application in the labeling, presentation and advertising of food and beverage products. In addition, there are other regulations and initiatives, at the non-institutional level, to promote this communication with the consumer, such as GDAs or color schemes, based on the dietary reference intakes of different nutrients included in Regulation 1169/2011. Food legislation has tried to regulate the existing situation in the market by creating a harmonized framework to guarantee the consumer protection, offering nutritional information based in the scientific evidence and increasingly comprehensive and understandable.

Symposium on "The challenge of translating nutrition research into public health nutrition". Session 4: Challenges facing the food industry in innovating for health. Regulatory challenges and opportunities for food innovation.

PubMed

Binns, Nino

2009-02-01

The primary role of the extensive and complex modern food legislation is to protect the consumer. Providing a framework for industry and enabling free trade are secondary aims. In the EU the 2006 Regulation on nutrition and health claims made on foods was adopted in December 2006. This Regulation defines detailed lists of permitted claims with precise conditions, requires foods making claims to meet specific nutrient profiles and requires the submission of a dossier for approval of new health claims. Nutrient profiles and an initial list of existing health claims will not be agreed until January 2009 and January 2010 respectively. The uncertainty about profiles and the initial list of claims as well as the prescriptive nature of the Regulation will have a major impact, some negative but some positive, on food innovation. Worldwide legislation on nutrition and health claims continues to develop. The current paper also provides an outline of some other key pieces of European legislation that affect food innovation. However, currently, all this legislation remains in development and up-to-date information can be sought from the reference material provided.

20 CFR 30.100 - In general, how does an employee file an initial claim for benefits?

Code of Federal Regulations, 2013 CFR

2013-04-01

... PROGRAMS, DEPARTMENT OF LABOR ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000 CLAIMS FOR COMPENSATION UNDER THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000, AS... employee may not want to claim for an occupational illness or a covered illness for which a payment has...

20 CFR 410.610 - Administrative actions that are initial determinations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... determinations. 410.610 Section 410.610 Employees' Benefits SOCIAL SECURITY ADMINISTRATION FEDERAL COAL MINE...) Withdrawal of claim or cancellation of withdrawal request. When a request for withdrawal of a claim, or a request for cancellation of a “request for withdrawal” of a claim, is denied by the Administration, the...

The physical and chemical stability of anti-tuberculosis fixed-dose combination products under accelerated climatic conditions.

PubMed

Bhutani, H; Mariappan, T T; Singh, S

2004-09-01

To determine the physical and chemical stability of anti-tuberculosis fixed-dose combinations (FDC) of rifampicin (RMP), isoniazid (INH), pyrazinamide (PZA) and ethambutol (EMB) sold on the Indian market. The products were stored for 3 months under ICH/WHO accelerated conditions (40 degrees C / 75% RH), with and without the original packaging in the presence and absence of light. The initial RMP, INH and PZA content was found to be within the range of 90-110% of the label claim. However, the products were found to have some chemical instability even initially; one of the tablets also showed physical instability. Under accelerated conditions, the unpackaged products underwent severe changes, whereas both physical and chemical changes were also observed in the packaged formulations. The physical changes were stronger under lighted conditions. A significant finding is that PZA and perhaps EMB may play a catalytic role in the interaction between INH and RMP. This study suggests that, unless they are packed in barrier packaging, anti-tuberculosis FDC formulations should be considered unstable, and due consideration should be given to their development pharmaceutics, packaging and stability testing.

The Indiana Chronic Disease Management Program's impact on medicaid claims: a longitudinal, statewide evaluation.

PubMed

Katz, Barry P; Holmes, Ann M; Stump, Timothy E; Downs, Steven M; Zillich, Alan J; Ackermann, Ronald T; Inui, Thomas S

2009-02-01

: Disease management programs have grown in popularity over the past decade as a strategy to curb escalating healthcare costs for persons with chronic diseases. : To evaluate the effect of the Indiana Chronic Disease Management Program (ICDMP) on the longitudinal changes in Medicaid claims statewide. : Phased implementation of a chronic disease management program in 3 regions of the state. Fourteen repeated cohorts of Medicaid members were drawn over a period of 3.5 years and the trends in claims were evaluated using a repeated measures model. : A total of 44,218 Medicaid members with diabetes and/or congestive heart failure in 3 geographic regions in Indiana. : Across all 3 regions and both disease classes, we found a flattening of cost trends between the pre- and post-ICDMP-initiation periods. This change in the slopes was significant for all of the models except for congestive heart failure in southern Indiana. Thus, the average per member claims paid was increasing at a faster rate before ICDMP but slowed once the program was initiated. To distinguish shorter and longer-term effects related to ICDMP, we estimated annual slopes within the pre- and post-ICDMP- time periods. A similar pattern was found in all regions: claims were increasing before ICDMP, flattened in the years around program initiation, and remained flat in the final year of follow-up. : This analysis shows that the trend in average total claims changed significantly after the implementation of ICDMP, with a decline in the rate of increase in claims paid observed for targeted Medicaid program populations across the state of Indiana.

9 CFR 317.369 - Labeling applications for nutrient content claims.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., and scientific data sufficient for such purpose, and data and information to the extent necessary to... accordance with 317.309(h). If no USDA or AOAC methods are available, the applicant shall submit the assay method used, and data establishing the validity of the method for assaying the nutrient in the particular...

9 CFR 381.469 - Labeling applications for nutrient content claims.

Code of Federal Regulations, 2010 CFR

2010-01-01

..., and scientific data sufficient for such purpose, and data and information to the extent necessary to... accordance with 381.409(h). If no USDA or AOAC methods are available, the applicant shall submit the assay method used, and data establishing the validity of the method for assaying the nutrient in the particular...

75 FR 76525 - Food Labeling; Health Claim; Phytosterols and Risk of Coronary Heart Disease

Federal Register 2010, 2011, 2012, 2013, 2014

2010-12-08

... b. Dietary supplements 3. Other Requirements a. Disqualifying total fat level b. Low saturated fat and low cholesterol criteria c. Trans fat considerations d. Minimum nutrient contribution requirement... diet low in saturated fat and cholesterol, (2) uses the term plant (or vegetable oil) sterol esters or...

21 CFR 101.61 - Nutrient content claims for the sodium content of foods.

Code of Federal Regulations, 2013 CFR

2013-04-01

... consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all... (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content...

21 CFR 101.61 - Nutrient content claims for the sodium content of foods.

Code of Federal Regulations, 2011 CFR

2011-04-01

... consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all... (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content...

21 CFR 101.61 - Nutrient content claims for the sodium content of foods.

Code of Federal Regulations, 2012 CFR

2012-04-01

... consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all... (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content...

21 CFR 101.61 - Nutrient content claims for the sodium content of foods.

Code of Federal Regulations, 2014 CFR

2014-04-01

... consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all... (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content...

21 CFR 101.61 - Nutrient content claims for the sodium content of foods.

Code of Federal Regulations, 2010 CFR

2010-04-01

... consumption with water or a diluent containing an insignificant amount, as defined in § 101.9(f)(1), of all... (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent... SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING Specific Requirements for Nutrient Content...

Single-Sex Schooling in Trinidad and Tobago: a Holistic Exploration

ERIC Educational Resources Information Center

Blair, Erik

2013-01-01

Single-sex schooling has been proposed as a way of addressing the disengagement of boys; the disproportion of gender in certain subjects; stereotyped gender images, and the labelling of some subjects as "masculine" or "feminine". However, there exists no clear research evidence to support such claims. Despite the lack of…

76 FR 2908 - Nonprofit Management LLC and Jeremy Ryan Claeys; Analysis of Proposed Consent Order To Aid Public...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-18

... involves the advertising, marketing, and sale of environmental certifications. From approximately February... proposed order bars respondents, in connection with the labeling, advertising, marketing, promotion...://www.testedgreen.com , as well as mass e-mails linking to their Web site. The marketing claimed that...

Ancient whole grain gluten-free egg-free Pasta

USDA-ARS?s Scientific Manuscript database

The USDA food guide recommends that at least ½ of all the grains eaten should be whole grains. The FDA allows food Health Claim labels for food containing 51% whole gains and 11 g of dietary fiber per serving. This is the only report demonstrating innovative ancient whole grain, gluten-free, egg-fre...

Whole grain gluten-free egg-free pasta

USDA-ARS?s Scientific Manuscript database

The USDA food guide recommends that at least ½ of all the grains eaten should be whole grains. The FDA allows food Health Claim labels for food containing 51% whole grains and 11 g of dietary fiber. This is the only report demonstrating innovative whole grain gluten free, egg free (no chemicals adde...

Whole grain gluten-free egg-free high protein pasta

USDA-ARS?s Scientific Manuscript database

The USDA food guide recommends that at least ½ of all the grains eaten should be whole grains. The FDA allows food Health Claim labels for food containing 51% whole gains and 11 g of dietary fiber. This is the only report demonstrating innovative whole grain, high protein, gluten-free, egg-free past...

Performing clinical studies involving hernia mesh devices: what every investigator should know about the FDA investigational device exemption (IDE) process.

PubMed

Ashar, B S; Dang, J M; Krause, D; Luke, M C

2011-12-01

The FDA's Center for Devices and Radiological Health (CDRH) is responsible for providing reasonable assurance of safety and effectiveness of all medical devices marketed within the US. To date, CDRH has cleared numerous hernia mesh devices for general use, but has not cleared/approved any mesh devices intended for certain specific uses, such as for infected wounds, hernia prevention, biofilm reduction, or prevention of adhesions. CDRH is requesting that manufacturers seeking specific hernia mesh device labeling claims consult with the Agency to determine the level of evidence necessary for justifying such claims.

Taking single virus detection and sizing to the limit with molecular sensitivity: the birth of nanoplasmonic-microcavity hybrid sensors

NASA Astrophysics Data System (ADS)

Arnold, S.

2013-03-01

The BioPhotonics community is buzzing at the prospect that ulta-small bio-nanoparticles such as Polio virus and protein can be detected label-free in their native state and sized one at a time. As the awareness that the claim of label-free single protein sensing through the frequency shift of a bare microcavity by A.M. Armani et al in Science in 2007 fades from lack of independent experimental confirmation or a viable physical mechanism to account for the magnitude of the reported wavelength shifts, a new approach has captured the community's interest. It is a product of a marriage between nano-optics and micro-photonics, and is poised to take label-free sensing to the limit.

The nutritional quality of foods carrying health-related claims in Germany, The Netherlands, Spain, Slovenia and the United Kingdom

PubMed Central

Kaur, A; Scarborough, P; Hieke, S; Kusar, A; Pravst, I; Raats, M; Rayner, M

2016-01-01

Backgroung/Objectives: Compares the nutritional quality of pre-packaged foods carrying health-related claims with foods that do not carry health-related claims. Subject/Methods: Cross-sectional survey of pre-packaged foods available in Germany, The Netherlands, Spain, Slovenia and the United Kingdom in 2013. A total of 2034 foods were randomly sampled from three food store types (a supermarket, a neighbourhood store and a discounter). Nutritional information was taken from nutrient declarations present on food labels and assessed through a comparison of mean levels, regression analyses and the application of a nutrient profile model currently used to regulate health claims in Australia and New Zealand (Food Standards Australia New Zealand's Nutrient Profiling Scoring Criterion, FSANZ NPSC). Results: Foods carrying health claims had, on average, lower levels, per 100 g, of the following nutrients, energy—29.3 kcal (P<0.05), protein—1.2 g (P<0.01), total sugars—3.1 g (P<0.05), saturated fat—2.4 g (P<0.001), and sodium—842 mg (P<0.001), and higher levels of fibre—0.8 g (P<0.001). A similar pattern was observed for foods carrying nutrition claims. Forty-three percent (confidence interval (CI) 41%, 45%) of foods passed the FSANZ NPSC, with foods carrying health claims more likely to pass (70%, CI 64%, 76%) than foods carrying nutrition claims (61%, CI 57%, 66%) or foods that did not carry either type of claim (36%, CI 34%, 38%). Conclusions: Foods carrying health-related claims have marginally better nutrition profiles than those that do not carry claims; these differences would be increased if the FSANZ NPSC was used to regulate health-related claims. It is unclear whether these relatively small differences have significant impacts on health. PMID:27406158

Impact of front-of-pack nutrition information and label design on children's choice of two snack foods: Comparison of warnings and the traffic-light system.

PubMed

Arrúa, Alejandra; Curutchet, María Rosa; Rey, Natalia; Barreto, Patricia; Golovchenko, Nadya; Sellanes, Andrea; Velazco, Guillermo; Winokur, Medy; Giménez, Ana; Ares, Gastón

2017-09-01

Research on the relative influence of package features on children's perception of food products is still necessary to aid policy design and development. The aim of the present work was to evaluate the relative influence of two front-of-pack (FOP) nutrition labelling schemes, the traffic light system and Chilean warning system, and label design on children's choice of two popular snack foods in Uruguay, wafer cookies and orange juice. A total of 442 children in grades 4 to 6 from 12 primary schools in Montevideo (Uruguay) participated in the study. They were asked to complete a choice-conjoint task with wafer cookies and orange juice labels, varying in label design and the inclusion of FOP nutrition information. Half of the children completed the task with labels featuring the traffic-light system (n = 217) and the other half with labels featuring the Chilean warning system (n = 225). Children's choices of wafer cookies and juice labels was significantly influenced by both label design and FOP nutritional labels. The relative impact of FOP nutritional labelling on children's choices was higher for the warning system compared to the traffic-light system. Results from the present work stress the need to regulate the design of packages and the inclusion of nutrient claims, and provide preliminary evidence of the potential of warnings to discourage children's choice of unhealthful products. Copyright © 2017 Elsevier Ltd. All rights reserved.

20 CFR 405.320 - Administrative law judge hearing procedures-general.

Code of Federal Regulations, 2011 CFR

2011-04-01

... PROCESS FOR ADJUDICATING INITIAL DISABILITY CLAIMS Administrative Law Judge Hearing § 405.320... medical, psychological, or vocational expert in your claim, the Medical and Vocational Expert Unit (see...

20 CFR 405.320 - Administrative law judge hearing procedures-general.

Code of Federal Regulations, 2010 CFR

2010-04-01

... PROCESS FOR ADJUDICATING INITIAL DISABILITY CLAIMS Administrative Law Judge Hearing § 405.320... medical, psychological, or vocational expert in your claim, the Medical and Vocational Expert Unit (see...

Analysis of Levodopa Content in Commercial Mucuna pruriens Products Using High-Performance Liquid Chromatography with Fluorescence Detection.

PubMed

Soumyanath, Amala; Denne, Tanya; Hiller, Amie; Ramachandran, Shaila; Shinto, Lynne

2018-02-01

Mucuna pruriens (MP) seeds contain levodopa (up to 2% by weight) and have been used in traditional Indian medicine to treat an illness named "Kampavata," now understood to be Parkinson's disease (PD). Studies have shown MP to be beneficial, and even superior, to levodopa alone in treating PD symptoms. Commercial products containing MP are readily available from online and retail sources to patients and physicians. Products often contain extracts of MP seeds, with significantly higher levodopa content than the seeds. However, MP products have limited regulatory controls with respect to quality and content of active ingredient. The aim of this study was to apply a quantitative method to determine levodopa content in readily available MP products that might be used by patients or in research studies. Levodopa present in six commercial MP products was quantified by solvent extraction followed by reversed-phase high-performance liquid chromatography (HPLC) coupled to fluorescence detection (FD). Certificates of analysis (COA) were obtained, from manufacturers of MP products, to assess the existence and implementation of specifications for levodopa content. HPLC-FD analysis revealed that the levodopa content of the six commercial MP products varied from 6% to 141% of individual label claims. No product contained levodopa within normal pharmacopeial limits of 90%-110% label claim. The maximum daily dose of levodopa delivered by the products varied from 14.4 to 720 mg/day. COAs were inconsistent in specifications for and verification of levodopa content. The commercial products tested varied widely in levodopa content, sometimes deviating widely from the label claim. These deficiencies could impact efficacy and safety of MP products used by PD patients and compromise the results of scientific studies on MP products. The HPLC-FD method described in this study could be utilized by both manufacturers and scientific researchers to verify levodopa content of MP products.

Do specific dietary constituents and supplements affect mental energy? Review of the evidence.

PubMed

Gorby, Heather E; Brownawell, Amy M; Falk, Michael C

2010-12-01

The numbers of marketing claims and food, beverage, and drug products claiming to increase mental energy have risen rapidly, thus increasing the need for scientific specificity in marketing and food label claims. Mental energy is a three-dimensional construct consisting of mood (transient feelings about the presence of fatigue or energy), motivation (determination and enthusiasm), and cognition (sustained attention and vigilance). The present review focuses on four dietary constituents/supplements (Ginkgo biloba, ginseng, glucose, and omega-3 polyunsaturated fatty acids) to illustrate the current state of the literature on dietary constituents and mental energy. The strongest evidence suggests effects of Ginkgo biloba on certain aspects of mood and on attention in healthy subjects, as well as associations between omega-3 polyunsaturated fatty acids and reduced risk of age-related cognitive decline. Limitations of the current data and challenges for future research are discussed. © 2010 International Life Sciences Institute.

Assessment of health claims, content, and safety of herbal supplements containing Ginkgo biloba

PubMed Central

Fransen, Heidi P.; Pelgrom, Sylvia M.G.J.; Stewart-Knox, Barbara; de Kaste, Dries; Verhagen, Hans

2010-01-01

Background European Regulation 1924/2006 states that all health claims made on foods need to be substantiated scientifically. Objective To apply the PASSCLAIM criteria for the scientific substantiation of health claims on foods to herbal supplements containing Ginkgo biloba. Evaluation of three selected claimed health effects for G. biloba (improvement of blood circulation, improvement of symptoms of old age, and improvement of memory) was achieved through review of publicly available scientific data. A total of 35 human intervention studies were evaluated. Commercially available products claimed to contain mainly G. biloba (N=29) were randomly sampled in the Netherlands and analyzed for their content on ginkgo extract. Also, a toxicological risk assessment was performed. Results The three selected health claims investigated could not be substantiated. This was mainly because of a lack of data from studies in healthy volunteers. In most studies results performed with a 24% standardized G. biloba extract were described. However, our chemical analysis showed that 25 of the 29 sampled products did not contain the required minimum 24% standardized extract. Moreover, in most preparations the content of substances typical for G. biloba did not conform to what was declared on the label. Since toxicity data for G. biloba are very limited, a safety limit could not be established. Conclusions Evidence is lacking for three health claims of herbal products with G. biloba. Neither safety nor efficacy can be guaranteed at the recommended daily dose. The multidisciplinary approach described in this paper provides good insight into issues that are relevant for the evaluation of health claims for herbal food supplements. PMID:20927202

Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.

PubMed

2006-10-11

This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration--February 2006.

Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance

PubMed Central

2006-01-01

This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials. It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling (see appendix point 1). It does not address the use of PRO instruments for purposes beyond evaluation of claims made about a drug or medical product in its labeling. By explicitly addressing the review issues identified in this guidance, sponsors can increase the efficiency of their endpoint discussions with the FDA during the product development process, streamline the FDA's review of PRO endpoint adequacy, and provide optimal information about the patient's perspective of treatment benefit at the time of product approval. A PRO is a measurement of any aspect of a patient's health status that comes directly from the patient (i.e., without the interpretation of the patient's responses by a physician or anyone else). In clinical trials, a PRO instrument can be used to measure the impact of an intervention on one or more aspects of patients' health status, hereafter referred to as PRO concepts, ranging from the purely symptomatic (response of a headache) to more complex concepts (e.g., ability to carry out activities of daily living), to extremely complex concepts such as quality of life, which is widely understood to be a multidomain concept with physical, psychological, and social components. Data generated by a PRO instrument can provide evidence of a treatment benefit from the patient perspective. For this data to be meaningful, however, there should be evidence that the PRO instrument effectively measures the particular concept that is studied. Generally, findings measured by PRO instruments may be used to support claims in approved product labeling if the claims are derived from adequate and well-controlled investigations that use PRO instruments that reliably and validly measure the specific concepts at issue. The glossary defines many of the terms used in this guidance. In particular, the term instrument refers to the actual questions or items contained in a questionnaire or interview schedule along with all the additional information and documentation that supports the use of these items in producing a PRO measure (e.g., interviewer training and instructions, scoring and interpretation manual). The term conceptual framework refers to how items are grouped according to subconcepts or domains (e.g., the item walking without help may be grouped with another item, walking with difficulty, within the domain of ambulation, and ambulation may be further grouped into the concept of physical ability). FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance documents means that something is suggested or recommended but not required. First publication of the Draft Guidance by the Food and Drug Administration- February 2006. PMID:17034633

Opioids with abuse-deterrent properties: A regulatory and technological overview.

PubMed

Haddox, J David

Three concurrent public health problems coexist in the United States: endemic nonmedical use/misuse of opioid analgesics, epidemic overdose fatalities involving opioid analgesics, and endemic chronic pain in adults. These intertwined issues comprise an opioid crisis that has spurred the development of formulations of opioids with abuse-deterrent properties and label claims (OADP). To reduce abuse and misuse of prescription opioids, the federal Food and Drug Administration (FDA) has issued a formal Guidance to drug developers that delineates four categories of testing to generate data sufficient for a description of a product's abuse-deterrent properties, along with associated claims, in its Full Prescribing Information (FPI). This article reviews the epidemiology of the crisis as background for the development of OADP, summarizes the FDA Guidance for Industry regarding abuse-deterrent technologies, and provides an overview of some technologies that are currently employed or are under study for incorporation into OADP. Such technologies include physical and chemical barriers to abuse, combined formulations of opioid agonists and antagonists, inclusion of aversive agents, use of delivery systems that deter abuse, development of new molecular entities and prodrugs, and formulation of products that include some combination of these approaches. Opioids employing these novel technologies are one part of a comprehensive intervention strategy that can deter abuse of prescription opioid analgesics without creating barriers to the safe use of prescription opioids. The maximal public health contribution of OADP will probably occur only when all opioids have FDA-recognized abuse-deterrent properties and label claims.

Influence of Label Design on Children's Perception of 2 Snack Foods.

PubMed

Arrúa, Alejandra; Vidal, Leticia; Antúnez, Lucía; Machín, Leandro; Martínez, Joseline; Curutchet, María Rosa; Giménez, Ana; Ares, Gastón

2017-03-01

To evaluate the influence of label design on children's perception of 2 popular snack foods across 3 income levels. Labels of 2 snack products (yogurt and sponge cake) were designed using a fractional factorial design with 3 2-level variables: cartoon character, nutrition claims, and front-of-package nutritional information. A total of 221 children (aged 9-13 years) from Montevideo, Uruguay, with different income levels, participated in the study. Children's attitude toward and liking of 2 food products. Low-income children showed a more positive attitude toward the products than did middle- and high-income children. The inclusion of a cartoon character in sponge cake labels significantly affected hedonic expectations regardless of income. Middle- and high-income children tended to use the term funny more frequently and the term boring less frequently to describe labels that included the cartoon character, compared with those that did not. Results showed that the inclusion of cartoon characters on food labels is associated with fun. Low-income children seem more susceptible to the marketing strategies of food companies than do middle- and high-income children. Copyright © 2016 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

A Radiochemical Biotechnological Approach: Preliminary Study of Lactose Uptake Rate by Kefir Cells, Using 14C-labeled Lactose, in Anaerobic Fermentation

NASA Astrophysics Data System (ADS)

Golfinopoulos, A.; Soupioni, M.; Kanellaki, M.; Koutinas, A. A.

2008-08-01

The effect of initial lactose concentration on lactose uptake rate by kefir free cells, during the lactose fermentation, was studied in this work. For the investigation 14C-labelled lactose was used due to the fact that labeled and unlabeled molecules are fermented in the same way. The results illustrated lactose uptake rates are about up to two fold higher at lower initial ∘Bé densities as compared with higher initial ∘Bé densities.

Marketing Issues for Non-Degree United Kingdom Higher Education: The Case of Foundation Degrees.

ERIC Educational Resources Information Center

Gibbs, Paul

2002-01-01

Discusses educational marketing in terms of branding and consumer trust. Argues that the labeling and marketing of Britain's new foundation degrees, employment-related higher education qualifications, is detrimental to their success. Suggests a need for more clarity and veracity in the claim for parity of esteem for vocational qualifications.…

Analytical content and variability of vitamins and minerals in adult multivitamin/mineral products: national estimates for the Dietary Supplement Ingredient Database (DSID)

USDA-ARS?s Scientific Manuscript database

Multivitamin/mineral products (MVMs) are the most commonly reported dietary supplements used by adults in the United States. During manufacturing, some MVM ingredients are added in amounts exceeding the label claims in order to compensate for losses during the shelf life. Establishing the health be...

76 FR 3584 - Time for Payment of Certain Excise Taxes, and Quarterly Excise Tax Payments for Small Alcohol...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-01-20

... 40 Cigars and cigarettes, Claims, Electronic fund transfers, Excise taxes, Labeling, Packaging and..., Regulations.gov , we will post, and you may view, copies of this notice, any electronic or mailed comments we... material that we consider unsuitable for posting. You also may view copies of this notice, any electronic...

Consumer Behavior Analysis of Fair Trade Coffee: Evidence from Field Research

ERIC Educational Resources Information Center

Stratton, Jeanine P.; Werner, Matt J.

2013-01-01

Consumers have shown increased interest in purchasing goods with pro- environmental claims or products that promote societal well-being, such as fair wages paid to farmers of the raw materials and workers in the manufacturing process of a good (e.g., social product labels, including Fair Trade). However, few studies have explored actual purchase…

The limited benefit of "product-by-process" claim.

PubMed

Chang, Bao-Chi; Wang, Shyh-Jen

2016-10-02

A product-by-process claim was initially developed when the invention could not otherwise be adequately defined. In the US, a patent applicant can use a product-by-process claim for a new product, no matter whether the product can also be defined by using structure features. However, the applicant mainly bears the burden to establish the novelty between the claimed product and the prior art product. Moreover, in terms of infringement, the very recent CAFC cases indicate that the product must be made by a process recited in the claim to infringe a product-by-process claim. Thus, an assignee almost can not take advantage from product-by-process claims during the patent enforcement by comparing with process claims. From the points of the burden during patent prosecution and confined scope in determining infringement, the benefit of using a product-by-process claim would be very limited.

ADOLESCENT IDENTITIES AND SEXUAL BEHAVIOR: AN EXAMINATION OF ANDERSON’S ‘PLAYER’ HYPOTHESIS

PubMed Central

Giordano, Peggy C.; Longmore, Monica A.; Manning, Wendy D.; Northcutt, Miriam J.

2009-01-01

We investigate the social and behavioral characteristics of male adolescents who self-identify as players, focusing particularly on Anderson’s claim that this social role is inextricably linked with poverty and minority status. Results indicate that African American respondents, those affiliated with liberal peers and young men who initially report a relatively high number of sexual partners are more likely to resonate with this identity label. Nevertheless, analyses reveal that a number of players within the sample are not disadvantaged African American youth, and there is considerable variability in their attitude and behavior profiles. Findings based on longitudinal analyses indicate that the player identity is a significant predictor of later variations in self-reported sexual behavior, net of traditional predictors, including prior behavior. Yet results of in-depth interviews conducted with a subset of the respondents complicate these quantitative findings, highlighting that young men’s perceptions of this identity are not as uniformly positive as Anderson’s depiction might lead us to expect. PMID:20161097

High-performance liquid chromatographic determination of isoniazid and 1-isonicotinyl-2-lactosylhydrazine in isoniazid tablet formulations.

PubMed

Butterfield, A G; Lovering, E G; Sears, R W

1980-02-01

A high-performance liquid chromatographic procedure is presented for the simultaneous determination of isoniazid and 1-isonicotinyl-2-lactosylhydrazine (I) in isoniazid tablet formulations. An aliquot of a diluted aqueous tablet extract is introduced onto a microparticulate cyanopropyl bonded-phase column using a valve-loop injector and chromatographed using a mobile phase of acetonitrile--0.01 M, pH 3.5 aqueous acetate buffer (5:95). Compound I can be determined at levels as low as 0.5% of the isoniazid label claim. The relative standard deviations are 0.4 and 0.7% for the simultaneous determination of isoniazid and I, respectively. Seven commercial tablet formulations contained 93.8--97.0% of the labeled isoniazid amounts and 0.3--5.8% of I, expressed as equivalent isoniazid relative to the labeled isoniazid level.

The emotion seen in a face can be a methodological artifact: The process of elimination hypothesis.

PubMed

DiGirolamo, Marissa A; Russell, James A

2017-04-01

The claim that certain facial expressions signal certain specific emotions has been supported by high observer agreement in labeling the emotion predicted for that expression. Our hypothesis was that, with a method common to the field, high observer agreement can be achieved through a process of elimination: As participants move from trial to trial and they encounter a type of expression not previously encountered in the experiment, they tend to eliminate labels they have already associated with expressions seen on previous trials; they then select among labels not previously used. Seven experiments (total N = 1,068) here showed that the amount of agreement can be altered through a process of elimination. One facial expression not previously theorized to signal any emotion was consensually labeled as disgusted (76%), annoyed (85%), playful (89%), and mischievous (96%). Three quite different facial expressions were labeled nonplussed (82%, 93%, and 82%). A prototypical sad expression was labeled disgusted (55%), and a prototypical fear expression was labeled surprised (55%). A facial expression was labeled with a made-up word ( tolen ; 53%). Similar results were obtained both in a context focused on demonstrating a process of elimination and in one similar to a commonly used method, with 4 target expressions embedded with other expressions in 24 randomly ordered trials. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

A concept taxonomy and an instrument hierarchy: tools for establishing and evaluating the conceptual framework of a patient-reported outcome (PRO) instrument as applied to product labeling claims.

PubMed

Erickson, Pennifer; Willke, Richard; Burke, Laurie

2009-01-01

To facilitate development and evaluation of a PRO instrument conceptual framework, we propose two tools--a PRO concept taxonomy and a PRO instrument hierarchy. FDA's draft guidance on patient reported outcome (PRO) measures states that a clear description of the conceptual framework of an instrument is useful for evaluating its adequacy to support a treatment benefit claim for use in product labeling the draft guidance, however does not propose tools for establishing or evaluating a PRO instrument's conceptual framework. We draw from our review of PRO concepts and instruments that appear in prescription drug labeling approved in the United States from 1997 to 2007. We propose taxonomy terms that define relationships between PRO concepts, including "family,"compound concept," and "singular concept." Based on the range of complexity represented by the concepts, as defined by the taxonomy, we propose nine instrument orders for PRO measurement. The nine orders range from individual event counts to multi-item, multiscale instruments. This analysis of PRO concepts and instruments illustrates that the taxonomy and hierarchy are applicable to PRO concepts across a wide range of therapeutic areas and provide a basis for defining the instrument conceptual framework complexity. Although the utility of these tools in the drug development, review, and approval processes has not yet been demonstrated, these tools could be useful to improve communication and enhance efficiency in the instrument development and review process.

Comparison of two data mining techniques in labeling diagnosis to Iranian pharmacy claim dataset: artificial neural network (ANN) versus decision tree model.

PubMed

Rezaei-Darzi, Ehsan; Farzadfar, Farshad; Hashemi-Meshkini, Amir; Navidi, Iman; Mahmoudi, Mahmoud; Varmaghani, Mehdi; Mehdipour, Parinaz; Soudi Alamdari, Mahsa; Tayefi, Batool; Naderimagham, Shohreh; Soleymani, Fatemeh; Mesdaghinia, Alireza; Delavari, Alireza; Mohammad, Kazem

2014-12-01

This study aimed to evaluate and compare the prediction accuracy of two data mining techniques, including decision tree and neural network models in labeling diagnosis to gastrointestinal prescriptions in Iran. This study was conducted in three phases: data preparation, training phase, and testing phase. A sample from a database consisting of 23 million pharmacy insurance claim records, from 2004 to 2011 was used, in which a total of 330 prescriptions were assessed and used to train and test the models simultaneously. In the training phase, the selected prescriptions were assessed by both a physician and a pharmacist separately and assigned a diagnosis. To test the performance of each model, a k-fold stratified cross validation was conducted in addition to measuring their sensitivity and specificity. Generally, two methods had very similar accuracies. Considering the weighted average of true positive rate (sensitivity) and true negative rate (specificity), the decision tree had slightly higher accuracy in its ability for correct classification (83.3% and 96% versus 80.3% and 95.1%, respectively). However, when the weighted average of ROC area (AUC between each class and all other classes) was measured, the ANN displayed higher accuracies in predicting the diagnosis (93.8% compared with 90.6%). According to the result of this study, artificial neural network and decision tree model represent similar accuracy in labeling diagnosis to GI prescription.

7 CFR 1499.14 - Noncompliance with an agreement.

Code of Federal Regulations, 2011 CFR

2011-01-01

... Noncompliance with an agreement. If a participant fails to comply with a term of an agreement, FAS may take one... a claim against the participant. FAS may also initiate a claim against a participant if the donated...

7 CFR 1499.14 - Noncompliance with an agreement.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Noncompliance with an agreement. If a participant fails to comply with a term of an agreement, FAS may take one... a claim against the participant. FAS may also initiate a claim against a participant if the donated...

Food label use and its relation to dietary intake among US adults.

PubMed

Ollberding, Nicholas Jay; Wolf, Randi L; Contento, Isobel

2010-08-01

Rates of diet-related chronic disease combined with the lack of current data on patterns of food label use by the US population warrant re-examination of the use and potential influence of this public health tool. The purpose of this study was to describe the prevalence of food label use and the association between food label use and nutrient intake in a nationally representative sample of US adults who participated in the 2005-2006 National Health and Nutrition Examination Survey. Data on food label use were collected during the interview portion of the survey, and nutrient intake was estimated using the average of two 24-hour dietary recalls. In this sample, 61.6% of participants reported using the Nutrition Facts panel, 51.6% looked at the list of ingredients, 47.2% looked at serving size, and 43.8% reviewed health claims at least sometimes when deciding to purchase a food product. There were significant differences (P<0.05) in food label use across all demographic characteristics examined. Significant differences (P<0.05) in mean nutrient intake of total energy, total fat, saturated fat, cholesterol, sodium, dietary fiber, and sugars were observed between food label users and non-users with label users reporting healthier nutrient consumption. The greatest differences observed were for total energy and fat and for use of specific nutrient information on the food label. Despite food label use being associated with improved dietary factors, label use alone is not expected to be sufficient in modifying behavior ultimately leading to improved health outcomes. 2010 American Dietetic Association. Published by Elsevier Inc. All rights reserved.

Is Early Prescribing of Opioid and Psychotropic Medications Associated With Delayed Return to Work and Increased Final Workers' Compensation Cost?

PubMed

Tao, Xuguang Grant; Lavin, Robert A; Yuspeh, Larry; Weaver, Virginia M; Bernacki, Edward J

2015-12-01

To explore the association between the initial 60 days of prescriptions for psychotropic medications and final workers' compensation claim outcomes. A cohort of 11,394 claimants involved in lost time injuries between 1999 and 2002 were followed through December 31, 2009. Logistic regressions and Cox Proportional Hazard Models were used in the analysis. The initial 60 days of prescriptions for psychotropic medications were significantly associated with a final claim cost at least $100,000. Odds ratios were 1.88 for short-acting opioids, 2.14 for hypnotics, antianxiety agents, or antidepressants, and 3.91 for long-acting opioids, respectively. Significant associations were also found between decreased time lost from work and decreased claim closures during the study period. Early prescription of opioids and other psychotropic drugs may be useful predictors of high claim costs and time lost from work.

Pharmacy claims data versus patient self-report to measure contraceptive method continuation.

PubMed

Triebwasser, Jourdan E; Higgins, Stephanie; Secura, Gina M; Zhao, Qiuhong; Peipert, Jeffrey F

2015-07-01

To compare self-reported 12-month continuation of oral contraceptive pills (OCPs), patch, and ring versus continuation by pharmacy claims data. Women in the Contraceptive CHOICE Project who chose OCPs, the patch, or the ring as their initial method were included. Continuation was assessed by periodic telephone survey and by obtaining prescription claims data. Continuation was defined as no gap of more than 30 days. Kaplan-Meier survival functions were used to estimate continuation rates and cumulative unintended pregnancy rates. Kappa statistic assessed the level of agreement between self-report and claims data. We analyzed 1510 women who initiated use by 3 months and provided information on discontinuation. Of OCP users, 59% continued their method at 12 months by self-report versus 38% by pharmacy claims. Patch and ring users had self-reported/pharmacy continuation of 45%/28% and 57%/37%, respectively. Kappa coefficients and their 95% confidence intervals between the two measurements were 0.46 (0.40, 0.52), 0.54 (0.39, 0.68), and 0.54 (0.47, 0.61) for OCP, patch, and ring, respectively. Among women who self-reported continuation, unintended pregnancy rates were 0.4% in those who continued by pharmacy claims versus 4.9% in those who discontinued according to claims data. Contraceptive continuation rates differ by self-report versus pharmacy claims with women overestimating their continuation by self-report. This article directly compares contraception continuation rates by self-report and by pharmacy claims data. The study suggests that previously reported continuation rates from survey data overestimate specific method use. Copyright © 2015 Elsevier Inc. All rights reserved.

Factual text and emotional pictures: overcoming a false dichotomy of cigarette warning labels.

PubMed

Popova, Lucy; Owusu, Daniel; Jenson, Desmond; Neilands, Torsten B

2017-04-20

In reviewing the first set of pictorial warning labels in the USA, the courts equated textual labels with facts and information, and images with emotion. This study tested the differences in perceived informativeness and emotion between textual and pictorial cigarette warning labels. An online study with 1838 US adults who were non-smokers (n=764), transitioning smokers (quit smoking in the past 2 years or currently trying to quit, n=505) or current smokers (n=569). Each participant evaluated 9 out of 81 text and pictorial cigarette warning labels. Participants reported to what extent they perceived the label as informative and factual and the negative emotions they felt while looking at each label. We used linear mixed models to account for the nesting of multiple observations within each participant. There were no significant differences in perceived informativeness between textual (mean 6.15 on a 9-point scale) and pictorial labels (6.14, p=0.80, Cohen's d=0.003). Textual labels evoked slightly less emotion (4.21 on a 9-point scale) than pictorial labels (4.42, p<0.001, Cohen's d=0.08). Perceived informativeness and emotion were strongly correlated (Pearson r=0.53, p<0.001). Our findings contradict courts' conclusions that pictorial messages are emotional and not factual. Pictorial labels are rated as informative and factual, textual labels evoke emotion, and emotionality and informativeness are strongly correlated. These findings serve as evidence for the Food and Drug Administration (FDA) to counteract the claim that pictorial warning labels, by definition, are not 'purely factual and uncontroversial'. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The effect of health/hedonic claims on consumer hedonic and sensory perception of sugar reduction: Case study with orange/passionfruit nectars.

PubMed

Oliveira, Denize; Ares, Gastón; Deliza, Rosires

2018-06-01

Sugar reduction in beverages can contribute to reduce consumption of this nutrient and to improve the health status of the population. However, such reduction can negatively affect consumer perception. Label information can be an effective tool to increase consumer interest in sugar-reduced products. In this context, the aim of the present work was to study the influence of health/hedonic claims on consumer hedonic and sensory perception of sugar reduction in orange/passionfruit nectars under expected and informed conditions. Sugar-reduced orange/passionfruit nectars (20% and 40% reduced in added sugar) featuring different claims (none, health claim or hedonic claim) were evaluated, together with a control product without reduction. Following a between-subjects experimental design, 206 participants evaluated the nectars under two experimental conditions: (a) expected, looking at the packages, and (b) informed, looking at the packages and tasting the nectars. In each experimental condition, participants evaluated their overall liking using a 9-point hedonic scale and answered a check-all-that-apply questions related to the sensory characteristics of the nectars. Results showed that although consumers did not have negative expectations about sugar-reduced nectars, the sensory characteristics of the products were the main determinants of consumers' hedonic reaction towards the nectars. The influence of claims on consumers' perception was modulated by their hedonic sensitivity towards sugar-reduction. The hedonic claim increased overall liking of those consumers with low hedonic sensitivity towards sugar reduction, whereas it had the opposite effect on the most sensitive consumers. Results from the present work suggest that although hedonic claims hold potential for a consumer segment, care must be taken to avoid the generation of unrealistic expectations about the sensory characteristics of sugar-reduced products. Copyright © 2018 Elsevier Ltd. All rights reserved.

Insulin use and persistence in patients with type 2 diabetes adding mealtime insulin to a basal regimen: a retrospective database analysis

PubMed Central

2011-01-01

Background The objective of this study was to characterize insulin use and examine factors associated with persistence to mealtime insulin among patients with type 2 diabetes (T2D) on stable basal insulin therapy initiating mealtime insulin therapy. Methods Insulin use among patients with T2D initiating mealtime insulin was investigated using Thomson Reuters MarketScan® research databases from July 2001 through September 2006. The first mealtime insulin claim preceded by 6 months with 2 claims for basal insulin was used as the index event. A total of 21 months of continuous health plan enrollment was required. Patients were required to have a second mealtime insulin claim during the 12-month follow-up period. Persistence measure 1 defined non-persistence as the presence of a 90-day gap in mealtime insulin claims, effective the date of the last claim prior to the gap. Persistence measure 2 required 1 claim per quarter to be persistent. Risk factors for non-persistence were assessed using logistic regression. Results Patients initiating mealtime insulin (n = 4752; 51% male, mean age = 60.3 years) primarily used vial/syringe (87%) and insulin analogs (60%). Patients filled a median of 2, 3, and 4 mealtime insulin claims at 3, 6, and 12 months, respectively, with a median time of 76 days between refills. According to measure 1, persistence to mealtime insulin was 40.7%, 30.2%, and 19.1% at 3, 6, and 12 months, respectively. Results for measure 2 were considerably higher: 74.3%, 55.3%, and 42.2% of patients were persistent at 3, 6, and 12 months, respectively. Initiating mealtime insulin with human insulin was a risk factor for non-persistence by both measures (OR < 0.80, p < 0.01). Additional predictors of non-persistence at 12 months included elderly age, increased insulin copayment, mental health comorbidity, and polypharmacy (p < 0.05 for all). Conclusions Mealtime insulin use and persistence were both considerably lower than expected, and were significantly lower for human insulin compared to analogs. PMID:21226935

Liver enzyme monitoring in patients treated with troglitazone.

PubMed

Graham, D J; Drinkard, C R; Shatin, D; Tsong, Y; Burgess, M J

2001-08-15

Soon after initial marketing in March 1997, troglitazone, the first thiazolidinedione antidiabetic agent, was found to cause life-threatening acute liver failure. The drug was removed from the market in March 2000. To evaluate the effect of US Food and Drug Administration (FDA) risk management efforts, including repeated labeling changes and "Dear Healthcare Professional" letters, on periodic liver enzyme monitoring of patients taking troglitazone. Claims data from a large, multistate managed care organization were used to establish 4 cohorts of patients (N = 7603) with at least 90 days of health plan enrollment before first troglitazone prescription during 4 consecutive periods spanning April 1997 to September 1999 and representing 4 progressively stringent liver monitoring recommendations. Percentage of eligible troglitazone users in each cohort with baseline, monthly (for up to 6 months of continuous use), and complete (baseline and monthly) enzyme monitoring, based on computerized records of laboratory claims. Baseline testing increased from 15% before any FDA monitoring recommendations (cohort 1) to 44.6% following 4 separate FDA interventions (cohort 4; P<.001). In cohort 4, 33.4% of users had follow-up testing after 1 month of therapy, falling to 13% after 5 months of continuous use. In all cohorts, less than 5% received all recommended liver enzyme tests by the third month of continuous use. The FDA risk management efforts did not achieve meaningful or sustained improvement in liver enzyme testing. Evaluation of the impact of regulatory actions is needed before such actions can be regarded as effective or sufficient.

Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: prevalence of related drug use.

PubMed

Frueh, Felix W; Amur, Shashi; Mummaneni, Padmaja; Epstein, Robert S; Aubert, Ronald E; DeLuca, Teresa M; Verbrugge, Robert R; Burckart, Gilbert J; Lesko, Lawrence J

2008-08-01

To review the labels of United States Food and Drug Administration (FDA)-approved drugs to identify those that contain pharmacogenomic biomarker information, and to collect prevalence information on the use of those drugs for which pharmacogenomic information is included in the drug labeling. Retrospective analysis. The Physicians' Desk Reference Web site, Drugs@FDA Web site, and manufacturers' Web sites were used to identify drug labels containing pharmacogenomic information, and the prescription claims database of a large pharmacy benefits manager (insuring > 55 million individuals in the United States) was used to obtain drug utilization data. Pharmacogenomic biomarkers were defined, FDA-approved drug labels containing this information were identified, and utilization of these drugs was determined. Of 1200 drug labels reviewed for the years 1945-2005, 121 drug labels contained pharmacogenomic information based on a key word search and follow-up screening. Of those, 69 labels referred to human genomic biomarkers, and 52 referred to microbial genomic biomarkers. Of the labels referring to human biomarkers, 43 (62%) pertained to polymorphisms in cytochrome P450 (CYP) enzyme metabolism, with CYP2D6 being most common. Of 36.1 million patients whose prescriptions were processed by a large pharmacy benefits manager in 2006, about 8.8 million (24.3%) received one or more drugs with human genomic biomarker information in the drug label. Nearly one fourth of all outpatients received one or more drugs that have pharmacogenomic information in the label for that drug. The incorporation and appropriate use of pharmacogenomic information in drug labels should be tested for its ability to improve drug use and safety in the United States.

Labeling Biomolecules with Radiorhenium - a Review of the Bifunctional Chelators

PubMed Central

Liu, Guozheng; Hnatowich, Donald J.

2007-01-01

For radiotherapy, biomolecules such as intact antibodies, antibody fragments, peptides, DNAs and other oligomers have all been labeled with radiorhenium (186Re and 188Re). Three different approaches have been employed that may be referred to as direct, indirect and integral labeling. Direct labeling applies to proteins and involves the initial reduction of endogenous disulfide bridges to provide chelation sites. Indirect labeling can apply to most biomolecules and involves the initial attachment of an exogenous chelator. Finally, integral labeling is a special case applying only to small molecules in which the metallic radionuclide serves to link two parts of a biomolecule together in forming the labeled complex. While the number of varieties for the direct and integral radiolabeling approaches is rather limited, a fairly large and diverse number of chelators have been reported in the case of indirect labeling. Our objective herein is to provide an overview of the various chelators that have been used in the indirect labeling of biomolecules with radiorhenium, including details on the labeling procedures, the stability of the radiolabel and, where possible, the influence of the label on biological properties. PMID:17504162

Non-Bayesian Noun Generalization in 3-to 5-Year-Old Children: Probing the Role of Prior Knowledge in the Suspicious Coincidence Effect

ERIC Educational Resources Information Center

Jenkins, Gavin W.; Samuelson, Larissa K.; Smith, Jodi R.; Spencer, John P.

2015-01-01

It is unclear how children learn labels for multiple overlapping categories such as "Labrador," "dog," and "animal." Xu and Tenenbaum (2007a) suggested that learners infer correct meanings with the help of Bayesian inference. They instantiated these claims in a Bayesian model, which they tested with preschoolers and…

Validating bifidobacterial species and subspecies identity in commercial probiotic products.

PubMed

Lewis, Zachery T; Shani, Guy; Masarweh, Chad F; Popovic, Mina; Frese, Steve A; Sela, David A; Underwood, Mark A; Mills, David A

2016-03-01

The ingestion of probiotics to attempt to improve health is increasingly common; however, quality control of some commercial products can be limited. Clinical practice is shifting toward the routine use of probiotics to aid in prevention of necrotizing enterocolitis in premature infants, and probiotic administration to term infants is increasingly common to treat colic and/or prevent atopic disease. Since bifidobacteria dominate the feces of healthy breast-fed infants, they are often included in infant-targeted probiotics. We evaluated 16 probiotic products to determine how well their label claims describe the species of detectable bifidobacteria in the product. Recently developed DNA-based methods were used as a primary means of identification, and were confirmed using culture-based techniques. We found that the contents of many bifidobacterial probiotic products differ from the ingredient list, sometimes at a subspecies level. Only 1 of the 16 probiotics perfectly matched its bifidobacterial label claims in all samples tested, and both pill-to-pill and lot-to-lot variation were observed. Given the known differences between various bifidobacterial species and subspecies in metabolic capacity and colonization abilities, the prevalence of misidentified bifidobacteria in these products is cause for concern for those involved in clinical trials and consumers of probiotic products.

The application status of Good Food Production Method (GFPM) production of corn crackers in SME Mawar Merah Luwu Utara

NASA Astrophysics Data System (ADS)

Latief, R.; Dirpan, A.; Tahir, M. M.; Albanjar, F. V.

2018-05-01

Good Food Production Method (GFPM) requires several requirements that must be fulfilled by all industries involved in the whole production chain from raw materials to the fonal product. This study aims to identify the application of GFPM in the production of corn chips, and assess the status of GFPM implementation which was conducted through observations, interwiews, and documentation of all activities related to the production process. The assessment used a reference adapted from the Decree of Indonesian Minister of Industry Affairs (Permenperin) number 75/M-Ind/Per/7/2010 and the regulation of Head of National Drug and Food Control Agency (KBPOM) number HK.03.1.23.04.12.22007 in 2012. The result showed several inappropriate conditios including: (1) absence of continuing maintanace of the wall and ceiling of the production room: (2) unstandardized ventilation in the production room; (3) absence of net weight and production labels on the packages; and (4) the absence of health label informing health claims and nutrition claims. The status of GFPM implementation in UKM Mawar Merah is at D (poor) level with a rate of IV.

Biological activity analysis of native and recombinant streptokinase using clot lysis and chromogenic substrate assay.

PubMed

Mahboubi, Arash; Sadjady, Seyyed Kazem; Mirzaei Saleh Abadi, Mohammad; Azadi, Saeed; Solaimanian, Roya

2012-01-01

DETERMINATION OF STREPTOKINASE ACTIVITY IS USUALLY ACCOMPLISHED THROUGH TWO ASSAY METHODS: a) Clot lysis, b) Chromogenic substrate assay. In this study the biological activity of two streptokinase products, namely Streptase®, which is a native product and Heberkinasa®, which is a recombinant product, was determined against the third international reference standard using the two forementioned assay methods. The results indicated that whilst the activity of Streptase® was found to be 101 ± 4% and 97 ± 5% of the label claim with Clot lysis and Chromogenic substrate assay respectively, for Heberkinasa® the potency values obtained were 42 ± 5% and 92.5 ± 2% of the label claim respectively. To shed some light on the reason for this finding, the n-terminal sequence of the streptokinase molecules present in the two products was determined. The results showed slight differences in the amino acid sequence of the recombinant product in comparison to the native one at the amino terminus. This finding supports those of other workers who found that n-terminal sequence of the streptokinase molecule can have significant effect on the activity of this protein.

Audit of lymphadenectomy in lung cancer resections using a specimen collection kit and checklist

PubMed Central

Osarogiagbon, Raymond U.; Sareen, Srishti; Eke, Ransome; Yu, Xinhua; McHugh, Laura M.; Kernstine, Kemp H.; Putnam, Joe B.; Robbins, Edward T.

2014-01-01

Background Audits of operative summaries and pathology reports reveal wide discordance in identifying the extent of lymphadenectomy performed (the communication gap). We tested the ability of a pre-labeled lymph node specimen collection kit and checklist to narrow the communication gap between operating surgeons, pathologists, and auditors of surgeons’ operation notes. Methods We conducted a prospective single cohort study of lung cancer resections performed with a lymph node collection kit from November 2010 to January 2013. We used the kappa statistic to compare surgeon claims on a checklist of lymph node stations harvested intraoperatively, to pathology reports, and an independent audit of surgeons’ operative summaries. Lymph node collection procedures were classified into 4 groups based on the anatomic origin of resected lymph nodes: mediastinal lymph node dissection, systematic sampling, random sampling and no sampling. Results From the pathology report, 73% of 160 resections had a mediastinal lymph node dissection or systematic sampling procedure, 27% had random sampling. The concordance with surgeon claims was 80% (kappa statistic 0.69 [CI 0.60 – 0.79]). Concordance between independent audits of the operation notes and either the pathology report (kappa 0.14 [0.04 – 0.23]), or surgeon claims (kappa 0.09 [0.03 – 0.22]), was poor. Conclusion A pre-labeled specimen collection kit and checklist significantly narrowed the communication gap between surgeons and pathologists in identifying the extent of lymphadenectomy. Audit of surgeons’ operation notes did not accurately reflect the procedure performed, bringing its value for quality improvement work into question. PMID:25530090

Medical-legal issues in headache: penal and civil Italian legislation, working claims, social security, off-label prescription.

PubMed

Aguggia, M; Cavallini, M; Varetto, L

2006-05-01

Primary headaches can be considered simultaneously as symptom and disease itself, while secondary headaches are expressions of a pathological process that can be systemic or locoregional. Because of its subjective features, headache is often difficult to assess and quantify by severity, frequency and invalidity rate, and for these reasons it has often been implicated in legal controversies. Headache has seldom been considered in the criminal law, except when it represents a typical symptom of a disease whose existence can be objectively assessed (i. e. raised intracranial pressure). Therefore, in civil legislation it is not yet coded to start claiming for invalidity compensation. In particular, one of the most debated medical-legal questions is represented by headaches occurring after head injury. Headache is often the principal symptom at the beginning of several toxic chronic syndromes, with many implications, especially in working claims, and, more recently, it may be referred to as one of the most frequent symptoms by victims of mobbing (i. e. psychological harassment in the workplace). The National Institute for Industrial Accident Insurance (INAIL) scales (instituted by the law 38/2000) mention the "Subjective cranial trauma syndrome" and give an invalidity rate evaluation. With reference to other headache forms, no legislation really exists at the present time, and headache is only considered as a symptom of a certain coded disease. Requests for invalidity social pension and the question of off-label prescriptions (drug prescription for a disease, without formal indication for it) are other controversial matters.

Associations with duration of compensation following whiplash sustained in a motor vehicle crash.

PubMed

Casey, Petrina P; Feyer, Anne Marie; Cameron, Ian D

2015-09-01

Continued exposure to compensation systems has been reported as deleterious to the health of participants. Understanding the associations with time to claim closure could allow for targeted interventions aimed at minimising the time participants are exposed to the compensation system. To identify the associations of extended time receiving compensation benefits with the aim of developing a prognostic model that predicts time to claim closure. Prospective cohort study in people with whiplash associated disorder. Time to claim closure, in a privately underwritten fault based third party traffic crash insurance scheme in New South Wales, Australia. Cox proportional hazard regression modelling. Of the 246 participants, 25% remained in the compensation system longer than 24 months with 15% remaining longer than three years. Higher initial disability (Functional Rating Index≥25 at baseline) (HRR: 95% CI, 1.916: 1.324-2.774, p<0.001); and lower initial mental health as measured by SF-36 Mental Component Score (HRR: 95% CI, 0.973: 0.960-0.987, p<0.001) were significantly and independently associated with an increased time-to-claim closure. Shorter time to claim closure was associated with having no legal involvement (HRR: 95% CI, 1.911: 1.169-3.123, p=0.009); and, not having a prior claim for compensation (HRR: 95% CI, 1.523: 1.062-2.198, p=0.022). Health and insurance related factors are independently associated with time to claim closure. Both factors need to be considered by insurers in their assessment of complexity of claims. Interventions aimed at minimising the impact of these factors could reduce claimants' exposure to the compensation system. In turn insurers can potentially reduce claims duration and cost, while improving the health outcomes of claimants. Copyright © 2015 Elsevier Ltd. All rights reserved.

Evaluation of selenium in dietary supplements using elemental speciation.

PubMed

Kubachka, Kevin M; Hanley, Traci; Mantha, Madhavi; Wilson, Robert A; Falconer, Travis M; Kassa, Zena; Oliveira, Aline; Landero, Julio; Caruso, Joseph

2017-03-01

Selenium-enriched dietary supplements containing various selenium compounds are readily available to consumers. To ensure proper selenium intake and consumer confidence, these dietary supplements must be safe and have accurate label claims. Varying properties among selenium species requires information beyond total selenium concentration to fully evaluate health risk/benefits A LC-ICP-MS method was developed and multiple extraction methods were implemented for targeted analysis of common "seleno-amino acids" and related oxidation products, selenate, selenite, and other species relatable to the quality and/or accuracy of the labeled selenium ingredients. Ultimately, a heated water extraction was applied to recover selenium species from non-selenized yeast supplements in capsule, tablet, and liquid forms. For selenized yeast supplements, inorganic selenium was monitored as a means of assessing selenium yeast quality. A variety of commercially available selenium supplements were evaluated and discrepancies between labeled ingredients and detected species were noted. Published by Elsevier Ltd.

Evaluation of selenium in dietary supplements using elemental speciation

PubMed Central

Kubachka, Kevin M.; Hanley, Traci; Mantha, Madhavi; Wilson, Robert A.; Falconer, Travis M.; Kassa, Zena; Oliveira, Aline; Landero, Julio; Caruso, Joseph

2016-01-01

Selenium-enriched dietary supplements containing various selenium compounds are readily available to consumers. To ensure proper selenium intake and consumer confidence, these dietary supplements must be safe and have accurate label claims. Varying properties among selenium species requires information beyond total selenium concentration to fully evaluate health risk/benefits A LC-ICP-MS method was developed and multiple extraction methods were implemented for targeted analysis of common “seleno-amino acids” and related oxidation products, selenate, selenite, and other species relatable to the quality and/or accuracy of the labeled selenium ingredients. Ultimately, a heated water extraction was applied to recover selenium species from non-selenized yeast supplements in capsule, tablet, and liquid forms. For selenized yeast supplements, inorganic selenium was monitored as a means of assessing selenium yeast quality. A variety of commercially available selenium supplements were evaluated and discrepancies between labeled ingredients and detected species were noted. PMID:27719915

FDA cigarette warning labels lower craving and elicit frontoinsular activation in adolescent smokers

PubMed Central

Do, Kathy T.

2015-01-01

Cigarette smoking is an economically and epidemiologically expensive public health concern. Most adult smokers become addicted during adolescence, rendering it a crucial period for prevention and intervention. Although litigation claims have delayed implementation, graphic warning labels proposed by the U.S. Food and Drug Administration (FDA) may be a promising way to achieve this goal. We aimed to determine the efficacy of the labels in reducing in-scanner craving and to characterize the neurobiological responses in adolescent and adult smokers and non-smokers. While undergoing functional magnetic resonance imaging, thirty-nine 13- to 18-year-old adolescent and forty-one 25- to 30-year-old adult smokers and non-smokers rated their desire to smoke when presented with emotionally graphic warning labels and comparison non-graphic labels. Compared with adult smokers, adolescent smokers exhibited greater craving reduction in response to the warning labels. Although smokers evinced overall blunted recruitment of insula and dorsolateral prefrontal cortex (DLPFC) relative to non-smokers, an effect that was stronger in adolescent smokers, parametrically increasing activation of these regions was associated with greater craving reduction. Functional connectivity analyses suggest that greater DLPFC regulation of limbic regions predicted cigarette craving. These data underscore a prominent role of frontoinsular circuitry in predicting the efficacy of FDA graphic warning labels in craving reduction in adult and adolescent smokers. PMID:25887154

Changes in Healthcare Utilization After Etanercept Initiation in Patients with Rheumatoid Arthritis: A Retrospective Claims Analysis.

PubMed

Accortt, Neil A; Schenfeld, Jennifer; Chang, Eunice; Papoyan, Elya; Broder, Michael S

2017-09-01

Effective treatment for rheumatoid arthritis (RA) may lead to lower overall and RA-related healthcare utilization. We evaluated healthcare utilization before and after initiation of the tumor necrosis factor inhibitor etanercept in patients with moderate to severe RA. This retrospective cohort study used data from the MarketScan ® claims database. Data from adult patients with RA newly exposed to etanercept between January 1, 2010 and December 31, 2013 were analyzed. Patients had at least one inpatient or outpatient claim for RA and at least one claim for etanercept (first claim was index date). Etanercept compliance was determined on the basis of proportion of days covered (PDC). Primary outcome was change in overall and RA-related healthcare utilization in the year before and year after etanercept initiation. McNemar's test and paired t test, respectively, were used to determine statistical significance for dichotomous and continuous variables. Data from 6737 patients were analyzed; mean age was 49.8 years and 77.3% were female. Overall outpatient services, office visits, outpatient hospital services, laboratory visits, and emergency department visits were significantly lower in the post-index period compared to pre-index. RA-related pharmacotherapy use (oral corticosteroids, opioid analgesics, nonsteroidal anti-inflammatory drugs, and nonbiologic disease-modifying antirheumatic drugs) was significantly lower in the post-index period compared to pre-index. Rates of RA-related total joint arthroplasty, joint reconstructions, and soft tissue procedures were similar in pre-index and post-index periods. High etanercept compliance (PDC ≥80%) was associated with significantly lower rates of RA-related outpatient services, office visits, diagnostic imaging studies, and joint reconstructions compared with noncompliance. Overall healthcare utilization decreased after etanercept initiation. Patients who were most compliant with etanercept had significantly lower utilization than less compliant patients. Amgen, Inc.

The Public Stigma of Mental Illness: What Do We Think; What Do We Know; What Can We Prove?

PubMed Central

Pescosolido, Bernice

2015-01-01

By the 1990s, sociology faced a frustrating paradox. Classic work on mental illness stigma and labeling theory reinforced that the “mark” of mental illness created prejudice and discrimination for individuals and family members. Yet that foundation, coupled with deinstitutionalization of mental health care, produced contradictory responses. Claims that stigma was dissipating were made, while others argued that intervention efforts were needed to reduce stigma. While signaling the critical role of theory-based research in establishing the pervasive effects of stigma, both claims directed resources away from social science research. Yet the contemporary scientific foundation underlying both claims was weak. A reply came in a resurgence of research directed toward mental illness stigma nationally and internationally, bringing together researchers from different disciplines for the first time. The author reports on the general population’s attitudes, beliefs, and behavioral dispositions that targeted public stigma and implications for the next decade of research and intervention efforts. PMID:23325423

Off-label prescribing to children: attitudes and experience of general practitioners

PubMed Central

Ekins-Daukes, Suzie; Helms, Peter J; Taylor, Michael W; McLay, James S

2005-01-01

Aim To identify experience with and attitudes towards paediatric off-label prescribing in primary care. Method A prospective questionnaire survey was sent to a sample of Scottish primary care practices (346 doctors in 80 general practices located throughout Scotland). Results Two hundred and two (58%) completed questionnaires were returned. Over 70% of GPs admitted to being familiar with the concept, and 40% to knowingly prescribing off-label. The most important sources of paediatric prescribing information were the British National Formulary (81%), personal experience (71%) and previous prescription notes (45%). The most common reason given by GPs for off-label prescribing was prescribing for a younger age than recommended, although prescribing data confirm that age is the least important and dose the most important reason for such prescribing. When asked to comment upon different causes for off-label prescribing, 80% of respondents expressed appropriate awareness of and concern for the described scenarios. Over 97% of GPs ranked development of paediatric formulations and clearer dosage information more highly than clinical trials as a means to reducing off-label prescribing. Conclusions Despite high levels of off-label prescribing in primary care in the UK, the majority of GPs claimed to be familiar with the concept, although less than half were aware of this common practice. A clear disparity between perceived and actual reasons for off-label prescribing was noted, possibly due to a reliance on personal experience, colleague experience or previous patient prescription notes as a guide to prescribing. PMID:16042667

21 CFR 314.550 - Promotional materials.

Code of Federal Regulations, 2013 CFR

2013-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS..., including promotional labeling as well as advertisements, intended for dissemination or publication within... intended time of initial dissemination of the labeling or initial publication of the advertisement. ...

21 CFR 314.550 - Promotional materials.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS..., including promotional labeling as well as advertisements, intended for dissemination or publication within... intended time of initial dissemination of the labeling or initial publication of the advertisement. ...

21 CFR 314.550 - Promotional materials.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS..., including promotional labeling as well as advertisements, intended for dissemination or publication within... intended time of initial dissemination of the labeling or initial publication of the advertisement. ...

21 CFR 314.550 - Promotional materials.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS..., including promotional labeling as well as advertisements, intended for dissemination or publication within... intended time of initial dissemination of the labeling or initial publication of the advertisement. ...

Regulation Catches Up to Reality.

PubMed

Edelman, Steven V

2017-01-01

The FDA recently conducted an Advisory Panel meeting to evaluate the safety, efficacy, and benefits of granting a nonadjunctive label claim for the DEXCOM G5 Mobile continuous glucose monitoring (CGM) system. If approved, this claim will allow users to make day-to-day treatment decisions, including insulin dosing directly from the glucose values and rate of changes arrows generated by the CGM device, without the requirement of a confirmatory measurement with a self-monitoring blood glucose (SMBG) meter. Sporadic SMBG testing gives limited data, while CGM gives a value every 5 minutes and has alerts, alarms, trending information and allows caregivers to follow the user in real time 24/7. This indication will lead to more wide spread use of CGM and improve overall care with protection of hypoglycemia.

43 CFR 2562.1 - Initiation of claim.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Public Lands: Interior Regulations Relating to Public Lands (Continued) BUREAU OF LAND MANAGEMENT, DEPARTMENT OF THE INTERIOR LAND RESOURCE MANAGEMENT (2000) ALASKA OCCUPANCY AND USE Trade and Manufacturing... productive industry, must file notice of the claim for recordation in the proper office for the district in...

21 CFR 101.65 - Implied nutrient content claims and related label statements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... must contain... (A) A raw fruit or vegetable Low fat as defined in § 101.62(b)(2) Low saturated fat as... raw, single-ingredient seafood or game meat Less than 5 grams (g) total fat per RA2 and per 100 g Less... practices such as vegetarianism or other nonnutrition related reason, e.g., “100 percent milk free;” (2) A...

Self-Concepts and Values Among Hispanic and Mainstream Navy Recruits.

DTIC Science & Technology

1982-02-01

used constructs among social scientists, humanists, and the public. Even philosophers deal with values in a special subdivision of their discipline... social science research on values as ethnocentric and they -. . . --s- ~ ~ ’ . -- -2- claim that it tends to label Hispanic values as inferior. Baca...their psycho- social characteristics. Whatley (1976), for example, found significant differences in values between first, second, third and fourth

Pangamic Acid (Vitamin B15, Pangametin, Sopangamine)

PubMed Central

French, W. N.; Levi, Leo

1966-01-01

Pangamic acid is shown to be a mixture of variable composition. Criteria of identity and methods of analysis are described for five pharmaceutical dosage forms. Experimental results indicate that the products are not uniform in composition and that composition does not conform to label claims. No satisfactory preclinical drug application for any such preparation has so far been submitted to the Food and Drug Directorate. PMID:5295884

76 FR 35619 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-17

...The Food and Drug Administration (FDA) is issuing this document to address labeling and effectiveness testing for certain over-the counter (OTC) sunscreen products containing specified active ingredients and marketed without approved applications. This document addresses labeling and effectiveness testing issues raised by the nearly 2,900 submissions that we received in response to the sunscreen proposed rule of August 27, 2007 (2007 proposed rule). The document also identifies specific claims that render a product that is subject to this rule misbranded or would not be allowed on any OTC sunscreen product marketed without an approved application. The document does not address issues related to sunscreen active ingredients or certain other issues regarding the GRASE determination for sunscreen products. The document requires OTC sunscreen products to comply with the content and format requirements for OTC drug labeling contained in the 1999 Drug Facts final rule (published in the Federal Register of March 17, 1999, by lifting the delay of implementation date for that rule that we published on September 3, 2004).

38 CFR 20.1510 - Rule 1510. Termination of the Initiative.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the Initiative. 20.1510 Section 20.1510 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF VETERANS AFFAIRS (CONTINUED) BOARD OF VETERANS' APPEALS: RULES OF PRACTICE Expedited Claims Adjudication Initiative-Pilot Program § 20.1510 Rule 1510. Termination of the Initiative. VA may terminate the Initiative at any...

Mundane science use in a practice theoretical perspective: Different understandings of the relations between citizen-consumers and public communication initiatives build on scientific claims.

PubMed

Halkier, Bente

2015-08-13

Public communication initiatives play a part in placing complicated scientific claims in citizen-consumers' everyday contexts. Lay reactions to scientific claims framed in public communication, and attempts to engage citizens, have been important subjects of discussion in the literatures of public understanding and public engagement with science. Many of the public communication initiatives, however, address lay people as consumers rather than citizens. This creates specific challenges for understanding public engagement with science and scientific citizenship. The article compares five different understandings of the relations between citizen-consumers and public issue communication involving science, where the first four types are widely represented in the Public Understanding of Science discussions. The fifth understanding is a practice theoretical perspective. The article suggests how the public understanding of and engagement in science literature can benefit from including a practice theoretical approach to research about mundane science use and public engagement. © The Author(s) 2015.

A tale of three labels: translating the JUPITER trial data into regulatory claims.

PubMed

Ridker, Paul M

2011-08-01

Whether a pivotal randomized trial will be interpreted in a similar and consistent manner by different regulatory agencies is uncertain as policy perspectives may play a role in data interpretation and the translation of trial results into clinical practice. Using a contemporary example, to compare and contrast regulatory claims in the United States, Europe, and Canada that derive from a pivotal clinical trial. The recently completed JUPITER trial of rosuvastatin as compared to placebo conducted among 17,802 men and women with LDL-C <130 mg/dL and hsCRP ≥ 2 mg/L, provides the only available data on rosuvastatin for primary prevention of cardiovascular disease. Thus, the JUPITER trial provides an opportunity to compare and contrast how regulatory agencies in the United States, Canada, and Europe chose to interpret an identical database. Labeling indications based on earlier statin trials of primary and secondary prevention were also reviewed. JUPITER demonstrated a 44% reduction (p < 0.000001) in the trial pre-specified primary endpoint (nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, coronary revascularization, or cardiovascular death) with no evidence of heterogeneity across geographic regions. In response to these data, the US Food and Drug Administration label for rosuvastatin in primary prevention came closest to the actual JUPITER trial population by stipulating that those eligible for treatment should be older men and women with hsCRP >2 mg/L, plus one additional risk factor for heart disease. The Canadian label is silent on age and hsCRP (the major trial inclusion criterion), stipulating instead that treatment can be considered for those with 'at least two conventional risk factors for cardiovascular disease,' a group more inclusive than that studied. In contrast, the European Medicines Agency label limits treatment only to 'high risk individuals' ignoring hsCRP and using instead a post hoc definition of 'high risk' that comprised a subgroup of less than 10% of the study population who contributed but 67 events to the study total and did not show statistical significance when compared to placebo. None of the regulatory labels included the trial primary endpoint; instead, each focused on separate and different components of the primary endpoint. Similar discrepancies were found between European and North American regulatory agencies with regard to earlier pivotal trials of statins for primary prevention, but not for secondary prevention. The JUPITER experience represents a case study and is not a systematic review of the regulatory decision process. Labeling indications can vary widely in different regulatory environments even when based on the same trial data.

Ultrastructural and cytochemical evidence for single impulse initiation zones in vestibular macular nerve fibers of rat

NASA Technical Reports Server (NTRS)

Ross, Muriel D.; Chee, Oliver; Black, Samuel; Cutler, Lynn

1991-01-01

Cupric ion-ferricyanide labeling methods and related ferrocyanide-stained tissues were used to locate the characterize, at the ultrastructural level, presumptive impulse initiation zones in the three types of vestibular macular nerve fibers. Large-diameter, M-type vestibular nerve fibers terminate in a calyx at the heminode, and labeling is coextensive with the base of the calyx. Intermediate, M/U-type nerve fibers have short, unmyelinated preterminal segments that sometimes bifurcate intamacularly, and small-diameter, U-type nerve fibers have long, unmyelinated preterminal axons and up to three branches. Preterminals of these nerve fibers display ultrastructural heterogeneity that is correlated with labeling patterns for sodium channels and/or associated polyanionic sites. They have a nodelike ultrastructure and label heavily from near the heminode to the base of the macula. Their intramacular branches, less organized ultrastructurally, label only slightly. Results indicate that vestibular nerve fibers have one impulse initiation zone, located near the heminode, that varies in length according to nerve fiber type. Structural heterogeneity may favor impulse conduction in the central direction, and length of the impulse initiation zone could influence nerve discharge patterns.

Consumer awareness and interest toward sodium reduction trends in Korea.

PubMed

Kim, Mina K; Lee, Kwang-Geun

2014-07-01

Reduction of dietary sodium intake by lowering amount of sodium in foods is a global industry target. Quantitative information on current consumer knowledge of sodium reduction trends in Korea is unknown. The objective of this study was to quantify the consumer knowledge and awareness of sodium and salt reduction in foods and to characterize consumer interest in health labeling on the food package. Additionally, comparison of consumer knowledge status between Korea and United States was followed. Consumers (n = 289) participated in an internet survey designed to gauge consumer knowledge and attitudes toward dietary sodium, the sodium content in representative food products (n = 27), and their interest toward specific health claims, including sodium labeling. Questions regarding demographics as well as consumption characteristics were asked. Sodium knowledge index and saltiness belief index were calculated based on the number of correct responses regarding the salt level and sodium content in given food products. Kano analysis was conducted to determine the role of nutrition labels in consumer satisfaction with products. Current consumer knowledge on the sodium content in food products was high, and consumers were adept at matching the sodium content with the salty taste intensity of food products. Consumers' knowledge of the relationship between diets high in sodium and an increased risk of developing previously reported sodium-related diseases, such as hypertension, coronary heart disease, kidney disease, and stomach cancer, were also high. Information on the nutrition panel that influences the consumer satisfaction (trans-fat, sodium, ingredient list, and country of origin) as well as adjective-nutrition claim pairs that appeal positively to purchase intent of the product were identified. This work provided the current status of Korean consumer knowledge on the amount of sodium in food and that sodium can be a risk factor of developing chronic diseases. It also provided practical information to food marketers on what consumers like and what they want to see on product labels in Korea. © 2014 Institute of Food Technologists®

32 CFR 516.35 - Preparation of claims for litigation.

Code of Federal Regulations, 2011 CFR

2011-07-01

... AUTHORITIES AND PUBLIC RELATIONS LITIGATION Legal Proceedings Initiated by the United States Medical Care and... applicable state law. (See Fed. R. Civ. P. 11) (2) Copies of all medical records and bills reflecting the... for litigation should briefly summarize the facts giving rise to the claim and the collection actions...

20 CFR 405.901 - Reimbursement of certain travel expenses.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Reimbursement of certain travel expenses. 405... FOR ADJUDICATING INITIAL DISABILITY CLAIMS Payment of Certain Travel Expenses § 405.901 Reimbursement of certain travel expenses. When you file a disability claim, you may incur certain travel expenses...

The impact of front-of-pack marketing attributes versus nutrition and health information on parents' food choices.

PubMed

Georgina Russell, Catherine; Burke, Paul F; Waller, David S; Wei, Edward

2017-09-01

Front-of-pack attributes have the potential to affect parents' food choices on behalf of their children and form one avenue through which strategies to address the obesogenic environment can be developed. Previous work has focused on the isolated effects of nutrition and health information (e.g. labeling systems, health claims), and how parents trade off this information against co-occurring marketing features (e.g. product imagery, cartoons) is unclear. A Discrete Choice Experiment was utilized to understand how front-of-pack nutrition, health and marketing attributes, as well as pricing, influenced parents' choices of cereal for their child. Packages varied with respect to the two elements of the Australian Health Star Rating system (stars and nutrient facts panel), along with written claims, product visuals, additional visuals, and price. A total of 520 parents (53% male) with a child aged between five and eleven years were recruited via an online panel company and completed the survey. Product visuals, followed by star ratings, were found to be the most significant attributes in driving choice, while written claims and other visuals were the least significant. Use of the Health Star Rating (HSR) system and other features were related to the child's fussiness level and parents' concerns about their child's weight with parents of fussy children, in particular, being less influenced by the HSR star information and price. The findings suggest that front-of-pack health labeling systems can affect choice when parents trade this information off against marketing attributes, yet some marketing attributes can be more influential, and not all parents utilize this information in the same way. Copyright © 2017. Published by Elsevier Ltd.

Electronic nicotine delivery systems: is there a need for regulation?

PubMed

Trtchounian, Anna; Talbot, Prue

2011-01-01

Electronic nicotine delivery systems (ENDS) purport to deliver nicotine to the lungs of smokers. Five brands of ENDS were evaluated for design features, accuracy and clarity of labelling and quality of instruction manuals and associated print material supplied with products or on manufacturers' websites. ENDS were purchased from online vendors and analysed for various parameters. While the basic design of ENDS was similar across brands, specific design features varied significantly. Fluid contained in cartridge reservoirs readily leaked out of most brands, and it was difficult to assemble or disassemble ENDS without touching nicotine-containing fluid. Two brands had designs that helped lessen this problem. Labelling of cartridges was very poor; labelling of some cartridge wrappers was better than labelling of cartridges. In general, packs of replacement cartridges were better labelled than the wrappers or cartridges, but most packs lacked cartridge content and warning information, and sometimes packs had confusing information. Used cartridges contained fluid, and disposal of nicotine-containing cartridges was not adequately addressed on websites or in manuals. Orders were sometimes filled incorrectly, and safety features did not always function properly. Print and internet material often contained information or made claims for which there is currently no scientific support. Design flaws, lack of adequate labelling and concerns about quality control and health issues indicate that regulators should consider removing ENDS from the market until their safety can be adequately evaluated.

The health fraud battle. Education is the best defense.

PubMed

Johnson, G C; Gottesman, R A

1989-06-01

Despite the regulatory and educational efforts of the Food and Drug Administration and other agencies and organizations, large numbers of American consumers continue to be fooled by unsubstantiated "miracle cure" claims made by manufacturers of fraudulent medical products. Physicians who are familiar with the language of health fraud advertising and product labels may be able to help patients avoid unnecessary expense, false hope, and physical and emotional harm.

"A Nation at Risk" Crosses the Pacific: Transnational Borrowing of the U.S. Crisis Discourse in the Debate on Education Reform in Japan

ERIC Educational Resources Information Center

Takayama, Keita

2007-01-01

There are three notable aspects to the recent crisis discourse in Japanese education. First, it is highly questionable whether the current state of Japanese education is deserving of a sensationalist label. Japanese scholars who were dubious of the crisis claim pointed to its highly ideological nature and to the lack of reliable longitudinal data…

Pork as a Source of Omega-3 (n-3) Fatty Acids

PubMed Central

Dugan, Michael E.R.; Vahmani, Payam; Turner, Tyler D.; Mapiye, Cletos; Juárez, Manuel; Prieto, Nuria; Beaulieu, Angela D.; Zijlstra, Ruurd T.; Patience, John F.; Aalhus, Jennifer L.

2015-01-01

Pork is the most widely eaten meat in the world, but typical feeding practices give it a high omega-6 (n-6) to omega-3 (n-3) fatty acid ratio and make it a poor source of n-3 fatty acids. Feeding pigs n-3 fatty acids can increase their contents in pork, and in countries where label claims are permitted, claims can be met with limited feeding of n-3 fatty acid enrich feedstuffs, provided contributions of both fat and muscle are included in pork servings. Pork enriched with n-3 fatty acids is, however, not widely available. Producing and marketing n-3 fatty acid enriched pork requires regulatory approval, development costs, quality control costs, may increase production costs, and enriched pork has to be tracked to retail and sold for a premium. Mandatory labelling of the n-6/n-3 ratio and the n-3 fatty acid content of pork may help drive production of n-3 fatty acid enriched pork, and open the door to population-based disease prevention polices (i.e., food tax to provide incentives to improve production practices). A shift from the status-quo, however, will require stronger signals along the value chain indicating production of n-3 fatty acid enriched pork is an industry priority. PMID:26694475

Quantitative Evaluation of Compliance with Recommendation for Sulfonylurea Dose Co-Administered with DPP-4 Inhibitors in Japan

PubMed Central

Kimura, Tomomi; Shiosakai, Kazuhito; Takeda, Yasuaki; Takahashi, Shinji; Kobayashi, Masahiko; Sakaguchi, Motonobu

2012-01-01

After the launch of dipeptidyl peptidase-4 (DPP-4), a new oral hypoglycemic drug (OHD), in December 2009, severe hypoglycemia cases were reported in Japan. Although the definite cause was unknown, co-administration with sulfonylureas (SU) was suspected as one of the potential risk factors. The Japan Association for Diabetes Education and Care (JADEC) released a recommendation in April 2010 to lower the dose of three major SUs (glimepiride, glibenclamide, and gliclazide) when adding a DPP-4 inhibitor. To evaluate the effectiveness of this risk minimization action along with labeling changes, dispensing records for 114,263 patients prescribed OHDs between December 2008 and December 2010 were identified in the Nihon-Chouzai pharmacy claims database. The adherence to the recommended dosing of SU co-prescribed with DPP-4 inhibitors increased from 46.3% before to 63.8% after the JADEC recommendation (p < 0.01 by time-series analysis), while no change was found in those for SU monotherapy and SU with other OHD co-prescriptions. The adherence was significantly worse for those receiving a glibenclamide prescription. The JADEC recommendation, along with labeling changes, appeared to have a favorable effect on the risk minimization action in Japan. In these instances, a pharmacy claims database can be a useful tool to evaluate risk minimization actions. PMID:24300302

Pork as a Source of Omega-3 (n-3) Fatty Acids.

PubMed

Dugan, Michael E R; Vahmani, Payam; Turner, Tyler D; Mapiye, Cletos; Juárez, Manuel; Prieto, Nuria; Beaulieu, Angela D; Zijlstra, Ruurd T; Patience, John F; Aalhus, Jennifer L

2015-12-16

Pork is the most widely eaten meat in the world, but typical feeding practices give it a high omega-6 (n-6) to omega-3 (n-3) fatty acid ratio and make it a poor source of n-3 fatty acids. Feeding pigs n-3 fatty acids can increase their contents in pork, and in countries where label claims are permitted, claims can be met with limited feeding of n-3 fatty acid enrich feedstuffs, provided contributions of both fat and muscle are included in pork servings. Pork enriched with n-3 fatty acids is, however, not widely available. Producing and marketing n-3 fatty acid enriched pork requires regulatory approval, development costs, quality control costs, may increase production costs, and enriched pork has to be tracked to retail and sold for a premium. Mandatory labelling of the n-6/n-3 ratio and the n-3 fatty acid content of pork may help drive production of n-3 fatty acid enriched pork, and open the door to population-based disease prevention polices (i.e., food tax to provide incentives to improve production practices). A shift from the status-quo, however, will require stronger signals along the value chain indicating production of n-3 fatty acid enriched pork is an industry priority.

Selected physical and chemical properties of Feverfew (Tanacetum parthenium) extracts important for formulated product quality and performance.

PubMed

Jin, Ping; Madieh, Shadi; Augsburger, Larry L

2008-01-01

The objectives of this research are: (1) to assess selected formulation-relevant physical properties of several commercial Feverfew extracts, including flowability, hygroscopicity, compressibility and compactibility (2) to develop and validate a suitable extraction method and HPLC assay, and (3) to determine the parthenolide content of several commercial Feverfew extracts. Carr's index, minimum orifice diameter and particle-particle interaction were used to evaluate powder flowability. Hygroscopicity was evaluated by determining the equilibrium moisture content (EMC) after storage at various % relative humidities. Heckle analysis and compression pressure-radial tensile strength relationship were used to represent compression and compaction properties of feverfew extracts. An adapted analytical method was developed based on literature methods and then validated for the determination of parthenolide in feverfew. The commercial extracts tested exhibited poor to very poor flowability. The comparatively low mean yield pressure suggested that feverfew extracts deformed mainly plastically. Hygroscopicity and compactibility varied greatly with source. No commercial feverfew extracts tested contained the label claimed parthenolide. Even different batches from the same manufacturer showed significantly different parthenolide content. Therefore, extract manufactures should commit to proper quality control procedures that ensure accurate label claims, and supplement manufacturers should take into account possible differences in physico-chemical properties when using extracts from multiple suppliers.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Golfinopoulos, A.; Soupioni, M.; Kanellaki, M.

The effect of initial lactose concentration on lactose uptake rate by kefir free cells, during the lactose fermentation, was studied in this work. For the investigation {sup 14}C-labelled lactose was used due to the fact that labeled and unlabeled molecules are fermented in the same way. The results illustrated lactose uptake rates are about up to two fold higher at lower initial (convolution sign)Be densities as compared with higher initial (convolution sign)Be densities.

Court finds ambiguity in denial of off-label AIDS drug.

PubMed

1998-03-06

A home intravenous drug therapy provider and an insurance company operated by the American Consulting Engineers Council have gone to court over disputed medical claims. An AIDS patient being treated with ganciclovir for CMV retinitis had a decrease in his white blood cell count, neutropenia, that endangered his life. The physicians prescribed neupogen, approved by the Food and Drug Administration (FDA) for cancer treatment, to counteract the neutropenia. The health care provider, I.V. Services of America, continued the neupogen treatment; the treatments were covered as an inpatient but denied after discharge. I.V. Services sued, alleging that the cause of the neutropenia should not bar coverage. The New York judge found in favor of the health care provider, calling the insurance company's position self serving and the denial of the claim arbitrary.

Caffeine-based food supplements and beverages: Trends of consumption for performance purposes and safety concerns.

PubMed

Bessada, Sílvia M F; Alves, Rita C; Oliveira, M Beatriz P P

2018-07-01

Nowadays, daily food supplementation regarding the improvement of physical and mental performance is a growing trend in sport practitioners, young students and active people. Food supplements are foodstuffs, labeled under food law and not obliged to safety assessments before their commercialization. Several products are commercialized claiming ergogenic effects as marketing strategies. Caffeine is often one of their main ingredients, as it increases both physical performance and concentration. This manuscript presents a general overview of the current caffeine-based food supplements and energy drinks available in the Portuguese market, as well as the consuming trends regarding their ergogenic effects, performance purposes, and active ingredients. Product claims, recommended daily intakes, caffeine pharmacology, and safety concerns aspects are also discussed aspects. Copyright © 2018 Elsevier Ltd. All rights reserved.

The effect of Employee Assistance Programs use on healthcare utilization.

PubMed

Zarkin, G A; Bray, J W; Qi, J

2000-04-01

To estimate the effect of Employee Assistance Program (EAP) use on healthcare utilization as measured by health claims. A unique data set that combines individual-level information on EAP utilization, demographic information, and health insurance claims from 1991 to 1995 for all employees of a large midwestern employer. Using "fixed-effect" econometric models that control for unobserved differences between individuals' propensities to use healthcare resources and the EAP, we perform our analyses in two steps. First, for those employees who visited the EAP, we test whether post-EAP claims differ from pre-EAP claims. Second, we combine claims data of individuals who went to an EAP with those of individuals who did not use an EAP to test whether differences in utilization exist between EAP users and nonusers. From the EAP we obtained the date of first EAP contact for all employees who used the service, and from the company's human resources department we obtained limited demographic data on all employees. We obtained healthcare utilization claims data on all employees and their dependents from the company's two healthcare plans: a fee-for-service (FFS) plan and a health maintenance organization (HMO) plan. We found that going to an EAP substantially increases both the probability of an alcohol, drug abuse, or mental health (ADM) claim and the number of ADM claims in the same quarter as EAP contact. The increased probability of an ADM claim persists for approximately 11 quarters after the initial contact, while the increased ADM charges persist for approximately six quarters after the initial EAP contact. Our results strongly suggest that the EAP is able to identify behavioral and other health problems that may affect workplace performance and prompt EAP users to access ADM and other healthcare. Consistent with the stated goals of many EAPs, including the one examined in this study, this process should improve individuals' health, family functioning, and workplace performance.

The effect of Employee Assistance Programs use on healthcare utilization.

PubMed Central

Zarkin, G A; Bray, J W; Qi, J

2000-01-01

OBJECTIVE: To estimate the effect of Employee Assistance Program (EAP) use on healthcare utilization as measured by health claims. DATA SOURCES: A unique data set that combines individual-level information on EAP utilization, demographic information, and health insurance claims from 1991 to 1995 for all employees of a large midwestern employer. STUDY DESIGN: Using "fixed-effect" econometric models that control for unobserved differences between individuals' propensities to use healthcare resources and the EAP, we perform our analyses in two steps. First, for those employees who visited the EAP, we test whether post-EAP claims differ from pre-EAP claims. Second, we combine claims data of individuals who went to an EAP with those of individuals who did not use an EAP to test whether differences in utilization exist between EAP users and nonusers. DATA COLLECTION METHODS: From the EAP we obtained the date of first EAP contact for all employees who used the service, and from the company's human resources department we obtained limited demographic data on all employees. We obtained healthcare utilization claims data on all employees and their dependents from the company's two healthcare plans: a fee-for-service (FFS) plan and a health maintenance organization (HMO) plan. PRINCIPAL FINDINGS: We found that going to an EAP substantially increases both the probability of an alcohol, drug abuse, or mental health (ADM) claim and the number of ADM claims in the same quarter as EAP contact. The increased probability of an ADM claim persists for approximately 11 quarters after the initial contact, while the increased ADM charges persist for approximately six quarters after the initial EAP contact. CONCLUSIONS: Our results strongly suggest that the EAP is able to identify behavioral and other health problems that may affect workplace performance and prompt EAP users to access ADM and other healthcare. Consistent with the stated goals of many EAPs, including the one examined in this study, this process should improve individuals' health, family functioning, and workplace performance. PMID:10778825

Injuries and illnesses from wood framing in residential construction, Washington State, 1993-1999.

PubMed

Shah, Syed Mahboob Ali; Bonauto, David; Silverstein, Barbara; Foley, Michael; Kalat, John

2003-11-01

The construction industry is associated with high rates of work-related injury. We used workers compensation data to describe the injuries and illnesses, claim rates, and claim costs associated with wood framing activities in construction. From 1993 to 1999, there were 33,021 accepted state fund workers compensation claims with direct costs of over $197 million. The average annual claim rate was 45 per 100 full-time equivalent. Statistically significant downward trends were noted in claim rates for all injuries and illnesses, compensable time loss claims, eye and fall injuries. However, these trends were not statistically significantly different from those observed in all other construction risk classes combined. The information in this report can be used to guide prevention efforts and to evaluate the effectiveness of Washington state initiatives to reduce injury and illness rates in wood frame construction.

Influence of label information on dark chocolate acceptability.

PubMed

Torres-Moreno, M; Tarrega, A; Torrescasana, E; Blanch, C

2012-04-01

The aim of the present work was to study how the information on product labels influences consumer expectations and their acceptance and purchase intention of dark chocolate. Six samples of dark chocolate, varying in brand (premium and store brand) and in type of product (regular dark chocolate, single cocoa origin dark chocolate and high percentage of cocoa dark chocolate), were evaluated by 109 consumers who scored their liking and purchase intention under three conditions: blind (only tasting the products), expected (observing product label information) and informed (tasting the products together with provision of the label information). In the expected condition, consumer liking was mainly affected by the brand. In the blind condition, differences in liking were due to the type of product; the samples with a high percentage of cocoa were those less preferred by consumers. Under the informed condition, liking of dark chocolates varied depending on both brand and type of product. Premium brand chocolates generated high consumer expectations of chocolate acceptability, which were fulfilled by the sensory characteristics of the products. Store brand chocolates created lower expectations, but when they were tasted they were as acceptable as premium chocolates. Claims of a high percentage of cocoa and single cocoa origin on labels did not generate higher expectations than regular dark chocolates. Copyright © 2011 Elsevier Ltd. All rights reserved.

Adolescents perceived effectiveness of the proposed European graphic tobacco warning labels.

PubMed

Vardavas, Constantine I; Connolly, Gregory; Karamanolis, Kostas; Kafatos, Anthony

2009-04-01

Graphical tobacco product labelling is a prominent source of health information and has an important position among tobacco control initiatives. However, little is known about its effectiveness among adolescents. With this above in mind, we aimed to research into how adolescents perceive the proposed EU graphic tobacco product warning labels as an effective means of preventing smoking initiation in comparison to the current EU text-only warning labels. Five hundred seventy four adolescents (13-18, 54% male) from Greece were privately interviewed, with the use of a digital questionnaire and randomly shown seven existing EU text-only and proposed EU graphic warning labels. Non-smoking respondents were asked to compare and rate the warnings effectiveness in regard to preventing them from smoking on a 1-5 Likert type scale. Irrespective of the warning category shown, on all occasions, non-smoking adolescents rated the suggested EU graphic labels as more effective in preventing them from smoking in comparison to the existing EU text-only warnings. Controlling for gender, age, current smoking status and number of cigarettes smoked per month, younger adolescents were found to opt for graphic warnings more often, and also perceive graphic warning labels as a more effective means of preventing them from smoking, in comparison to their elder peers (P < 0.001). The proposed EU graphic warning labels may play an important role in preventing of smoking initiation during the crucial years of early adolescence when smoking experimentation and early addiction usually take place.

The targeting mechanism of DHA ligand and its conjugate with Gemcitabine for the enhanced tumor therapy

PubMed Central

Li, Siwen; Qin, Jingyi; Tian, Caiping; Cao, Jie; Fida, Guissi; Wang, Zhaohui; Chen, Haiyan; Qian, Zhiyu; Chen, Wei R; Gu, Yueqing

2014-01-01

Docosahexaenoic acid (DHA), an omega-3 C22 natural fatty acid serving as a precursor for metabolic and biochemical pathways, was reported as a targeting ligand of anticancer drugs. However, its tumor targeting ability and mechanism has not been claimed. Here we hypothesized that the uptake of DHA by tumor cells is related to the phosphatidylethanolamine (PE) contents in cell membranes. Thus, in this manuscript, the tumor-targeting ability of DHA was initially demonstrated in vitro and in vivo on different tumor cell lines by labeling DHA with fluorescence dyes. Subsequently, the tumor targeting ability was then correlated with the contents of PE in cell membranes to study the uptake mechanism. Further, DHA was conjugated with anticancer drug gemcitabine (DHA-GEM) for targeted tumor therapy. Our results demonstrated that DHA exhibited high tumor targeting ability and PE is the main mediator, which confirmed our hypothesis. The DHA-GEM displayed enhanced therapeutic efficacy than that of GEM itself, indicating that DHA is a promising ligand for tumor targeted therapy. PMID:25004114

38 CFR 20.1502 - Rule 1502. Eligibility.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (CONTINUED) BOARD OF VETERANS' APPEALS: RULES OF PRACTICE Expedited Claims Adjudication Initiative-Pilot Program § 20.1502 Rule 1502. Eligibility. To participate in the Initiative, a claimant must: (a) At the...

Arsenic-Based Life: An Active Learning Assignment for Teaching Scientific Discourse

ERIC Educational Resources Information Center

Johnson, R. Jeremy

2017-01-01

Among recent high profile scientific debates was the proposal that life could exist with arsenic in place of phosphorous in its nucleic acids and other biomolecules. Soon after its initial publication, scientists across diverse disciplines began to question this extraordinary claim. Using the original article, its claims, its scientific support,…

The Regional Dimension of Education Hubs: Leading and Brokering Geopolitics

ERIC Educational Resources Information Center

Lee, Jack T.

2015-01-01

Several education hubs have emerged in the last decade in Asia and the Middle East. These ambitious policy initiatives share a common interest in cross-border higher education even though diverse rationales underpin their development. While some claim to be an international education hub, others claim to be a regional education hub or…

77 FR 22204 - Administrative Claims Under the Federal Tort Claims Act and Related Statutes

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

...) since the last time the regulations were updated. These regulations are being amended to reflect those... rule. All interested parties should comment at this time because we will not initiate an additional... Job Corps activity; (3) They are in authorized travel status; or (4) They are engaged in any...

Order of Operations: On Convention and Met-Before Acronyms

ERIC Educational Resources Information Center

Zazkis, Rina; Rouleau, Annette

2018-01-01

In our exploration of the order of operations we focus on the following claim: "In the conventional order of operations, division should be performed before multiplication." This initially surprising claim is based on the acronym BEDMAS, a popular mnemonic used in Canada to assist students in remembering the order of operations. The…

20 CFR 405.705 - When the expedited appeals process may be used.

Code of Federal Regulations, 2010 CFR

2010-04-01

... PROCESS FOR ADJUDICATING INITIAL DISABILITY CLAIMS Expedited Appeals Process for Constitutional Issues § 405.705 When the expedited appeals process may be used. If you have filed a disability claim, you may... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false When the expedited appeals process may be...

Functional food awareness and perceptions in relation to information sources in older adults.

PubMed

Vella, Meagan N; Stratton, Laura M; Sheeshka, Judy; Duncan, Alison M

2014-05-17

The functional food industry has experienced innovative and economic expansion, yet research into consumer perceptions of functional foods and their associated health claims is limited. Among consumers, older adults could benefit from functional foods due to age-related issues pertaining to food and health. The purpose of this research was to identify the need for information related to functional foods among older adults (≥60 years old) and to assess awareness and perceptions of health claims on functional food packages. Community-dwelling older adults (n = 200) completed a researcher administered questionnaire designed to collect information about functional foods including current consumption, motivating factors for consumption, perceived need for information, sources of information for functional foods and awareness of health claims. Prevalence of functional food consumption among participants was 93.0%. Increased awareness and knowledge was the most commonly reported factor that would promote functional food consumption (85.5%) and 63.5% of participants wanted more information about functional foods with preferred sources being newspapers/magazines/books (68.5%) and food labels (66.1%). Participants were predominately (93.5%) aware of health claims on functional foods and those with more education were more likely to report being aware of health claims (p = 0.045). Although functional food consumption among older adults in this sample is high, there is a need for further information regarding functional foods. These results inform stakeholders regarding the potential for information to influence functional food acceptance among older adult consumers.

From the SAIN,LIM system to the SENS algorithm: a review of a French approach of nutrient profiling.

PubMed

Tharrey, Marion; Maillot, Matthieu; Azaïs-Braesco, Véronique; Darmon, Nicole

2017-08-01

Nutrient profiling aims to classify or rank foods according to their nutritional composition to assist policies aimed at improving the nutritional quality of foods and diets. The present paper reviews a French approach of nutrient profiling by describing the SAIN,LIM system and its evolution from its early draft to the simplified nutrition labelling system (SENS) algorithm. Considered in 2010 by WHO as the 'French model' of nutrient profiling, SAIN,LIM classifies foods into four classes based on two scores: a nutrient density score (NDS) called SAIN and a score of nutrients to limit called LIM, and one threshold on each score. The system was first developed by the French Food Standard Agency in 2008 in response to the European regulation on nutrition and health claims (European Commission (EC) 1924/2006) to determine foods that may be eligible for bearing claims. Recently, the European regulation (EC 1169/2011) on the provision of food information to consumers allowed simplified nutrition labelling to facilitate consumer information and help them make fully informed choices. In that context, the SAIN,LIM was adapted to obtain the SENS algorithm, a system able to rank foods for simplified nutrition labelling. The implementation of the algorithm followed a step-by-step, systematic, transparent and logical process where shortcomings of the SAIN,LIM were addressed by integrating specificities of food categories in the SENS, reducing the number of nutrients, ordering the four classes and introducing European reference intakes. Through the French example, this review shows how an existing nutrient profiling system can be specifically adapted to support public health nutrition policies.

Assessment of hypoallergenicity of ten skincare products.

PubMed

Brandt, Staci; Lio, Peter

2014-03-01

Sensitive skin is a common skin complaint frequently associated with skin diseases or adverse reactions to cosmetic products. Manufacturers have produced numerous products targeted for patients with sensitive skin and frequently label these products as being hypoallergenic. This term implies that the product may be less likely to cause an allergic reaction and be better suited for those with sensitive skin. However, there is no federal regulatory definition of this term and products may not have clinical support of their claim. Patch testing ingredients is frequently done to identify potential irritants; however, patch-testing product formulations may provide more realistic expectations about potential skin sensitivity and help support claims of hypoallergenicity. Ten skincare products were assessed for their sensitizing potential and hypoallergenicity in 14 repeat insult patch test clinical studies, involving over 2,000 subjects. In these studies, the products were deemed to be hypoallergenic if there was no evidence of sensitization or allergic reactions. The results from these trials demonstrated that all ten products were well tolerated, showed no sensitization or allergic reactions, and support claims of hypoallergenicity.

Viability and proliferation potential of adipose-derived stem cells following labeling with a positron-emitting radiotracer.

PubMed

Elhami, Esmat; Goertzen, Andrew L; Xiang, Bo; Deng, Jixian; Stillwell, Chris; Mzengeza, Shadreck; Arora, Rakesh C; Freed, Darren; Tian, Ganghong

2011-07-01

Adipose-derived stem cells (ASCs) have promising potential in regenerative medicine and cell therapy. Our objective is to examine the biological function of the labeled stem cells following labeling with a readily available positron emission tomography (PET) tracer, (18)F-fluoro-2-deoxy-D: -glucose (FDG). In this work we characterize labeling efficiency through assessment of FDG uptake and retention by the ASCs and the effect of FDG on cell viability, proliferation, transdifferentiation, and cell function in vitro using rat ASCs. Samples of 10(5) ASCs (from visceral fat tissue) were labeled with concentrations of FDG (1-55 Bq/cell) in 0.75 ml culture medium. Label uptake and retention, as a function of labeling time, FDG concentration, and efflux period were measured to determine optimum cell labeling conditions. Cell viability, proliferation, DNA structure damage, cell differentiation, and other cell functions were examined. Non-labeled ASC samples were used as a control for all experimental groups. Labeled ASCs were injected via tail vein in several healthy rats and initial cell biodistribution was assessed. Our results showed that FDG uptake and retention by the stem cells did not depend on FDG concentration but on labeling and efflux periods and glucose content of the labeling and efflux media. Cell viability, transdifferentiation, and cell function were not greatly affected. DNA damage due to FDG radioactivity was acute, but reversible; cells managed to repair the damage and continue with cell cycles. Over all, FDG (up to 25 Bq/cell) did not impose severe cytotoxicity in rat ASCs. Initial biodistribution of the FDG-labeled ASCs was 80% + retention in the lungs. In the delayed whole-body images (2-3 h postinjection) there was some activity distribution resembling typical FDG uptake patterns. For in vivo cell tracking studies with PET tracers, the parameter of interest is the amount of radiotracer that is present in the cells being labeled and consequent biological effects. From our study we developed a labeling protocol for labeling ASCs with a readily available PET tracer, FDG. Our results indicate that ASCs can be safely labeled with FDG concentration up to 25 Bq/cell, without compromising their biological function. A labeling period of 90 min in glucose-free medium and efflux of 60 min in complete media resulted in optimum label retention, i.e., 60% + by the stem cells. The initial biodistribution of the implanted FDG-labeled stem cells can be monitored using microPET imaging.

Healthcare costs among adults with type 2 diabetes initiating saxagliptin or linagliptin: a US-based claims analysis.

PubMed

Kong, Amanda M; Farahbakhshian, Sepehr; Pendergraft, Trudy; Brouillette, Matthew A; Mukherjee, Biswarup; Smith, David M; Sheehan, John J

2017-10-01

To compare healthcare costs of adults with type 2 diabetes (T2D) after initiation of saxagliptin or linagliptin, two antidiabetic medications in the dipeptidyl peptidase-4 inhibitor medication class. Patients with T2D who were at least 18 years old and initiated saxagliptin or linagliptin (index date) between 1 June 2011 and 30 June 2014 were identified in the MarketScan Commercial and Medicare Supplemental Databases. All-cause healthcare costs and diabetes-related costs (T2D diagnosis on a medical claim and/or an antidiabetic medication claim) were measured in the 1 year follow-up period. Saxagliptin and linagliptin initiators were matched using propensity score methods. Cost ratios (CRs) and predicted costs were estimated from generalized linear models and recycled predictions. There were 34,560 saxagliptin initiators and 18,175 linagliptin initiators identified (mean ages 57 and 59; 55% and 56% male, respectively). Before matching, saxagliptin initiators had significantly lower all-cause total healthcare costs than linagliptin initiators (mean = $15,335 [SD $28,923] vs. mean = $20,069 [SD $48,541], p < .001) and significantly lower diabetes-related total healthcare costs (mean = $6109 [SD $13,851] vs. mean = $7393 [SD $26,041], p < .001). In matched analyses (n = 16,069 per cohort), saxagliptin initiators had lower all-cause follow-up costs than linagliptin initiators (CR = 0.953, 95% CI = 0.932-0.974, p < .001; predicted costs = $17,211 vs. $18,068). There was no significant difference in diabetes-related total costs after matching; however, diabetes-related medical costs were significantly lower for saxagliptin initiators (CR = 0.959, 95% CI = 0.927-0.993, p = 0.017; predicted costs = $3989 vs. $4159). Adult patients with T2D initiating treatment with saxagliptin had lower total all-cause healthcare costs and diabetes-related medical costs over 1 year compared with patients initiating treatment with linagliptin.

38 CFR 20.1506 - Rule 1506. Board review of cases.

Code of Federal Regulations, 2010 CFR

2010-07-01

... AFFAIRS (CONTINUED) BOARD OF VETERANS' APPEALS: RULES OF PRACTICE Expedited Claims Adjudication Initiative... certified and transferred to the Board under the Initiative to determine whether the record is adequate for...

38 CFR 20.1508 - Rule 1508. Waiver.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) BOARD OF VETERANS' APPEALS: RULES OF PRACTICE Expedited Claims Adjudication Initiative-Pilot Program... virtue of electing participation in the Initiative. (b) Evidence obtained or submitted after the... revocation of participation in the Initiative, as provided by § 20.1509(c)(2). (2) Evidence submitted by...

The extent to which the public health 'war on obesity' reflects the ethical values and principles of critical health promotion: a multimedia critical discourse analysis.

PubMed

O'Hara, Lily; Taylor, Jane; Barnes, Margaret

2015-12-01

The discipline of health promotion is responsible for implementing strategies within weight-related public health initiatives (WR-PHI). It is imperative that such initiatives be subjected to critical analysis through a health promotion ethics lens to help ensure ethical health promotion practice. Multimedia critical discourse analysis was used to examine the claims, values, assumptions, power relationships and ideologies within Australian WR-PHI. The Health Promotion Values and Principles Continuum was used as a heuristic to evaluate the extent to which the WR-PHI reflected the ethical values of critical health promotion: active participation of people in the initiative; respect for personal autonomy; beneficence; non-maleficence; and strong evidential and theoretical basis for practice. Ten initiatives were analysed. There was some discourse about the need for participation of people in the WR-PHI, but people were routinely labelled as 'target groups' requiring 'intervention'. Strong evidence of a coercive and paternalistic discourse about choice was identified, with minimal attention to respect for personal autonomy. There was significant emphasis on the beneficiaries of the WR-PHI but minimal attention to the health benefits, and nothing about the potential for harm. Discourse about the evidence of need was objectivist, and there was no discussion about the theoretical foundations of the WR-PHI. The WR-PHI were not reflective of the ethical values and principles of critical health promotion. So what? Health promotion researchers and practitioners engaged in WR-PHI should critically reflect on the extent to which they are consistent with the ethical aspects of critical health promotion practice.

Validation of an administrative claims-based diagnostic code for pneumonia in a US-based commercially insured COPD population

PubMed Central

Kern, David M; Davis, Jill; Williams, Setareh A; Tunceli, Ozgur; Wu, Bingcao; Hollis, Sally; Strange, Charlie; Trudo, Frank

2015-01-01

Objective To estimate the accuracy of claims-based pneumonia diagnoses in COPD patients using clinical information in medical records as the reference standard. Methods Selecting from a repository containing members’ data from 14 regional United States health plans, this validation study identified pneumonia diagnoses within a group of patients initiating treatment for COPD between March 1, 2009 and March 31, 2012. Patients with ≥1 claim for pneumonia (International Classification of Diseases Version 9-CM code 480.xx–486.xx) were identified during the 12 months following treatment initiation. A subset of 800 patients was randomly selected to abstract medical record data (paper based and electronic) for a target sample of 400 patients, to estimate validity within 5% margin of error. Positive predictive value (PPV) was calculated for the claims diagnosis of pneumonia relative to the reference standard, defined as a documented diagnosis in the medical record. Results A total of 388 records were reviewed; 311 included a documented pneumonia diagnosis, indicating 80.2% (95% confidence interval [CI]: 75.8% to 84.0%) of claims-identified pneumonia diagnoses were validated by the medical charts. Claims-based diagnoses in inpatient or emergency departments (n=185) had greater PPV versus outpatient settings (n=203), 87.6% (95% CI: 81.9%–92.0%) versus 73.4% (95% CI: 66.8%–79.3%), respectively. Claims-diagnoses verified with paper-based charts had similar PPV as the overall study sample, 80.2% (95% CI: 71.1%–87.5%), and higher PPV than those linked to electronic medical records, 73.3% (95% CI: 65.5%–80.2%). Combined paper-based and electronic records had a higher PPV, 87.6% (95% CI: 80.9%–92.6%). Conclusion Administrative claims data indicating a diagnosis of pneumonia in COPD patients are supported by medical records. The accuracy of a medical record diagnosis of pneumonia remains unknown. With increased use of claims data in medical research, COPD researchers can study pneumonia with confidence that claims data are a valid tool when studying the safety of COPD therapies that could potentially lead to increased pneumonia susceptibility or severity. PMID:26229461

Risk of Contractors’ Claims On the Example of Road Works

NASA Astrophysics Data System (ADS)

Rybka, Iwona; Bondar-Nowakowska, Elżbieta; Pawluk, Katarzyna; Połoński, Mieczysław

2017-10-01

The aim of the study is to analyse claims filed by building contractors during the project implementation. The work is divided into two parts. In the first part problems associated with the management of claims in the construction process were discussed. Bearing in mind that claims may result in prolongation of the investment or exceeding planned budget, possibilities of applying information included in documents connected with claims procedure to risk management was analysed in the second part of the study. The basis of the analysis is a review of 226 documents. They originate from 8 construction sites completed in the last 5 years in southwestern Poland. In each case, these were linear road projects, executed by different contractors, according to conditions in the contract set out in the “Yellow Book” FIDIC. In the study, other documents relating events that according to contractors entitled them to claim were also analysed. They included among others: project documentation, terms of reference, construction log, reports and correspondence under the contract. The events constituting the reason for contractors` claims were classified according to their sources. 8 areas of potential threats were distinguished. They were presented in the form of a block diagram. Most events initiating the claims were reported in the following group - adverse actions of third parties, while the fewest were recorded in the group - the lack of access to the construction site. Based on calculated similarity indicators it was found that considered construction sites were diversified in terms of the number of the events occurrence that generated the claim and their sources. In recent years, many road projects are completed behind the schedule and their initially planned budgets are significantly exceeded. Conducted research indicated that data derived from the analysis of documents connected with claims can be applied to identify and classify both cost and schedule risk factors. Obtained data can also be useful at the stage of risk control because early diagnosis of threats in relation to technical and organizational aspects is necessary to take effective action.

Validation of an administrative claims-based diagnostic code for pneumonia in a US-based commercially insured COPD population.

PubMed

Kern, David M; Davis, Jill; Williams, Setareh A; Tunceli, Ozgur; Wu, Bingcao; Hollis, Sally; Strange, Charlie; Trudo, Frank

2015-01-01

To estimate the accuracy of claims-based pneumonia diagnoses in COPD patients using clinical information in medical records as the reference standard. Selecting from a repository containing members' data from 14 regional United States health plans, this validation study identified pneumonia diagnoses within a group of patients initiating treatment for COPD between March 1, 2009 and March 31, 2012. Patients with ≥1 claim for pneumonia (International Classification of Diseases Version 9-CM code 480.xx-486.xx) were identified during the 12 months following treatment initiation. A subset of 800 patients was randomly selected to abstract medical record data (paper based and electronic) for a target sample of 400 patients, to estimate validity within 5% margin of error. Positive predictive value (PPV) was calculated for the claims diagnosis of pneumonia relative to the reference standard, defined as a documented diagnosis in the medical record. A total of 388 records were reviewed; 311 included a documented pneumonia diagnosis, indicating 80.2% (95% confidence interval [CI]: 75.8% to 84.0%) of claims-identified pneumonia diagnoses were validated by the medical charts. Claims-based diagnoses in inpatient or emergency departments (n=185) had greater PPV versus outpatient settings (n=203), 87.6% (95% CI: 81.9%-92.0%) versus 73.4% (95% CI: 66.8%-79.3%), respectively. Claims-diagnoses verified with paper-based charts had similar PPV as the overall study sample, 80.2% (95% CI: 71.1%-87.5%), and higher PPV than those linked to electronic medical records, 73.3% (95% CI: 65.5%-80.2%). Combined paper-based and electronic records had a higher PPV, 87.6% (95% CI: 80.9%-92.6%). Administrative claims data indicating a diagnosis of pneumonia in COPD patients are supported by medical records. The accuracy of a medical record diagnosis of pneumonia remains unknown. With increased use of claims data in medical research, COPD researchers can study pneumonia with confidence that claims data are a valid tool when studying the safety of COPD therapies that could potentially lead to increased pneumonia susceptibility or severity.

Field Evaluation of Whole Airliner Decontamination Technologies for Narrow-Body Aircraft

DTIC Science & Technology

2008-01-01

eight Apex 6 log G. Stearothermophilus biological indicators (BIs) were placed throughout the cabin for the formal evaluation; 20 were placed in...Twenty-eight 6 log G. Stearothermophilus biological indicators (BIs) were placed throughout the cabin, and all of these were deactivated, except in...Corporation has indicated to the authors of this report that STERIS makes no label claims for Vaprox® sterilant , STERIS’s brand of 35% liquid hydrogen

New aquaculture drugs under FDA review

USGS Publications Warehouse

Bowker, James D.; Gaikowski, Mark P.

2012-01-01

Only eight active pharmaceutical ingredients available in 18 drug products have been approved by the U.S. Food and Drug Administration for use in aquaculture. The approval process can be lengthy and expensive, but several new drugs and label claims are under review. Progress has been made on approvals for Halamid (chloramine-T), Aquaflor (florfenicol) and 35% PeroxAid (hydrogen peroxide) as therapeutic drugs. Data are also being generated for AQUI-S 20E, a fish sedative.

"Can I Borrow Your Glasses?": A Prescription for Learning to See the Cultural Roots of Identity Terms and Implicit Categories through Others' Lenses

ERIC Educational Resources Information Center

Stevick, E. Doyle

2017-01-01

Why is there so much confusion and conflict around common identity labels, a problem that extends well beyond any stereotypes that they may evoke? How do we escape the seeming paradox that we reject racism but still speak frequently of black and white? Who claims the power to determine or name others' identities? The confusion and conflict about…

Impact of Out-of-Pocket Costs on Prescription Fills Among New Initiators of Biologic Therapies for Rheumatoid Arthritis.

PubMed

Hopson, Sari; Saverno, Kim; Liu, Larry Z; AL-Sabbagh, Ahmad; Orazem, John; Costantino, Mary E; Pasquale, Margaret K

2016-02-01

Biologic disease-modifying antirheumatic drug (DMARD) therapies are a mainstay of treatment for rheumatoid arthritis (RA), yet high member out-of-pocket (OOP) costs for such therapies may limit patient access to these therapies. To understand whether there is a relationship between OOP costs and the initial fill and subsequent refills of biologic DMARD treatments for RA members. Members of a national Medicare Advantage and Prescription Drug (MAPD) plan with an adjudicated (paid or reversed) claim for a biologic DMARD indicated for RA were identified from July 1, 2007, to December 31, 2012, and followed retrospectively. The first adjudicated claim date was the index date. Members were required to have 180 days of continuous enrollment pre- and post-index and ≥ 1 diagnosis for RA (ICD-9-CM: 714.0 or 714.2) during pre-index or ≤ 30 days post-index. Low-income subsidy and Medicaid-Medicare dual-eligible patients were excluded. The analysis used multivariate regression models to examine associations between initial prescription (Rx) abandonment rates and OOP costs and factors influencing the refill of a biologic DMARD therapy based on pharmacy claims. The final sample size included 864 MAPD members with an adjudicated claim for a biologic DMARD. The majority were female (77.4%) and mean age was 63.5 years (SD = 10.9). Most (78%) had conventional nonbiologic DMARD utilization during pre-index. The overall initial abandonment rate was 18.2% for biologic DMARDs, ranging from 1.3% for the lowest OOP cost group ($0-$250) to 32.7% for the highest OOP cost group (> $550; P < 0.0001 for Cochran-Armitage trend test). ORs for abandonment rose from 18.4 to 32.7 to 41.2 for OOP costs of $250.01-$400.00, $400.01-$550.00, and > $550.00 respectively, relative to OOP costs of ≤ $250.00 (all P < 0.0001). Meeting the catastrophic coverage limit and utilization of a specialty pharmacy for the index claim were both associated with a decreased likelihood of abandoning therapy (OR = 0.29 and OR = 0.14, respectively; both P < 0.05). Among the subset of 533 members with a paid claim, 82.4% had at least 1 refill post-index. The negative association between OOP cost and likelihood of refilling an Rx was highly significant (P < 0.0001). This study suggests that the higher the member OOP cost, the less likely an MAPD member is to initiate or refill a biologic DMARD therapy for RA. Further research is needed to understand reasons for initial Rx abandonment and lack of refills, including benefit design and adverse events.

Read the Label. English as a Second Language Initiative. Teacher's Guide.

ERIC Educational Resources Information Center

Council on Family Health, New York, NY.

The teacher's guide was developed as part of an initiative by the Council on Family Health to encourage speakers of English as a second language (ESL) to read and understand the information on over-the-counter and prescription drugs. It contains classroom activities, handout materials, and suggestions for presenting lessons on label reading. It is…

75 FR 51058 - Web-Distributed Labeling User Acceptance Pilot

Federal Register 2010, 2011, 2012, 2013, 2014

2010-08-18

... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2010-0632; FRL-8840-1] Web-Distributed Labeling User... Pesticide Programs (OPP) is exploring a new initiative called ``web-distributed labeling'' (web-distributed... Internet. Through this Federal Register Notice, OPP is announcing its intention to conduct a web...

77 FR 22236 - Administrative Claims Under the Federal Tort Claims Act and Related Statutes

Federal Register 2010, 2011, 2012, 2013, 2014

2012-04-13

... Investment Act (WIA) since the last time the regulations were updated. These regulations are being amended to... at this time because we will not initiate an additional comment period. If no significant adverse...) They are engaged in any authorized Job Corps activity; (3) They are in authorized travel status; or (4...

75 FR 62901 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-13

... supporting the Statement of Claim (``initial documents''). The claimant may file in hard copy, submitting... the claimant to reproduce. The claimant then files, in hard copy, the Tracking Form and any materials... permit claimants to file their claims in hard copy. The proposed rule change specifies that if a claimant...

A Natural Experiment: Using Immersive Technologies to Study the Impact of "All-Natural" Labeling on Perceived Food Quality, Nutritional Content, and Liking.

PubMed

Liu, Rebecca; Hooker, Neal H; Parasidis, Efthimios; Simons, Christopher T

2017-03-01

The "all-natural" label is used extensively in the United States. At many point-of-purchase locations, employed servers provide food samples and call out specific label information to influence consumers' purchase decisions. Despite these ubiquitous practices, it is unclear what information is conveyed to consumers by the all-natural label or how it impacts judgments of perceived food quality, nutritional content, and acceptance. We used a novel approach incorporating immersive technology to simulate a virtual in-store sampling scenario where consumers were asked by a server to evaluate identical products with only one being labeled all-natural. Another condition evaluated the impact of the in-store server additionally emphasizing the all-natural status of one sample. Results indicated the all-natural label significantly improved consumer's perception of product quality and nutritional content, but not liking or willingness to pay, when compared to the regular sample. With the simple emphasis of the all-natural claim by the in-store server, these differences in quality and nutritional content became even more pronounced, and willingness to pay increased significantly by an average of 8%. These results indicate that in a virtual setting consistent with making food purchases, an all-natural front-of-pack label improves consumer perceptions of product quality and nutritional content. In addition, information conveyed to consumers by employed servers has a further, substantial impact on these variables suggesting that consumers are highly susceptible to social influence at the point of purchase. © 2017 Institute of Food Technologists®.

42 CFR 433.114 - Procedures for obtaining initial approval; notice of decision.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Mechanized Claims Processing and Information Retrieval Systems § 433.114 Procedures for obtaining initial... the system, the notice will include all of the following information: (1) The findings of fact upon...

42 CFR 433.114 - Procedures for obtaining initial approval; notice of decision.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Mechanized Claims Processing and Information Retrieval Systems § 433.114 Procedures for obtaining initial... the system, the notice will include all of the following information: (1) The findings of fact upon...

42 CFR 433.114 - Procedures for obtaining initial approval; notice of decision.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Mechanized Claims Processing and Information Retrieval Systems § 433.114 Procedures for obtaining initial... the system, the notice will include all of the following information: (1) The findings of fact upon...

42 CFR 433.114 - Procedures for obtaining initial approval; notice of decision.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Mechanized Claims Processing and Information Retrieval Systems § 433.114 Procedures for obtaining initial... the system, the notice will include all of the following information: (1) The findings of fact upon...

Taking the Initiative: Risk-Reduction Strategies and Decreased Malpractice Costs.

PubMed

Raper, Steven E; Rose, Deborah; Nepps, Mary Ellen; Drebin, Jeffrey A

2017-11-01

To heighten awareness of attending and resident surgeons regarding strategies for defense against malpractice claims, a series of risk reduction initiatives have been carried out in our Department of Surgery. We hypothesized that emphasis on certain aspects of risk might be associated with decreased malpractice costs. The relative impact of Department of Surgery initiatives was assessed when compared with malpractice experience for the rest of the Clinical Practices of the University of Pennsylvania (CPUP). Surgery and CPUP malpractice claims, indemnity, and expenses were obtained from the Office of General Counsel. Malpractice premium data were obtained from CPUP finance. The Department of Surgery was assessed in comparison with all other CPUP departments. Cost data (yearly indemnity and expenses), and malpractice premiums (total and per physician) were expressed as a percentage of the 5-year mean value preceding implementation of the initiative program. Surgery implemented 38 risk reduction initiatives. Faculty participated in 27 initiatives; house staff participated in 10 initiatives; and advanced practitioners in 1 initiative. Department of Surgery claims were significantly less than CPUP (74.07% vs 81.07%; p < 0.05). The mean yearly indemnity paid by the Department of Surgery was significantly less than that of the other CPUP departments (84.08% vs 122.14%; p < 0.05). Department of Surgery-paid expenses were also significantly less (83.17% vs 104.96%; p < 0.05), and surgical malpractice premiums declined from baseline, but remained significantly higher than CPUP premiums. The data suggest that educating surgeons on malpractice and risk reduction may play a role in decreasing malpractice costs. Additional extrinsic factors may also affect cost data. Emphasis on risk reduction appears to be cumulative and should be part of an ongoing program. Copyright © 2017 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Culture-Independent Metagenomic Surveillance of Commercially Available Probiotics with High-Throughput Next-Generation Sequencing.

PubMed

Patro, Jennifer N; Ramachandran, Padmini; Barnaba, Tammy; Mammel, Mark K; Lewis, Jada L; Elkins, Christopher A

2016-01-01

Millions of people consume dietary supplements either following a doctor's recommendation or at their own discretion to improve their overall health and well-being. This is a rapidly growing trend, with an associated and expanding manufacturing industry to meet the demand for new health-related products. In this study, we examined the contents and microbial viability of several popular probiotic products on the United States market. Culture-independent methods are proving ideal for fast and efficient analysis of foodborne pathogens and their associated microbial communities but may also be relevant for analyzing probiotics containing mixed microbial constituents. These products were subjected to next-generation whole-genome sequencing and analyzed by a custom in-house-developed k-mer counting method to validate manufacturer label information. In addition, the batch variability of respective products was examined to determine if any changes in their formulations and/or the manufacturing process occurred. Overall, the products we tested adhered to the ingredient claims and lot-to-lot differences were minimal. However, there were a few discrepancies in the naming of closely related Lactobacillus and Bifidobacterium species, whereas one product contained an apparent Enterococcus contaminant in two of its three lots. With the microbial contents of the products identified, we used traditional PCR and colony counting methods to comparatively assess our results and verify the viability of the microbes in these products with regard to the labeling claims. Of all the supplements examined, only one was found to be inaccurate in viability. Our use of next-generation sequencing as an analytical tool clearly demonstrated its utility for quickly analyzing commercially available products containing multiple microbes to ensure consumer safety. IMPORTANCE The rapidly growing supplement industry operates without a formal premarket approval process. Consumers rely on product labels to be accurate and true. Those products containing live microbials report both identity and viability on most product labels. This study used next-generation sequencing technology as an analytical tool in conjunction with classic culture methods to examine the validity of the labels on supplement products containing live microbials found in the United States marketplace. Our results show the importance of testing these products for identity, viability, and potential contaminants, as well as introduce a new culture-independent diagnostic approach for testing these products. Podcast: A podcast concerning this article is available.

Culture-Independent Metagenomic Surveillance of Commercially Available Probiotics with High-Throughput Next-Generation Sequencing

PubMed Central

Patro, Jennifer N.; Ramachandran, Padmini; Barnaba, Tammy; Mammel, Mark K.; Lewis, Jada L.

2016-01-01

ABSTRACT Millions of people consume dietary supplements either following a doctor’s recommendation or at their own discretion to improve their overall health and well-being. This is a rapidly growing trend, with an associated and expanding manufacturing industry to meet the demand for new health-related products. In this study, we examined the contents and microbial viability of several popular probiotic products on the United States market. Culture-independent methods are proving ideal for fast and efficient analysis of foodborne pathogens and their associated microbial communities but may also be relevant for analyzing probiotics containing mixed microbial constituents. These products were subjected to next-generation whole-genome sequencing and analyzed by a custom in-house-developed k-mer counting method to validate manufacturer label information. In addition, the batch variability of respective products was examined to determine if any changes in their formulations and/or the manufacturing process occurred. Overall, the products we tested adhered to the ingredient claims and lot-to-lot differences were minimal. However, there were a few discrepancies in the naming of closely related Lactobacillus and Bifidobacterium species, whereas one product contained an apparent Enterococcus contaminant in two of its three lots. With the microbial contents of the products identified, we used traditional PCR and colony counting methods to comparatively assess our results and verify the viability of the microbes in these products with regard to the labeling claims. Of all the supplements examined, only one was found to be inaccurate in viability. Our use of next-generation sequencing as an analytical tool clearly demonstrated its utility for quickly analyzing commercially available products containing multiple microbes to ensure consumer safety. IMPORTANCE The rapidly growing supplement industry operates without a formal premarket approval process. Consumers rely on product labels to be accurate and true. Those products containing live microbials report both identity and viability on most product labels. This study used next-generation sequencing technology as an analytical tool in conjunction with classic culture methods to examine the validity of the labels on supplement products containing live microbials found in the United States marketplace. Our results show the importance of testing these products for identity, viability, and potential contaminants, as well as introduce a new culture-independent diagnostic approach for testing these products. Podcast: A podcast concerning this article is available. PMID:27303722

Are health nudges coercive?

PubMed

Quigley, Muireann

2014-01-01

Governments and policy-makers have of late displayed renewed attention to behavioural research in an attempt to achieve a range of policy goals, including health promotion. In particular, approaches which could be labelled as 'nudges' have gained traction with policy-makers. A range of objections to nudging have been raised in the literature. These include claims that nudges undermine autonomy and liberty, may lead to a decrease in responsibility in decision-making, lack transparency, involve deception, and involve manipulation, potentially occasioning coercion. In this article I focus on claims of coercion, examining nudges within two of the main approaches to coercion-the pressure approach and the more recent enforcement approach. I argue that coercion entails an element of control over the behaviour of agents which is not plausibly displayed by the kinds of serious examples of nudges posited in the literature.

Patterns of free amino acids in German convenience food products: marked mismatch between label information and composition.

PubMed

Hermanussen, M; Gonder, U; Jakobs, C; Stegemann, D; Hoffmann, G

2010-01-01

Free amino acids affect food palatability. As information on amino acids in frequently purchased pre-packaged food is virtually absent, we analyzed free amino acid patterns of 17 frequently purchased ready-to-serve convenience food products, and compared them with the information obtained from the respective food labels. Quantitative amino acid analysis was performed using ion-exchange chromatography. gamma-Aminobutyric acid (GABA) concentrations were verified using a stable isotope dilution gas chromatography/mass spectrometry (GC-MS) method. The patterns of free amino acids were compared with information obtained from food labels. An obvious mismatch between free amino acid patterns and food label information was detected. Even on considering that tomatoes and cereal proteins are naturally rich in glutamate, the concentrations of free glutamate outranged the natural concentration of this amino acid in several products, and strongly suggested artificial enrichment. Free glutamate was found to be elevated even in dishes that explicitly state 'no glutamate added'. Arginine was markedly elevated in lentils. Free cysteine was generally low, possibly reflecting thermal destruction of this amino acid during food processing. The meat and brain-specific dipeptide carnosine (CARN) was present in most meat-containing products. Some products did not contain detectable amounts of CARN in spite of meat content being claimed on the food labels. We detected GABA at concentrations that contribute significantly to the taste sensation. This investigation highlights a marked mismatch between food label information and food composition.

Your business in court and at Federal agencies: 2011-2012.

PubMed

Reiss, John B; Crowder, Dawn; McCabe, Brittany; DeFeo, Marisa; Rifin, Marta; Talbot, Meghan

2013-01-01

FDA transparency effort continued, including the Secretary's adopting eight measures to improve access to Agency information and activities. A continuing problem was shortages of prescription drugs, which probably was enhanced by increased manufacturing recalls. FDA issued more device Guidances for regulatory clarity. Enforcement involving drugs and devices increased, including GMP and GLP enforcement and surveillance of internet claims. The Supreme Court decided generic drug manufacturers may cause the FDA to revise incorrectly listed use codes, and pharmaceutical detailers may not receive overtime payments. FDA initiated implementation of the Food Safety and Modernization Act, including two pilot tracking systems for supply chain tracing and to determine how quickly data can be gathered. The Agency issued guidance for new dietary supplements. FDA failed to impose graphic labeling requirements on the tobacco industry, but established it can regulate electronic cigarettes as tobacco. The Agency issued guidelines for the use of nanomaterials in cosmetics, and reviewed the effectiveness of sunscreen products. FDA is being given more authority over larger areas of the U.S. economy, but its resources are not increased proportionately. The pharmaceutical industry made major payments for alleged violations of the Drug Rebate Statute, Anti-Kickback Statute, Wholesale Price and Off-Label Use prohibitions. The government continues using the Responsible Corporate Officer doctrine to make company managers responsible for corporate conduct about which they had no knowledge. Companies should have a robust compliance program in effect. The FTC and the SEC continue their oversight activities, including SEC's enforcement of the Foreign Corrupt Practices Act. The defense of product liability litigation continues grappling with federal preemption of state laws.

Effects of comparative claims in prescription drug direct-to-consumer advertising on consumer perceptions and recall.

PubMed

O'Donoghue, Amie C; Williams, Pamela A; Sullivan, Helen W; Boudewyns, Vanessa; Squire, Claudia; Willoughby, Jessica Fitts

2014-11-01

Although pharmaceutical companies cannot make comparative claims in direct-to-consumer (DTC) ads for prescription drugs without substantial evidence, the U.S. Food and Drug Administration permits some comparisons based on labeled attributes of the drug, such as dosing. Researchers have examined comparative advertising for packaged goods; however, scant research has examined comparative DTC advertising. We conducted two studies to determine if comparative claims in DTC ads influence consumers' perceptions and recall of drug information. In Experiment 1, participants with osteoarthritis (n=1934) viewed a fictitious print or video DTC ad that had no comparative claim or made an efficacy comparison to a named or unnamed competitor. Participants who viewed print (but not video) ads with named competitors had greater efficacy and lower risk perceptions than participants who viewed unnamed competitor and noncomparative ads. In Experiment 2, participants with high cholesterol or high body mass index (n=5317) viewed a fictitious print or video DTC ad that had no comparative claim or made a comparison to a named or unnamed competitor. We varied the type of comparison (of indication, dosing, or mechanism of action) and whether the comparison was accompanied by a visual depiction. Participants who viewed print and video ads with named competitors had greater efficacy perceptions than participants who viewed unnamed competitor and noncomparative ads. Unlike Experiment 1, named competitors in print ads resulted in higher risk perceptions than unnamed competitors. In video ads, participants who saw an indication comparison had greater benefit recall than participants who saw dosing or mechanism of action comparisons. In addition, visual depictions of the comparison decreased risk recall for video ads. Overall, the results suggest that comparative claims in DTC ads could mislead consumers about a drug's efficacy and risk; therefore, caution should be used when presenting comparative claims in DTC ads. Published by Elsevier Ltd.

42 CFR 433.117 - Initial approval of replacement systems.

Code of Federal Regulations, 2010 CFR

2010-10-01

... and Information Retrieval Systems § 433.117 Initial approval of replacement systems. (a) A replacement system must meet all conditions of initial approval of a mechanized claims processing and information retrieval system. (b) The agency must submit a APD that includes— (1) The date the replacement system will...

Pediatric patient-reported outcome instruments for research to support medical product labeling: report of the ISPOR PRO good research practices for the assessment of children and adolescents task force.

PubMed

Matza, Louis S; Patrick, Donald L; Riley, Anne W; Alexander, John J; Rajmil, Luis; Pleil, Andreas M; Bullinger, Monika

2013-06-01

Patient-reported outcome (PRO) instruments for children and adolescents are often included in clinical trials with the intention of collecting data to support claims in a medical product label. The purpose of the current task force report is to recommend good practices for pediatric PRO research that is conducted to inform regulatory decision making and support claims made in medical product labeling. The recommendations are based on the consensus of an interdisciplinary group of researchers who were assembled for a task force associated with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). In those areas in which supporting evidence is limited or in which general principles may not apply to every situation, this task force report identifies factors to consider when making decisions about the design and use of pediatric PRO instruments, while highlighting issues that require further research. Five good research practices are discussed: 1) Consider developmental differences and determine age-based criteria for PRO administration: Four age groups are discussed on the basis of previous research (<5 years old, 5-7 years, 8-11 years, and 12-18 years). These age groups are recommended as a starting point when making decisions, but they will not fit all PRO instruments or the developmental stage of every child. Specific age ranges should be determined individually for each population and PRO instrument. 2) Establish content validity of pediatric PRO instruments: This section discusses the advantages of using children as content experts, as well as strategies for concept elicitation and cognitive interviews with children. 3) Determine whether an informant-reported outcome instrument is necessary: The distinction between two types of informant-reported measures (proxy vs. observational) is discussed, and recommendations are provided. 4) Ensure that the instrument is designed and formatted appropriately for the target age group. Factors to consider include health-related vocabulary, reading level, response scales, recall period, length of instrument, pictorial representations, formatting details, administration approaches, and electronic data collection (ePRO). 5) Consider cross-cultural issues. Additional research is needed to provide methodological guidance for future studies, especially for studies involving young children and parents' observational reports. As PRO data are increasingly used to support pediatric labeling claims, there will be more information regarding the standards by which these instruments will be judged. The use of PRO instruments in clinical trials and regulatory submissions will help ensure that children's experience of disease and treatment are accurately represented and considered in regulatory decisions. Copyright © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

The impact of tort reform and quality improvements on medical liability claims: a tale of 2 States.

PubMed

Illingworth, Kenneth D; Shaha, Steven H; Tzeng, Tony H; Sinha, Michael S; Saleh, Khaled J

2015-05-01

The purpose of this study was to determine the effect of tort reform and quality improvement measures on medical liability claims in 2 groups of hospitals within the same multihospital organization: one in Texas, which implemented medical liability tort reform caps on noneconomic damages in 2003, and one in Louisiana, which did not undergo significant tort reform during the same time period. Significant reduction in medical liability claims per quarter in Texas was found after tort reform implementation (7.27 to 1.4; P<.05). A significant correlation was found between the increase in mean Centers for Medicare & Medicaid Services performance score and the decrease in the frequency of claims observed in Louisiana (P<.05). Although tort reform caps on noneconomic damages in Texas caused the largest initial decrease, increasing quality improvement measures without increasing financial burden also decreased liability claims in Louisiana. Uniquely, this study showed that increasing patient quality resulted in decreased medical liability claims. © 2014 by the American College of Medical Quality.

Algorithms to Identify Statin Intolerance in Medicare Administrative Claim Data.

PubMed

Colantonio, Lisandro D; Kent, Shia T; Huang, Lei; Chen, Ligong; Monda, Keri L; Serban, Maria-Corina; Manthripragada, Angelika; Kilgore, Meredith L; Rosenson, Robert S; Muntner, Paul

2016-10-01

To compare characteristics of patients with possible statin intolerance identified using different claims-based algorithms versus patients with high adherence to statins. We analyzed 134,863 Medicare beneficiaries initiating statins between 2007 and 2011. Statin intolerance and discontinuation, and high adherence to statins, defined by proportion of days covered ≥80 %, were assessed during the 365 days following statin initiation. Definition 1 of statin intolerance included statin down-titration or discontinuation with ezetimibe initiation, having a claim for a rhabdomyolysis or antihyperlipidemic event followed by statin down-titration or discontinuation, or switching between ≥3 types of statins. Definition 2 included beneficiaries who met Definition 1 and those who down-titrated statin intensity. We also analyzed beneficiaries who met Definition 2 of statin intolerance or discontinued statins. The prevalence of statin intolerance was 1.0 % (n = 1320) and 5.2 % (n = 6985) using Definitions 1 and 2, respectively. Overall, 45,266 (33.6 %) beneficiaries had statin intolerance by Definition 2 or discontinued statins and 55,990 (41.5 %) beneficiaries had high adherence to statins. Compared with beneficiaries with high adherence to statins, those with statin intolerance and who had statin intolerance or discontinued statins were more likely to be female versus male, and black, Hispanic or Asian versus white. The multivariable adjusted odds ratio for statin intolerance by Definitions 1 and 2 comparing patients initiating high versus low/moderate intensity statins were 2.82 (95%CI: 2.42-3.29), and 8.58 (8.07-9.12), respectively, and for statin intolerance or statin discontinuation was 2.35 (2.25-2.45). Definitions of statin intolerance presented herein can be applied to analyses using administrative claims data.

Tuberculosis Prevention in the Private Sector: Using Claims-Based Methods to Identify and Evaluate Latent Tuberculosis Infection Treatment With Isoniazid Among the Commercially Insured.

PubMed

Stockbridge, Erica L; Miller, Thaddeus L; Carlson, Erin K; Ho, Christine

Targeted identification and treatment of people with latent tuberculosis infection (LTBI) are key components of the US tuberculosis elimination strategy. Because of recent policy changes, some LTBI treatment may shift from public health departments to the private sector. To (1) develop methodology to estimate initiation and completion of treatment with isoniazid for LTBI using claims data, and (2) estimate treatment completion rates for isoniazid regimens from commercial insurance claims. Medical and pharmacy claims data representing insurance-paid services rendered and prescriptions filled between January 2011 and March 2015 were analyzed. Four million commercially insured individuals 0 to 64 years of age. Six-month and 9-month treatment completion rates for isoniazid LTBI regimens. There was an annual isoniazid LTBI treatment initiation rate of 12.5/100 000 insured persons. Of 1074 unique courses of treatment with isoniazid for which treatment completion could be assessed, almost half (46.3%; confidence interval, 43.3-49.3) completed 6 or more months of therapy. Of those, approximately half (48.9%; confidence interval, 44.5-53.3) completed 9 months or more. Claims data can be used to identify and evaluate LTBI treatment with isoniazid occurring in the commercial sector. Completion rates were in the range of those found in public health settings. These findings suggest that the commercial sector may be a valuable adjunct to more traditional venues for tuberculosis prevention. In addition, these newly developed claims-based methods offer a means to gain important insights and open new avenues to monitor, evaluate, and coordinate tuberculosis prevention.

Asian herbal‐tobacco cigarettes: “not medicine but less harmful”?

PubMed Central

Chen, Aiyin; Glantz, Stanton; Tong, Elisa

2007-01-01

Objective To describe the development and health claims of Asian herbal‐tobacco cigarettes. Methods Analysis of international news sources, company websites, and the transnational tobacco companies' (TTC) documents. PubMed searches of herbs and brands. Results Twenty‐three brands were identified, mainly from China. Many products claimed to relieve respiratory symptoms and reduce toxins, with four herb‐only products advertised for smoking cessation. No literature was found to verify the health claims, except one Korean trial of an herb‐only product. Asian herbal‐tobacco cigarettes were initially produced by China by the 1970s and introduced to Japan in the 1980s. Despite initial news about research demonstrating a safer cigarette, the TTC analyses of these cigarettes suggest that these early products were not palatable and had potentially toxic cardiovascular effects. By the late 1990s, China began producing more herbal‐tobacco cigarettes in a renewed effort to reduce harmful constituents in cigarettes. After 2000, tobacco companies from Korea, Taiwan, and Thailand began producing similar products. Tobacco control groups in Japan, Taiwan, and Thailand voiced concern over the health claims of herbal‐tobacco products. In 2005, China designated two herbal‐tobacco brands as key for development. Conclusion Asian herbal‐tobacco cigarettes claim to reduce harm, but no published literature is available to verify these claims or investigate unidentified toxicities. The increase in Asian herbal‐tobacco cigarette production by 2000 coincides with the Asian tobacco companies' regular scientific meetings with TTCs and their interest in harm reduction. Asia faces additional challenges in tobacco control with these culturally concordant products that may discourage smokers from quitting. PMID:17400933

"The Tribunal Was the Most Stressful Thing: More Stressful than My Son's Diagnosis or Behaviour"--The Experiences of Families Who Go to the Special Educational Needs and Disability Tribunal (SENDisT)

ERIC Educational Resources Information Center

Runswick-Cole, Katherine

2007-01-01

It is more than 10 years since the Special Educational Needs Tribunal was established in 1994 as an independent panel which arbitrates in disputes between parents of children with the label special educational needs and Local Education Authorities (LEAs) in England. In 2002 the Tribunal began hearing claims for disability discrimination and was…

Effect of dry-air chilling on sensory descriptive profiles of cooked broiler breast meat deboned four hours after the initiation of chilling

USDA-ARS?s Scientific Manuscript database

Air chilled chicken products are gaining popularity in the USA. It has been claimed that air chilling (AC) results in improved tenderness and flavor of broiler meat compared with immersion chilling (IC). However, there is a lack of published sensory study results to support the claims. The objecti...

Leisure identities, globalization, and the politics of place

Treesearch

Daniel R. Williams

2002-01-01

As a particularly modern modality for making and resisting claims bout the use and meaning of places leisure has a prominent role in the politics of place. This is particularly evident in land use politics in the western U.S., which serves as a launching point for examining the ways in which leisure makes competing claims on a place. Within leisure studies initial...

Functional food awareness and perceptions in relation to information sources in older adults

PubMed Central

2014-01-01

Background The functional food industry has experienced innovative and economic expansion, yet research into consumer perceptions of functional foods and their associated health claims is limited. Among consumers, older adults could benefit from functional foods due to age-related issues pertaining to food and health. The purpose of this research was to identify the need for information related to functional foods among older adults (≥60 years old) and to assess awareness and perceptions of health claims on functional food packages. Methods Community-dwelling older adults (n = 200) completed a researcher administered questionnaire designed to collect information about functional foods including current consumption, motivating factors for consumption, perceived need for information, sources of information for functional foods and awareness of health claims. Results Prevalence of functional food consumption among participants was 93.0%. Increased awareness and knowledge was the most commonly reported factor that would promote functional food consumption (85.5%) and 63.5% of participants wanted more information about functional foods with preferred sources being newspapers/magazines/books (68.5%) and food labels (66.1%). Participants were predominately (93.5%) aware of health claims on functional foods and those with more education were more likely to report being aware of health claims (p = 0.045). Conclusions Although functional food consumption among older adults in this sample is high, there is a need for further information regarding functional foods. These results inform stakeholders regarding the potential for information to influence functional food acceptance among older adult consumers. PMID:24886306

Lucky Belief in Science Education - Gettier Cases and the Value of Reliable Belief-Forming Processes

NASA Astrophysics Data System (ADS)

Brock, Richard

2018-05-01

The conceptualisation of knowledge as justified true belief has been shown to be, at the very least, an incomplete account. One challenge to the justified true belief model arises from the proposition of situations in which a person possesses a belief that is both justified and true which some philosophers intuit should not be classified as knowledge. Though situations of this type have been imagined by a number of writers, they have come to be labelled Gettier cases. Gettier cases arise when a fallible justification happens to lead to a true belief in one context, a case of `lucky belief'. In this article, it is argued that students studying science may make claims that resemble Gettier cases. In some contexts, a student may make a claim that is both justified and true but which arises from an alternative conception of a scientific concept. A number of instances of lucky belief in topics in science education are considered leading to an examination of the criteria teachers use to assess students' claims in different contexts. The possibility of lucky belief leads to the proposal that, in addition to the acquisition of justified true beliefs, the development of reliable belief-forming processes is a significant goal of science education. The pedagogic value of various kinds of claims is considered and, it is argued, the criteria used to judge claims may be adjusted to suit the context of assessment. It is suggested that teachers should be alert to instances of lucky belief that mask alternative conceptions.

High cost sharing and specialty drug initiation under Medicare Part D: a case study in patients with newly diagnosed chronic myeloid leukemia.

PubMed

Doshi, Jalpa A; Li, Pengxiang; Huo, Hairong; Pettit, Amy R; Kumar, Rishab; Weiss, Brenda M; Huntington, Scott F

2016-03-01

Specialty drugs often offer medical advances but are frequently subject to high cost sharing. This is particularly true with Medicare Part D, where after meeting a deductible, patients without low-income subsidies (non-LIS) typically face 25% to 33% coinsurance (initial coverage phase with "specialty tier" cost sharing), followed by ~50% coinsurance (coverage gap phase), and then 5% coinsurance (catastrophic phase). Yet, no studies have examined the impact of such high cost sharing on specialty drug initiation under Part D. Oral tyrosine kinase inhibitors (TKIs) have revolutionized the treatment of chronic myeloid leukemia (CML), making it an apt case study. A retrospective claims-based analysis utilizing 2011 to 2013 100% Medicare claims. TKI initiation rates and time to initiation were compared between fee-for-service non-LIS Part D patients newly diagnosed with CML and their LIS counterparts who faced nominal cost sharing of ≤ $5. The first 30-day TKI fill "straddled" benefit phases, for a mean out-of-pocket cost of $2600 or more for non-LIS patients. Non-LIS patients were less likely than LIS patients to have a TKI claim within 6 months of diagnosis (45.3% vs 66.9%; P < .001) and those initiating a TKI took twice as long to fill it (mean = 50.9 vs 23.7 days; P < .001). Cox regressions controlling for sociodemographic, clinical, and plan characteristics confirmed descriptive findings (hazard ratio, 0.59; 95% CI, 0.45-0.76). Extensive sensitivity analyses confirmed the robustness of our findings. High cost sharing was associated with reduced and/or delayed initiation of TKIs. We discuss policy strategies to reduce current financial barriers that adversely impact access to critical therapies under Medicare Part D.

Serious Fall Injuries Before and After Initiation of Hemodialysis Among Older ESRD Patients in the United States: A Retrospective Cohort Study.

PubMed

Plantinga, Laura C; Patzer, Rachel E; Franch, Harold A; Bowling, C Barrett

2017-07-01

Because initiation of dialysis therapy often occurs in the setting of acute illness and may signal worsening health and functional decline, we examined whether rates of serious fall injuries among older hemodialysis patients differ before and after dialysis therapy initiation. Retrospective cohort study of claims data from the 2 years spanning dialysis therapy initiation among patients initiating dialysis therapy in 2010 to 2012. Claims from 81,653 Medicare end-stage renal disease beneficiaries aged 67 to 100 years. Post- versus pre-dialysis therapy initiation periods, defined as on or after versus before dialysis therapy initiation. Serious fall injuries were defined using diagnostic codes for falls in combination with fractures, brain injuries, or joint dislocation. Incidence rate ratios (overall and stratified) for post- versus pre-dialysis therapy initiation periods were estimated using generalized estimating equation models with a negative binomial link. Overall, 12,757 serious fall injuries occurred in the pre- and post-dialysis therapy initiation periods. Annual rates of serious fall injuries were 64.4 (95% CI, 62.7-66.2) and 107.8 (95% CI, 105.4-110.3) per 1,000 patient-years, respectively, in the pre- and post-dialysis therapy initiation periods (incidence rate ratio, 1.62; 95% CI, 1.56-1.67). Relative rates of serious fall injuries in the post- vs pre-dialysis initiation periods were of greater magnitude among patients who were younger (<75 years), had pre-end-stage renal disease nephrology care, had albumin levels > 3g/dL, were able to walk and transfer, did not need assistance with activities of daily living, and were not institutionalized compared with relative rates among their counterparts. Potential misclassification due to the use of claims data and survival bias among those initiating hemodialysis therapy. Among older Medicare beneficiaries receiving hemodialysis, serious fall injuries are common, the post-dialysis initiation period is a high-risk time for falls, and dialysis therapy initiation may be an important time to screen for fall risk factors and implement multifactorial fall prevention strategies. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

20 CFR 10.911 - How is the death gratuity payment process initiated?

Code of Federal Regulations, 2014 CFR

2014-04-01

...' COMPENSATION ACT, AS AMENDED Death Gratuity § 10.911 How is the death gratuity payment process initiated? (a) Either the employing agency or a living claimant (survivor or alternate beneficiary) may initiate the... agency notifying OWCP of the employee's death, each claimant must file a claim with OWCP in order to...

20 CFR 10.911 - How is the death gratuity payment process initiated?

Code of Federal Regulations, 2011 CFR

2011-04-01

...' COMPENSATION ACT, AS AMENDED Death Gratuity § 10.911 How is the death gratuity payment process initiated? (a) Either the employing agency or a living claimant (survivor or alternate beneficiary) may initiate the... agency notifying OWCP of the employee's death, each claimant must file a claim with OWCP in order to...

20 CFR 10.911 - How is the death gratuity payment process initiated?

Code of Federal Regulations, 2012 CFR

2012-04-01

...' COMPENSATION ACT, AS AMENDED Death Gratuity § 10.911 How is the death gratuity payment process initiated? (a) Either the employing agency or a living claimant (survivor or alternate beneficiary) may initiate the... agency notifying OWCP of the employee's death, each claimant must file a claim with OWCP in order to...

Effects of an icon-based menu labelling initiative on consumer food choice.

PubMed

Kerins, Claire; Cunningham, Katie; Finucane, Francis M; Gibson, Irene; Jones, Jenni; Kelly, Colette

2017-01-01

The purpose of this study was to examine the impact of an icon-based menu labelling initiative on consumer buying behaviour. This quasi-experimental study recruited a convenience sample of eight food service establishments, all with at least one menu item meeting the heart healthy criteria. Data from sales of all menu items sold over an 8-week period were collated 4 weeks prior to and 4 weeks during the display of information icons related to healthy food choices on menus. The absolute change in menu item sales showed a non-significant trend towards an increase in healthier menu item selections. Furthermore, there was no association between the type of food service establishment and the percentage change in labelled menu item sales. The study did not find a statistically significant influence of the icon-based menu labels on consumer food choice. Given the limited amount of research that examines alternative menu labelling formats in real-world settings, more studies are necessary to confirm these results. Further research is needed to identify the optimal format, content and impact of menu labels on consumer behaviour.

20 CFR 410.672 - Reopening initial, revised or reconsidered determinations of the Administration and decisions of...

Code of Federal Regulations, 2011 CFR

2011-04-01

... claim has been filed; or (3) An individual previously determined to be dead, and on whose account... location or identification of his or her body; or (5) Such initial, revised, or reconsidered determination...

Off-label use of atypical antipsychotics: cause for concern?

PubMed

McKean, Andrew; Monasterio, Erik

2012-05-01

Licensed indications for medicines were designed to regulate the claims that can be made about a medicine by a pharmaceutical company. Off-label prescribing (i.e. prescribing a drug for an indication outside of that for which it is licensed) is legal and an integral part of medical practice. In psychiatry, off-label prescribing is common and gives clinicians scope to treat patients who are refractory to standard therapy or where there is no licensed medication for an indication. However, efficacy or safety of such off-label use may not be established. There is a growing list of licensed indications for atypical antipsychotics (AAP) beyond schizophrenia and bipolar affective disorder, and also more evidence for other indications where pharmaceutical companies have not obtained a license. Pharmaceutical companies have promoted AAPs for off-label indications to increase sales and consequently have been fined by the US FDA for this. Since the 1990s, AAP use has expanded considerably, for example, the off-label use of quetiapine alone accounted for an estimated 17% of the AAP spend in New Zealand in 2010. There are a number of potential problems with the expanded use of AAPs outside of schizophrenia and related psychoses. A larger population will be exposed to their adverse effects, which include weight gain, type 2 diabetes mellitus, sudden cardiac death and increased mortality rates in the elderly with dementia. There are also concerns with the abuse of these agents, in particular quetiapine. Given that an increasing percentage of the population is being treated with these agents, off-label prescribing of AAPs is a cause for concern; they have a propensity to cause significant side effects and their efficacy and long-term safety for most off-label indications remains largely unknown, and therefore the risks and benefits of their use should be carefully weighed up prior to prescribing these agents off-label.

Nutrition labelling and the choices logo in Israel: positions and perceptions of leading health policy makers.

PubMed

Gesser-Edelsburg, A; Endevelt, R; Tirosh-Kamienchick, Y

2014-02-01

Based on the Social Marketing approach and Diffusion of Innovations Theory that indicates the importance of opinion leaders with respect to the spreading of new ideas, concepts or practices within a community, the present study aimed to examine positions and perceptions of Israeli leading dietitians and health officials regarding nutrition labelling and the Choices logo, before it was launched in Israel in February 2011, as well as how they would communicate it to the public as agents of influence. The study involved in-depth face-to-face and telephone interviews with 15 senior dietitians and Health Ministry officials using semi-structured protocols including questions about nutrition labelling and the Choices logo. The respondents considered that the nutrition facts panels usually found on the backs of packages are too complicated for the average consumer. Simiularly, fronts of packages are cluttered with advertisements and health claims, causing confusion. The study participants would like to see an integrative label on the front of the package to facilitate consumers' decisions. However, the Choices logo raises ethical and social questions about the conflict between corporate interests and public health: (i) the label's relativity versus objectivity; (ii) the consumer's responsibility to create a balanced diet; (iii) the label's credibility; and (iv) bias against companies, products and audiences. The results of the present study highlight the importance of a need for an integrated programme of nutrition promotion, including the use of social marketing based on a cooperative effort between the food industry, regulators and professionals, to recommend changes and adjustments in nutritional front of package labelling with the aim of promoting healthier nutrition consumption. © 2013 The Authors Journal of Human Nutrition and Dietetics © 2013 The British Dietetic Association Ltd.

Use of food labels, awareness of nutritional programmes and participation in the special supplemental program for Women, Infants and Children (WIC): results from the National Health and Nutrition Examination Survey (2005-2006).

PubMed

Wojcicki, Janet M; Heyman, Melvin B

2013-07-01

Use of nutritional labels in choosing food is associated with healthier eating habits including lower fat intake. Current public health efforts are focusing on the revamping of nutritional labels to make them easier to read and use for the consumer. The study aims to assess the frequency of use of nutritional labels and awareness of the United States Department of Agriculture (USDA) nutritional programmes by low-income women including those participating in the Special Supplemental Nutrition Program for Women, Infants and Children (WIC) as surveyed in the National Health and Nutrition Examination Survey 2005-2006. Many low-income women do not regularly use the nutrition facts panel information on the food label and less than half had heard of the USDA Dietary Guidelines for Americans (38.9%). In multivariate logistic regression, we found that WIC participation was associated with reduced use of the nutrition facts panel in choosing food products [odds ratio (OR) 0.45, 95% confidence interval (CI) 0.22-0.91], the health claims information (OR 0.54, 95% CI 0.32-0.28) and the information on carbohydrates when deciding to buy a product (OR 0.44, 95% CI 0.20-0.97) in comparison with WIC eligible non-participants. Any intervention to improve use of nutritional labels and knowledge of the USDA's nutritional programmes needs to target low-income women, including WIC participants. Future studies should evaluate possible reasons for the low use of nutrition labels among WIC participants in comparison with eligible non-participants. © 2011 John Wiley & Sons Ltd.