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

26 CFR 1.613-6 - Statement to be attached to return when depletion is claimed on percentage basis.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 26 Internal Revenue 7 2011-04-01 2009-04-01 true Statement to be attached to return when depletion is claimed on percentage basis. 1.613-6 Section 1.613-6 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE TREASURY (CONTINUED) INCOME TAX (CONTINUED) INCOME TAXES (CONTINUED) Natural Resources § 1...

Doctors' confusion over ratios and percentages in drug solutions: the case for standard labelling

PubMed Central

Wheeler, Daniel Wren; Remoundos, Dionysios Dennis; Whittlestone, Kim David; Palmer, Michael Ian; Wheeler, Sarah Jane; Ringrose, Timothy Richard; Menon, David Krishna

2004-01-01

The different ways of expressing concentrations of drugs in solution, as ratios or percentages or mass per unit volume, are a potential cause of confusion that may contribute to dose errors. To assess doctors' understanding of what they signify, all active subscribers to doctors.net.uk, an online community exclusively for UK doctors, were invited to complete a brief web-based multiple-choice questionnaire that explored their familiarity with solutions of adrenaline (expressed as a ratio), lidocaine (expressed as a percentage) and atropine (expressed in mg per mL), and their ability to calculate the correct volume to administer in clinical scenarios relevant to all specialties. 2974 (24.6%) replied. The mean score achieved was 4.80 out of 6 (SD 1.38). Only 85.2% and 65.8% correctly identified the mass of drug in the adrenaline and lidocaine solutions, respectively, whilst 93.1% identified the correct concentration of atropine. More would have administered the correct volume of adrenaline and lidocaine in clinical scenarios (89.4% and 81.0%, respectively) but only 65.5% identified the correct volume of atropine. The labelling of drug solutions as ratios or percentages is antiquated and confusing. Labelling should be standardized to mass per unit volume. PMID:15286190

26 CFR 1.613-6 - Statement to be attached to return when depletion is claimed on percentage basis.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 26 Internal Revenue 7 2010-04-01 2010-04-01 true Statement to be attached to return when depletion....613-6 Statement to be attached to return when depletion is claimed on percentage basis. In addition to... depletion deduction under section 613 for any taxable year shall attach to his return for such year a...

Health-related claims on food labels in Australia: understanding environmental health officers' roles and implications for policy.

PubMed

Condon-Paoloni, Deanne; Yeatman, Heather R; Grigonis-Deane, Elizabeth

2015-01-01

Health and related claims on food labels can support consumer education initiatives that encourage purchase of healthier foods. A new food Standard on Nutrition, Health and Related Claims became law in January 2013. Implementation will need careful monitoring and enforcement to ensure that claims are truthful and have meaning. The current study explored factors that may impact on environmental health officers' food labelling policy enforcement practices. The study used a mixed-methods approach, using two previously validated quantitative questionnaire instruments that provided measures of the level of control that the officers exercised over their work, as well as qualitative, semi-structured, in-depth interviews. Local government; Australia. Thirty-seven officers in three Australian states participated in semi-structured in-depth interviews, as well as completing the quantitative questionnaires. Senior and junior officers, including field officers, participated in the study. The officers reported a high level of autonomy and control of their work, but also a heavy workload, dominated by concerns for public health and food safety, with limited time for monitoring food labels. Compliance of labels with proposed health claims regulations was not considered a priority. Lipsky's theory of street-level bureaucracy was used to enhance understanding of officers' work practices. Competing priorities affect environmental health officers' monitoring and enforcement of regulations. Understanding officers' work practices and their perceptions of enforcement is important to increase effectiveness of policy implementation and hence its capacity to augment education initiatives to optimize health benefits.

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.

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.

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

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...

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...

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.

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

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...

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

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.

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.

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.

FDA regulation of labeling and promotional claims in therapeutic color vision devices: a tutorial.

PubMed

Drum, Bruce

2004-01-01

The Food and Drug Administration (FDA) is responsible for determining whether medical device manufacturers have provided reasonable assurance, based on valid scientific evidence, that new devices are safe and effective for their intended use before they are introduced into the U.S. market. Most existing color vision devices pose so little risk that their manufacturers are not required to submit a premarket notification [510(k)] to FDA prior to market. However, even low-risk devices may not be acceptable if they are marketed on the basis of misleading or excessive claims. Although most color vision devices are diagnostic, two types that are therapeutic rather than diagnostic are colored lenses intended to improve deficient color vision and colored lenses intended to improve reading performance. Both of these devices have presented special regulatory challenges to FDA because the intended uses and effectiveness claims initially proposed by the manufacturers were not supported by valid scientific evidence. In each instance, however, FDA worked with the manufacturer to restrict labeling and promotional claims in ways that were consistent with the available device performance data and that allowed for the legal marketing of the device.

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.

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.

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."

Percentage compensation arrangements: suspect, but not illegal.

PubMed

Fedor, F P

2001-01-01

Percentage compensation arrangements, in which a service is outsourced to a contractor that is paid in accordance with the level of its performance, are widely used in many business sectors. The HHS Office of Inspector General (OIG) has shown concern that these arrangements in the healthcare industry may offer incentives for the performance of unnecessary services or cause false claims to be made to Federal healthcare programs in violation of the antikickback statute and the False Claims Act. Percentage compensation arrangements can work and need not run afoul of the law as long as the healthcare organization carefully oversees the arrangement and sets specific safeguards in place. These safeguards include screening contractors, carefully evaluating their compliance programs, and obligating them contractually to perform within the limits of the law.

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.

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).

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.

The regulation of patient-reported outcome claims: need for a flexible standard.

PubMed

Morris, Louis A; Miller, David W

2002-01-01

We review the FDA's policies for the regulation of patient-reported outcome (PRO) claims such as quality of life, productivity, satisfaction and symptom reports and suggest alternative standards for substantiation. We base our review on FDA regulatory activities and public statements in the field of advertising substantiation. We compare these activities to the FDA's label substantiation policies and policies for health-economic (HE) claim substantiation. There is an overt inconsistency between the FDA's policies for substantiation of PRO claims in product labels and substantiation for such claims in advertising materials. This results in a higher standard for PRO claims in promotional vehicles than in product labels. Rather than relying on a "substantial evidence" standard, the FDA should consider a more flexible standard, such as the one currently applied to information included in the Clinical Trials section of product labels, or adopting a "competent and reliable scientific evidence" standard as set forth in Section 114 of the Food and Drug Administration Modernization Act (FDAMA) for HE data. We conclude that there needs to be greater consistency for substantiation in product labels and promotional materials. Furthermore, reconceptualizing most PRO claims as benefit extrapolations as opposed to efficacy information suggests a less rigorous standard is necessary.

9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

Code of Federal Regulations, 2014 CFR

2014-01-01

... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

Code of Federal Regulations, 2013 CFR

2013-01-01

... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

Code of Federal Regulations, 2011 CFR

2011-01-01

... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

9 CFR 317.356 - Nutrient content claims for “light” or “lite.”

Code of Federal Regulations, 2012 CFR

2012-01-01

... âlite.â 317.356 Section 317.356 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE... Labeling § 317.356 Nutrient content claims for “light” or “lite.” (a) General requirements. A claim using... claims in § 317.313; and (3) The product for which the claim is made is labeled in accordance with § 317...

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...

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…

9 CFR 412.1 - Label approval.

Code of Federal Regulations, 2014 CFR

2014-01-01

... foreign language or printing labels that bear a statement of the quantity of contents in accordance with... Policy Book, (except for “natural” and negative claims (e.g., “gluten free”)), health claims, ingredient and processing method claims (e.g., high-pressure processing), structure-function claims, claims...

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.

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. ...

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. ...

27 CFR 5.40 - Statements of age and percentage.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Distilled Spirits § 5.40 Statements of age and percentage. (a) Statements of age and percentage for whisky. In the case of straight whisky bottled in conformity with the bottled in bond labeling requirements and of domestic or foreign whisky, whether or not mixed or blended, all of which is 4 years old or...

27 CFR 5.40 - Statements of age and percentage.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Distilled Spirits § 5.40 Statements of age and percentage. (a) Statements of age and percentage for whisky. In the case of straight whisky bottled in conformity with the bottled in bond labeling requirements and of domestic or foreign whisky, whether or not mixed or blended, all of which is 4 years old or...

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

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...

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.

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...

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 101.14 - 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 101.14 - 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...

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

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

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 101.70 - 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 101.70 - 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...

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.

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

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

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 âgood... Nutrition Labeling § 317.354 Nutrient content claims for “good source,” “high,” and “more.” (a) General... nutrient content claims in § 317.313; and (3) The product for which the claim is made is labeled in...

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

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 âgood... Nutrition Labeling § 381.454 Nutrient content claims for “good source,” “high,” and “more.” (a) General... nutrient content claims in § 381.413; and (3) The product for which the claim is made is labeled in...

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...

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

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...

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...

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.

Consumer perceptions of graded, graphic and text label presentations for qualified health claims.

PubMed

Kapsak, Wendy Reinhardt; Schmidt, David; Childs, Nancy M; Meunier, John; White, Christy

2008-03-01

On December 18, 2002, the Food and Drug Administration (FDA) announced the Consumer Health Information for Better Nutrition Initiative. The initiative's goal is to make available more and better information about conventional foods and dietary supplements to help Americans improve their health and reduce risk of disease by making sound dietary decisions. It included a rating system to assess the "weight of the publicly available evidence." It assigns one of four ranked levels to the claim thus resulting in qualified health claims. Two phases of research were conducted by the International Food Information Council (IFIC) Foundation. Qualitative research to assess consumer understanding, vocabulary, and familiarity with claims helped with the design and orientation of the second quantitative research phase. The quantitative phase employed a Web-based survey. The claim formats included: report card graphic, report card text, embedded claim text, point-counterpoint, structure/function claim, and nutrient content claim. Respondents were asked to rate the product for perceived strength of scientific evidence provided to support the claim, and questions about the product's perceived healthfulness, quality, safety, and purchase intent. Consumers found it difficult to discriminate across four levels and showed inclination to project the scientific validity grade onto other product attributes. Consumers showed preference for simpler messages.

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

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...

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.

Obesity and trends in malpractice claims for physicians and surgeons.

PubMed

Weber, Cynthia E; Talbot, Lindsay J; Geller, Justin M; Kuo, Marissa C; Wai, Philip Y; Kuo, Paul C

2013-08-01

The increasing prevalence of obesity has altered the practice of medicine and surgery, with the emergence of new operations and medications. We hypothesized that the landscape of medical malpractice claims has also changed. We queried the Physician Insurers Association of American database for 1990 through 1999 and 2000 through 2009 for cases corresponding to International Classification of Diseases, 9th edition, codes for obesity. We extracted adjudicatory outcome, closed and paid claims data, indemnity payments, primary alleged error codes, National Association of Insurance Commissioners severity of injury class, procedural codes, and medical specialty data. A total of 411 obesity claims were filed from 1990 to 1999 and 1,591 obesity claims were filed from 2000 to 2009. General surgery was the specialty with the greatest number of obesity claims from 1990 to 1999 and was second to family practice for 2000 to 2009. Although the percentage of paid general surgery obesity claims has decreased significantly from 69% in 1990-1999 to 36% in 2000-2009, the mean indemnity payments have increased substantially ($94,000 to $368,000). Recently, the percentage of paid general surgery obesity claims has significantly decreased; however, individual and total indemnity payments have increased. Obesity continues to impact general surgery malpractice substantially. Efforts to manage this component of physician and hospital practices must continue. Copyright © 2013 Mosby, Inc. All rights reserved.

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

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...

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...

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.

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)

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

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...

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.

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...

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, 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, 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...

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...

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.

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.

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...

A Comparison of Self-reported Medication Adherence to Concordance Between Part D Claims and Medication Possession.

PubMed

Savitz, Samuel T; Stearns, Sally C; Zhou, Lei; Thudium, Emily; Alburikan, Khalid A; Tran, Richard; Rodgers, Jo E

2017-05-01

Medicare Part D claims indicate medication purchased, but people who are not fully adherent may extend prescription use beyond the interval prescribed. This study assessed concordance between Part D claims and medication possession at a study visit in relation to self-reported medication adherence. We matched Part D claims for 6 common medications to medications brought to a study visit in 2011-2013 for the Atherosclerosis Risk in Communities study. The combined data consisted of 3027 medication events (claims, medications possessed, or both) for 2099 Atherosclerosis Risk in Communities study participants. Multinomial logistic regression estimated the association of concordance (visit only, Part D only, or both) with self-reported medication adherence while controlling for sociodemographic characteristics, veteran status, and availability under Generic Drug Discount Programs. Relative to participants with high adherence, medication events for participants with low adherence were approximately 25 percentage points less likely to match and more likely to be visit only (P<0.001). The results were similar but smaller in magnitude (approximately 2-3 percentage points) for participants with medium adherence. Compared with females, medication events for male veterans were approximately 11 percentage points less likely to match and more likely to be visit only. Events for medications available through Generic Drug Discount Programs were 3 percentage points more likely to be visit only. Part D claims were substantially less likely to be concordant with medications possessed at study visit for participants with low self-reported adherence. This result supports the construction of adherence proxies such as proportion days covered using Part D claims.

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

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

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...

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...

A Comparison of Self-Reported Medication Adherence to Concordance Between Part D Claims and Medication Possession

PubMed Central

Savitz, Samuel T.; Stearns, Sally C.; Zhou, Lei; Thudium, Emily; Alburikan, Khalid A.; Tran, Richard; Rodgers, Jo E.

2017-01-01

Objective Medicare Part D claims indicate medication purchased, but people who are not fully adherent may extend prescription use beyond the interval prescribed. This study assessed concordance between Part D claims and medication possession at a study visit in relation to self-reported medication adherence. Methods We matched Part D claims for six common medications to medications brought to a study visit in 2011–2013 for the Atherosclerosis Risk in Communities Study (ARIC). The combined data consisted of 3,027 medication events (claims, medications possessed or both) for 2,099 ARIC participants. Multinomial logistic regression estimated the association of concordance (Visit Only, Part D Only, or Both) with self-reported medication adherence while controlling for socio-demographic characteristics, veteran status, and availability under Generic Drug Discount Programs (GDDPs). Results Relative to participants with high adherence (p<0.05), medication events for participants with low adherence were approximately 25 percentage points less likely to match and more likely to be Visit Only. The results were similar but smaller in magnitude (approximately 2–3 percentage points) for participants with medium adherence. Compared to females, medication events for male veterans were approximately 11 percentage points less likely to match and more likely to be Visit Only. Events for medications available through GDDP were 3 percentage points more likely to be Visit Only. Conclusions Part D claims were substantially less likely to be concordant with medications possessed at study visit for participants with low self-reported adherence. This result supports the construction of adherence proxies such as proportion days covered using Part D claims. PMID:28221276

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.

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...

Optimal Use of Available Claims to Identify a Medicare Population Free of Coronary Heart Disease

PubMed Central

Kent, Shia T.; Safford, Monika M.; Zhao, Hong; Levitan, Emily B.; Curtis, Jeffrey R.; Kilpatrick, Ryan D.; Kilgore, Meredith L.; Muntner, Paul

2015-01-01

We examined claims-based approaches for identifying a study population free of coronary heart disease (CHD) using data from 8,937 US blacks and whites enrolled during 2003–2007 in a prospective cohort study linked to Medicare claims. Our goal was to minimize the percentage of persons at study entry with self-reported CHD (previous myocardial infarction or coronary revascularization). We assembled 6 cohorts without CHD claims by requiring 6 months, 1 year, or 2 years of continuous Medicare fee-for-service insurance coverage prior to study entry and using either a fixed-window or all-available look-back period. We examined adding CHD-related claims to our “base algorithm,” which included claims for myocardial infarction and coronary revascularization. Using a 6-month fixed-window look-back period, 17.8% of participants without claims in the base algorithm reported having CHD. This was reduced to 3.6% using an all-available look-back period and adding other CHD claims to the base algorithm. Among cohorts using all-available look-back periods, increasing the length of continuous coverage from 6 months to 1 or 2 years reduced the sample size available without lowering the percentage of persons with self-reported CHD. This analysis demonstrates approaches for developing a CHD-free cohort using Medicare claims. PMID:26443420

Evaluation of the percentage of ganglion cells in the ganglion cell layer of the rodent retina

PubMed Central

Schlamp, Cassandra L.; Montgomery, Angela D.; Mac Nair, Caitlin E.; Schuart, Claudia; Willmer, Daniel J.

2013-01-01

Purpose Retinal ganglion cells comprise a percentage of the neurons actually residing in the ganglion cell layer (GCL) of the rodent retina. This estimate is useful to extrapolate ganglion cell loss in models of optic nerve disease, but the values reported in the literature are highly variable depending on the methods used to obtain them. Methods We tested three retrograde labeling methods and two immunostaining methods to calculate ganglion cell number in the mouse retina (C57BL/6). Additionally, a double-stain retrograde staining method was used to label rats (Long-Evans). The number of total neurons was estimated using a nuclear stain and selecting for nuclei that met specific criteria. Cholinergic amacrine cells were identified using transgenic mice expressing Tomato fluorescent protein. Total neurons and total ganglion cell numbers were measured in microscopic fields of 104 µm2 to determine the percentage of neurons comprising ganglion cells in each field. Results Historical estimates of the percentage of ganglion cells in the mouse GCL range from 36.1% to 67.5% depending on the method used. Experimentally, retrograde labeling methods yielded a combined estimate of 50.3% in mice. A retrograde method also yielded a value of 50.21% for rat retinas. Immunolabeling estimates were higher at 64.8%. Immunolabeling may introduce overestimates, however, with non-specific labeling effects, or ectopic expression of antigens in neurons other than ganglion cells. Conclusions Since immunolabeling methods may overestimate ganglion cell numbers, we conclude that 50%, which is consistently derived from retrograde labeling methods, is a reliable estimate of the ganglion cells in the neuronal population of the GCL. PMID:23825918

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

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…

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.

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

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...

[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.

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.

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.

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.

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...

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.

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.

Nutrition Label Viewing during a Food-Selection Task: Front-of-Package Labels vs Nutrition Facts Labels.

PubMed

Graham, Dan J; Heidrick, Charles; Hodgin, Katie

2015-10-01

Earlier research has identified consumer characteristics associated with viewing Nutrition Facts labels; however, little is known about those who view front-of-package nutrition labels. Front-of-package nutrition labels might appeal to more consumers than do Nutrition Facts labels, but it might be necessary to provide consumers with information about how to locate and use these labels. This study quantifies Nutrition Facts and front-of-package nutrition label viewing among American adult consumers. Attention to nutrition information was measured during a food-selection task. One hundred and twenty-three parents (mean age=38 years, mean body mass index [calculated as kg/m(2)]=28) and one of their children (aged 6 to 9 years) selected six foods from a university laboratory-turned-grocery aisle. Participants were randomized to conditions in which front-of-package nutrition labels were present or absent, and signage explaining front-of-package nutrition labels was present or absent. Adults' visual attention to Nutrition Facts labels and front-of-package nutrition labels was objectively measured via eye-tracking glasses. To examine whether there were significant differences in the percentages of participants who viewed Nutrition Facts labels vs front-of-package nutrition labels, McNemar's tests were conducted across all participants, as well as within various sociodemographic categories. To determine whether hypothesized factors, such as health literacy and education, had stronger relationships with front-of-package nutrition label vs Nutrition Facts label viewing, linear regression assessed the magnitude of relationships between theoretically and empirically derived factors and each type of label viewing. Overall, front-of-package nutrition labels were more likely to be viewed than Nutrition Facts labels; however, for all subgroups, higher rates of front-of-package nutrition label viewership occurred only when signage was present drawing attention to the presence and

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.

37 CFR 1.75 - Claim(s).

Code of Federal Regulations, 2011 CFR

2011-07-01

... 37 Patents, Trademarks, and Copyrights 1 2011-07-01 2011-07-01 false Claim(s). 1.75 Section 1.75 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Specification § 1.75 Claim(s). (a...

37 CFR 1.75 - Claim(s).

Code of Federal Regulations, 2014 CFR

2014-07-01

... 37 Patents, Trademarks, and Copyrights 1 2014-07-01 2014-07-01 false Claim(s). 1.75 Section 1.75 Patents, Trademarks, and Copyrights UNITED STATES PATENT AND TRADEMARK OFFICE, DEPARTMENT OF COMMERCE GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Specification § 1.75 Claim(s). (a...

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...

37 CFR 1.75 - Claim(s).

Code of Federal Regulations, 2010 CFR

2010-07-01

... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Claim(s). 1.75 Section 1.75... GENERAL RULES OF PRACTICE IN PATENT CASES National Processing Provisions Specification § 1.75 Claim(s). (a.... (35 U.S.C. 6; 15 U.S.C. 1113, 1126) [31 FR 12922, Oct. 4, 1966, as amended at 36 FR 12690, July 3...

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®

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.

32 CFR 536.120 - Claims payable as maritime claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 3 2010-07-01 2010-07-01 true Claims payable as maritime claims. 536.120... ACCOUNTS CLAIMS AGAINST THE UNITED STATES Maritime Claims § 536.120 Claims payable as maritime claims. A claim is cognizable under this subpart if it arises in or on a maritime location, involves some...

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.

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...

Lessons regarding the safety of orthopaedic patient care: an analysis of four hundred and sixty-four closed malpractice claims.

PubMed

Matsen, Frederick A; Stephens, Linda; Jette, Jocelyn L; Warme, Winston J; Posner, Karen L

2013-02-20

An orthopaedic malpractice claim alleges that the patient sustained a preventable iatrogenic injury. The analysis of a representative series of malpractice claims provides a unique view of alleged orthopaedic adverse events, revealing what can potentially go wrong across a spectrum of practice settings and anatomic locations. The goal of this study was to identify high-impact targets in order to institute measures to reduce claims through efforts focused on patient safety. The authors investigated 464 consecutive closed malpractice claims from the nation's largest insurer of medical liability. We analyzed the claims by anatomical site, type of care rendered, type of allegation, and payment. We calculated an "impact factor" for each claim type by dividing the percentage of total payments for each type by the percentage of total claims for that type. Our analysis revealed major concerns regarding patient safety within this series of malpractice claims. One-third of the claims alleged permanent disabling injuries, including amputations, brain damage, and major nerve damage. The highest impact allegations were failure to protect structures in the surgical field (41% of total payments to plaintiffs, 15% of all claims, impact factor of 2.7) and failure to prevent, diagnose, and/or treat complications of treatment (16% of total payments, 7% of all claims, impact factor of 2.3). Spine procedures had high impact (1.9), representing 28% of dollars paid and 15% of claims, with 45% of spine claims involving death or severe permanent injury. Failure of implant positioning was commonly alleged in hip and knee arthroplasty. In claims related to fracture care, the most common allegations were related to malunions, nonunions, dislocations, failure to protect structures in the surgical field, infection, and treatment complications. Total payment for the eighty-eight claims paid was $17,917,614 (U.S. dollars adjusted to 2009). Regarding clinical relevance, this analysis suggests risk

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.

Using nutrition labeling as a potential tool for changing eating habits of university dining hall patrons.

PubMed

Driskell, Judy A; Schake, Marian C; Detter, Hillary A

2008-12-01

The purpose of this cross-sectional study was to examine the influence of the nutritional labeling Nutrition Bytes on the eating habits of adults eating in dining halls at a Midwestern university and to assess differences between sexes. Dining hall patrons (114 men, 91 women) 19 years of age or older voluntarily completed a descriptive 15-item written questionnaire that examined the use and nonuse of Nutrition Bytes, which contains much of the information included in the Nutrition Facts label. A significantly higher percentage of women than men patrons reported currently using Nutrition Bytes labels (P<0.001). Predominant reasons for using Nutrition Bytes labels were: general knowledge, concern about overall health, calorie counting, and concern about a certain nutrient(s). Predominant reasons given for not using Nutrition Bytes labels were: will not change my mind about food items selected and not enough time. Reasons given by men and women for using or not using Nutrition Bytes labels were similar. Significantly higher percentages of women than men using Nutrition Bytes labels indicated being interested in having serving sizes (P<0.005) and ingredients (P<0.0005) listed, whereas higher percentages of men than women indicated being interested in having protein listed (P<0.05). The percentages of users who indicated nearly always and sometimes changing their food choices after reading Nutrition Bytes labels inside the dining halls were 12% and 80%, respectively, whereas 23% and 65%, respectively, indicated changing their food choices after reading the nutrition label when eating outside the dining halls. Nutrition Bytes labeling seemed to positively impact food choices of these adult dining hall patrons, and likely would do so at other dining halls.

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.

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.

Rates, amounts, and determinants of ambulatory blood pressure monitoring claim reimbursements among Medicare beneficiaries.

PubMed

Kent, Shia T; Shimbo, Daichi; Huang, Lei; Diaz, Keith M; Viera, Anthony J; Kilgore, Meredith; Oparil, Suzanne; Muntner, Paul

2014-12-01

Ambulatory blood pressure monitoring (ABPM) can be used to identify white coat hypertension and guide hypertensive treatment. We determined the percentage of ABPM claims submitted between 2007 and 2010 that were reimbursed. Among 1970 Medicare beneficiaries with submitted claims, ABPM was reimbursed for 93.8% of claims that had an International Classification of Diseases, Ninth Revision, diagnosis code of 796.2 ("elevated blood pressure reading without diagnosis of hypertension") versus 28.5% of claims without this code. Among claims without an International Classification of Diseases, Ninth Revision, diagnosis code of 796.2 listed, those for the component (eg, recording, scanning analysis, physician review, reporting) versus full ABPM procedures and performed by institutional versus non-institutional providers were each more than two times as likely to be successfully reimbursed. Of the claims reimbursed, the median payment was $52.01 (25th-75th percentiles, $32.95-$64.98). In conclusion, educating providers on the ABPM claims reimbursement process and evaluation of Medicare reimbursement may increase the appropriate use of ABPM and improve patient care. Copyright © 2014 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

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.

Licensing and labelling of drugs in a paediatric oncology ward

PubMed Central

van den Berg, Henk; Tak, Nanda

2011-01-01

AIM Paediatric drug prescriptions are known for their high percentages of off-label and unlicensed use. In paediatric oncology data available are scarce. The aim of this paper is an analysis of the licensing and labelling status of all prescribed medication over a 2 week period in a Dutch paediatric oncology centre. METHODS An analysis of the delivery of medication by the hospital pharmacy to patients admitted to the paediatric oncology centre was carried out. RESULTS In total 268 precriptions were filed for 39 patients. In 87% of children unlicensed medication was used. Fifty-nine per cent of the children received at least two unlicensed drugs. In total 72% of the drugs were used licensed and on-label was found in 57% of the prescriptions. There was a trend that in younger children percentages were lower. International and local guidelines necessitated in many cases unlicensed use, e.g. intrathecal prednisolone, low dose medication such as heparin, ethanol and vancomycin for locking intravenous devices and higher intravenous vancomycin dosages. There were no major differences with respect to type of malignancy. CONCLUSION Our figures are substantially higher than the figures reported from adult oncology. Comparison with other paediatric reports are cumbersome, due to different percentages of diseases in the reports and other rules to dispense medication in the outpatient setting. Our data are in line with reports mentioning the higher percentages of unlicensed and off-label use. Our data further underpin the need for more research on suitable formulations, dosages, safety and efficacy in these children. PMID:21453298

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.

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.

US Consumers' Understanding of Nutrition Labels in 2013: The Importance of Health Literacy.

PubMed

Persoskie, Alexander; Hennessy, Erin; Nelson, Wendy L

2017-09-28

We examined US adults' understanding of a Nutrition Facts panel (NFP), which requires health literacy (ie, prose, document, and quantitative literacy skills), and the association between label understanding and dietary behavior. Data were from the Health Information National Trends Survey, a nationally representative survey of health information seeking among US adults (N = 3,185) conducted from September 6, 2013, through December 30, 2013. Participants viewed an ice cream nutrition label and answered 4 questions that tested their ability to apply basic arithmetic and understanding of percentages to interpret the label. Participants reported their intake of sugar-sweetened soda, fruits, and vegetables. Regression analyses tested associations among label understanding, demographic characteristics, and self-reported dietary behaviors. Approximately 24% of people could not determine the calorie content of the full ice-cream container, 21% could not estimate the number of servings equal to 60 g of carbohydrates, 42% could not estimate the effect on daily calorie intake of foregoing 1 serving, and 41% could not calculate the percentage daily value of calories in a single serving. Higher scores for label understanding were associated with consuming more vegetables and less sugar-sweetened soda, although only the association with soda consumption remained significant after adjusting for demographic factors. Many consumers have difficulty interpreting nutrition labels, and label understanding correlates with self-reported dietary behaviors. The 2016 revised NFP labels may address some deficits in consumer understanding by eliminating the need to perform certain calculations (eg, total calories per package). However, some tasks still require the ability to perform calculations (eg, percentage daily value of calories). Schools have a role in teaching skills, such as mathematics, needed for nutrition label understanding.

27 CFR 19.517 - Statements required on labels under an exemption from label approval.

Code of Federal Regulations, 2011 CFR

2011-04-01

... chapter; (d) State of distillation. In the case of whisky, the state of distillation statement on the... conform to the requirements of § 19.518; (g) Age of whisky containing no neutral spirits. In the case of whisky containing no neutral spirits, statements of age and percentage by volume on the label must...

Data linkage of inpatient hospitalization and workers' claims data sets to characterize occupational falls.

PubMed

Bunn, Terry L; Slavova, Svetla; Bathke, Arne

2007-07-01

The identification of industry, occupation, and associated injury costs for worker falls in Kentucky have not been fully examined. The purpose of this study was to determine the associations between industry and occupation and 1) hospitalization length of stay; 2) hospitalization charges; and 3) workers' claims costs in workers suffering falls, using linked inpatient hospitalization discharge and workers' claims data sets. Hospitalization cases were selected with ICD-9-CM external cause of injury codes for falls and payer code of workers' claims for years 2000-2004. Selection criteria for workers'claims cases were International Association of Industrial Accident Boards and Commissions Electronic Data Interchange Nature (IAIABCEDIN) injuries coded as falls and/or slips. Common data variables between the two data sets such as date of birth, gender, date of injury, and hospital admission date were used to perform probabilistic data linkage using LinkSolv software. Statistical analysis was performed with non-parametric tests. Construction falls were the most prevalent for male workers and incurred the highest hospitalization and workers' compensation costs, whereas most female worker falls occurred in the services industry. The largest percentage of male worker falls was from one level to another, while the largest percentage of females experienced a fall, slip, or trip (not otherwise classified). When male construction worker falls were further analyzed, laborers and helpers had longer hospital stays as well as higher total charges when the worker fell from one level to another. Data linkage of hospitalization and workers' claims falls data provides additional information on industry, occupation, and costs that are not available when examining either data set alone.

External validation of Medicare claims codes for digital mammography and computer-aided detection.

PubMed

Fenton, Joshua J; Zhu, Weiwei; Balch, Steven; Smith-Bindman, Rebecca; Lindfors, Karen K; Hubbard, Rebecca A

2012-08-01

While Medicare claims are a potential resource for clinical mammography research or quality monitoring, the validity of key data elements remains uncertain. Claims codes for digital mammography and computer-aided detection (CAD), for example, have not been validated against a credible external reference standard. We matched Medicare mammography claims for women who received bilateral mammograms from 2003 to 2006 to corresponding mammography data from the Breast Cancer Surveillance Consortium (BCSC) registries in four U.S. states (N = 253,727 mammograms received by 120,709 women). We assessed the accuracy of the claims-based classifications of bilateral mammograms as either digital versus film and CAD versus non-CAD relative to a reference standard derived from BCSC data. Claims data correctly classified the large majority of film and digital mammograms (97.2% and 97.3%, respectively), yielding excellent agreement beyond chance (κ = 0.90). Claims data correctly classified the large majority of CAD mammograms (96.6%) but a lower percentage of non-CAD mammograms (86.7%). Agreement beyond chance remained high for CAD classification (κ = 0.83). From 2003 to 2006, the predictive values of claims-based digital and CAD classifications increased as the sample prevalences of each technology increased. Medicare claims data can accurately distinguish film and digital bilateral mammograms and mammograms conducted with and without CAD. The validity of Medicare claims data regarding film versus digital mammography and CAD suggests that these data elements can be useful in research and quality improvement. ©2012 AACR.

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…

Malpractice in distal radius fracture management: an analysis of closed claims.

PubMed

DeNoble, Peter H; Marshall, Astrid C; Barron, O Alton; Catalano, Louis W; Glickel, Steven Z

2014-08-01

Distal radius fractures comprise the majority of hand- and wrist-related malpractice claims. We hypothesized that a majority of lawsuits would be for malunions resulting from nonsurgical treatment. Additional goals of this study were to quantify costs associated with claims, determine independent risk factors for making an indemnity payment, and illustrate trends over time. Seventy closed malpractice claims filed for alleged negligent treatment of distal radius fractures by orthopedic surgeons insured by the largest medical professional liability insurer in New York State (NYS) from 1981 to 2005 were reviewed. We separately reviewed defendants' personal closed malpractice claim histories from 1975 to 2011. Overall incidence of malpractice claims among distal radius fractures treated in NYS was calculated using the NYS Statewide Planning and Research Cooperative System database and the 2008 American Academy of Orthopedic Surgeons census data. The overall incidence of malpractice claims for distal radius fracture management was low. Malunion was the most common complaint across claims regardless of treatment type. Claims for surgically treated fractures increased over time. A majority of claims documented poor doctor-patient relationships. Male plaintiffs in this group were significantly older than males treated for distal radius fractures in NYS. Most defendants had a history of multiple malpractice suits, all were male, and only a small percentage were fellowship-trained in hand surgery. Defendants lacking American Board of Orthopedic Surgery certification were significantly more likely to make indemnity payments. Thirty-eight of 70 cases resulted in an indemnity payment. Malunion and poor doctor-patient relationships are the major features of malpractice litigation involving distal radius fracture management. Older defendant age and lack of American Board of Orthopedic Surgery certification increase the likelihood of making an indemnity payment. Economic and

Licensing and labelling of drugs in a paediatric oncology ward.

PubMed

van den Berg, Henk; Tak, Nanda

2011-09-01

Paediatric drug prescriptions are known for their high percentages of off-label and unlicensed use. In paediatric oncology data available are scarce. The aim of this paper is an analysis of the licensing and labelling status of all prescribed medication over a 2 week period in a Dutch paediatric oncology centre. An analysis of the delivery of medication by the hospital pharmacy to patients admitted to the paediatric oncology centre was carried out. In total 268 precriptions were filed for 39 patients. In 87% of children unlicensed medication was used. Fifty-nine per cent of the children received at least two unlicensed drugs. In total 72% of the drugs were used licensed and on-label was found in 57% of the prescriptions. There was a trend that in younger children percentages were lower. International and local guidelines necessitated in many cases unlicensed use, e.g. intrathecal prednisolone, low dose medication such as heparin, ethanol and vancomycin for locking intravenous devices and higher intravenous vancomycin dosages. There were no major differences with respect to type of malignancy. Our figures are substantially higher than the figures reported from adult oncology. Comparison with other paediatric reports are cumbersome, due to different percentages of diseases in the reports and other rules to dispense medication in the outpatient setting. Our data are in line with reports mentioning the higher percentages of unlicensed and off-label use. Our data further underpin the need for more research on suitable formulations, dosages, safety and efficacy in these children. © 2011 The Authors. British Journal of Clinical Pharmacology © 2011 The British Pharmacological Society.

16 CFR 306.12 - Labels.

Code of Federal Regulations, 2011 CFR

2011-01-01

... biodiesel, biomass-based diesel, biodiesel blends, and biomass-based diesel blends. The label is 3 inches (7... biodiesel blends containing more than 5 percent and no greater than 20 percent biodiesel by volume. (i) The...” followed immediately by the numerical value representing the volume percentage of biodiesel in the fuel (e...

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.

32 CFR 536.85 - Claims payable under the Federal Tort Claims Act.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 3 2013-07-01 2013-07-01 false Claims payable under the Federal Tort Claims Act... AND ACCOUNTS CLAIMS AGAINST THE UNITED STATES Claims Cognizable Under the Federal Tort Claims Act § 536.85 Claims payable under the Federal Tort Claims Act. (a) Unless otherwise prescribed, claims for...

Colour and label evaluation of commercial pasteurised red juices and related drinks.

PubMed

Fallico, B; Arena, E; Chiappara, E; Ballistreri, G

2010-01-01

Despite growing demand by consumers for healthy beverages, artificial colours are still widely used. Levels of anthocyanins and artificial colours were determined by HPLC with UV-Vis detection in red orange juices and other red beverages (nectar, juice-based, health, carbonated and sports drinks). The contribution of pigments to the visible colour of the beverage was calculated. Red orange juice samples contained about 34 mg l(-1) of anthocyanins, which were responsible for about 92% of the visible colour. Red juice-based drinks, containing from 0% to 30% of red orange, berry, grape or pomegranate juices, had low levels of anthocyanins (about 7 mg l(-1)) and high levels of E129 (about 32 mg l(-1)), which were responsible for about 90.7% of the colour of these beverages. Red health drinks, enriched with vitamins and polyphenols, contained from 3% to 50% of red fruit juices. Also in this case the E129 levels were higher (about 22 mg l(-1)) than anthocyanins (about 9 mg l(-1)), and were responsible for the colour of the beverages (76.1%). High levels of artificial colours were found in red orange carbonated drinks, but in comparable amounts with those found in the other beverage samples, while anthocyanins were only present in trace amounts. Although all of the beverages claimed to contain red fruits on the labels, no correlation was found between the level of anthocyanins and the declared percentage of red fruits. These labels generally conformed with the requirements of the law, but food product labels can often be misleading to consumers about the real characteristics of the product.

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.

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

Food nutrition labelling practice in China.

PubMed

Tao, Yexuan; Li, Ji; Lo, Y Martin; Tang, Qingya; Wang, Youfa

2011-03-01

The present study aimed to scrutinize the food nutrition labelling practice in China before the Chinese Food Nutrition Labeling Regulation (CFNLR) era. Nutrition information of pre-packaged foods collected from a supermarket between December 2007 and January 2008 was analysed and compared with findings from a survey conducted in Beijing. Information collected from a supermarket in Shanghai. A total of 850 pre-packaged foods. In the Shanghai survey, the overall labelling rate was 30·9 %, similar to that found in the Beijing study (29·7 %). While only 20·5 % of the snacks in Shanghai had nutrition labelling, the percentage of food items labelled with SFA (8·6 %), trans fatty acid (4·7 %) or fibre (12·1 %) was very low. Of those food items with nutrition labels, a considerable proportion (7-15 %) did not label energy, fat, carbohydrate or protein. Food products manufactured by Taiwan and Hong Kong companies had a lower labelling rate (13·6 %) than those manufactured by domestic (31·6 %) or international manufacturers (33·8 %). The very low food nutrition labelling rate among products sold in large chain supermarkets in major cities of China before CFNLR emphasizes the need for such critical regulations to be implemented in order to reinforce industrial compliance with accurate nutrition labelling.

Percentages and Milk Fat

ERIC Educational Resources Information Center

Bu, Lingguo; Marjanovich, Angel

2017-01-01

Percentages have proven to be a challenging concept in school mathematics. At the surface, a percentage is merely a rational number, representing a ratio between a number and 100. At the conceptual core, however, a percentage is sensitive to the context, making sense with respect to a network of related quantities. In the effort of the authors to…

Labelling and Marketing of Bivalve and Gastropod Molluscs Retailed in Sardinia, Italy Between 2009 and 2013.

PubMed

Meloni, Domenico

2015-05-28

The aim of the present survey was to investigate the correct enforcement of the Community rules on the labelling and marketing of bivalve and gastropod molluscs retailed in Sardinia, Italy between 2009 and 2013. A total of 1500 packages and labels for live bivalve and gastropod molluscs were considered. A total of 375 labels (25%) presented non-compliance concerning the wrong trade name and additional wrong or missing information. The highest percentage of anomalous labels has been detected in small-scale retail shops (35%) and open-air markets (25%) compared with the big retailing chains (20%). The 5% of packages were not in compliance with the European Community rules on packaging of bivalve and gastropod molluscs. The high percentage of non-compliance with the European regulations on labelling results is a strong limitation for the consumers and highlights the need to improve the control system about labelling of seafood products.

Defining hip fracture with claims data: outpatient and provider claims matter.

PubMed

Berry, S D; Zullo, A R; McConeghy, K; Lee, Y; Daiello, L; Kiel, D P

2017-07-01

Medicare claims are commonly used to identify hip fractures, but there is no universally accepted definition. We found that a definition using inpatient claims identified fewer fractures than a definition including outpatient and provider claims. Few additional fractures were identified by including inconsistent diagnostic and procedural codes at contiguous sites. Medicare claims data is commonly used in research studies to identify hip fractures, but there is no universally accepted definition of fracture. Our purpose was to describe potential misclassification when hip fractures are defined using Medicare Part A (inpatient) claims without considering Part B (outpatient and provider) claims and when inconsistent diagnostic and procedural codes occur at contiguous fracture sites (e.g., femoral shaft or pelvic). Participants included all long-stay nursing home residents enrolled in Medicare Parts A and B fee-for-service between 1/1/2008 and 12/31/2009 with follow-up through 12/31/2011. We compared the number of hip fractures identified using only Part A claims to (1) Part A plus Part B claims and (2) Part A and Part B claims plus discordant codes at contiguous fracture sites. Among 1,257,279 long-stay residents, 40,932 (3.2%) met the definition of hip fracture using Part A claims, and 41,687 residents (3.3%) met the definition using Part B claims. 4566 hip fractures identified using Part B claims would not have been captured using Part A claims. An additional 227 hip fractures were identified after considering contiguous fracture sites. When ascertaining hip fractures, a definition using outpatient and provider claims identified 11% more fractures than a definition with only inpatient claims. Future studies should publish their definition of fracture and specify if diagnostic codes from contiguous fracture sites were used.

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.

Manual handling incident claims in the healthcare sector: Factors and outcomes.

PubMed

Dockrell, Sara; Johnson, Muriel; Ganly, Joe; Bennett, Kathleen

2011-01-01

Manual handling (MH) incidents may result in injury, absenteeism and/or compensation claim. This study investigated the factors associated with MH incidents among healthcare workers who had made a claim, and the management and outcome of those workers. A national sample of healthcare sector MH incident claim files (n=247) were accessed and 35~files met the inclusion criteria. Data were collected and presented graphically or descriptively using percentages (and 95% Confidence intervals, CI). Chi-square (χ2) tests were used for comparing proportions between groups. SPSS (v14.0) was used for analysis. Significance at p<0.05 is assumed. Attendants accounted for the highest number of claimants. The majority of claims (74%, 95% CI 68%, 81%) were for back injury; 11% (8%, 15%) for neck injury. Fifty-one percent (43%, 60%) involved patient-handling tasks at the time of incident; 46% (37%, 54%) involved inanimate handling. Ninety-one percent (89%, 94%) took sick leave, with 52% (43%, 60%) taking > 52 weeks. Only 58% (49%, 65%) returned to work. Claimants who had been in communication with employers were significantly more likely to return to work than those who did not (χ2 test, p=0.017). Improved management of MH incidents and injured workers are recommended.

Labelling and Marketing of Bivalve and Gastropod Molluscs Retailed in Sardinia, Italy Between 2009 and 2013

PubMed Central

2015-01-01

The aim of the present survey was to investigate the correct enforcement of the Community rules on the labelling and marketing of bivalve and gastropod molluscs retailed in Sardinia, Italy between 2009 and 2013. A total of 1500 packages and labels for live bivalve and gastropod molluscs were considered. A total of 375 labels (25%) presented non-compliance concerning the wrong trade name and additional wrong or missing information. The highest percentage of anomalous labels has been detected in small-scale retail shops (35%) and open-air markets (25%) compared with the big retailing chains (20%). The 5% of packages were not in compliance with the European Community rules on packaging of bivalve and gastropod molluscs. The high percentage of non-compliance with the European regulations on labelling results is a strong limitation for the consumers and highlights the need to improve the control system about labelling of seafood products. PMID:27800397

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.

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.

Small Claims Court.

ERIC Educational Resources Information Center

McKitric, Eloise; Davis, Janet

The study examined individuals and companies who used small claims courts and the results of decisions reached in small claims cases. A review of studies including an empirical study of two Ohio small claims courts monitored for 12 months made it clear that small claims courts need to be examined to determine if utilization and accessibility to…

32 CFR 536.74 - Scope for claims under the Military Claims Act.

Code of Federal Regulations, 2011 CFR

2011-07-01

... (normally a resident) of the United States at the time of the incident giving rise to the claim. See § 536... AND ACCOUNTS CLAIMS AGAINST THE UNITED STATES Claims Cognizable Under the Military Claims Act § 536.74... claims against the United States for death or personal injury, or damage to, or loss or destruction of...

32 CFR 536.74 - Scope for claims under the Military Claims Act.

Code of Federal Regulations, 2010 CFR

2010-07-01

... (normally a resident) of the United States at the time of the incident giving rise to the claim. See § 536... AND ACCOUNTS CLAIMS AGAINST THE UNITED STATES Claims Cognizable Under the Military Claims Act § 536.74... claims against the United States for death or personal injury, or damage to, or loss or destruction of...

Hip Arthroplasty Malpractice Claims in the Netherlands: Closed Claim Study 2000-2012.

PubMed

Zengerink, Imme; Reijman, Max; Mathijssen, Nina M C; Eikens-Jansen, Manon P; Bos, P Koen

2016-09-01

A total hip arthroplasty (THA) is a successful and reliable operation with few complications. These complications however, do form a potential source for compensation claims. In the Netherlands, there are no studies available concerning filed claims after THA. The aim of this study was to determine the incidence of claims related to THAs in the Netherlands and the reasons to claim, which claims lead to compensation, the costs involved for the insurer, and the demographics of the claimants. In this observational study, we analyzed all closed claims from 2000 to 2012 from the national largest insurer of medical liability and compared it to data from our national implant registry in the Netherlands. With the intention to contribute to prevention, we have identified the demographics of the claimant, the reasons for filing claims, and the outcome of claims. Overall, 516 claims were expressed in 280 closed claim files after THA. Claims were most often related to sciatic nerve injury (19.6%). Most claimants were women (71.6%) with an average age of 63.1 years. The median cost per compensated claim is €5.921. The claimant is more likely to be female and to be younger than the average patient receiving a THA. The incidence of a claim after a THA is 0.14%-0.30%. Nerve damage is the most common reason to file for compensation. The distribution in reasons to claim does not resemble the complication rate in literature after a THA. The outcome of this study can be used to improve patient care, safety, and costs. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

How do design features influence consumer attention when looking for nutritional information on food labels? Results from an eye-tracking study on pan bread labels.

PubMed

Antúnez, Lucía; Vidal, Leticia; Sapolinski, Alejandra; Giménez, Ana; Maiche, Alejandro; Ares, Gastón

2013-08-01

The aim of this work was to evaluate consumer visual processing of food labels when evaluating the salt content of pan bread labels and to study the influence of label design and nutritional labelling format on consumer attention. A total of 16 pan bread labels, designed according to a full factorial design, were presented to 52 participants, who were asked to decide whether the sodium content of each label was medium or low, while their eye movements were recorded using an eye tracker. Results showed that most participants looked at nutrition labels and the traffic light system to conclude on the salt content of the labels. However, the average percentage of participants who looked at the actual sodium content was much lower. Nutrition information format affected participants' processing of nutrition information. Among other effects, the inclusion of the traffic light system increased participants' attention towards some kind of nutrition information and facilitated its processing, but not its understanding.

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

Label Design Affects Medication Safety in an Operating Room Crisis: A Controlled Simulation Study.

PubMed

Estock, Jamie L; Murray, Andrew W; Mizah, Margaret T; Mangione, Michael P; Goode, Joseph S; Eibling, David E

2018-06-01

Several factors contribute to medication errors in clinical practice settings, including the design of medication labels. The objective of this study was to quantify the impact of label design on medication safety in a realistic, high-stress clinical situation. Ninety-six anesthesia trainee participants were randomly assigned to either the redesigned or the current label condition. Participants were blinded to the study's focus on medication label design and their assigned label condition. Each participant was the sole anesthesia provider in a simulated operating room scenario involving an unexpected vascular injury. The surgeon asked the participant to administer hetastarch to the simulated patient because of hemodynamic instability. The fluid drawer of the anesthesia cart contained three 500-ml intravenous bags of hetastarch and one 500-ml intravenous bag of lidocaine. We hypothesized that redesigned labels would help participants correctly select hetastarch from the cart. If the participants incorrectly selected lidocaine from the cart, we hypothesized that the redesigned labels would help participants detect the lidocaine before administration. The percentage of participants who correctly selected hetastarch from the cart was significantly higher for the redesigned labels than the current labels (63% versus 40%; odds ratio, 2.61 [95% confidence interval, 1.1-6.1]; P = 0.03). Of the participants who incorrectly selected lidocaine from the cart, the percentage who detected the lidocaine before administration did not differ by label condition. The redesigned labels helped participants correctly select hetastarch from the cart, thus preventing some potentially catastrophic medication errors from reaching the simulated patient.

Pediatric radiology malpractice claims - characteristics and comparison to adult radiology claims.

PubMed

Breen, Micheál A; Dwyer, Kathy; Yu-Moe, Winnie; Taylor, George A

2017-06-01

Medical malpractice is the primary method by which people who believe they have suffered an injury in the course of medical care seek compensation in the United States and Canada. An increasing body of research demonstrates that failure to correctly diagnose is the most common allegation made in malpractice claims against radiologists. Since the 1994 survey by the Society of Chairmen of Radiology in Children's Hospitals (SCORCH), no other published studies have specifically examined the frequency or clinical context of malpractice claims against pediatric radiologists or arising from pediatric imaging interpretation. We hypothesize that the frequency, character and outcome of malpractice claims made against pediatric radiologists differ from those seen in general radiology practice. We searched the Controlled Risk Insurance Co. (CRICO) Strategies' Comparative Benchmarking System (CBS), a private repository of approximately 350,000 open and closed medical malpractice claims in the United States, for claims related to pediatric radiology. We further queried these cases for the major allegation, the clinical environment in which the claim arose, the clinical severity of the alleged injury, indemnity paid (if payment was made), primary imaging modality involved (if applicable) and primary International Classification of Diseases, 9th revision (ICD-9) diagnosis underlying the claim. There were a total of 27,056 fully coded claims of medical malpractice in the CBS database in the 5-year period between Jan. 1, 2010, and Dec. 31, 2014. Of these, 1,472 cases (5.4%) involved patients younger than 18 years. Radiology was the primary service responsible for 71/1,472 (4.8%) pediatric cases. There were statistically significant differences in average payout for pediatric radiology claims ($314,671) compared to adult radiology claims ($174,033). The allegations were primarily diagnosis-related in 70% of pediatric radiology claims. The most common imaging modality implicated in

Percentage Problems in Bridging Courses

ERIC Educational Resources Information Center

Kachapova, Farida; Kachapov, Ilias

2012-01-01

Research on teaching high school mathematics shows that the topic of percentages often causes learning difficulties. This article describes a method of teaching percentages that the authors used in university bridging courses. In this method, the information from a word problem about percentages is presented in a two-way table. Such a table gives…

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,…

Modeling number of claims and prediction of total claim amount

NASA Astrophysics Data System (ADS)

Acar, Aslıhan Şentürk; Karabey, Uǧur

2017-07-01

In this study we focus on annual number of claims of a private health insurance data set which belongs to a local insurance company in Turkey. In addition to Poisson model and negative binomial model, zero-inflated Poisson model and zero-inflated negative binomial model are used to model the number of claims in order to take into account excess zeros. To investigate the impact of different distributional assumptions for the number of claims on the prediction of total claim amount, predictive performances of candidate models are compared by using root mean square error (RMSE) and mean absolute error (MAE) criteria.

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.

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.

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...

"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.

Nutrition labels in bar graph format deemed most useful for consumer purchase decisions using adaptive conjoint analysis.

PubMed

Geiger, C J; Wyse, B W; Parent, C R; Hansen, R G

1991-07-01

This study estimated the effects of changing multiple levels and combinations of nutrition information format, load, expression, and order on consumers' perceptions of label usefulness in purchase decisions using adaptive conjoint analysis. A shopping mall intercept survey, which was administered by a marketing research firm, assessed consumer preferences for 12 label alternatives produced on Campbell's soup cans to portray nutrition information realistically; 252 of 258 respondents completed the computer interactive interview. Consumers significantly preferred the bar graph format to the bar graph/nutrient density and traditional label formats. Consumers considered the bar graph/nutrient density format to be as useful as the traditional label format. There was a highly significant difference among the three levels of information load; the most information load was preferred regardless of nutrient importance. Consumers significantly preferred nutrition information stated in absolute numbers and percentages vs in absolute numbers only in traditional, or in percentages only expressions. There was a significant difference between consumer preferences for the two types of information order. The findings indicate that consumers clearly preferred the nutrition label that displayed all nutrient values using a bar graph format, offered the most information load, and expressed nutrient values using both absolute numbers and percentages. Consumers also preferred nutrition information rearranged in an order that grouped nutrients that should be consumed in adequate amounts on the top, calories in the middle, and nutrients that should be consumed in lesser amounts on the bottom of the label.

Academic Radiologist Subspecialty Identification Using a Novel Claims-Based Classification System.

PubMed

Rosenkrantz, Andrew B; Wang, Wenyi; Hughes, Danny R; Ginocchio, Luke A; Rosman, David A; Duszak, Richard

2017-06-01

The objective of the present study is to assess the feasibility of a novel claims-based classification system for payer identification of academic radiologist subspecialties. Using a categorization scheme based on the Neiman Imaging Types of Service (NITOS) system, we mapped the Medicare Part B services billed by all radiologists from 2012 to 2014, assigning them to the following subspecialty categories: abdominal imaging, breast imaging, cardiothoracic imaging, musculoskeletal imaging, nuclear medicine, interventional radiology, and neuroradiology. The percentage of subspecialty work relative value units (RVUs) to total billed work RVUs was calculated for each radiologist nationwide. For radiologists at the top 20 academic departments funded by the National Institutes of Health, those percentages were compared with subspecialties designated on faculty websites. NITOS-based subspecialty assignments were also compared with the only radiologist subspecialty classifications currently recognized by Medicare (i.e., nuclear medicine and interventional radiology). Of 1012 academic radiologists studied, the median percentage of Medicare-billed NITOS-based subspecialty work RVUs matching the subspecialty designated on radiologists' own websites ranged from 71.3% (for nuclear medicine) to 98.9% (for neuroradiology). A NITOS-based work RVU threshold of 50% correctly classified 89.8% of radiologists (5.9% were not mapped to any subspecialty; subspecialty error rate, 4.2%). In contrast, existing Medicare provider codes identified only 46.7% of nuclear medicine physicians and 39.4% of interventional radiologists. Using a framework based on a recently established imaging health services research tool that maps service codes based on imaging modality and body region, Medicare claims data can be used to consistently identify academic radiologists by subspecialty in a manner not possible with the use of existing Medicare physician specialty identifiers. This method may facilitate

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.

"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.

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

32 CFR 750.8 - Claims: Responsibility of the Tort Claims Unit Norfolk.

Code of Federal Regulations, 2011 CFR

2011-07-01

... received in proper form. (c) Adjudicating the claim. (1) The Tort Claims Unit Norfolk shall evaluate and... is a narrative summary of the facts upon which the suit is based and has as enclosures the claims...

32 CFR 750.8 - Claims: Responsibility of the Tort Claims Unit Norfolk.

Code of Federal Regulations, 2012 CFR

2012-07-01

... received in proper form. (c) Adjudicating the claim. (1) The Tort Claims Unit Norfolk shall evaluate and... is a narrative summary of the facts upon which the suit is based and has as enclosures the claims...

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.

Calorie Labeling, Fast Food Purchasing and Restaurant Visits

PubMed Central

Elbel, Brian; Mijanovich, Tod; Dixon, Beth; Abrams, Courtney; Weitzman, Beth; Kersh, Rogan; Auchincloss, Amy H.; Ogedegbe, Gbenga

2013-01-01

Objective Obesity is a pressing public health problem without proven population-wide solutions. Researchers sought to determine whether a city-mandated policy requiring calorie labeling at fast food restaurants was associated with consumer awareness of labels, calories purchased and fast food restaurant visits. Design and Methods Difference-in-differences design, with data collected from consumers outside fast food restaurants and via a random digit dial telephone survey, before (December 2009) and after (June 2010) labeling in Philadelphia (which implemented mandatory labeling) and Baltimore (matched comparison city). Measures included: self-reported use of calorie information, calories purchased determined via fast food receipts, and self-reported weekly fast-food visits. Results The consumer sample was predominantly Black (71%), and high school educated (62%). Post-labeling, 38% of Philadelphia consumers noticed the calorie labels for a 33 percentage point (p<.001) increase relative to Baltimore. Calories purchased and number of fast food visits did not change in either city over time. Conclusions While some consumer reports noticing and using calorie information, no population level changes were noted in calories purchased or fast food visits. Other controlled studies are needed to examine the longer term impact of labeling as it becomes national law. PMID:24136905

Malpractice claims for endoscopy

PubMed Central

Hernandez, Lyndon V; Klyve, Dominic; Regenbogen, Scott E

2013-01-01

AIM: To summarize the magnitude and time trends of endoscopy-related claims and to compare total malpractice indemnity according to specialty and procedure. METHODS: We obtained data from a comprehensive database of closed claims from a trade association of professional liability insurance carriers, representing over 60% of practicing United States physicians. Total payments by procedure and year were calculated, and were adjusted for inflation (using the Consumer Price Index) to 2008 dollars. Time series analysis was performed to assess changes in the total value of claims for each type of procedure over time. RESULTS: There were 1901 endoscopy-related closed claims against all providers from 1985 to 2008. The specialties include: internal medicine (n = 766), gastroenterology (n = 562), general surgery (n = 231), general and family practice (n = 101), colorectal surgery (n = 87), other specialties (n = 132), and unknown (n = 22). Colonoscopy represented the highest frequencies of closed claims (n = 788) and the highest total indemnities ($54 093 000). In terms of mean claims payment, endoscopic retrograde cholangiopancreatography (ERCP) ranked the highest ($374  794) per claim. Internists had the highest number of total claims (n = 766) and total claim payment ($70  730  101). Only total claim payments for colonoscopy and ERCP seem to have increased over time. Indeed, there was an average increase of 15.5% per year for colonoscopy and 21.9% per year for ERCP after adjusting for inflation. CONCLUSION: There appear to be differences in malpractice coverage costs among specialties and the type of endoscopic procedure. There is also evidence for secular trend in total claim payments, with colonoscopy and ERCP costs rising yearly even after adjusting for inflation. PMID:23596540

Clinically relevant safety issues associated with St. John's wort product labels.

PubMed

Clauson, Kevin A; Santamarina, Marile L; Rutledge, Jennifer C

2008-07-17

St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0-8) for 23.9% completeness. The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues which could enhance the quality of

Clinically relevant safety issues associated with St. John's wort product labels

PubMed Central

Clauson, Kevin A; Santamarina, Marile L; Rutledge, Jennifer C

2008-01-01

Background St. John's wort (SJW), used to treat depression, is popular in the USA, Canada, and parts of Europe. However, there are documented interactions between SJW and prescription medications including warfarin, cyclosporine, indinavir, and oral contraceptives. One source of information about these safety considerations is the product label. The aim of this study was to evaluate the clinically relevant safety information included on labeling in a nationally representative sample of SJW products from the USA. Methods Eight clinically relevant safety issues were identified: drug interactions (SJW-HIV medications, SJW-immunosupressants, SJW-oral contraceptives, and SJW-warfarin), contraindications (bipolar disorder), therapeutic duplication (antidepressants), and general considerations (phototoxicity and advice to consult a healthcare professional (HCP)). A list of SJW products was identified to assess their labels. Percentages and totals were used to present findings. Results Of the seventy-four products evaluated, no product label provided information for all 8 evaluation criteria. Three products (4.1%) provided information on 7 of the 8 criteria. Four products provided no safety information whatsoever. Percentage of products with label information was: SJW-HIV (8.1%), SJW-immunosupressants (5.4%), SJW-OCPs (8.1%), SJW-warfarin (5.4%), bipolar (1.4%), antidepressants (23.0%), phototoxicity (51.4%), and consult HCP (87.8%). Other safety-related information on labels included warnings about pregnancy (74.3%), lactation (64.9%), discontinue if adverse reaction (23.0%), and not for use in patients under 18 years old (13.5%). The average number of a priori safety issues included on a product label was 1.91 (range 0–8) for 23.9% completeness. Conclusion The vast majority of SJW products fail to adequately address clinically relevant safety issues on their labeling. A few products do provide an acceptable amount of information on clinically relevant safety issues

Zolpidem prescribing practices before and after Food and Drug Administration required product labeling changes

PubMed Central

Norman, Jessica L; Fixen, Danielle R; Saseen, Joseph J; Saba, Laura M; Linnebur, Sunny A

2017-01-01

Background: Women have higher morning serum zolpidem concentrations than men after taking an evening dose, potentially leading to increased risk of harm. On 19 April 2013, the United States Food and Drug Administration required labeling changes for zolpidem, recommending an initial dose of no greater than 5 mg (immediate release) or 6.25 mg (controlled release) per night in women. Objectives: The primary objective of this study was to compare prescribing practices before and after the 2013 zolpidem labeling change. A secondary objective was to evaluate serious adverse events potentially related to zolpidem. Methods: Electronic medical records of adults receiving care through the University of Colorado Health system were accessed for study inclusion if patients were provided a first-time prescription for zolpidem either prior to or after the Food and Drug Administration labeling change. Patients were randomly chosen from eight strata based on age, gender, and date of zolpidem initiation (before/after the labeling change). Demographic and zolpidem prescribing data were collected. Low-dose zolpidem was considered 5 mg (immediate release) or 6.25 mg (controlled release) daily or less. Documentation of potentially related serious adverse events within the patients’ records was also evaluated. Results: A total of 400 patients were included in the study. The overall percentage of patients prescribed low-dose zolpidem increased from 44% to 58% after the labeling change (p = 0.0020). In a pre-specified subgroup analysis, the percentage of patients prescribed low-dose zolpidem increased in all groups, including young men (38%–50%, p = 0.23), elderly men (34%–40%, p = 0.53), and elderly women (60%–74%, p = 0.14), but the change was only significant in young women (42%–70%, p = 0.0045). Conclusion: After Food and Drug Administration–mandated labeling changes for zolpidem in 2013, the percentage of overall patients in our health system

Zolpidem prescribing practices before and after Food and Drug Administration required product labeling changes.

PubMed

Norman, Jessica L; Fixen, Danielle R; Saseen, Joseph J; Saba, Laura M; Linnebur, Sunny A

2017-01-01

Women have higher morning serum zolpidem concentrations than men after taking an evening dose, potentially leading to increased risk of harm. On 19 April 2013, the United States Food and Drug Administration required labeling changes for zolpidem, recommending an initial dose of no greater than 5 mg (immediate release) or 6.25 mg (controlled release) per night in women. The primary objective of this study was to compare prescribing practices before and after the 2013 zolpidem labeling change. A secondary objective was to evaluate serious adverse events potentially related to zolpidem. Electronic medical records of adults receiving care through the University of Colorado Health system were accessed for study inclusion if patients were provided a first-time prescription for zolpidem either prior to or after the Food and Drug Administration labeling change. Patients were randomly chosen from eight strata based on age, gender, and date of zolpidem initiation (before/after the labeling change). Demographic and zolpidem prescribing data were collected. Low-dose zolpidem was considered 5 mg (immediate release) or 6.25 mg (controlled release) daily or less. Documentation of potentially related serious adverse events within the patients' records was also evaluated. A total of 400 patients were included in the study. The overall percentage of patients prescribed low-dose zolpidem increased from 44% to 58% after the labeling change (p = 0.0020). In a pre-specified subgroup analysis, the percentage of patients prescribed low-dose zolpidem increased in all groups, including young men (38%-50%, p = 0.23), elderly men (34%-40%, p = 0.53), and elderly women (60%-74%, p = 0.14), but the change was only significant in young women (42%-70%, p = 0.0045). After Food and Drug Administration-mandated labeling changes for zolpidem in 2013, the percentage of overall patients in our health system, and specifically young women, with initial prescriptions for low

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 538.6 - Claims.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 3 2014-07-01 2014-07-01 false Claims. 538.6 Section 538.6 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY CLAIMS AND ACCOUNTS MILITARY PAYMENT CERTIFICATES § 538.6 Claims. Claims for conversion of military payment certificates, as well as claims arising out of...

7 CFR 205.303 - Packaged products labeled “100 percent organic” or “organic.”

Code of Federal Regulations, 2011 CFR

2011-01-01

... Information § 205.303 Packaged products labeled “100 percent organic” or “organic.” (a) Agricultural products... product, the following: (1) The term, “100 percent organic” or “organic,” as applicable, to modify the name of the product; (2) For products labeled “organic,” the percentage of organic ingredients in the...

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...

Framing and Claiming: How Information-Framing Affects Expected Social Security Claiming Behavior.

PubMed

Brown, Jeffrey R; Kapteyn, Arie; Mitchell, Olivia S

2016-03-01

This paper provides evidence that Social Security benefit claiming decisions are strongly affected by framing and are thus inconsistent with expected utility theory. Using a randomized experiment that controls for both observable and unobservable differences across individuals, we find that the use of a "breakeven analysis" encourages early claiming. Respondents are more likely to delay when later claiming is framed as a gain, and the claiming age is anchored at older ages. Additionally, the financially less literate, individuals with credit card debt, and those with lower earnings are more influenced by framing than others.

32 CFR 536.120 - Claims payable as maritime claims.

Code of Federal Regulations, 2014 CFR

2014-07-01

... claim is cognizable under this subpart if it arises in or on a maritime location, involves some... scope of employment. This class of claims includes, but is not limited to: (a) Damage to a ship, boat, barge, or other watercraft; (b) An injury that involves a ship, boat, barge, or other watercraft; (c...

32 CFR 536.120 - Claims payable as maritime claims.

Code of Federal Regulations, 2012 CFR

2012-07-01

... claim is cognizable under this subpart if it arises in or on a maritime location, involves some... scope of employment. This class of claims includes, but is not limited to: (a) Damage to a ship, boat, barge, or other watercraft; (b) An injury that involves a ship, boat, barge, or other watercraft; (c...

32 CFR 536.120 - Claims payable as maritime claims.

Code of Federal Regulations, 2013 CFR

2013-07-01

... claim is cognizable under this subpart if it arises in or on a maritime location, involves some... scope of employment. This class of claims includes, but is not limited to: (a) Damage to a ship, boat, barge, or other watercraft; (b) An injury that involves a ship, boat, barge, or other watercraft; (c...

78 FR 19632 - Administrative Claims Under the Federal Tort Claims Act and Related Statutes

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

... Administration 20 CFR Parts 638 and 670 RIN 1290-AA25 Administrative Claims Under the Federal Tort Claims Act and... governing administrative claims under the Federal Tort Claims Act and related statutes. DATES: Effective... (this is not a toll-free number). Individuals with hearing or speech impairments may access this...

Restaurant menu labeling laws and alcohol use.

PubMed

Restrepo, Brandon J; Ali, Mir M

2017-09-01

The goal of this study was to analyze the effect of local and state mandatory restaurant menu labeling laws on alcohol use. Using a difference-in-differences estimation approach and data on adults aged 21 and older (n=2,157,722) from the 2002-2012 Behavioral Risk Factor Surveillance System, we estimated the effect of menu labeling laws on self-reported consumption of alcoholic beverages in the past month. The regression analysis indicates that on average implementation of menu labeling laws is associated with a 1.2 percentage-point drop in the fraction of survey respondents reporting that they drank an alcoholic beverage in the past month (95% confidence interval=-0.020, -0.004), compared with jurisdictions that had not implemented menu labeling laws. Moreover, we find that the estimated policy effects on alcohol use are larger among men than among women and larger among minorities than among non-Hispanic whites. Further provision of calorie information on foods and beverages in food service establishments, such as through federal menu labeling regulations, may have the potential to lead to a meaningful reduction in alcohol use throughout the U.S. and may result in larger reductions in alcohol use among men and minorities. Published by Elsevier Inc.

Fluorescence correlation spectroscopy analysis for accurate determination of proportion of doubly labeled DNA in fluorescent DNA pool for quantitative biochemical assays.

PubMed

Hou, Sen; Sun, Lili; Wieczorek, Stefan A; Kalwarczyk, Tomasz; Kaminski, Tomasz S; Holyst, Robert

2014-01-15

Fluorescent double-stranded DNA (dsDNA) molecules labeled at both ends are commonly produced by annealing of complementary single-stranded DNA (ssDNA) molecules, labeled with fluorescent dyes at the same (3' or 5') end. Because the labeling efficiency of ssDNA is smaller than 100%, the resulting dsDNA have two, one or are without a dye. Existing methods are insufficient to measure the percentage of the doubly-labeled dsDNA component in the fluorescent DNA sample and it is even difficult to distinguish the doubly-labeled DNA component from the singly-labeled component. Accurate measurement of the percentage of such doubly labeled dsDNA component is a critical prerequisite for quantitative biochemical measurements, which has puzzled scientists for decades. We established a fluorescence correlation spectroscopy (FCS) system to measure the percentage of doubly labeled dsDNA (PDL) in the total fluorescent dsDNA pool. The method is based on comparative analysis of the given sample and a reference dsDNA sample prepared by adding certain amount of unlabeled ssDNA into the original ssDNA solution. From FCS autocorrelation functions, we obtain the number of fluorescent dsDNA molecules in the focal volume of the confocal microscope and PDL. We also calculate the labeling efficiency of ssDNA. The method requires minimal amount of material. The samples have the concentration of DNA in the nano-molar/L range and the volume of tens of microliters. We verify our method by using restriction enzyme Hind III to cleave the fluorescent dsDNA. The kinetics of the reaction depends strongly on PDL, a critical parameter for quantitative biochemical measurements. Copyright © 2013 Elsevier B.V. All rights reserved.

Estimation of Missed Statin Prescription Use in an Administrative Claims Dataset.

PubMed

Wade, Rolin L; Patel, Jeetvan G; Hill, Jerrold W; De, Ajita P; Harrison, David J

2017-09-01

Nonadherence to statin medications is associated with increased risk of cardiovascular disease and poses a challenge to lipid management in patients who are at risk for atherosclerotic cardiovascular disease. Numerous studies have examined statin adherence based on administrative claims data; however, these data may underestimate statin use in patients who participate in generic drug discount programs or who have alternative coverage. To estimate the proportion of patients with missing statin claims in a claims database and determine how missing claims affect commonly used utilization metrics. This retrospective cohort study used pharmacy data from the PharMetrics Plus (P+) claims dataset linked to the IMS longitudinal pharmacy point-of-sale prescription database (LRx) from January 1, 2012, through December 31, 2014. Eligible patients were represented in the P+ and LRx datasets, had ≥1 claim for a statin (index claim) in either database, and had ≥ 24 months of continuous enrollment in P+. Patients were linked between P+ and LRx using a deterministic method. Duplicate claims between LRx and P+ were removed to produce a new dataset comprised of P+ claims augmented with LRx claims. Statin use was then compared between P+ and the augmented P+ dataset. Utilization metrics that were evaluated included percentage of patients with ≥ 1 missing statin claim over 12 months in P+; the number of patients misclassified as new users in P+; the number of patients misclassified as nonstatin users in P+; the change in 12-month medication possession ratio (MPR) and proportion of days covered (PDC) in P+; the comparison between P+ and LRx of classifications of statin treatment patterns (statin intensity and patients with treatment modifications); and the payment status for missing statin claims. Data from 965,785 patients with statin claims in P+ were analyzed (mean age 56.6 years; 57% male). In P+, 20.1% had ≥ 1 missing statin claim post-index; 13.7% were misclassified as

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...

The Effect of a Federal Controlled Substance Act Schedule Change on Hydrocodone Combination Products Claims in a Medicaid Population.

PubMed

Tran, Stephanie; Lavitas, Pavel; Stevens, Karen; Greenwood, Bonnie C; Clements, Karen; Alper, Caroline J; Lenz, Kimberly; Price, Mylissa; Hydery, Tasmina; Arnold, Jennifer L; Takeshita, Mito; Bacon, Rachel; Peristere, Justin P; Jeffrey, Paul L

2017-05-01

schedule change, the rate of HCP claims per 1,000 members per month decreased at a greater rate than non-HCP analgesics in the period after the HCP schedule change (P < 0.001). The percentage of HCP claims for new start members decreased after the HCP schedule change (44.9% vs. 34.1% of all HCP claims pre- to post-schedule change; P < 0.001). In the group of new starts, there was not a significant difference in the average daily dose (26.3 mg vs. 26.4 mg; P = 0.69), while there was a decrease in average number of tablets dispensed per claim (from 37.1 to 20.3 tablets; P < 0.001) and an increase in the percentage of claims for a shorter days supply (from 57.7% to 81.6%; P < 0.001). The findings of this study suggest that the HCP schedule change may have contributed to the decrease in claims for HCPs in a Medicaid population. After the HCP schedule change, there was a trend towards decreased HCP use among new starts. No outside funding supported this study. The authors have nothing to disclose. Study concept and design were contributed by all authors except for Arnold and Clements. Tran, Arnold, and Clements took the lead in data collection, along with Peristere, and data interpretation was performed by all the authors, except Arnold. The manuscript was written primarily by Tran, along with Lavitas, Stevens, and Greenwood, and revised by all the authors except Arnold and Peristere. A poster of this research project was presented at the Academy of Managed Care Pharmacy's 2016 Annual Meeting in San Francisco, California, April 2016.

Framing and Claiming: How Information-Framing Affects Expected Social Security Claiming Behavior

PubMed Central

Brown, Jeffrey R.; Kapteyn, Arie; Mitchell, Olivia S.

2017-01-01

This paper provides evidence that Social Security benefit claiming decisions are strongly affected by framing and are thus inconsistent with expected utility theory. Using a randomized experiment that controls for both observable and unobservable differences across individuals, we find that the use of a “breakeven analysis” encourages early claiming. Respondents are more likely to delay when later claiming is framed as a gain, and the claiming age is anchored at older ages. Additionally, the financially less literate, individuals with credit card debt, and those with lower earnings are more influenced by framing than others. PMID:28579641

7 CFR 868.308 - Percentages.

Code of Federal Regulations, 2011 CFR

2011-01-01

... FOR CERTAIN AGRICULTURAL COMMODITIES United States Standards for Milled Rice Principles Governing... in U.S. Nos. 1 and 2 Milled Rice and the percentage of objectionable seeds in U.S. No. 1 Brewers Milled Rice is reported to the nearest hundredth percent. The percentages of all other factors are...

7 CFR 868.308 - Percentages.

Code of Federal Regulations, 2010 CFR

2010-01-01

... FOR CERTAIN AGRICULTURAL COMMODITIES United States Standards for Milled Rice Principles Governing... in U.S. Nos. 1 and 2 Milled Rice and the percentage of objectionable seeds in U.S. No. 1 Brewers Milled Rice is reported to the nearest hundredth percent. The percentages of all other factors are...

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.

Solving Problems with the Percentage Bar

ERIC Educational Resources Information Center

van Galen, Frans; van Eerde, Dolly

2013-01-01

At the end of primary school all children more of less know what a percentage is, but yet they often struggle with percentage problems. This article describes a study in which students of 13 and 14 years old were given a written test with percentage problems and a week later were interviewed about the way they solved some of these problems. In a…

44 CFR 62.20 - Claims appeals.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 44 Emergency Management and Assistance 1 2012-10-01 2011-10-01 true Claims appeals. 62.20 Section... OF CLAIMS Claims Adjustment, Claims Appeals, and Judicial Review § 62.20 Claims appeals. (a.... Decision means the insurer's final claim determination, which is the insurer's written denial, in whole or...

44 CFR 62.20 - Claims appeals.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 44 Emergency Management and Assistance 1 2013-10-01 2013-10-01 false Claims appeals. 62.20 Section... OF CLAIMS Claims Adjustment, Claims Appeals, and Judicial Review § 62.20 Claims appeals. (a.... Decision means the insurer's final claim determination, which is the insurer's written denial, in whole or...

44 CFR 62.20 - Claims appeals.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 44 Emergency Management and Assistance 1 2014-10-01 2014-10-01 false Claims appeals. 62.20 Section... OF CLAIMS Claims Adjustment, Claims Appeals, and Judicial Review § 62.20 Claims appeals. (a.... Decision means the insurer's final claim determination, which is the insurer's written denial, in whole or...

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

32 CFR 842.5 - Claims forms.

Code of Federal Regulations, 2010 CFR

2010-07-01

... certain is sufficient to file a claim. The claimant should use these forms when filing a claim: (a) Claim... of or Damage to Personal Property Incident to Service, or DD Forms 1842, Claim for Personal Property Against the United States, and 1844, Schedule of Property and Claim Analysis Chart, to file the claim. (b...

32 CFR 842.5 - Claims forms.

Code of Federal Regulations, 2011 CFR

2011-07-01

... certain is sufficient to file a claim. The claimant should use these forms when filing a claim: (a) Claim... of or Damage to Personal Property Incident to Service, or DD Forms 1842, Claim for Personal Property Against the United States, and 1844, Schedule of Property and Claim Analysis Chart, to file the claim. (b...

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

Formalizing Probabilistic Safety Claims

NASA Technical Reports Server (NTRS)

Herencia-Zapana, Heber; Hagen, George E.; Narkawicz, Anthony J.

2011-01-01

A safety claim for a system is a statement that the system, which is subject to hazardous conditions, satisfies a given set of properties. Following work by John Rushby and Bev Littlewood, this paper presents a mathematical framework that can be used to state and formally prove probabilistic safety claims. It also enables hazardous conditions, their uncertainties, and their interactions to be integrated into the safety claim. This framework provides a formal description of the probabilistic composition of an arbitrary number of hazardous conditions and their effects on system behavior. An example is given of a probabilistic safety claim for a conflict detection algorithm for aircraft in a 2D airspace. The motivation for developing this mathematical framework is that it can be used in an automated theorem prover to formally verify safety claims.

32 CFR 536.75 - Claims payable under the Military Claims Act.

Code of Federal Regulations, 2011 CFR

2011-07-01

..., acting within the scope of their employment, that is determined to be negligent or wrongful; or (2..., chapter 11. (c) Maritime claims. Claims that arise on the high seas or within the territorial waters of a...

32 CFR 536.77 - Applicable law for claims under the Military Claims Act.

Code of Federal Regulations, 2011 CFR

2011-07-01

... subpart C claims. (i) Interpretation of meanings and construction of questions of law under the MCA will... 32 National Defense 3 2011-07-01 2009-07-01 true Applicable law for claims under the Military Claims Act. 536.77 Section 536.77 National Defense Department of Defense (Continued) DEPARTMENT OF THE...

Evaluating a Surprising Claim

NASA Astrophysics Data System (ADS)

Hayden, Howard C.

2013-11-01

A television advertisement and a website present an interesting question: can rail company CSX really move a ton of freight 468 miles on a gallon of fuel, or is the claim preposterous? Let us examine the claim, first by understanding what is meant, looking at their data, and then converting units to examine the claim quantitatively.

Evaluating a Surprising Claim

ERIC Educational Resources Information Center

Hayden, Howard C.

2013-01-01

A television advertisement and a website present an interesting question: can rail company CSX "really" move a ton of freight 468 miles on a gallon of fuel, or is the claim preposterous? Let us examine the claim, first by understanding what is meant, looking at their data, and then converting units to examine the claim quantitatively.

32 CFR 536.77 - Applicable law for claims under the Military Claims Act.

Code of Federal Regulations, 2013 CFR

2013-07-01

...) The United States will only be liable for the portion of loss or damage attributable to the fault of... preparation and presentation of the claim. (vi) Punitive or exemplary damages are not payable. (vii) Claims... will be considered as an element of damages under paragraph (b)(3)(ii) of this section. Claims for...

32 CFR 536.77 - Applicable law for claims under the Military Claims Act.

Code of Federal Regulations, 2012 CFR

2012-07-01

...) The United States will only be liable for the portion of loss or damage attributable to the fault of... preparation and presentation of the claim. (vi) Punitive or exemplary damages are not payable. (vii) Claims... will be considered as an element of damages under paragraph (b)(3)(ii) of this section. Claims for...

32 CFR 536.77 - Applicable law for claims under the Military Claims Act.

Code of Federal Regulations, 2014 CFR

2014-07-01

...) The United States will only be liable for the portion of loss or damage attributable to the fault of... preparation and presentation of the claim. (vi) Punitive or exemplary damages are not payable. (vii) Claims... will be considered as an element of damages under paragraph (b)(3)(ii) of this section. Claims for...

Ultra-processed family foods in Australia: nutrition claims, health claims and marketing techniques.

PubMed

Pulker, Claire Elizabeth; Scott, Jane Anne; Pollard, Christina Mary

2018-01-01

To objectively evaluate voluntary nutrition and health claims and marketing techniques present on packaging of high-market-share ultra-processed foods (UPF) in Australia for their potential impact on public health. Cross-sectional. Packaging information from five high-market-share food manufacturers and one retailer were obtained from supermarket and manufacturers' websites. Ingredients lists for 215 UPF were examined for presence of added sugar. Packaging information was categorised using a taxonomy of nutrition and health information which included nutrition and health claims and five common food marketing techniques. Compliance of statements and claims with the Australia New Zealand Food Standards Code and with Health Star Ratings (HSR) were assessed for all products. Almost all UPF (95 %) contained added sugars described in thirty-four different ways; 55 % of UPF displayed a HSR; 56 % had nutrition claims (18 % were compliant with regulations); 25 % had health claims (79 % were compliant); and 97 % employed common food marketing techniques. Packaging of 47 % of UPF was designed to appeal to children. UPF carried a mean of 1·5 health and nutrition claims (range 0-10) and 2·6 marketing techniques (range 0-5), and 45 % had HSR≤3·0/5·0. Most UPF packaging featured nutrition and health statements or claims despite the high prevalence of added sugars and moderate HSR. The degree of inappropriate or inaccurate statements and claims present is concerning, particularly on packaging designed to appeal to children. Public policies to assist parents to select healthy family foods should address the quality and accuracy of information provided on UPF packaging.

76 FR 35086 - Proposed Information Collection (Fully Developed Claim (Fully Developed Claims-Applications for...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-15

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0747] Proposed Information Collection (Fully Developed Claim (Fully Developed Claims--Applications for Compensation, Pension, DIC, Death Pension, and/or... Claims--Applications for Compensation, Pension, DIC, Death Pension, and/or Accrued Benefits, VA Forms 21...

32 CFR 750.6 - Claims: Presentment.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 5 2013-07-01 2013-07-01 false Claims: Presentment. 750.6 Section 750.6 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS... Claims Act shall be submitted on DD Form 1842. 2 The claim and all other papers requiring the signature...

32 CFR 750.6 - Claims: Presentment.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 5 2010-07-01 2010-07-01 false Claims: Presentment. 750.6 Section 750.6 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS... Claims Act shall be submitted on DD Form 1842. 2 The claim and all other papers requiring the signature...

32 CFR 750.6 - Claims: Presentment.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 5 2011-07-01 2011-07-01 false Claims: Presentment. 750.6 Section 750.6 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS... Claims Act shall be submitted on DD Form 1842. 2 The claim and all other papers requiring the signature...

32 CFR 750.6 - Claims: Presentment.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 5 2012-07-01 2012-07-01 false Claims: Presentment. 750.6 Section 750.6 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS... Claims Act shall be submitted on DD Form 1842. 2 The claim and all other papers requiring the signature...

Graphic warning labels in cigarette advertisements: recall and viewing patterns.

PubMed

Strasser, Andrew A; Tang, Kathy Z; Romer, Daniel; Jepson, Christopher; Cappella, Joseph N

2012-07-01

The Family Smoking Prevention and Control Act gave the U.S. Food and Drug Administration (FDA) legal authority to mandate graphic warning labels on cigarette advertising and packaging. The FDA requires that these graphic warning labels be embedded into cigarette advertising and packaging by September 2012. The aim of this study was to examine differences in recall and viewing patterns of text-only versus graphic cigarette warning labels and the association between viewing patterns and recall. Participants (current daily smokers; N=200) were randomized to view a cigarette advertisement with either text-only or graphic warning labels. Viewing patterns were measured using eye-tracking, and recall was later assessed. Sessions were conducted between November 2008 and November 2009. Data analysis was conducted between March 2011 and July 2011. There was a significant difference in percentage correct recall of the warning label between those in the text-only versus graphic warning label condition, 50% vs 83% (χ(2)=23.74, p=0.0001). Time to first viewing of the graphic warning label text and dwell time duration (i.e., time spent looking) on the graphic image were significantly associated with correct recall. Warning labels that drew attention more quickly and resulted in longer dwell times were associated with better recall. Graphic warning labels improve smokers' recall of warning and health risks; these labels do so by drawing and holding attention. Copyright © 2012 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

32 CFR 842.103 - Filing a claim.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 6 2011-07-01 2011-07-01 false Filing a claim. 842.103 Section 842.103 National... CLAIMS Claims Under the National Guard Claims Act (32 U.S.C. 715) § 842.103 Filing a claim. This paragraph explains how to file a claim under the National Guard Claims Act. (a) How and when filed. A claim...

32 CFR 842.103 - Filing a claim.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 6 2013-07-01 2013-07-01 false Filing a claim. 842.103 Section 842.103 National... CLAIMS Claims Under the National Guard Claims Act (32 U.S.C. 715) § 842.103 Filing a claim. This paragraph explains how to file a claim under the National Guard Claims Act. (a) How and when filed. A claim...

32 CFR 842.103 - Filing a claim.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 6 2012-07-01 2012-07-01 false Filing a claim. 842.103 Section 842.103 National... CLAIMS Claims Under the National Guard Claims Act (32 U.S.C. 715) § 842.103 Filing a claim. This paragraph explains how to file a claim under the National Guard Claims Act. (a) How and when filed. A claim...

32 CFR 842.103 - Filing a claim.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 6 2014-07-01 2014-07-01 false Filing a claim. 842.103 Section 842.103 National... CLAIMS Claims Under the National Guard Claims Act (32 U.S.C. 715) § 842.103 Filing a claim. This paragraph explains how to file a claim under the National Guard Claims Act. (a) How and when filed. A claim...

22 CFR 304.6 - Claims investigation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 22 Foreign Relations 2 2011-04-01 2009-04-01 true Claims investigation. 304.6 Section 304.6 Foreign Relations PEACE CORPS CLAIMS AGAINST GOVERNMENT UNDER FEDERAL TORT CLAIMS ACT Procedures § 304.6 Claims investigation. (a) When a claim has been filed with the Peace Corps, the General Counsel will send...

22 CFR 304.6 - Claims investigation.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 22 Foreign Relations 2 2014-04-01 2014-04-01 false Claims investigation. 304.6 Section 304.6 Foreign Relations PEACE CORPS CLAIMS AGAINST GOVERNMENT UNDER FEDERAL TORT CLAIMS ACT Procedures § 304.6 Claims investigation. (a) When a claim has been filed with the Peace Corps, the General Counsel will send...

Fine bakery wares with label claims in Europe and their categorisation by nutrient profiling models.

PubMed

Trichterborn, J; Harzer, G; Kunz, C

2011-03-01

This study assesses a range of commercially available fine bakery wares with nutrition or health related on-pack communication against the criteria of selected nutrient profiling models. Different purposes of the application of nutrient profiles were considered, including front-of-pack signposting and the regulation of claims or advertising. More than 200 commercially available fine bakery wares carrying claims were identified in Germany, France, Spain, Sweden and United Kingdom and evaluated against five nutrient profiling models. All models were assessed regarding their underlying principles, generated results and inter-model agreement levels. Total energy, saturated fatty acids, sugars, sodium and fibre were critical parameters for the categorisation of products. The Choices Programme was the most restrictive model in this category, while the Food and Drug Administration model allowed the highest number of products to qualify. According to all models, more savoury than sweet products met the criteria. On average, qualifying products contained less than half the amounts of nutrients to limit and more than double the amount of fibre compared with all the products in the study. None of the models had a significant impact on the average energy contents. Nutrient profiles can be applied to identify fine bakery wares with a significantly better nutritional composition than the average range of products positioned as healthier. Important parameters to take into account include energy, saturated fatty acids, sugars, sodium and fibre. Different criteria sets for subcategories of fine bakery wares do not seem necessary.

44 CFR 62.21 - Claims adjustment.

Code of Federal Regulations, 2010 CFR

2010-10-01

... HOMELAND SECURITY INSURANCE AND HAZARD MITIGATION National Flood Insurance Program SALE OF INSURANCE AND ADJUSTMENT OF CLAIMS Claims Adjustment, Claims Appeals, and Judicial Review § 62.21 Claims adjustment. (a) In...

32 CFR 536.15 - Claims policies.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Command Claims Service or an ACO, including those which occur in the area of responsibility of a CPO. On... promptly with maximum use of small claims procedures. (2) Consideration under all subparts. Prior to denial... claim is presented. A claim presented as a personnel claim will be considered as a tort prior to denial...

32 CFR 536.15 - Claims policies.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Command Claims Service or an ACO, including those which occur in the area of responsibility of a CPO. On... promptly with maximum use of small claims procedures. (2) Consideration under all subparts. Prior to denial... claim is presented. A claim presented as a personnel claim will be considered as a tort prior to denial...

Percentage Energy from Fat Screener: Overview

Cancer.gov

A short assessment instrument to estimate an individual's usual intake of percentage energy from fat. The foods asked about on the instrument were selected because they were the most important predictors of variability in percentage energy.

Claims-Based Definition of Death in Japanese Claims Database: Validity and Implications

PubMed Central

Ooba, Nobuhiro; Setoguchi, Soko; Ando, Takashi; Sato, Tsugumichi; Yamaguchi, Takuhiro; Mochizuki, Mayumi; Kubota, Kiyoshi

2013-01-01

Background For the pending National Claims Database in Japan, researchers will not have access to death information in the enrollment files. We developed and evaluated a claims-based definition of death. Methodology/Principal Findings We used healthcare claims and enrollment data between January 2005 and August 2009 for 195,193 beneficiaries aged 20 to 74 in 3 private health insurance unions. We developed claims-based definitions of death using discharge or disease status and Charlson comorbidity index (CCI). We calculated sensitivity, specificity and positive predictive values (PPVs) using the enrollment data as a gold standard in the overall population and subgroups divided by demographic and other factors. We also assessed bias and precision in two example studies where an outcome was death. The definition based on the combination of discharge/disease status and CCI provided moderate sensitivity (around 60%) and high specificity (99.99%) and high PPVs (94.8%). In most subgroups, sensitivity of the preferred definition was also around 60% but varied from 28 to 91%. In an example study comparing death rates between two anticancer drug classes, the claims-based definition provided valid and precise hazard ratios (HRs). In another example study comparing two classes of anti-depressants, the HR with the claims-based definition was biased and had lower precision than that with the gold standard definition. Conclusions/Significance The claims-based definitions of death developed in this study had high specificity and PPVs while sensitivity was around 60%. The definitions will be useful in future studies when used with attention to the possible fluctuation of sensitivity in some subpopulations. PMID:23741526

Solar Power Use Claims Guidance

EPA Pesticide Factsheets

The Toolbox for Renewable Energy Project Development's Solar Power Use Claims Guidance page helps electricity consumers understand the legal right that RECs offer their owners when making solar power use claims and provides resources for making claims.

31 CFR 535.222 - Suspension of claims eligible for Claims Tribunal.

Code of Federal Regulations, 2014 CFR

2014-07-01

... be presented to the Iran-United States Claims Tribunal under the terms of Article II of the... Iran, dated January 19, 1981, and all claims for equitable or other judicial relief in connection with... or counterclaim in any pending or subsequent judicial proceeding commenced by the Government of Iran...

31 CFR 535.222 - Suspension of claims eligible for Claims Tribunal.

Code of Federal Regulations, 2013 CFR

2013-07-01

... be presented to the Iran-United States Claims Tribunal under the terms of Article II of the... Iran, dated January 19, 1981, and all claims for equitable or other judicial relief in connection with... or counterclaim in any pending or subsequent judicial proceeding commenced by the Government of Iran...

31 CFR 535.222 - Suspension of claims eligible for Claims Tribunal.

Code of Federal Regulations, 2012 CFR

2012-07-01

... be presented to the Iran-United States Claims Tribunal under the terms of Article II of the... Iran, dated January 19, 1981, and all claims for equitable or other judicial relief in connection with... or counterclaim in any pending or subsequent judicial proceeding commenced by the Government of Iran...

31 CFR 535.222 - Suspension of claims eligible for Claims Tribunal.

Code of Federal Regulations, 2010 CFR

2010-07-01

... be presented to the Iran-United States Claims Tribunal under the terms of Article II of the... Iran, dated January 19, 1981, and all claims for equitable or other judicial relief in connection with... or counterclaim in any pending or subsequent judicial proceeding commenced by the Government of Iran...

31 CFR 535.222 - Suspension of claims eligible for Claims Tribunal.

Code of Federal Regulations, 2011 CFR

2011-07-01

... be presented to the Iran-United States Claims Tribunal under the terms of Article II of the... Iran, dated January 19, 1981, and all claims for equitable or other judicial relief in connection with... or counterclaim in any pending or subsequent judicial proceeding commenced by the Government of Iran...

Diagnostic labels assigned to patients with orthopedic conditions and the influence of the label on selection of interventions: a qualitative study of orthopaedic clinical specialists.

PubMed

Miller-Spoto, Marcia; Gombatto, Sara P

2014-06-01

A variety of diagnostic classification systems are used by physical therapists, but little information about how therapists assign diagnostic labels and how the labels are used to direct intervention is available. The purposes of this study were: (1) to examine the diagnostic labels assigned to patient problems by physical therapists who are board-certified Orthopaedic Clinical Specialists (OCSs) and (2) to determine whether the label influences selection of interventions. A cross-sectional survey was conducted. Two written cases were developed for patients with low back and shoulder pain. A survey was used to evaluate the diagnostic label assigned and the interventions considered important for each case. The cases and survey were sent to therapists who are board-certified OCSs. Respondents assigned a diagnostic label and rated the importance of intervention categories for each case. Each diagnostic label was coded based on the construct it represented. Percentage responses for each diagnostic label code and intervention category were calculated. Relative importance of intervention category based on diagnostic label was examined. For the low back pain and shoulder pain cases, respectively, "Combination" (48.5%, 34.9%) and "Pathology/Pathophysiology" (32.7%, 57.3%) diagnostic labels were most common. Strengthening (85.9%, 98.1%), stretching (86.8%, 84.9%), neuromuscular re-education (87.6%, 93.4%), functional training (91.4%, 88.6%), and mobilization/manipulation (85.1%, 86.8%) were considered the most important interventions. Relative importance of interventions did not differ based on diagnostic label (χ2=0.050-1.263, P=.261-.824). The low response rate may limit the generalizability of the findings. Also, examples provided for labels may have influenced responses, and some of the label codes may have represented overlapping constructs. There is little consistency with which OCS therapists assign diagnostic labels, and the label does not seem to influence

Graphic Warning Labels in Cigarette Advertisements: Recall and Viewing Patterns

PubMed Central

Strasser, Andrew A.; Tang, Kathy Z.; Romer, Daniel; Jepson, Chris; Cappella, Joseph N.

2012-01-01

Background The Family Smoking Prevention and Control Act gave the U.S. Food and Drug Administration (FDA) legal authority to mandate graphic warning labels on cigarette advertising and packaging. The FDA requires that these graphic warning labels be embedded into cigarette advertising and packaging by September 2012. Purpose The aim of this study was to examine differences in recall and viewing patterns of text-only versus graphic cigarette warning labels; and, the association between viewing patterns and recall. Methods Participants (current daily smokers; N=200) were randomized to view a cigarette advertisement with either text-only or graphic warning labels. Viewing patterns were measured using eye-tracking, and recall was later assessed. Sessions were conducted between November 2008 and November 2009. Data analysis was conducted between March 2011 and July 2011. Results There was a significant difference in percentage correct recall of the warning label between those in the text-only versus graphic warning label condition, 50% versus 83% (χ2 =23.74, p=0.0001). Time to first view of the graphic warning label text, and dwell time duration (i.e., time spent looking) on the graphic image were significantly associated with correct recall. Warning labels that drew attention more quickly and resulted in longer dwell times were associated with better recall. Conclusions Graphic warning labels improve smokers’ recall of warning and health risks; they do so by drawing and holding attention. PMID:22704744

Can front-of-pack labelling schemes guide healthier food choices? Australian shoppers' responses to seven labelling formats.

PubMed

Watson, Wendy L; Kelly, Bridget; Hector, Debra; Hughes, Clare; King, Lesley; Crawford, Jennifer; Sergeant, John; Chapman, Kathy

2014-01-01

There is evidence that easily accessible, comprehensible and consistent nutrient information on the front of packaged foods could assist shoppers to make healthier food choices. This study used an online questionnaire of 4357 grocery shoppers to examine Australian shoppers' ability to use a range of front-of-pack labels to identify healthier food products. Seven different front-of-pack labelling schemes comprising variants of the Traffic Light labelling scheme and the Percentage Daily Intake scheme, and a star rating scheme, were applied to nine pairs of commonly purchased food products. Participants could also access a nutrition information panel for each product. Participants were able to identify the healthier product in each comparison over 80% of the time using any of the five schemes that provided information on multiple nutrients. No individual scheme performed significantly better in terms of shoppers' ability to determine the healthier product, shopper reliance on the 'back-of-pack' nutrition information panel, and speed of use. The scheme that provided information about energy only and a scheme with limited numerical information of nutrient type or content performed poorly, as did the nutrition information panel alone (control). Further consumer testing is necessary to determine the optimal format and content of an interpretive front-of-pack nutrition labelling scheme. Copyright © 2013 Elsevier Ltd. All rights reserved.

32 CFR 842.119 - Nonassertable claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 6 2010-07-01 2010-07-01 false Nonassertable claims. 842.119 Section 842.119 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE CLAIMS AND LITIGATION... following are considered nonassertable claims and should not be asserted: (1) Claims against any department...

Metastasizing patent claims on BRCA1.

PubMed

Kepler, Thomas B; Crossman, Colin; Cook-Deegan, Robert

2010-05-01

Many patents make claims on DNA sequences; some include claims on oligonucleotides related to the primary patented gene. We used bioinformatics to quantify the reach of one such claim from patent 4,747,282 on BRCA1. We find that human chromosome 1 (which does not contain BRCA1) contains over 300,000 oligonucleotides covered by this claim, and that 80% of cDNA and mRNA sequences contributed to GenBank before the patent application was filed also contain at least one claimed oligonucleotide. Any "isolated" DNA molecules that include such 15 bp nucleotide sequences would fall under the claim as granted by the US Patent and Trademark Office. Anyone making, using, selling, or importing such a molecule for any purpose within the United States would thus be infringing the claim. This claim and others like it turn out, on examination, to be surprisingly broad, and if enforced would have substantial implications for medical practice and scientific research. Copyright 2010 Elsevier Inc. All rights reserved.

28 CFR 801.3 - Processing the claim.

Code of Federal Regulations, 2010 CFR

2010-07-01

... TORT CLAIMS ACT PROCEDURE § 801.3 Processing the claim. (a) Will CSOSA/PSA contact you about your claim... acknowledgement indicating the filing date (that is, the date CSOSA/PSA received your claim) and the assigned claim number. Refer to the claim number in any further correspondence you may have with CSOSA/PSA on the...

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.

38 CFR 21.1030 - Claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... forms include: (i) DA Form 2171, Request for Tuition Assistance-Army Continuing Education System; (ii... REHABILITATION AND EDUCATION Claims and Applications for Educational Assistance Claims § 21.1030 Claims. (a... administered by VA for pursuit of a program of education, he or she must file an application for educational...

Making Sense of Fractions and Percentages

ERIC Educational Resources Information Center

Whitin, David J.; Whitin, Phyllis

2012-01-01

Because fractions and percentages can be difficult for children to grasp, connecting them whenever possible is beneficial. Linking them can foster representational fluency as children simultaneously see the part-whole relationship expressed numerically (as a fraction and as a percentage) and visually (as a pie chart). NCTM advocates these…

Analysis of 23 364 patient-generated, physician-reviewed malpractice claims from a non-tort, blame-free, national patient insurance system: lessons learned from Sweden.

PubMed

Pukk-Härenstam, K; Ask, J; Brommels, M; Thor, J; Penaloza, R V; Gaffney, F A

2009-02-01

In Sweden, patient malpractice claims are handled administratively and compensated if an independent physician review confirms patient injury resulting from medical error. Full access to all malpractice claims and hospital discharge data for the country provided a unique opportunity to assess the validity of patient claims as indicators of medical error and patient injury. To determine: (1) the percentage of patient malpractice claims validated by independent physician review, (2) actual malpractice claims rates (claims frequency / clinical volume) and (3) differences between Swedish and other national malpractice claims rates. DESIGN, SETTING AND MATERIAL: Swedish national malpractice claims and hospital discharge data were combined, and malpractice claims rates were determined by county, hospital, hospital department, surgical procedure, patient age and sex and compared with published studies on medical error and malpractice. From 1997 to 2004, there were 23 364 inpatient malpractice claims filed by Swedish patients treated at hospitals reporting 11 514 798 discharges. The overall claims rate, 0.20%, was stable over the period of study and was similar to that found in other tort and administrative compensation systems. Over this 8-year period, 49.5% (range 47.0-52.6%) of filed claims were judged valid and eligible for compensation. Claims rates varied significantly across hospitals; surgical specialties accounted for 46% of discharges, but 88% of claims. There were also large differences in claims rates for procedures. Patient-generated malpractice claims, as collected in the Swedish malpractice insurance system and adjusted for clinical volumes, have a high validity, as assessed by standardised physician review, and provide unique new information on malpractice risks, preventable medical errors and patient injuries. Systematic collection and analysis of patient-generated quality of care complaints should be encouraged, regardless of the malpractice compensation

The Age-related Positivity Effect and Tobacco Warning Labels

PubMed Central

Roberts, Megan E.; Peters, Ellen; Ferketich, Amy K.; Klein, Elizabeth G.

2016-01-01

Objectives This study tested whether age is a factor in viewing time for tobacco warning labels. The approach drew from previous work demonstrating an age-related positivity effect, whereby older adults show preferences toward positive and away from negative stimuli. Methods Participants were 295 daily smokers from Appalachian Ohio (age range: 21–68). All participants took part in an eye-tracking paradigm that captured the attention paid to elements of health warning labels in the context of magazine advertisements. Participants also reported on their past cessation attempts and their beliefs about the dangers of smoking. Results Consistent with theory on age-related positivity, older age predicted weaker beliefs about smoking risks, but only among those with no past-year quit attempts. In support of our primary hypothesis, older age was also related to a lower percentage of time spent viewing tobacco warning labels, both overall (text + image) and for the graphic image alone. These associations remained after controlling for cigarettes smoked per day. Conclusions Overall, findings suggest that age is an important consideration for the design of future graphic warning labels and other tobacco risk communications. For older adults, warning labels may need to be tailored to overcome the age-related positivity effect. PMID:27617273

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

32 CFR 536.115 - Claims procedures for claims arising overseas under international agreements.

Code of Federal Regulations, 2012 CFR

2012-07-01

... otherwise allowed under the FCA or MCA. For example, receiving state claims offices in Germany require that....S. involvement. If the filing period is about to expire for claims arising in Germany, have the...

32 CFR 536.115 - Claims procedures for claims arising overseas under international agreements.

Code of Federal Regulations, 2010 CFR

2010-07-01

... otherwise allowed under the FCA or MCA. For example, receiving state claims offices in Germany require that....S. involvement. If the filing period is about to expire for claims arising in Germany, have the...

32 CFR 536.115 - Claims procedures for claims arising overseas under international agreements.

Code of Federal Regulations, 2011 CFR

2011-07-01

... otherwise allowed under the FCA or MCA. For example, receiving state claims offices in Germany require that....S. involvement. If the filing period is about to expire for claims arising in Germany, have the...

32 CFR 536.115 - Claims procedures for claims arising overseas under international agreements.

Code of Federal Regulations, 2013 CFR

2013-07-01

... otherwise allowed under the FCA or MCA. For example, receiving state claims offices in Germany require that....S. involvement. If the filing period is about to expire for claims arising in Germany, have the...

32 CFR 536.115 - Claims procedures for claims arising overseas under international agreements.

Code of Federal Regulations, 2014 CFR

2014-07-01

... otherwise allowed under the FCA or MCA. For example, receiving state claims offices in Germany require that....S. involvement. If the filing period is about to expire for claims arising in Germany, have the...

32 CFR 842.94 - Assertable claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

..., against a tort-feasor when: (a) Damage results from negligence and the claim is for: (1) More than $100... ADMINISTRATIVE CLAIMS Property Damage Tort Claims in Favor of the United States (31 U.S.C. 3701, 3711-3719) § 842.... (The two claims should be consolidated and processed under subpart N). (d) The Tort-feasor or his...

32 CFR 536.2 - Claims authorities.

Code of Federal Regulations, 2012 CFR

2012-07-01

.../85256F33005C2B92/(JAGCNETDocID)/HOME?OPENDOCUMENT. Select the link “Claims Resources.” (1) Tort claims. (i) The... Secretary of Defense, the Secretary of Transportation, and the Secretary of Health and Human Services. (v... Claims Act (NGCA), 32 U.S.C. 715 (see subpart F of this part). (vii) Claims under International...

32 CFR 536.2 - Claims authorities.

Code of Federal Regulations, 2014 CFR

2014-07-01

.../85256F33005C2B92/(JAGCNETDocID)/HOME?OPENDOCUMENT. Select the link “Claims Resources.” (1) Tort claims. (i) The... Secretary of Defense, the Secretary of Transportation, and the Secretary of Health and Human Services. (v... Claims Act (NGCA), 32 U.S.C. 715 (see subpart F of this part). (vii) Claims under International...

Influence of Interpretation Aids on Attentional Capture, Visual Processing, and Understanding of Front-of-Package Nutrition Labels.

PubMed

Antúnez, Lucía; Giménez, Ana; Maiche, Alejandro; Ares, Gastón

2015-01-01

To study the influence of 2 interpretational aids of front-of-package (FOP) nutrition labels (color code and text descriptors) on attentional capture and consumers' understanding of nutritional information. A full factorial design was used to assess the influence of color code and text descriptors using visual search and eye tracking. Ten trained assessors participated in the visual search study and 54 consumers completed the eye-tracking study. In the visual search study, assessors were asked to indicate whether there was a label high in fat within sets of mayonnaise labels with different FOP labels. In the eye-tracking study, assessors answered a set of questions about the nutritional content of labels. The researchers used logistic regression to evaluate the influence of interpretational aids of FOP nutrition labels on the percentage of correct answers. Analyses of variance were used to evaluate the influence of the studied variables on attentional measures and participants' response times. Response times were significantly higher for monochromatic FOP labels compared with color-coded ones (3,225 vs 964 ms; P < .001), which suggests that color codes increase attentional capture. The highest number and duration of fixations and visits were recorded on labels that did not include color codes or text descriptors (P < .05). The lowest percentage of incorrect answers was observed when the nutrient level was indicated using color code and text descriptors (P < .05). The combination of color codes and text descriptors seems to be the most effective alternative to increase attentional capture and understanding of nutritional information. Copyright © 2015 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Dietary Supplements for Musculoskeletal Pain: Science Versus Claims.

PubMed

Crawford, Cindy; Saldanha, Leila; Costello, Rebecca; Deuster, Patricia A

2018-01-01

Special Operations Forces (SOF) face unique challenges that manifest themselves both mentally and physically. The extremes of training and combat can affect the readiness to perform at peak levels, especially when confronted with musculoskeletal pain. Many SOF Operators turn to dietary supplements in hopes of gaining an edge. Although some supplements are now being marketed for pain, decisions to use these products need to be driven by information that is evidence based. We describe SOF-specific evidence-based recommendations for the use of dietary ingredients for pain that emerged from a rigorous scientific evaluation. These recommendations are compared with the label claims made in the commercial market by companies selling products to combat musculoskeletal pain. This information can be used by the SOF medical community to assist Operators in making informed decisions when considering or selecting dietary supplements for maintaining and optimizing performance. 2018.

Category labels versus feature labels: category labels polarize inferential predictions.

PubMed

Yamauchi, Takashi; Yu, Na-Yung

2008-04-01

What makes category labels different from feature labels in predictive inference? This study suggests that category labels tend to make inductive reasoning polarized and homogeneous. In two experiments, participants were shown two schematic pictures of insects side by side and predicted the value of a hidden feature of one insect on the basis of the other insect. Arbitrary verbal labels were shown above the two pictures, and the meanings of the labels were manipulated in the instructions. In one condition, the labels represented the category membership of the insects, and in the other conditions, the same labels represented attributes of the insects. When the labels represented category membership, participants' responses became substantially polarized and homogeneous, indicating that the mere reference to category membership can modify reasoning processes.

A study on the consumer's perception of front-of-pack nutrition labeling

PubMed Central

Kim, Woo Kyoung

2009-01-01

The goal of this research is to investigate the present situation for front of pack labeling in Korea and the perception of consumers for the new system of labeling, front of pack labeling, based on the consumer survey. We investigated the number of processed foods with front of pack labeling in one retailer in Youngin-si. And we also surveyed 1,019 participants nationwide whose ages were from 20 to 49; the knowledge of nutrition labeling, the knowledge of 'front of pack labeling', and the opinion about the labeling system. The data were analyzed using SAS statistics program. The results were as follows: 13.4% of processed foods had front of pack labeling, and 16.8% of the consumers always checked the nutrition labeling, while 32.7% of the consumers seldom checked it. In addition, 44.3% of the consumers think that 'front of pack labeling' is necessary, and 58.3% of the consumers think it is important to show the percentage of daily value as a way of 'front of pack labeling'. However, 32% of the consumer think the possibility of 'front of pack labeling' is slim. Meanwhile, 58.3% of the consumers think that it is important to have the color difference according to contents. The number of favorite nutrients in the front of pack was four or five. It seems that the recognition of current nutrition labeling has the influence on the willingness of using the future 'front of pack labeling'. Along with our study, the policy for 'front of pack labeling' has to be updated and improved constantly since 'front of pack labeling' helps consumer understand nutrition facts. PMID:20098583

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

32 CFR 842.110 - Claims not payable.

Code of Federal Regulations, 2011 CFR

2011-07-01

... National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE CLAIMS AND LITIGATION... International Agreements Claims Act. (4) The Air Force Admiralty Claims Act and the Admiralty Extensions Act. (5...) Claims from the combat activities of the armed forces during war or armed conflict. (c) Claims for...

29 CFR 15.42 - Claim procedures.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Are there limits on claims under the MPCECA? 15.205 What types of claims for property damage are... a claim for loss of or damages to personal property under the WIA? 15.304 Are there limits to claims for loss of or damages to personal property under the WIA? Authority: 28 U.S.C. 2672; 28 CFR § 14.11...

Prostate Cancer Screening In Men Ages 75 And Older Fell By 8 Percentage Points After Task Force Recommendation

PubMed Central

Howard, David H.; Tangka, Florence K.; Guy, Gery P.; Ekwueme, Donatus U.; Lipscomb, Joseph

2016-01-01

In 2008 the US Preventive Services Task Force recommended against screening men ages 75 and older for prostate cancer. Using Medicare Current Beneficiary Survey Access to Care files and linked claims, we compared trends in prostate-specific antigen (PSA) testing rates between men ages 75 and older and men ages 65–74. We estimate that the revised recommendation led to a 7.9-percentage-point decline in annual PSA testing rates over two years among men ages 75 and older. Although 42 percent of men in this age group continue to receive PSA tests, our results highlight the potential of guidelines with negative recommendations to reduce the use of low-value medical care. PMID:23459740

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.

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.

23 CFR 190.5 - Bonus project claims.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 23 Highways 1 2013-04-01 2013-04-01 false Bonus project claims. 190.5 Section 190.5 Highways... CONTROLLING OUTDOOR ADVERTISING ON THE INTERSTATE SYSTEM § 190.5 Bonus project claims. (a) The State may claim... limits and areas excluded from the claim and form FHWA-1175, for the one-half percent bonus claim. (b...

23 CFR 190.5 - Bonus project claims.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 23 Highways 1 2011-04-01 2011-04-01 false Bonus project claims. 190.5 Section 190.5 Highways... CONTROLLING OUTDOOR ADVERTISING ON THE INTERSTATE SYSTEM § 190.5 Bonus project claims. (a) The State may claim... limits and areas excluded from the claim and form FHWA-1175, for the one-half percent bonus claim. (b...

23 CFR 190.5 - Bonus project claims.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 23 Highways 1 2014-04-01 2014-04-01 false Bonus project claims. 190.5 Section 190.5 Highways... CONTROLLING OUTDOOR ADVERTISING ON THE INTERSTATE SYSTEM § 190.5 Bonus project claims. (a) The State may claim... limits and areas excluded from the claim and form FHWA-1175, for the one-half percent bonus claim. (b...

23 CFR 190.5 - Bonus project claims.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 23 Highways 1 2010-04-01 2010-04-01 false Bonus project claims. 190.5 Section 190.5 Highways... CONTROLLING OUTDOOR ADVERTISING ON THE INTERSTATE SYSTEM § 190.5 Bonus project claims. (a) The State may claim... limits and areas excluded from the claim and form FHWA-1175, for the one-half percent bonus claim. (b...

23 CFR 190.5 - Bonus project claims.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 23 Highways 1 2012-04-01 2012-04-01 false Bonus project claims. 190.5 Section 190.5 Highways... CONTROLLING OUTDOOR ADVERTISING ON THE INTERSTATE SYSTEM § 190.5 Bonus project claims. (a) The State may claim... limits and areas excluded from the claim and form FHWA-1175, for the one-half percent bonus claim. (b...

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.

Recent developments in false claims enforcement: a minefield for health care providers.

PubMed

Whitaker, Glenn V; Walton, Victor A

2007-01-01

Actions under the False Claims Act represent potentially billions of dollars in damages returned to the state and federal governments each year for fraud recovery. Over the past several years, health care providers have been the target of about half of the FCA suits filed and have paid out an even greater percentage of the damages recovered. Because of the enumerable opportunities for fraud, waste, and abuse in the health care industry, it will likely continue to be a prominent target of FCA suits. Key provisions of the Deficit Reduction Act of 2005, effective on January 1, 2007, will only increase the reach of the FCA. Providers beware.

Lessons to be learned: a retrospective analysis of physiotherapy injury claims.

PubMed

Johnson, Gillian M; Skinner, Margot A; Stephen, Rachel E

2012-08-01

Retrospective, descriptive analysis. To describe the prevalence and nature of insurance claims for injuries attributed to physiotherapy care. In New Zealand, a national insurance scheme, the Accident Compensation Corporation, provides comprehensive, no-fault personal injury coverage. The patterns of injury sustained during physiotherapy care have not previously been described. De-identified data for all injuries registered with the Accident Compensation Corporation from 2005 to 2010 and attributed to physiotherapy were accessed. Prevalence patterns (percentages) of new-claim data were determined for physiotherapy intervention category, injury site, nature of injury, age, and sex. A subcategory, exercise-related injuries, was analyzed according to injury site and whether the injury was related (primary) or unrelated (secondary) to the intended therapeutic goal. There were 279 claims related to physiotherapy care filed with the Accident Compensation Corporation during the studied reporting period. Injury was attributed predominantly to exercise (n = 88, 31.5% of cases) and manual therapy (n = 74, 26.5% of cases). The prevalence of events categorized as exercise related was greatest in those who were 55 to 59 years of age (n = 14, 16.3%) and greater in females (n = 47, 54.7%). Of the exercise-related injuries, 39.8% were in the lower-limb region and 35.2% were categorized as sprains/strains. Injuries attributed to exercise exceeded those linked to other therapies provided by physiotherapists, yet exercise therapy rarely features as a cause of adverse events reported to the physiotherapy profession. The proportion of exercise-related injury events underlines the need for ensuring safe and careful consideration of exercise prescription. Harm, level 4.

Body mass index and percentage of body fat as indicators for obesity in an adolescent athletic population.

PubMed

Etchison, William C; Bloodgood, Elizabeth A; Minton, Cholly P; Thompson, Nancy J; Collins, Mary Ann; Hunter, Stephen C; Dai, Hongying

2011-05-01

Body mass index (BMI) is widely accepted in determining obesity. Skinfold thickness measurements have been commonly used to determine percentage of body fat. The authors hypothesize that because BMI does not measure fat directly but relies on body weight alone, a large percentage of athletic adolescents will be misclassified as obese by BMI. Cross-sectional study. To compare BMI and skinfold measurements as indicators for obesity in the adolescent athletic population, anthropometric data (height, weight, percentage body fat, age, and sex) were recorded from 33 896 student athletes (average age, 15 years; range, 11-19 years) during preparticipation physical examinations from 1985 to 2003. BMI was calculated from height and weight. Percentage of body fat was determined by measuring skinfold thickness. According to their BMI percentile, 13.31% of adolescent athletes were obese. Using the skinfold method, only 5.95% were obese. Of those classified as obese by the BMI, 62% were considered false positives by the skinfold method. In contrast, there was a 99% probability that the nonobese by BMI would not be obese by the skinfold method (negative predictive value = 0.99). BMI is a measurement of relative body weight, not body composition. Because lean mass weighs far more than fat, many adolescent athletes are incorrectly classified as obese based on BMI. Skinfold testing provides a more accurate body assessment than BMI in adolescent athletes. Correct body composition data can help to provide better diet and activity guidelines and prevent the psychological problems associated with being labeled as obese.

48 CFR 1604.7101 - Filing health benefit claims/court review of disputed claims.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Filing health benefit... System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION GENERAL ADMINISTRATIVE MATTERS Disputed Health Benefit Claims 1604.7101 Filing health benefit claims/court review of...

48 CFR 1604.7101 - Filing health benefit claims/court review of disputed claims.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Filing health benefit... System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION GENERAL ADMINISTRATIVE MATTERS Disputed Health Benefit Claims 1604.7101 Filing health benefit claims/court review of...

48 CFR 1604.7101 - Filing health benefit claims/court review of disputed claims.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Filing health benefit... System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION GENERAL ADMINISTRATIVE MATTERS Disputed Health Benefit Claims 1604.7101 Filing health benefit claims/court review of...

48 CFR 1604.7101 - Filing health benefit claims/court review of disputed claims.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Filing health benefit... System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION GENERAL ADMINISTRATIVE MATTERS Disputed Health Benefit Claims 1604.7101 Filing health benefit claims/court review of...

48 CFR 1604.7101 - Filing health benefit claims/court review of disputed claims.

Code of Federal Regulations, 2010 CFR

2010-10-01

... System OFFICE OF PERSONNEL MANAGEMENT FEDERAL EMPLOYEES HEALTH BENEFITS ACQUISITION REGULATION GENERAL ADMINISTRATIVE MATTERS Disputed Health Benefit Claims 1604.7101 Filing health benefit claims/court review of... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Filing health benefit...

Operating room fires: a closed claims analysis.

PubMed

Mehta, Sonya P; Bhananker, Sanjay M; Posner, Karen L; Domino, Karen B

2013-05-01

To assess patterns of injury and liability associated with operating room (OR) fires, closed malpractice claims in the American Society of Anesthesiologists Closed Claims Database since 1985 were reviewed. All claims related to fires in the OR were compared with nonfire-related surgical anesthesia claims. An analysis of fire-related claims was performed to identify causative factors. There were 103 OR fire claims (1.9% of 5,297 surgical claims). Electrocautery was the ignition source in 90% of fire claims. OR fire claims more frequently involved older outpatients compared with other surgical anesthesia claims (P < 0.01). Payments to patients were more often made in fire claims (P < 0.01), but payment amounts were lower (median $120,166) compared to nonfire surgical claims (median $250,000, P < 0.01). Electrocautery-induced fires (n = 93) increased over time (P < 0.01) to 4.4% claims between 2000 and 2009. Most (85%) electrocautery fires occurred during head, neck, or upper chest procedures (high-fire-risk procedures). Oxygen served as the oxidizer in 95% of electrocautery-induced OR fires (84% with open delivery system). Most electrocautery-induced fires (n = 75, 81%) occurred during monitored anesthesia care. Oxygen was administered via an open delivery system in all high-risk procedures during monitored anesthesia care. In contrast, alcohol-containing prep solutions and volatile compounds were present in only 15% of OR fires during monitored anesthesia care. Electrocautery-induced fires during monitored anesthesia care were the most common cause of OR fires claims. Recognition of the fire triad (oxidizer, fuel, and ignition source), particularly the critical role of supplemental oxygen by an open delivery system during use of the electrocautery, is crucial to prevent OR fires. Continuing education and communication among OR personnel along with fire prevention protocols in high-fire-risk procedures may reduce the occurrence of OR fires.

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

32 CFR 537.15 - Statutory authority for maritime claims and claims involving civil works of a maritime nature.

Code of Federal Regulations, 2010 CFR

2010-07-01

... claims involving civil works of a maritime nature. 537.15 Section 537.15 National Defense Department of....15 Statutory authority for maritime claims and claims involving civil works of a maritime nature. (a... affirmative claims involving civil works of a maritime nature is set out at 33 U.S.C. 408. ...

32 CFR 537.15 - Statutory authority for maritime claims and claims involving civil works of a maritime nature.

Code of Federal Regulations, 2011 CFR

2011-07-01

... claims involving civil works of a maritime nature. 537.15 Section 537.15 National Defense Department of....15 Statutory authority for maritime claims and claims involving civil works of a maritime nature. (a... affirmative claims involving civil works of a maritime nature is set out at 33 U.S.C. 408. ...

32 CFR 537.15 - Statutory authority for maritime claims and claims involving civil works of a maritime nature.

Code of Federal Regulations, 2014 CFR

2014-07-01

... claims involving civil works of a maritime nature. 537.15 Section 537.15 National Defense Department of....15 Statutory authority for maritime claims and claims involving civil works of a maritime nature. (a... affirmative claims involving civil works of a maritime nature is set out at 33 U.S.C. 408. ...

32 CFR 537.15 - Statutory authority for maritime claims and claims involving civil works of a maritime nature.

Code of Federal Regulations, 2013 CFR

2013-07-01

... claims involving civil works of a maritime nature. 537.15 Section 537.15 National Defense Department of....15 Statutory authority for maritime claims and claims involving civil works of a maritime nature. (a... affirmative claims involving civil works of a maritime nature is set out at 33 U.S.C. 408. ...

32 CFR 537.15 - Statutory authority for maritime claims and claims involving civil works of a maritime nature.

Code of Federal Regulations, 2012 CFR

2012-07-01

... claims involving civil works of a maritime nature. 537.15 Section 537.15 National Defense Department of....15 Statutory authority for maritime claims and claims involving civil works of a maritime nature. (a... affirmative claims involving civil works of a maritime nature is set out at 33 U.S.C. 408. ...

Unfalsifiability of security claims.

PubMed

Herley, Cormac

2016-06-07

There is an inherent asymmetry in computer security: Things can be declared insecure by observation, but not the reverse. There is no observation that allows us to declare an arbitrary system or technique secure. We show that this implies that claims of necessary conditions for security (and sufficient conditions for insecurity) are unfalsifiable. This in turn implies an asymmetry in self-correction: Whereas the claim that countermeasures are sufficient is always subject to correction, the claim that they are necessary is not. Thus, the response to new information can only be to ratchet upward: Newly observed or speculated attack capabilities can argue a countermeasure in, but no possible observation argues one out. Further, when justifications are unfalsifiable, deciding the relative importance of defensive measures reduces to a subjective comparison of assumptions. Relying on such claims is the source of two problems: once we go wrong we stay wrong and errors accumulate, and we have no systematic way to rank or prioritize measures.

Unfalsifiability of security claims

PubMed Central

Herley, Cormac

2016-01-01

There is an inherent asymmetry in computer security: Things can be declared insecure by observation, but not the reverse. There is no observation that allows us to declare an arbitrary system or technique secure. We show that this implies that claims of necessary conditions for security (and sufficient conditions for insecurity) are unfalsifiable. This in turn implies an asymmetry in self-correction: Whereas the claim that countermeasures are sufficient is always subject to correction, the claim that they are necessary is not. Thus, the response to new information can only be to ratchet upward: Newly observed or speculated attack capabilities can argue a countermeasure in, but no possible observation argues one out. Further, when justifications are unfalsifiable, deciding the relative importance of defensive measures reduces to a subjective comparison of assumptions. Relying on such claims is the source of two problems: once we go wrong we stay wrong and errors accumulate, and we have no systematic way to rank or prioritize measures. PMID:27217574

32 CFR 751.10 - Form of claim.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Claims Against the United States § 751.10 Form of claim. The claim should be submitted on DD Form 1842 (Claim for Personal Property) accompanied by DD Form 1844 (List of Property). If DD Forms 1842 and 1844 1...

Time series forecasting of future claims amount of SOCSO's employment injury scheme (EIS)

NASA Astrophysics Data System (ADS)

Zulkifli, Faiz; Ismail, Isma Liana; Chek, Mohd Zaki Awang; Jamal, Nur Faezah; Ridzwan, Ahmad Nur Azam Ahmad; Jelas, Imran Md; Noor, Syamsul Ikram Mohd; Ahmad, Abu Bakar

2012-09-01

The Employment Injury Scheme (EIS) provides protection to employees who are injured due to accidents whilst working, commuting from home to the work place or during employee takes a break during an authorized recess time or while travelling that is related with his work. The main purpose of this study is to forecast value on claims amount of EIS for the year 2011 until 2015 by using appropriate models. These models were tested on the actual EIS data from year 1972 until year 2010. Three different forecasting models are chosen for comparisons. These are the Naïve with Trend Model, Average Percent Change Model and Double Exponential Smoothing Model. The best model is selected based on the smallest value of error measures using the Mean Squared Error (MSE) and Mean Absolute Percentage Error (MAPE). From the result, the best model that best fit the forecast for the EIS is the Average Percent Change Model. Furthermore, the result also shows the claims amount of EIS for the year 2011 to year 2015 continue to trend upwards from year 2010.

Improving the design of nutrition labels to promote healthier food choices and reasonable portion sizes.

PubMed

Roberto, C A; Khandpur, N

2014-07-01

Accurate and easy-to-understand nutrition labeling is a worthy public health goal that should be considered an important strategy among many to address obesity and poor diet. Updating the Nutrition Facts Panel on packaged foods, developing a uniform front-of-package labeling system and providing consumers with nutrition information on restaurant menus offer important opportunities to educate people about food's nutritional content, increase awareness of reasonable portion sizes and motivate consumers to make healthier choices. The aims of this paper were to identify and discuss: (1) current concerns with nutrition label communication strategies; (2) opportunities to improve the communication of nutrition information via food labels, with a specific focus on serving size information; and (3) important future areas of research on nutrition labeling as a tool to improve diet. We suggest that research on nutrition labeling should focus on ways to improve food labels' ability to capture consumer attention, reduce label complexity and convey numeric nutrition information in simpler and more meaningful ways, such as through interpretive food labels, the addition of simple text, reduced use of percentages and easy-to-understand presentation of serving size information.

Variable percentage sampler

DOEpatents

Miller, Jr., William H.

1976-01-01

A remotely operable sampler is provided for obtaining variable percentage samples of nuclear fuel particles and the like for analyses. The sampler has a rotating cup for a sample collection chamber designed so that the effective size of the sample inlet opening to the cup varies with rotational speed. Samples of a desired size are withdrawn from a flowing stream of particles without a deterrent to the flow of remaining particles.

[Professional liability claims against dentists].

PubMed

Moscoso Matus, Karla; Smok Vásquez, Pía

2015-03-01

The frequency and features of malpractice lawsuits against dentists in Chile are not well known. To determine the magnitude and frequency of professional liability claims against dentists. A retrospective analysis of the Medical Liability Unit of the Legal Medical Service of Chile database. This public organization deals with most professional liability claims in Chile. Between 2007 and 2012, 3,990 expert opinions about liability of health care professionals were requested. Odontology was the fifth specialty most commonly sued and dentists, the second most frequently sued professionals. Sixty nine percent of cases originated in private clinics, which is coincident with a higher frequency of dentists working in private practice. Most petitioners were adult women and most claims originated from surgical interventions and infections. In 35% of claims against dentists, a violation of Lex Artis was confirmed, compared with 9% of all expert opinions that generated in the unit. Claims against dentists are more common than previously thought and these professionals should adopt preventive measures to avoid them.

32 CFR 536.19 - Disaster claims planning.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 3 2010-07-01 2010-07-01 true Disaster claims planning. 536.19 Section 536.19... AGAINST THE UNITED STATES The Army Claims System § 536.19 Disaster claims planning. All ACOs will prepare... requirements related to disaster claims planning. ...

44 CFR 11.74 - Claims not allowed.

Code of Federal Regulations, 2014 CFR

2014-10-01

... business. Claims are not payable for property normally used for business or profit. (9) Unserviceable... arose during the conduct of personal business are not payable. (2) Subrogation claims. Claims based upon..., insurance policies, money orders, and traveler's checks. (12) Government property. Claims are not payable...

Rates and Characteristics of Paid Malpractice Claims Among US Physicians by Specialty, 1992-2014.

PubMed

Schaffer, Adam C; Jena, Anupam B; Seabury, Seth A; Singh, Harnam; Chalasani, Venkat; Kachalia, Allen

2017-05-01

-2014), and 32.1% (35 293 of 109 865) involved a patient death. Diagnostic error was the most common type of allegation, present in 31.8% (35 349 of 111 066) of paid claims, ranging from 3.5% in anesthesiology (153 of 4317) to 87.0% in pathology (915 of 1052). Between 1992 and 2014, the rate of malpractice claims paid on behalf of physicians in the United States declined substantially. Mean compensation amounts and the percentage of paid claims exceeding $1 million increased, with wide differences in rates and characteristics across specialties. A better understanding of the causes of variation among specialties in paid malpractice claims may help reduce both patient injury and physicians' risk of liability.

32 CFR 536.76 - Claims not payable under the Military Claims Act.

Code of Federal Regulations, 2010 CFR

2010-07-01

... which was in violation of DA directives, such as illegal war trophies. (e) Claims for rent, damage, or... therein by and for the Department of the Army (DA) or Department of Defense (DOD). See § 536.34(m) and paragraph 2-15m of DA Pam 27-162. (f) Claims not in the best interests of the United States, contrary to...

41 CFR 105-55.003 - Antitrust, fraud, tax, interagency claims, and claims over $100,000 excluded.

Code of Federal Regulations, 2010 CFR

2010-07-01

...) This part does not apply to tax debts. (c) This part does not apply to claims between GSA and other... 41 Public Contracts and Property Management 3 2010-07-01 2010-07-01 false Antitrust, fraud, tax... § 105-55.003 Antitrust, fraud, tax, interagency claims, and claims over $100,000 excluded. (a) The...

32 CFR 536.15 - Claims policies.

Code of Federal Regulations, 2014 CFR

2014-07-01

... payable claims nor did it intend that small non-meritous claims be paid. Practically any claim, regardless... fair analysis should be paramount. Personal contact with claimants or their representatives is... will publish written interpretations of this part. Interpretations will have the same force and effect...

32 CFR 536.15 - Claims policies.

Code of Federal Regulations, 2013 CFR

2013-07-01

... payable claims nor did it intend that small non-meritous claims be paid. Practically any claim, regardless... fair analysis should be paramount. Personal contact with claimants or their representatives is... will publish written interpretations of this part. Interpretations will have the same force and effect...

32 CFR 536.15 - Claims policies.

Code of Federal Regulations, 2012 CFR

2012-07-01

... payable claims nor did it intend that small non-meritous claims be paid. Practically any claim, regardless... fair analysis should be paramount. Personal contact with claimants or their representatives is... will publish written interpretations of this part. Interpretations will have the same force and effect...

45 CFR 504.4 - Place of filing claims.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 45 Public Welfare 3 2010-10-01 2010-10-01 false Place of filing claims. 504.4 Section 504.4 Public... WAR CLAIMS ACT OF 1948, AS AMENDED FILING OF CLAIMS AND PROCEDURES THEREFOR § 504.4 Place of filing claims. Claims must be mailed or delivered in person to the Foreign Claims Settlement Commission, 600 E...

42 CFR 431.972 - Claims sampling procedures.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Estimating Improper Payments in Medicaid and CHIP § 431.972 Claims sampling procedures. (a) Claims universe. (1) The PERM claims universe includes payments that were originally paid (paid claims) and for which... must establish controls to ensure FFS and managed care universes are accurate and complete, including...

42 CFR 431.972 - Claims sampling procedures.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Estimating Improper Payments in Medicaid and CHIP § 431.972 Claims sampling procedures. (a) Claims universe. (1) The PERM claims universe includes payments that were originally paid (paid claims) and for which... must establish controls to ensure FFS and managed care universes are accurate and complete, including...

42 CFR 431.972 - Claims sampling procedures.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Estimating Improper Payments in Medicaid and CHIP § 431.972 Claims sampling procedures. (a) Claims universe. (1) The PERM claims universe includes payments that were originally paid (paid claims) and for which... must establish controls to ensure FFS and managed care universes are accurate and complete, including...

37 CFR 360.5 - Copies of claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Section 360.5 Patents, Trademarks, and Copyrights COPYRIGHT ROYALTY BOARD, LIBRARY OF CONGRESS SUBMISSION OF ROYALTY CLAIMS FILING OF CLAIMS TO ROYALTY FEES COLLECTED UNDER COMPULSORY LICENSE Cable Claims... hand delivery or by mail, file an original and one copy of the claim to cable royalty fees. ...

16 CFR 260.7 - Environmental marketing claims.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 16 Commercial Practices 1 2010-01-01 2010-01-01 false Environmental marketing claims. 260.7... USE OF ENVIRONMENTAL MARKETING CLAIMS § 260.7 Environmental marketing claims. Guidance about the use of environmental marketing claims is set forth in this section. Each guide is followed by several...

12 CFR 380.32 - Claims bar date.

Code of Federal Regulations, 2012 CFR

2012-01-01

... LIQUIDATION AUTHORITY Receivership Administrative Claims Process § 380.32 Claims bar date. Upon its appointment as receiver for a covered financial company, the Corporation as receiver shall establish a claims bar date by which date creditors of the covered financial company shall present their claims, together...

12 CFR 226.22 - Determination of annual percentage rate.

Code of Federal Regulations, 2010 CFR

2010-01-01

... annual percentage rate shall be considered accurate if it is not more than 1/8 of 1 percentage point... more than 1/4 of 1 percentage point above or below the annual percentage rate determined in accordance... transaction. (d) Certain transactions involving ranges of balances. For purposes of disclosing the annual...

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.

29 CFR 15.24 - Unallowable claims.

Code of Federal Regulations, 2011 CFR

2011-07-01

... the Military Personnel and Civilian Employees' Claims Act of 1964 § 15.24 Unallowable claims. Claims... paper or other materials. No compensation is authorized for the time spent by the claimant in its..., telephone calls, cost of transporting claimant or family members, inconvenience, time spent in preparation...

29 CFR 15.24 - Unallowable claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... the Military Personnel and Civilian Employees' Claims Act of 1964 § 15.24 Unallowable claims. Claims... paper or other materials. No compensation is authorized for the time spent by the claimant in its..., telephone calls, cost of transporting claimant or family members, inconvenience, time spent in preparation...

32 CFR 750.43 - Claims payable.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 5 2010-07-01 2010-07-01 false Claims payable. 750.43 Section 750.43 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS... of missiles and weapons, sonic booms, training and field exercises, and maneuvers that include...

32 CFR 750.43 - Claims payable.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 32 National Defense 5 2014-07-01 2014-07-01 false Claims payable. 750.43 Section 750.43 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS... of missiles and weapons, sonic booms, training and field exercises, and maneuvers that include...

32 CFR 750.43 - Claims payable.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 5 2012-07-01 2012-07-01 false Claims payable. 750.43 Section 750.43 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS... of missiles and weapons, sonic booms, training and field exercises, and maneuvers that include...

32 CFR 750.43 - Claims payable.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 5 2011-07-01 2011-07-01 false Claims payable. 750.43 Section 750.43 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS... of missiles and weapons, sonic booms, training and field exercises, and maneuvers that include...

32 CFR 750.43 - Claims payable.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 5 2013-07-01 2013-07-01 false Claims payable. 750.43 Section 750.43 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS... of missiles and weapons, sonic booms, training and field exercises, and maneuvers that include...

Marketing whole grain breads in Canada via food labels.

PubMed

Sumanac, Dunja; Mendelson, Rena; Tarasuk, Valerie

2013-03-01

A recommendation for increased whole grain consumption was released in Canada in 2007 to promote adequate intakes of fibre and magnesium. Since then, a proliferation of 'whole grain' claims on food packaging has been observed, but whole grain labelling is voluntary and unregulated in Canada. Through a detailed survey of bread sold in three supermarkets, this study examined how the presence of front-of-package reference to whole grain relates to (i) the presence and nature of whole grain ingredients, (ii) nutrient content, and (iii) price of the product. Twenty-one percent of breads bore a reference to whole grain on the front-of-package and the front-of-package reference to whole grain was a better predictor of fibre content than any information that could be gleaned from the ingredient list. On average, breads with a whole grain reference were higher in fibre and magnesium and lower in sodium. Mean price did not differ by presence of a whole grain reference, but breads with whole grain labelling were less likely to be low in price. Voluntary nutrition labelling may be targeting a discrete market of health-conscious consumers who are willing to pay premium prices for more healthful options. Copyright © 2012 Elsevier Ltd. All rights reserved.

45 CFR 504.1 - Claim defined.

Code of Federal Regulations, 2014 CFR

2014-10-01

... Regulations Relating to Public Welfare (Continued) FOREIGN CLAIMS SETTLEMENT COMMISSION OF THE UNITED STATES, DEPARTMENT OF JUSTICE RECEIPT, ADMINISTRATION, AND PAYMENT OF CLAIMS UNDER TITLE I OF THE WAR CLAIMS ACT OF... military servicemen held as prisoners of war by forces hostile to the United States. (b) A properly...

45 CFR 504.1 - Claim defined.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Regulations Relating to Public Welfare (Continued) FOREIGN CLAIMS SETTLEMENT COMMISSION OF THE UNITED STATES, DEPARTMENT OF JUSTICE RECEIPT, ADMINISTRATION, AND PAYMENT OF CLAIMS UNDER TITLE I OF THE WAR CLAIMS ACT OF... military servicemen held as prisoners of war by forces hostile to the United States. (b) A properly...

45 CFR 504.1 - Claim defined.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Regulations Relating to Public Welfare (Continued) FOREIGN CLAIMS SETTLEMENT COMMISSION OF THE UNITED STATES, DEPARTMENT OF JUSTICE RECEIPT, ADMINISTRATION, AND PAYMENT OF CLAIMS UNDER TITLE I OF THE WAR CLAIMS ACT OF... military servicemen held as prisoners of war by forces hostile to the United States. (b) A properly...

45 CFR 504.1 - Claim defined.

Code of Federal Regulations, 2011 CFR

2011-10-01

... Regulations Relating to Public Welfare (Continued) FOREIGN CLAIMS SETTLEMENT COMMISSION OF THE UNITED STATES, DEPARTMENT OF JUSTICE RECEIPT, ADMINISTRATION, AND PAYMENT OF CLAIMS UNDER TITLE I OF THE WAR CLAIMS ACT OF... military servicemen held as prisoners of war by forces hostile to the United States. (b) A properly...

40 CFR 35.6600 - Contractor claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Contractor claims. 35.6600 Section 35... Actions Procurement Requirements Under A Cooperative Agreement § 35.6600 Contractor claims. (a) General... prepared by the contractor to support a claim against the recipient; and (4) The award official determines...

32 CFR 584.3 - Paternity claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... process paternity claims against male Army soldiers. These procedures apply to claims made in the... claims against them. Commanders will ensure that soldiers are advised of their legal rights and will... questioning, advise the soldier of his right to remain silent under article, 31, UCMJ, and his right to...

32 CFR 842.72 - Filing a claim.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 6 2010-07-01 2010-07-01 false Filing a claim. 842.72 Section 842.72 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE CLAIMS AND LITIGATION ADMINISTRATIVE... receives a claim, send it to the US sending State office for delivery to the receiving State. (b) Claims...

38 CFR 14.617 - Disposition of claims.

Code of Federal Regulations, 2013 CFR

2013-07-01

... Foreign Countries § 14.617 Disposition of claims. (a) Disposition of claims arising in Philippines. All claims arising under 38 U.S.C. 515(b) in the Philippines, including a complete investigation report and a... other than the Philippines. When a claim is received in an American Embassy or Consulate, the Embassy or...

38 CFR 14.617 - Disposition of claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... Foreign Countries § 14.617 Disposition of claims. (a) Disposition of claims arising in Philippines. All claims arising under 38 U.S.C. 515(b) in the Philippines, including a complete investigation report and a... other than the Philippines. When a claim is received in an American Embassy or Consulate, the Embassy or...

38 CFR 14.617 - Disposition of claims.

Code of Federal Regulations, 2012 CFR

2012-07-01

... Foreign Countries § 14.617 Disposition of claims. (a) Disposition of claims arising in Philippines. All claims arising under 38 U.S.C. 515(b) in the Philippines, including a complete investigation report and a... other than the Philippines. When a claim is received in an American Embassy or Consulate, the Embassy or...

38 CFR 14.617 - Disposition of claims.

Code of Federal Regulations, 2011 CFR

2011-07-01

... Foreign Countries § 14.617 Disposition of claims. (a) Disposition of claims arising in Philippines. All claims arising under 38 U.S.C. 515(b) in the Philippines, including a complete investigation report and a... other than the Philippines. When a claim is received in an American Embassy or Consulate, the Embassy or...

38 CFR 14.617 - Disposition of claims.

Code of Federal Regulations, 2014 CFR

2014-07-01

... Foreign Countries § 14.617 Disposition of claims. (a) Disposition of claims arising in Philippines. All claims arising under 38 U.S.C. 515(b) in the Philippines, including a complete investigation report and a... other than the Philippines. When a claim is received in an American Embassy or Consulate, the Embassy or...

32 CFR 757.18 - Asserting the claim.

Code of Federal Regulations, 2011 CFR

2011-07-01

... there is no prescribed form or content for investigating these claims, the claims file will contain...'s claim as an item of special damages with the injured person's claim or suit. (ii) An agreement... through the injured person against the liable third person or brings an original suit in its own name or...

32 CFR 757.18 - Asserting the claim.

Code of Federal Regulations, 2014 CFR

2014-07-01

... there is no prescribed form or content for investigating these claims, the claims file will contain...'s claim as an item of special damages with the injured person's claim or suit. (ii) An agreement... through the injured person against the liable third person or brings an original suit in its own name or...

32 CFR 757.18 - Asserting the claim.

Code of Federal Regulations, 2012 CFR

2012-07-01

... there is no prescribed form or content for investigating these claims, the claims file will contain...'s claim as an item of special damages with the injured person's claim or suit. (ii) An agreement... through the injured person against the liable third person or brings an original suit in its own name or...

32 CFR 757.18 - Asserting the claim.

Code of Federal Regulations, 2010 CFR

2010-07-01

... there is no prescribed form or content for investigating these claims, the claims file will contain...'s claim as an item of special damages with the injured person's claim or suit. (ii) An agreement... through the injured person against the liable third person or brings an original suit in its own name or...

Reserving by detailed conditioning on individual claim

NASA Astrophysics Data System (ADS)

Kartikasari, Mujiati Dwi; Effendie, Adhitya Ronnie; Wilandari, Yuciana

2017-03-01

The estimation of claim reserves is an important activity in insurance companies to fulfill their liabilities. Recently, reserving method of individual claim have attracted a lot of interest in the actuarial science, which overcome some deficiency of aggregated claim method. This paper explores the Reserving by Detailed Conditioning (RDC) method using all of claim information for reserving with individual claim of liability insurance from an Indonesian general insurance company. Furthermore, we compare it to Chain Ladder and Bornhuetter-Ferguson method.

20 CFR 356.3 - False claims.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false False claims. 356.3 Section 356.3 Employees' Benefits RAILROAD RETIREMENT BOARD ADMINISTRATIVE REMEDIES FOR FRAUDULENT CLAIMS OR STATEMENTS CIVIL MONETARY PENALTY INFLATION ADJUSTMENT § 356.3 False claims. In the case of penalties assessed under 31 U.S...

29 CFR 15.24 - Unallowable claims.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 7-12-12) Claims Under the Military Personnel and Civilian Employees' Claims Act of 1964 § 15.24... time spent by the claimant in its preparation or for supposed literary value. (g) Incidental expenses... family members, inconvenience, time spent in preparation of claim, or cost of insurance premiums) are not...

42 CFR 401.607 - Claims collection.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Claims collection. 401.607 Section 401.607 Public... PROVISIONS GENERAL ADMINISTRATIVE REQUIREMENTS Claims Collection and Compromise § 401.607 Claims collection... appropriate, by— (1) Direct collections in lump sums or in installments; or (2) Offsets against monies owed to...

27 CFR 72.32 - Interest claimed.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2013-04-01 2013-04-01 false Interest claimed. 72.32 Section 72.32 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT... Remission or Mitigation of Forfeitures § 72.32 Interest claimed. Any person claiming an interest in property...

26 CFR 403.36 - Interest claimed.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 26 Internal Revenue 18 2013-04-01 2013-04-01 false Interest claimed. 403.36 Section 403.36... ADMINISTRATION DISPOSITION OF SEIZED PERSONAL PROPERTY Remission or Mitigation of Forfeitures § 403.36 Interest claimed. Any person claiming an interest in property seized by an officer of the Internal Revenue Service...

26 CFR 403.36 - Interest claimed.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 26 Internal Revenue 18 2014-04-01 2014-04-01 false Interest claimed. 403.36 Section 403.36... ADMINISTRATION DISPOSITION OF SEIZED PERSONAL PROPERTY Remission or Mitigation of Forfeitures § 403.36 Interest claimed. Any person claiming an interest in property seized by an officer of the Internal Revenue Service...

26 CFR 403.36 - Interest claimed.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 26 Internal Revenue 18 2012-04-01 2012-04-01 false Interest claimed. 403.36 Section 403.36... ADMINISTRATION DISPOSITION OF SEIZED PERSONAL PROPERTY Remission or Mitigation of Forfeitures § 403.36 Interest claimed. Any person claiming an interest in property seized by an officer of the Internal Revenue Service...

27 CFR 72.32 - Interest claimed.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2014-04-01 2014-04-01 false Interest claimed. 72.32 Section 72.32 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT... Remission or Mitigation of Forfeitures § 72.32 Interest claimed. Any person claiming an interest in property...

27 CFR 72.32 - Interest claimed.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 27 Alcohol, Tobacco Products and Firearms 2 2012-04-01 2011-04-01 true Interest claimed. 72.32 Section 72.32 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU, DEPARTMENT... Remission or Mitigation of Forfeitures § 72.32 Interest claimed. Any person claiming an interest in property...

32 CFR 842.43 - Filing a claim.

Code of Federal Regulations, 2010 CFR

2010-07-01

... completed Standard Form 95 or other signed and written demand for money damages in a sum certain. A claim... Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE CLAIMS AND LITIGATION ADMINISTRATIVE... amend a claim at any time prior to final action. To amend a claim, the claimant or his or her authorized...

Improving the claims process with EDI.

PubMed

Moynihan, J J

1993-01-01

Electronic data interchange (EDI) is redefining the healthcare claims process. The traditional managerial approach to claims processing emphasizes information flow within the patient accounting department and between patient accounting and other departments. EDI enlarges the scope of the claims process to include information exchange between providers and payers. Using EDI to improve both external and internal information exchange makes the claims process more efficient and less expensive. This article is excerpted from "The Healthcare Financial Manager's Guide to Healthcare EDI," by James J. Moynihan, published by the Healthcare Financial Management Association.

32 CFR 752.4 - Affirmative claims.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 32 National Defense 5 2012-07-01 2012-07-01 false Affirmative claims. 752.4 Section 752.4 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS ADMIRALTY CLAIMS § 752.4... States under the jurisdiction of the Department of the Navy or for which the Department of the Navy has...

32 CFR 536.2 - Claims authorities.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 3 2011-07-01 2009-07-01 true Claims authorities. 536.2 Section 536.2 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY CLAIMS AND ACCOUNTS CLAIMS AGAINST THE... shortages in postal accounts caused by unbonded Army personnel (39 U.S.C. 411 and Department of Defense (DOD...

32 CFR 536.2 - Claims authorities.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 3 2010-07-01 2010-07-01 true Claims authorities. 536.2 Section 536.2 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY CLAIMS AND ACCOUNTS CLAIMS AGAINST THE... shortages in postal accounts caused by unbonded Army personnel (39 U.S.C. 411 and Department of Defense (DOD...

32 CFR 536.2 - Claims authorities.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 3 2013-07-01 2013-07-01 false Claims authorities. 536.2 Section 536.2 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY CLAIMS AND ACCOUNTS CLAIMS AGAINST THE... shortages in postal accounts caused by unbonded Army personnel (39 U.S.C. 411 and Department of Defense (DOD...

43 CFR 2623.2 - Claims protected.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 43 Public Lands: Interior 2 2013-10-01 2013-10-01 false Claims protected. 2623.2 Section 2623.2... Extended To Include Mineral Sections § 2623.2 Claims protected. (a) Valid applications, claims, or rights protected by the provisions of subsection (c) of section 1 of the Act of January 25, 1927, include...

43 CFR 2623.2 - Claims protected.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 43 Public Lands: Interior 2 2014-10-01 2014-10-01 false Claims protected. 2623.2 Section 2623.2... Extended To Include Mineral Sections § 2623.2 Claims protected. (a) Valid applications, claims, or rights protected by the provisions of subsection (c) of section 1 of the Act of January 25, 1927, include...

43 CFR 2623.2 - Claims protected.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 43 Public Lands: Interior 2 2012-10-01 2012-10-01 false Claims protected. 2623.2 Section 2623.2... Extended To Include Mineral Sections § 2623.2 Claims protected. (a) Valid applications, claims, or rights protected by the provisions of subsection (c) of section 1 of the Act of January 25, 1927, include...

43 CFR 2623.2 - Claims protected.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 43 Public Lands: Interior 2 2011-10-01 2011-10-01 false Claims protected. 2623.2 Section 2623.2... Extended To Include Mineral Sections § 2623.2 Claims protected. (a) Valid applications, claims, or rights protected by the provisions of subsection (c) of section 1 of the Act of January 25, 1927, include...

37 CFR 7.12 - Claim of color.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 37 Patents, Trademarks, and Copyrights 1 2010-07-01 2010-07-01 false Claim of color. 7.12 Section... § 7.12 Claim of color. (a) If color is claimed as a feature of the mark in the basic application and/or registration, the international application must include a statement that color is claimed as a...

44 CFR 11.73 - Allowable claims.

Code of Federal Regulations, 2013 CFR

2013-10-01

... supervisor, but these claims shall be limited to a maximum of $1,000.00. (4) Mobile homes. Claims may be allowed for damage to or loss of mobile homes and their content under the provisions of paragraph (c)(2) of this section. Claims for structural damage to mobile homes resulting from such structural damage...

44 CFR 11.73 - Allowable claims.

Code of Federal Regulations, 2014 CFR

2014-10-01

... supervisor, but these claims shall be limited to a maximum of $1,000.00. (4) Mobile homes. Claims may be allowed for damage to or loss of mobile homes and their content under the provisions of paragraph (c)(2) of this section. Claims for structural damage to mobile homes resulting from such structural damage...

44 CFR 11.73 - Allowable claims.

Code of Federal Regulations, 2011 CFR

2011-10-01

... supervisor, but these claims shall be limited to a maximum of $1,000.00. (4) Mobile homes. Claims may be allowed for damage to or loss of mobile homes and their content under the provisions of paragraph (c)(2) of this section. Claims for structural damage to mobile homes resulting from such structural damage...

44 CFR 11.73 - Allowable claims.

Code of Federal Regulations, 2012 CFR

2012-10-01

... supervisor, but these claims shall be limited to a maximum of $1,000.00. (4) Mobile homes. Claims may be allowed for damage to or loss of mobile homes and their content under the provisions of paragraph (c)(2) of this section. Claims for structural damage to mobile homes resulting from such structural damage...

5 CFR 180.104 - Allowable claims.

Code of Federal Regulations, 2011 CFR

2011-01-01

... mobile homes may be allowed only in cases of collision, theft, or vandalism. (5) Money. Claims for money... claimant's supervisor. (4) Mobile homes. Claims may be allowed for damage to or loss of mobile homes and their contents under the provisions of § 180.104(c)(2). Claims for structural damage to mobile homes...

5 CFR 180.104 - Allowable claims.

Code of Federal Regulations, 2012 CFR

2012-01-01

... mobile homes may be allowed only in cases of collision, theft, or vandalism. (5) Money. Claims for money... claimant's supervisor. (4) Mobile homes. Claims may be allowed for damage to or loss of mobile homes and their contents under the provisions of § 180.104(c)(2). Claims for structural damage to mobile homes...

5 CFR 180.104 - Allowable claims.

Code of Federal Regulations, 2014 CFR

2014-01-01

... mobile homes may be allowed only in cases of collision, theft, or vandalism. (5) Money. Claims for money... claimant's supervisor. (4) Mobile homes. Claims may be allowed for damage to or loss of mobile homes and their contents under the provisions of § 180.104(c)(2). Claims for structural damage to mobile homes...

5 CFR 180.104 - Allowable claims.

Code of Federal Regulations, 2010 CFR

2010-01-01

... mobile homes may be allowed only in cases of collision, theft, or vandalism. (5) Money. Claims for money... claimant's supervisor. (4) Mobile homes. Claims may be allowed for damage to or loss of mobile homes and their contents under the provisions of § 180.104(c)(2). Claims for structural damage to mobile homes...

5 CFR 180.104 - Allowable claims.

Code of Federal Regulations, 2013 CFR

2013-01-01

... mobile homes may be allowed only in cases of collision, theft, or vandalism. (5) Money. Claims for money... claimant's supervisor. (4) Mobile homes. Claims may be allowed for damage to or loss of mobile homes and their contents under the provisions of § 180.104(c)(2). Claims for structural damage to mobile homes...

44 CFR 11.73 - Allowable claims.

Code of Federal Regulations, 2010 CFR

2010-10-01

... supervisor, but these claims shall be limited to a maximum of $1,000.00. (4) Mobile homes. Claims may be allowed for damage to or loss of mobile homes and their content under the provisions of paragraph (c)(2) of this section. Claims for structural damage to mobile homes resulting from such structural damage...

Optimizing claims payment for successful risk management.

PubMed

Frates, Janice; Ginty, Mary Jo; Baker, Linda

2002-05-01

Disputed claims and delayed payments are among the principal sources of provider and vendor dissatisfaction with managed care payment systems. Timely and accurate claims-payment systems are essential to ensure provider and vendor satisfaction, fiscal stability, and regulatory compliance. A focused analysis of conditions contributing to late payment of claims can disclose problems in provider, vendor, or payer operational and billing procedures, contracting processes, information systems, or human resources management. Resolution of these conditions equips claims-processing staff with tools to resolve problem claims promptly, thereby lowering costs.

10 CFR 1014.10 - Action on approved claims.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 10 Energy 4 2011-01-01 2011-01-01 false Action on approved claims. 1014.10 Section 1014.10 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT § 1014.10 Action on approved claims. (a) Payment of any approved claim shall not be made unless the claimant...

10 CFR 1014.10 - Action on approved claims.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 10 Energy 4 2012-01-01 2012-01-01 false Action on approved claims. 1014.10 Section 1014.10 Energy DEPARTMENT OF ENERGY (GENERAL PROVISIONS) ADMINISTRATIVE CLAIMS UNDER FEDERAL TORT CLAIMS ACT § 1014.10 Action on approved claims. (a) Payment of any approved claim shall not be made unless the claimant...

22 CFR 304.12 - Action on approved claim.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 22 Foreign Relations 2 2011-04-01 2009-04-01 true Action on approved claim. 304.12 Section 304.12 Foreign Relations PEACE CORPS CLAIMS AGAINST GOVERNMENT UNDER FEDERAL TORT CLAIMS ACT Procedures § 304.12 Action on approved claim. (a) Payment of a claim approved under this subpart is contingent on claimant's...

22 CFR 304.12 - Action on approved claim.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 22 Foreign Relations 2 2014-04-01 2014-04-01 false Action on approved claim. 304.12 Section 304.12 Foreign Relations PEACE CORPS CLAIMS AGAINST GOVERNMENT UNDER FEDERAL TORT CLAIMS ACT Procedures § 304.12 Action on approved claim. (a) Payment of a claim approved under this subpart is contingent on claimant's...

32 CFR 750.13 - Claims: Single service responsibility.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 5 2010-07-01 2010-07-01 false Claims: Single service responsibility. 750.13 Section 750.13 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY CLAIMS GENERAL CLAIMS REGULATIONS General Provisions for Claims § 750.13 Claims: Single service responsibility. (a) The Department of Defense has assigned...

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.

32 CFR 536.119 - Scope for maritime claims.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 3 2011-07-01 2009-07-01 true Scope for maritime claims. 536.119 Section 536... CLAIMS AGAINST THE UNITED STATES Maritime Claims § 536.119 Scope for maritime claims. The AMCSA applies worldwide and includes claims that arise on high seas or within the territorial waters of a foreign country...

46 CFR 327.4 - Claim requirements.

Code of Federal Regulations, 2010 CFR

2010-10-01

... statements made in the claim are subject to the provision of 18 U.S.C. 287 and 1001 and all other penalty... physicians and hospitals related to a seaman's claim for injury, illness, or death shall be attached. If the... years. (5) If the claim does not involve a seaman's death, the following information shall be submitted...

Neonatal hypoglycaemia: learning from claims.

PubMed

Hawdon, Jane M; Beer, Jeanette; Sharp, Deborah; Upton, Michele

2017-03-01

Neonatal hypoglycaemia is a potential cause of neonatal morbidity, and on rare but tragic occasions causes long-term neurodevelopmental harm with consequent emotional and practical costs for the family. The organisational cost to the NHS includes the cost of successful litigation claims. The purpose of the review was to identify themes that could alert clinicians to common pitfalls and thus improve patient safety. The NHS Litigation Authority (NHS LA) Claims Management System was reviewed to identify and review 30 claims for injury secondary to neonatal hypoglycaemia, which were notified to the NHS LA between 2002 and 2011. NHS LA. Anonymised documentation relating to 30 neonates for whom claims were made relating to neonatal hypoglycaemia. Dates of birth were between 1995 and 2010. Review of documentation held on the NHS LA database. Identifiable risk factors for hypoglycaemia, presenting clinical signs, possible deficits in care, financial costs of litigation. All claims related to babies of at least 36 weeks' gestation. The most common risk factor for hypoglycaemia was low birth weight or borderline low birth weight, and the most common reported presenting sign was abnormal feeding behaviour. A number of likely deficits in care were reported, all of which were avoidable. In this 10-year reporting period, there were 25 claims for which damages were paid, with a total financial cost of claims to the NHS of £162 166 677. Acknowledging that these are likely to be the most rare but most seriously affected cases, the clinical themes arising from these cases should be used for further development of training and guidance to reduce harm and redivert NHS funds from litigation to direct care. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Neonatal hypoglycaemia: learning from claims

PubMed Central

Hawdon, Jane M; Beer, Jeanette; Sharp, Deborah; Upton, Michele

2017-01-01

Objectives Neonatal hypoglycaemia is a potential cause of neonatal morbidity, and on rare but tragic occasions causes long-term neurodevelopmental harm with consequent emotional and practical costs for the family. The organisational cost to the NHS includes the cost of successful litigation claims. The purpose of the review was to identify themes that could alert clinicians to common pitfalls and thus improve patient safety. Design The NHS Litigation Authority (NHS LA) Claims Management System was reviewed to identify and review 30 claims for injury secondary to neonatal hypoglycaemia, which were notified to the NHS LA between 2002 and 2011. Setting NHS LA. Patients Anonymised documentation relating to 30 neonates for whom claims were made relating to neonatal hypoglycaemia. Dates of birth were between 1995 and 2010. Interventions Review of documentation held on the NHS LA database. Main outcome measures Identifiable risk factors for hypoglycaemia, presenting clinical signs, possible deficits in care, financial costs of litigation. Results All claims related to babies of at least 36 weeks’ gestation. The most common risk factor for hypoglycaemia was low birth weight or borderline low birth weight, and the most common reported presenting sign was abnormal feeding behaviour. A number of likely deficits in care were reported, all of which were avoidable. In this 10-year reporting period, there were 25 claims for which damages were paid, with a total financial cost of claims to the NHS of £162 166 677. Conclusions Acknowledging that these are likely to be the most rare but most seriously affected cases, the clinical themes arising from these cases should be used for further development of training and guidance to reduce harm and redivert NHS funds from litigation to direct care. PMID:27553590

32 CFR 536.18 - Cross-servicing of claims.

Code of Federal Regulations, 2010 CFR

2010-07-01

... AGAINST THE UNITED STATES The Army Claims System § 536.18 Cross-servicing of claims. (a) Where claims..., E1.2 (posted on the USARCS Web site; for the address see § 536.2(a)). Tables listing claims offices worldwide are posted to the USARCS Web site at that address. U.S. Air Force claims offices may be identified...

Characteristics of claims in the management of septic arthritis in Japan: Retrospective analyses of judicial precedents and closed claims.

PubMed

Otaki, Yasuhiro; DaSilva, Makiko Ishida; Saito, Yuichi; Oyama, Yasuaki; Oiso, Giichiro; Yoshida, Tomohiko; Fukuhara, Masakazu; Moriyama, Mitsuru

2018-03-01

Septic arthritis (SA) cases can result in claims or litigation because of poor prognosis even if it is unavoidable. Although these claims or litigation are useful for understanding causes and background factors of medical errors, the characteristics of malpractice claims associated with SA remain undetermined in Japan. This study aimed to increase our understanding of malpractice claims in the clinical management of SA. We analyzed 6 civil precedents and 16 closed claims of SA from 8530 malpractice claims processed between July 2004 and June 2014 by the Tokyo office of Sompo Japan Nipponkoa Insurance, Incorporated. We also studied 5 accident and 21 incident reports of SA based on project data compiled by the Japan Council for Quality Health Care. The rate of negligence was 83.3% in the precedents and 75.0% in closed claims. Two main malpractice claim patterns were revealed: SA in a lower extremity joint following sepsis caused by methicillin-resistant Staphylococcus aureus in newborns and SA in an injection site following joint injection. These two patterns accounted for 83.3% and 56.3% of judicial cases and closed claim cases, respectively. Breakdowns in care process of accident and incident reports were clearly differentiated from judicial cases or closed claim cases (Fisher's exact test, p < 0.001). It is important to pay particular attention to SA following sepsis in newborns and to monitor for any signs of SA after joint injection to ensure early diagnosis. Analysis of both malpractice claims and accident and incident reports is essential to ensure a full understanding of the situation in Japan. Copyright © 2017. Published by Elsevier Taiwan LLC.

Economic Impact of Above-Label Dosing with Etanercept, Adalimumab, or Ustekinumab in Patients with Psoriasis.

PubMed

Feldman, Steven R; Zhao, Yang; Zhou, Huanxue; Herrera, Vivian; Tian, Haijun; Li, Yunfeng

2017-05-01

Patients with moderate-to-severe psoriasis may be treated with above-label doses of biologics in an attempt to optimize outcomes. Dose escalation will have an effect on the cost of treatment. To examine costs related to above-label use of etanercept, adalimumab, and ustekinumab among patients with moderate-to-severe psoriasis. A retrospective study was performed using a large U.S. claims database. Patients were included in the study if they were aged ≥ 18 years with a diagnosis of psoriasis (excluding psoriatic arthritis) and had at least 1 medication fill for etanercept, adalimumab, or ustekinumab between January 1, 2011, and June 30, 2012. In addition, patients were required to have continuous enrollment for 12 months before, and 18 months after, the first biologic use (index biologic) during the maintenance period (defined as the period following the induction period in which each agent was titrated to its recommended maintenance dose per label) and at least 1 prescription filled for the index biologic during the 18 months after the maintenance period. Extensive above-label use was defined as taking an above-label dose (at least 10% higher than indicated in the label) for ≥ 180 days over a 12-month period following the maintenance period. Percentages of patients with extensive above-label use, mean number of days of above-label use, and additional costs associated with extensive above-label use (abovelabel cost minus on-label cost) were examined. The study included 3,310 patients who started treatment with etanercept (n = 1,443), adalimumab (n = 1,447), or ustekinumab (n = 420). Extensive above-label use occurred in 20.0% of etanercept patients, 2.6% of adalimumab patients, and 14.8% of ustekinumab patients. The mean duration of extensive above-label use was roughly similar for the 3 biologics (mean days [±SD]: 282 [±55] for etanercept, 279 [±57] for adalimumab, and 305 [±43] for ustekinumab). Additional annual costs per patient because of extensive

Rates and Characteristics of Paid Malpractice Claims Among US Physicians by Specialty, 1992-2014

PubMed Central

Schaffer, Adam C.; Jena, Anupam B.; Seabury, Seth A.; Singh, Harnam; Chalasani, Venkat

2017-01-01

.6%) exceeded $1 million (4304 of 69 617 [6.2%] in 1992-1996 and 4322 of 54 081 [8.0%] in 2009-2014), and 32.1% (35 293 of 109 865) involved a patient death. Diagnostic error was the most common type of allegation, present in 31.8% (35 349 of 111 066) of paid claims, ranging from 3.5% in anesthesiology (153 of 4317) to 87.0% in pathology (915 of 1052). Conclusions and Relevance Between 1992 and 2014, the rate of malpractice claims paid on behalf of physicians in the United States declined substantially. Mean compensation amounts and the percentage of paid claims exceeding $1 million increased, with wide differences in rates and characteristics across specialties. A better understanding of the causes of variation among specialties in paid malpractice claims may help reduce both patient injury and physicians’ risk of liability. PMID:28346582

Analysis of NHSLA claims in orthopedic surgery.

PubMed

Khan, Irfan H; Jamil, Wiqqas; Lynn, Sam Mathew; Khan, Osman H; Markland, Kate; Giddins, Grey

2012-05-01

National Health Service (NHS) statistics in the United Kingdom demonstrate an increase in clinical negligence claims over the past 30 years. Reasons for this include elements of a cultural shift in attitudes toward the medical profession and the growth of the legal services industry. This issue affects medical and surgical health providers worldwide.The authors analyzed 2117 NHS Litigation Authority (NHSLA) orthopedic surgery claims between 1995 and 2001 with respect to these clinical areas: emergency department, outpatient care, surgery (elective or trauma operations), and inpatient care. The authors focused on the costs of settling and defending claims, costs attributable to clinical areas, common causes of claims, and claims relating to elective or trauma surgery. Numbers of claims and legal costs increased most notably in surgery (elective and trauma) and in the emergency department. However, claims are being defended more robustly. The annual cost for a successful defense has remained relatively stable, showing a slight decline. The common causes of claims are postoperative complication; wrong, delayed, or failure of diagnosis; inadequate consent; and wrong-site surgery. Certain surgical specialties (eg, spine and lower-limb surgery) have the most claims made during elective surgery, whereas upper-limb surgery has the most claims made during trauma surgery.The authors recommend that individual trusts liaise with orthopedic surgeons to devise strategies to address areas highlighted in our study. Despite differences in health care systems worldwide, the underlying issues are common. With improved understanding, physicians can deliver the service they promise their patients. Copyright 2012, SLACK Incorporated.

Simulating the Impact of Sugar-Sweetened Beverage Warning Labels in Three Cities.

PubMed

Lee, Bruce Y; Ferguson, Marie C; Hertenstein, Daniel L; Adam, Atif; Zenkov, Eli; Wang, Peggy I; Wong, Michelle S; Gittelsohn, Joel; Mui, Yeeli; Brown, Shawn T

2018-02-01

A number of locations have been considering sugar-sweetened beverage point-of-purchase warning label policies to help address rising adolescent overweight and obesity prevalence. To explore the impact of such policies, in 2016 detailed agent-based models of Baltimore, Philadelphia, and San Francisco were developed, representing their populations, school locations, and food sources, using data from various sources collected between 2005 and 2014. The model simulated, over a 7-year period, the mean change in BMI and obesity prevalence in each of the cities from sugar-sweetened beverage warning label policies. Data analysis conducted between 2016 and 2017 found that implementing sugar-sweetened beverage warning labels at all sugar-sweetened beverage retailers lowered obesity prevalence among adolescents in all three cities. Point-of-purchase labels with 8% efficacy (i.e., labels reducing probability of sugar-sweetened beverage consumption by 8%) resulted in the following percentage changes in obesity prevalence: Baltimore: -1.69% (95% CI= -2.75%, -0.97%, p<0.001); San Francisco: -4.08% (95% CI= -5.96%, -2.2%, p<0.001); Philadelphia: -2.17% (95% CI= -3.07%, -1.42%, p<0.001). Agent-based simulations showed how warning labels may decrease overweight and obesity prevalence in a variety of circumstances with label efficacy and literacy rate identified as potential drivers. Implementing a warning label policy may lead to a reduction in obesity prevalence. Focusing on warning label design and store compliance, especially at supermarkets, may further increase the health impact. Copyright © 2018 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Self-report of diabetes and claims-based identification of diabetes among Medicare beneficiaries.

PubMed

Day, Hannah R; Parker, Jennifer D

2013-11-01

This report compares self-reported diabetes in the National Health Interview Survey (NHIS) with diabetes identified using the Medicare Chronic Condition (CC) Summary file. NHIS records have been linked with Medicare data from the Centers for Medicare & Medicaid Services. The CC Summary file, one of several linked files derived from Medicare claims data, contains indicators for chronic conditions based on an established algorithm. This analysis was limited to 2005 NHIS participants aged 65 and over whose records were linked to 2005 Medicare data. Linked NHIS participants had at least 1 month of fee-for-service Medicare coverage in 2005. Concordance between self-reported diabetes and the CC Summary indicator for diabetes is compared and described by demographics, socioeconomic status, health status indicators, and geographic characteristics. Of the Medicare beneficiaries in the 2005 NHIS, 20.0% self-reported diabetes and 27.8% had an indicator for diabetes in the CC Summary file. Of those who self-reported diabetes in NHIS, the percentage with a CC Summary indicator for diabetes was high (93.1%). Of those with a CC Summary indicator for diabetes, the percentage self-reporting diabetes was comparatively lower (67.0%). Statistically significant differences by subgroup existed in the percentage concordance between the two sources. Of those with self-reported diabetes, the percentage with a CC Summary indicator differed by sex and age. Of those with a CC Summary indicator for diabetes, the percentage with self-reported diabetes differed by age, self-rated health, number of self-reported conditions, and geographic location. Among Medicare beneficiaries who self-reported diabetes in NHIS, a high concordance was observed with identification of diabetes in the CC Summary file. However, among Medicare beneficiaries with an indicator for diabetes in the CC Summary file, concordance with self-reported diabetes in NHIS is comparatively lower. Differences exist by subgroup.

76 FR 36176 - Fully Developed Claim (Fully Developed Claims-Applications for Compensation, Pension, DIC, Death...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-06-21

... DEPARTMENT OF VETERANS AFFAIRS [OMB Control No. 2900-0747] Fully Developed Claim (Fully Developed Claims--Applications for Compensation, Pension, DIC, Death Pension, and/or Accrued Benefits); Correction AGENCY: Veterans Benefits Administration, Department of Veterans Affairs. ACTION: Notice; correction...

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.

Functional foods: health claim-food product compatibility and the impact of health claim framing on consumer evaluation.

PubMed

van Kleef, Ellen; van Trijp, Hans C M; Luning, Pieternel

2005-06-01

Two studies are reported, which aim to strengthen the scientific underpinning of strategic decisions regarding functional food development, as to (1) which health benefits to claim, (2) with which product (category), and (3) in which communication format. The first exploratory study is a secondary analysis of 10 different health claims systematically combined with 10 different food carriers to evaluate their combined suitability for functional food positioning. The results show that consumers tend to prefer functional food concepts that primarily communicate disease-related health benefits in carriers with a healthy image or health positioning history. Study 2 examines health claim format and systematically varies the way in which specific health benefits are being communicated to the consumer. Two physiologically oriented claims (heart disease and osteoporosis) and two psychologically oriented food claims (stress and lack of energy) are expressed in enhanced function format versus disease risk reduction format. Also, it includes the individual difference variable of 'regulatory focus' and the health status of the respondent to explore how these factors impact health claim evaluation. The results show that consumer evaluations primarily differ to the extent that health claims are personally relevant in addressing an experienced disease state. Framing is important, but its effect differs by health benefit. No strong effects for consumers' regulatory focus were found. Underlying mechanisms of these effects and their implications for the development of functional foods are discussed.

Nature of Medical Malpractice Claims Against Radiation Oncologists.

PubMed

Marshall, Deborah; Tringale, Kathryn; Connor, Michael; Punglia, Rinaa; Recht, Abram; Hattangadi-Gluth, Jona

2017-05-01

To examine characteristics of medical malpractice claims involving radiation oncologists closed during a 10-year period. Malpractice claims filed against radiation oncologists from 2003 to 2012 collected by a nationwide liability insurance trade association were analyzed. Outcomes included the nature of claims and indemnity payments, including associated presenting diagnoses, procedures, alleged medical errors, and injury severity. We compared the likelihood of a claim resulting in payment in relation to injury severity categories (death as referent) using binomial logistic regression. There were 362 closed claims involving radiation oncology, 102 (28%) of which were paid, resulting in $38 million in indemnity payments. The most common alleged errors included "improper performance" (38% of closed claims, 18% were paid; 29% [$11 million] of total indemnity), "errors in diagnosis" (25% of closed claims, 46% were paid; 44% [$17 million] of total indemnity), and "no medical misadventure" (14% of closed claims, 8% were paid; less than 1% [$148,000] of total indemnity). Another physician was named in 32% of claims, and consent issues/breach of contract were cited in 18%. Claims for injury resulting in death represented 39% of closed claims and 25% of total indemnity. "Improper performance" was the primary alleged error associated with injury resulting in death. Compared with claims involving death, major temporary injury (odds ratio [OR] 2.8, 95% confidence interval [CI] 1.29-5.85, P=.009), significant permanent injury (OR 3.1, 95% CI 1.48-6.46, P=.003), and major permanent injury (OR 5.5, 95% CI 1.89-16.15, P=.002) had a higher likelihood of a claim resulting in indemnity payment. Improper performance was the most common alleged malpractice error. Claims involving significant or major injury were more likely to be paid than those involving death. Insights into the nature of liability claims against radiation oncologists may help direct efforts to improve quality of care

Nature of Medical Malpractice Claims Against Radiation Oncologists

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

Marshall, Deborah; Tringale, Kathryn; Connor, Michael

Purpose: To examine characteristics of medical malpractice claims involving radiation oncologists closed during a 10-year period. Methods and Materials: Malpractice claims filed against radiation oncologists from 2003 to 2012 collected by a nationwide liability insurance trade association were analyzed. Outcomes included the nature of claims and indemnity payments, including associated presenting diagnoses, procedures, alleged medical errors, and injury severity. We compared the likelihood of a claim resulting in payment in relation to injury severity categories (death as referent) using binomial logistic regression. Results: There were 362 closed claims involving radiation oncology, 102 (28%) of which were paid, resulting in $38more » million in indemnity payments. The most common alleged errors included “improper performance” (38% of closed claims, 18% were paid; 29% [$11 million] of total indemnity), “errors in diagnosis” (25% of closed claims, 46% were paid; 44% [$17 million] of total indemnity), and “no medical misadventure” (14% of closed claims, 8% were paid; less than 1% [$148,000] of total indemnity). Another physician was named in 32% of claims, and consent issues/breach of contract were cited in 18%. Claims for injury resulting in death represented 39% of closed claims and 25% of total indemnity. “Improper performance” was the primary alleged error associated with injury resulting in death. Compared with claims involving death, major temporary injury (odds ratio [OR] 2.8, 95% confidence interval [CI] 1.29-5.85, P=.009), significant permanent injury (OR 3.1, 95% CI 1.48-6.46, P=.003), and major permanent injury (OR 5.5, 95% CI 1.89-16.15, P=.002) had a higher likelihood of a claim resulting in indemnity payment. Conclusions: Improper performance was the most common alleged malpractice error. Claims involving significant or major injury were more likely to be paid than those involving death. Insights into the nature of liability claims

20 CFR 10.737 - How is a LEO claim filed, and who can file a LEO claim?

Code of Federal Regulations, 2012 CFR

2012-04-01

... Form CA-721; a death claim should be filed on Form CA-722. All claims should be submitted to the... 20 Employees' Benefits 1 2012-04-01 2012-04-01 false How is a LEO claim filed, and who can file a...' COMPENSATION ACT, AS AMENDED Special Provisions Non-Federal Law Enforcement Officers § 10.737 How is a LEO...

20 CFR 10.737 - How is a LEO claim filed, and who can file a LEO claim?

Code of Federal Regulations, 2010 CFR

2010-04-01

... Form CA-721; a death claim should be filed on Form CA-722. All claims should be submitted to the... 20 Employees' Benefits 1 2010-04-01 2010-04-01 false How is a LEO claim filed, and who can file a...' COMPENSATION ACT, AS AMENDED Special Provisions Non-Federal Law Enforcement Officers § 10.737 How is a LEO...

20 CFR 10.737 - How is a LEO claim filed, and who can file a LEO claim?

Code of Federal Regulations, 2011 CFR

2011-04-01

... Form CA-721; a death claim should be filed on Form CA-722. All claims should be submitted to the... 20 Employees' Benefits 1 2011-04-01 2011-04-01 false How is a LEO claim filed, and who can file a...' COMPENSATION ACT, AS AMENDED Special Provisions Non-Federal Law Enforcement Officers § 10.737 How is a LEO...

20 CFR 10.737 - How is a LEO claim filed, and who can file a LEO claim?

Code of Federal Regulations, 2014 CFR

2014-04-01

... Form CA-721; a death claim should be filed on Form CA-722. All claims should be submitted to the... 20 Employees' Benefits 1 2014-04-01 2012-04-01 true How is a LEO claim filed, and who can file a...' COMPENSATION ACT, AS AMENDED Special Provisions Non-Federal Law Enforcement Officers § 10.737 How is a LEO...