Sample records for labeling package insert

  1. 21 CFR 516.165 - Records and reports.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... within 60 days thereafter. The report must contain data and information for the full reporting period..., include a summary of those changes and the holder's and distributor's current package labeling, including any package inserts. For large-size package labeling or large shipping cartons, submit a...

  2. 21 CFR 516.165 - Records and reports.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... within 60 days thereafter. The report must contain data and information for the full reporting period..., include a summary of those changes and the holder's and distributor's current package labeling, including any package inserts. For large-size package labeling or large shipping cartons, submit a...

  3. Reading about over-the-counter medications.

    PubMed

    Nabors, Laura A; Lehmkuhl, Heather D; Parkins, Irina S; Drury, Anna M

    2004-01-01

    Many adolescents and young adults purchase and use over-the-counter (OTC) medications, and some may take these medications without reading about how to use them. Most do read package inserts and labels to learn about the medication, but studies examining what influences label reading for youth are needed. This study assessed factors related to label reading for young people, including demographic variables (gender, health status) and the types of information they were seeking about the medication. Eight hundred and seventy-six high school and college students participated, and most reported reading labels or package inserts to learn about medications. Participants experiencing pain were more likely to read labels, except for those experiencing headaches who reported being less likely to read labels. When reading labels, participants were interested in information about side effects, ingredients, dosage instructions, and symptoms treated by the medication. Future research should examine whether youth take medications as directed and what factors make labels and inserts easier to read and understand.

  4. Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts.

    PubMed

    Gillet, Philippe; Maltha, Jessica; Hermans, Veerle; Ravinetto, Raffaella; Bruggeman, Cathrien; Jacobs, Jan

    2011-02-13

    The present study assessed malaria RDT kits for adequate and correct packaging, design and labelling of boxes and components. Information inserts were studied for readability and accuracy of information. Criteria for packaging, design, labelling and information were compiled from Directive 98/79 of the European Community (EC), relevant World Health Organization (WHO) documents and studies on end-users' performance of RDTs. Typography and readability level (Flesch-Kincaid grade level) were assessed. Forty-two RDT kits from 22 manufacturers were assessed, 35 of which had evidence of good manufacturing practice according to available information (i.e. CE-label affixed or inclusion in the WHO list of ISO13485:2003 certified manufacturers). Shortcomings in devices were (i) insufficient place for writing sample identification (n=40) and (ii) ambiguous labelling of the reading window (n=6). Buffer vial labels were lacking essential information (n=24) or were of poor quality (n=16). Information inserts had elevated readability levels (median Flesch Kincaid grade 8.9, range 7.1-12.9) and user-unfriendly typography (median font size 8, range 5-10). Inadequacies included (i) no referral to biosafety (n=18), (ii) critical differences between depicted and real devices (n=8), (iii) figures with unrealistic colours (n=4), (iv) incomplete information about RDT line interpretations (n=31) and no data on test characteristics (n=8). Other problems included (i) kit names that referred to Plasmodium vivax although targeting a pan-species Plasmodium antigen (n=4), (ii) not stating the identity of the pan-species antigen (n=2) and (iii) slight but numerous differences in names displayed on boxes, device packages and information inserts. Three CE labelled RDT kits produced outside the EC had no authorized representative affixed and the shape and relative dimensions of the CE symbol affixed did not comply with the Directive 98/79/EC. Overall, RDTs with evidence of GMP scored better compared to those without but inadequacies were observed in both groups. Overall, malaria RDTs showed shortcomings in quality of construction, design and labelling of boxes, device packages, devices and buffers. Information inserts were difficult to read and lacked relevant information.

  5. Deficiencies of product labeling directions for the preparation of radiopharmaceuticals.

    PubMed

    Hung, Joseph C; Ponto, James A; Gadient, Katie R; Frie, Julia A; Aksamit, Carolyn M; Enquist, Cassandra L; Carrels, Katie E

    2004-01-01

    To identify potential deficiencies in product labeling (package insert) instructions for the preparation of radiopharmaceuticals. Preparation instructions, which include both reconstitution and quality control (QC) directions, as stated in the package inserts were evaluated for all commercially available reconstituted radiopharmaceuticals. Reviews of the package inserts were initially performed by each author, and then all identified deficiencies were compiled and evaluated by all authors. The preparation scenario for each package insert evaluated was based on a centralized nuclear pharmacy operation assuming typical support personnel, standard operating equipment, and workload. The instructions as stated in each package insert for the preparation (including QC) were rated as inadequate if a satisfactory preparation could not be prepared by a nuclear pharmacist or physician when instructions were followed exactly. Identified deficiencies in package insert instructions for the preparation of radiopharmaceuticals fell into the following five categories: (1) absent or incomplete directions (especially with regard to QC procedures); (2) restrictive directions (e.g., specific requirement to use designated needles, chromatography solvents, counting devices), (3) inconsistent directions (e.g., different reconstituted volumes for the same final drug product, unworkable expiration times); (4) impractical directions (e.g., unrealistically low reconstituted activity limits, dangerously high number of radiolabeled particles); and (5) vague directions (e.g., use of the words "should," "may," "recommend"). Manufacturers' directions for the preparation of radiopharmaceuticals often contain deficiencies and should be viewed as standard guidance rather than as requirements. Just as physicians are permitted to use U.S. Food and Drug Administration (FDA)-approved drugs for off-label indications, nuclear pharmacists should be allowed to use alternative methods for preparing radiopharmaceuticals, provided those methods have been validated to be as good as the stated directions and that the nuclear pharmacists do not engage in activities that fall outside the normal practice of pharmacy. Manufacturers, FDA, nuclear pharmacists, and nuclear physicians should work together to address identified deficiencies in package insert directions.

  6. Malaria rapid diagnostic kits: quality of packaging, design and labelling of boxes and components and readability and accuracy of information inserts

    PubMed Central

    2011-01-01

    Background The present study assessed malaria RDT kits for adequate and correct packaging, design and labelling of boxes and components. Information inserts were studied for readability and accuracy of information. Methods Criteria for packaging, design, labelling and information were compiled from Directive 98/79 of the European Community (EC), relevant World Health Organization (WHO) documents and studies on end-users' performance of RDTs. Typography and readability level (Flesch-Kincaid grade level) were assessed. Results Forty-two RDT kits from 22 manufacturers were assessed, 35 of which had evidence of good manufacturing practice according to available information (i.e. CE-label affixed or inclusion in the WHO list of ISO13485:2003 certified manufacturers). Shortcomings in devices were (i) insufficient place for writing sample identification (n = 40) and (ii) ambiguous labelling of the reading window (n = 6). Buffer vial labels were lacking essential information (n = 24) or were of poor quality (n = 16). Information inserts had elevated readability levels (median Flesch Kincaid grade 8.9, range 7.1 - 12.9) and user-unfriendly typography (median font size 8, range 5 - 10). Inadequacies included (i) no referral to biosafety (n = 18), (ii) critical differences between depicted and real devices (n = 8), (iii) figures with unrealistic colours (n = 4), (iv) incomplete information about RDT line interpretations (n = 31) and no data on test characteristics (n = 8). Other problems included (i) kit names that referred to Plasmodium vivax although targeting a pan-species Plasmodium antigen (n = 4), (ii) not stating the identity of the pan-species antigen (n = 2) and (iii) slight but numerous differences in names displayed on boxes, device packages and information inserts. Three CE labelled RDT kits produced outside the EC had no authorized representative affixed and the shape and relative dimensions of the CE symbol affixed did not comply with the Directive 98/79/EC. Overall, RDTs with evidence of GMP scored better compared to those without but inadequacies were observed in both groups. Conclusion Overall, malaria RDTs showed shortcomings in quality of construction, design and labelling of boxes, device packages, devices and buffers. Information inserts were difficult to read and lacked relevant information. PMID:21314992

  7. The Use of Cigarette Package Inserts to Supplement Pictorial Health Warnings: An Evaluation of the Canadian Policy.

    PubMed

    Thrasher, James F; Osman, Amira; Abad-Vivero, Erika N; Hammond, David; Bansal-Travers, Maansi; Cummings, K Michael; Hardin, James W; Moodie, Crawford

    2015-07-01

    Canada is the first country in the world to require cigarette manufacturers to enclose package inserts to supplement the exterior pictorial health warning label (HWL). In June 2012, Canada implemented new HWL package inserts that include cessation tips accompanied by a pictorial image. This study aims to assess the extent to which adult smokers report reading the newly mandated HWL inserts and to see whether reading them is associated with making a quit attempt. Data were analyzed from an online consumer panel of Canadian adult smokers, aged 18-64 years. Five waves of data were collected between September 2012 and January 2014, separated by 4-months intervals (n = 1,000 at each wave). Logistic generalized estimating equation (GEE) models were estimated to assess correlates of reading inserts and whether doing so is associated with making a quit attempt by the subsequent wave. At each wave, between 26% and 31% of the sample reported having read HWL package inserts at least once in the prior month. Smokers who read them were more likely to be younger, female, have higher income, intend to quit, have recently tried to quit, and thought more frequently about health risks because of warning labels. In models that adjusted for these and other potential confounders, smokers who read the inserts a few times or more in the past month were more likely to make a quit attempt at the subsequent wave compared to smokers who did not read the inserts. HWL package inserts with cessation-related tips and messages appear to increase quit attempts made by smokers. © The Author 2014. Published by Oxford University Press on behalf of the Society for Research on Nicotine and Tobacco. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  8. 9 CFR 381.123 - Official inspection mark; official establishment number.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... label of a canned product, or on other packaging or labeling in the container, e.g., on aluminum pans... insert label placed under a transparent covering if clearly visible and legible and accompanied by the...

  9. 9 CFR 381.123 - Official inspection mark; official establishment number.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... label of a canned product, or on other packaging or labeling in the container, e.g., on aluminum pans... insert label placed under a transparent covering if clearly visible and legible and accompanied by the...

  10. A Tale of Two Citizens: A State Attorney General and a Hematologist Facilitate Translation of Research Into US Food and Drug Administration Actions—A SONAR Report

    PubMed Central

    Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P.; McKoy, June M.; Lopez, Isaac S.; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R.; Ray, Paul; Sartor, Oliver; Bennett, Charles L.

    2012-01-01

    Purpose: Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Methods: Case study. Results: The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. Conclusion: New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon. PMID:23598851

  11. A tale of two citizens: a State Attorney General and a hematologist facilitate translation of research into US Food and Drug Administration actions--a SONAR report.

    PubMed

    Chen, Brian; Restaino, John; Norris, LeAnn; Xirasagar, Sudha; Qureshi, Zaina P; McKoy, June M; Lopez, Isaac S; Trenery, Alyssa; Murday, Alanna; Kahn, Adam; Mattison, Donald R; Ray, Paul; Sartor, Oliver; Bennett, Charles L

    2012-11-01

    Pharmaceutical safety is a public health issue. In 2005, the Connecticut Attorney General (AG) raised concerns over adverse drug reactions in off-label settings, noting that thalidomide was approved to treat a rare illness, but more than 90% of its use was off label. A hematologist had reported thalidomide with doxorubicin or dexamethasone was associated with venous thromboembolism (VTE) rates of 25%. We review US Food and Drug Administration (FDA) and manufacturer responses to a citizen petition filed to address these thalidomide safety issues. Case study. The AG petitioned the FDA requesting thalidomide-related safety actions. Coincidentally, the manufacturer submitted a supplemental New Drug Approval (sNDA), requesting approval to treat multiple myeloma with thalidomide-dexamethasone. FDA safety officers reviewed the petition and the literature and noted that VTE risks with thalidomide were not appropriately addressed in the existing package insert. In the sNDA application, the manufacturer reported thalidomide-associated toxicities for multiple myeloma were primarily somnolence and neurotoxicity, and a proposed package insert did not focus on VTE risks. In October, the FDA informed the Oncology Drug Division that VTE risks with thalidomide were poorly addressed in the existing label. After reviewing this memorandum, an Oncology Drug Division reviewer informed the manufacturer that approval of the sNDA would be delayed until several thalidomide-associated VTE safety actions, including revisions of the package insert, were implemented. The manufacturer and FDA agreed on these actions, and the sNDA was approved. New approaches addressing off-label safety are needed. The conditions that facilitated the successful response to this citizen petition are uncommon.

  12. Mass Spec Studio for Integrative Structural Biology

    PubMed Central

    Rey, Martial; Sarpe, Vladimir; Burns, Kyle; Buse, Joshua; Baker, Charles A.H.; van Dijk, Marc; Wordeman, Linda; Bonvin, Alexandre M.J.J.; Schriemer, David C.

    2015-01-01

    SUMMARY The integration of biophysical data from multiple sources is critical for developing accurate structural models of large multiprotein systems and their regulators. Mass spectrometry (MS) can be used to measure the insertion location for a wide range of topographically sensitive chemical probes, and such insertion data provide a rich, but disparate set of modeling restraints. We have developed a software platform that integrates the analysis of label-based MS data with protein modeling activities (Mass Spec Studio). Analysis packages can mine any labeling data from any mass spectrometer in a proteomics-grade manner, and link labeling methods with data-directed protein interaction modeling using HADDOCK. Support is provided for hydrogen/ deuterium exchange (HX) and covalent labeling chemistries, including novel acquisition strategies such as targeted HX-tandem MS (MS2) and data-independent HX-MS2. The latter permits the modeling of highly complex systems, which we demonstrate by the analysis of microtubule interactions. PMID:25242457

  13. Development of Multifunctional Active Film and Its Application in Modified Atmosphere Packaging of Shiitake Mushrooms.

    PubMed

    Wang, Hong Jiang; An, Duck Soon; Lee, Dong Sun

    2016-09-01

    Agar-based films with multiple functions (CO 2 absorption, water vapor absorption, and antimicrobial activity) were developed, tested for their properties, and then applied to the packaging of fresh shiitake mushrooms as an insert label. The films were cast from an agar-based aqueous solution containing a dissolving plasticizer (glycerol), a CO 2 absorbent (sodium carbonate [SC] alone or a combination of SC and sodium glycinate [SC-SG]), and a volatile antimicrobial agent (carvacrol [CRV]). The agar of the film matrix is designed to serve as a water vapor absorbent. The multifunctional films tended to have poor mechanical properties, with a hard texture and an opaque and yellowish color. The CO 2 absorbent, either SC alone or SC-SG, affected CRV retention and release along with the CO 2 and water vapor absorption behavior. Both films (SC-CRV and SC-SG-CRV films) showed good inhibitory effects against Pseudomonas fluorescens and Saccharomyces cerevisiae . SC-CRV film had a higher and faster CO 2 absorption property, higher retention and extended release of CRV, and lower and slower water vapor absorption and was assessed to be better suited for use in shiitake mushroom packaging. The packaging in which the SC-CRV film with an appropriate amount of CRV was used as an insert label was able to generate the desired atmosphere and less moisture condensation inside the package, producing the best preservation of quality in terms of mushroom color, firmness, flavor score, and microbial counts after 6 days of storage at 10°C. A tailored modified atmosphere packaging system using multifunctional film would be useful in the preservation of CO 2 -sensitive fresh commodities.

  14. 21 CFR 310.515 - Patient package inserts for estrogens.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Patient package inserts for estrogens. 310.515... package inserts for estrogens. (a) Requirement for a patient package insert. FDA concludes that the safe... patient package insert containing information concerning the drug's benefits and risks. An estrogen drug...

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

    PubMed

    Weiss, Stephanie M; Smith-Simone, Stephanie Y

    2010-03-01

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

  16. Drugs dispensed at the Division of Neonatology at University Hospital in Río Cuarto, Córdoba, Argentina.

    PubMed

    Fungo, Marta Stella Maris; Vega, Elena María

    2013-04-01

    The objective was to analyze the number of drugs dispensed by the Pharmacy Department to the Neonatology Division, to find out if the use of these drugs is described on the package insert approved by the Administración Nacional de Medicamentos, Alimentos y Tecnología, ANMAT (Drug, Food and Technology Administration of Argentina) and to compare such information with that provided by Medical Associations and Commissions. Analytical, observational and retrospective study in which drugs were analyzed based on dosage units, costs and relevance in the 2011 annual budget. We analyzed the information found in ANMAT-approved label inserts, in the Neonatal Pharmacopeia of the Sociedad Argentina de Pediatría and in the Formularies of the Confederación Médica Argentina and the Comisión Nacional del Medicamento (National Medication Commission). A total of 102 drugs (91 drug substances) were dispensed throughout 2011. Drugs most commonly supplied were: antiinfective agents for systemic use (24.51%), agents for the blood and blood forming organs, cardiovascular system, and nervous system (12.72% each). The total expenditure was ARS 263,285.52. Only 21 drugs accounted for 90.73% of the cost. Out of the 14 drugs in this group, only 1 had information related to its use in neonatology in all its labels (package inserts), only 4 in some of their product information and there was no information at all in any of the remaining 9 drugs. The Neonatal Pharmacopeia reported on 12 of the 14 drugs, while the Formularies made a reference to 9 of the 14 drugs. The most widely used drugs were antiinfectives for systemic use. A total of 21 drugs accounted for 90.73% of the annual cost in drugs. Out of 14, only 1 had information of its use in neonatology in all its labels and 9 corresponded to off-label use.

  17. [The development and operation of a package inserts service system for electronic medical records].

    PubMed

    Yamada, Hidetoshi; Nishimura, Sachiho; Shimamori, Yoshimitsu; Sato, Seiji; Hayase, Yukitoshi

    2003-03-01

    To promote the appropriate use of pharmaceuticals and to prevent side effects, physicians need package inserts on medicinal drugs as soon as possible. A medicinal drug information service system was established for electronic medical records to speed up and increase the efficiency of package insert communications within a medical institution. Development of this system facilitates access to package inserts by, for example, physicians. The time required to maintain files of package inserts was shortened, and the efficiency of the drug information service increased. As a source of package inserts for this system, package inserts using a standard generalized markup language (SGML) form were used, which are accessible to the public on the homepage of the Organization for Pharmaceutical Safety and Research (OPSR). This study found that a delay occurred in communicating revised package inserts from pharmaceutical companies to the OPSR. Therefore a pharmaceutical department page was set up as part of the homepage of the medical institution for electronic medical records to shorten the delay in the revision of package inserts posted on the medicinal drug information service homepage of the OPSR. The usefulness of this package insert service system for electronic medical records is clear. For more effective use of this system based on the OPSR homepage pharmaceutical companies have been requested to provide quicker updating of package inserts.

  18. Readability assessment of package inserts of biological medicinal products from the European medicines agency website.

    PubMed

    Piñero-López, Ma Ángeles; Modamio, Pilar; Lastra, Cecilia F; Mariño, Eduardo L

    2014-07-01

    Package inserts that accompany medicines are a common source of information aimed at patients and should match patient abilities in terms of readability. Our objective was to determine the degree of readability of the package inserts for biological medicinal products commercially available in 2007 and compare them with the readability of the same package inserts in 2010. A total of 33 package inserts were selected and classified into five groups according to the type of medicine: monoclonal antibody-based products, cytokines, therapeutic enzymes, recombinant blood factors and other blood-related products, and recombinant hormones. The package inserts were downloaded from the European Medicines Agency website in 2007 and 2010. Readability was evaluated for the entire text of five of the six sections of the package inserts and for the 'Annex' when there was one. Three readability formulas were used: SMOG (Simple Measure of Gobbledygook) grade, Flesh-Kincaid grade level, and Szigriszt's perspicuity index. No significant differences were found between the readability results for the 2007 package inserts and those from 2010 according to any of the three readability indices studied (p>0.05). However, there were significant differences (p<0.05) between the readability scores of the sections of the package inserts in both 2007 and 2010. The readability of the package inserts was above the recommended sixth grade reading level (ages 11-12) and may lead to difficulties of understanding for people with limited literacy. All the sections should be easy to read and, therefore, the readability of the medicine package inserts studied should be improved.

  19. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 5 2014-04-01 2014-04-01 false Patient package inserts for oral contraceptives... Patient package inserts for oral contraceptives. (a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the...

  20. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 5 2012-04-01 2012-04-01 false Patient package inserts for oral contraceptives... Patient package inserts for oral contraceptives. (a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the...

  1. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 5 2013-04-01 2013-04-01 false Patient package inserts for oral contraceptives... Patient package inserts for oral contraceptives. (a) Requirement for a patient package insert. The safe and effective use of oral contraceptive drug products requires that patients be fully informed of the...

  2. Comparison of Unlicensed and Off-Label Use of Antipsychotics Prescribed to Child and Adolescent Psychiatric Outpatients for Treatment of Mental and Behavioral Disorders with Different Guidelines: The China Food and Drug Administration Versus the FDA.

    PubMed

    Zhu, Xiuqing; Hu, Jinqing; Sun, Bin; Deng, Shuhua; Wen, Yuguan; Chen, Weijia; Qiu, Chang; Shang, Dewei; Zhang, Ming

    2018-04-01

    This study aims to compare the prevalence of unlicensed and off-label use of antipsychotics among child and adolescent psychiatric outpatients with guidelines proposed by the China Food and Drug Administration (CFDA) and the U.S. Food and Drug Administration (FDA), and to identify factors associated with inconsistencies between the two regulations. A retrospective analysis of 29,326 drug prescriptions for child and adolescent outpatients from the Affiliated Brain Hospital of Guangzhou Medical University was conducted. Antipsychotics were classified as "unlicensed" or "off-label use" according to the latest pediatric license information registered by the CFDA and the FDA or the package inserts of antipsychotics authorized by the CFDA or the FDA for the treatment of pediatric mental and behavioral disorders, respectively. Binary logistic regression analysis was performed to assess factors associated with inconsistencies between the two regulations. The total unlicensed use, according to the CFDA analysis, was higher than that found in the FDA analysis (74.14% vs. 22.04%, p < 0.001). However, the total off-label use, according to the FDA analysis, was higher than that found in the CFDA analysis (46.53% vs. 15.77%, p < 0.001). Antipsychotic drug classes, age group, number of diagnoses, and diagnosis of schizophrenia and schizotypal and delusional disorders were associated with inconsistent unlicensed use. Antipsychotic drug classes, age group, number of prescribed psychotropic drugs, gender, diagnosis of schizophrenia and schizotypal and delusional disorders, diagnosis of mood [affective] disorders, diagnosis of mental retardation, and diagnosis of psychological development disorders were associated with inconsistent off-label use. The difference in prevalence of total unlicensed and off-label use of antipsychotics between the two regulations was statistically significant. This inconsistency could be partly attributed to differences in pediatric license information and package inserts of antipsychotics. The results indicate a need for further clinical pediatric studies and better harmonization between agencies regarding antipsychotic used in pediatrics.

  3. 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 meaning of front-of-package nutrition labels. Consumers should receive education about the availability and use of new nutrition labels. Copyright © 2015 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  4. [High prevalence of off-label and unlicensed drug prescribing in a Brazilian intensive care unit].

    PubMed

    Ferreira, Lilian de Abreu; Ibiapina, Cássio da Cunha; Machado, Márcia Gomes Penido; Fagundes, Eleonora Druve Tavares

    2012-01-01

    To describe the use and determine the prevalence of off-label and unlicensed drug use prescribing in a pediatric intensive care unit in a Southeastern Brazilian hospital Cross-sectional study of inpatients in a pediatric intensive care unit from May 2008 through January 2009. The classification according to the Brazilian regulatory agency (Agência de Vigilância Sanitária - Anvisa) approval criteria was based on the Anvisa electronic package insert list, Pharmaceuticals Dictionary, and the analysis was conducted through R software. We analysed 1,054 prescription items for 73 patients. Females predominated (52%), and the patients' age ranged from 0 to 16 years. Among the prescribed items, 23.4% were off-label, 12.6% were unlicensed, 1.4% were both off-label and unlicensed, 86% had at least one item off-label, and 67% had at least one unlicensed drug. The most frequently prescribed therapeutic groups were systemic anti-bacterial, analgesic, psycholeptic, and antiasmathic agents. The current study results confirm the high prevalence of unlicensed and off-label drug use in a pediatric intensive care unit.

  5. 16 CFR 305.15 - Labeling for lighting products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ...) Package labeling. For purposes of labeling under this section, packaging for such fluorescent lamp... individually or in small numbers. The encircled capital letter “E” on packages containing fluorescent lamp... ink, on the surface of the package on which printing or a label normally appears. If the package...

  6. 9 CFR 112.10 - Special packaging and labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Special packaging and labeling. 112.10... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING § 112.10 Special packaging and labeling. A biological product, which requires special packaging and/or...

  7. [A research of letter color visibility in package insert information using simulator].

    PubMed

    Kamimura, Naoki; Kinoshita, Noriyuki; Onaga, Midori; Watanabe, Yurika; Ijuin, Kazushige; Shikamura, Yoshiaki; Negishi, Kenichi; Kaiho, Fusao; Ohta, Takafumi

    2012-01-01

    Package insert of pharmaceutical drug is one of the most prioritized information for pharmacists to secure safety of patients. However, the color of character, size, font and so on are various company by company product to product from a viewpoint of visibility. It may be cause a serious accident in case visibility is unclear, although it is the most important information. Moreover, package insert with high visibility is required for color vision defectives from a viewpoint of a universal design. Then, the authors selected the package insert which has the boxed warning in the ethical pharmaceutical currently stored mostly in the present health insurance pharmacy and quantified the red color using the color meter. We advocate the state of a suitable package insert from a viewpoint of a universal design, whether the red color is high visible or not for color vision defectives using simulator.

  8. 21 CFR 211.130 - Packaging and labeling operations.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control § 211.130 Packaging and labeling operations. There shall be written procedures designed to... manufacture and control of the batch. (d) Examination of packaging and labeling materials for suitability and...

  9. 49 CFR 172.404 - Labels for mixed and consolidated packaging.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 49 Transportation 2 2012-10-01 2012-10-01 false Labels for mixed and consolidated packaging. 172..., TRAINING REQUIREMENTS, AND SECURITY PLANS Labeling § 172.404 Labels for mixed and consolidated packaging. (a) Mixed packaging. When compatible hazardous materials having different hazard classes are packed...

  10. 49 CFR 172.404 - Labels for mixed and consolidated packaging.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 49 Transportation 2 2014-10-01 2014-10-01 false Labels for mixed and consolidated packaging. 172..., TRAINING REQUIREMENTS, AND SECURITY PLANS Labeling § 172.404 Labels for mixed and consolidated packaging. (a) Mixed packaging. When compatible hazardous materials having different hazard classes are packed...

  11. 49 CFR 172.404 - Labels for mixed and consolidated packaging.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 49 Transportation 2 2011-10-01 2011-10-01 false Labels for mixed and consolidated packaging. 172..., TRAINING REQUIREMENTS, AND SECURITY PLANS Labeling § 172.404 Labels for mixed and consolidated packaging. (a) Mixed packaging. When compatible hazardous materials having different hazard classes are packed...

  12. 49 CFR 172.404 - Labels for mixed and consolidated packaging.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 49 Transportation 2 2013-10-01 2013-10-01 false Labels for mixed and consolidated packaging. 172..., TRAINING REQUIREMENTS, AND SECURITY PLANS Labeling § 172.404 Labels for mixed and consolidated packaging. (a) Mixed packaging. When compatible hazardous materials having different hazard classes are packed...

  13. 49 CFR 172.404 - Labels for mixed and consolidated packaging.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 2 2010-10-01 2010-10-01 false Labels for mixed and consolidated packaging. 172..., TRAINING REQUIREMENTS, AND SECURITY PLANS Labeling § 172.404 Labels for mixed and consolidated packaging. (a) Mixed packaging. When hazardous materials having different hazard classes are packed within the...

  14. [Research on Insufficient Information for Pharmaceutical Products].

    PubMed

    Tomita, Takashi

    2017-01-01

     Several issues concerning medicines remain unclear, including the availability of known, but not easily recognizable information. This review evaluates the mechanisms of side effects and the various risk indications included in package inserts. The results can be summarized as follows. 1) Short-term exposure to gatifloxacin significantly induced insulin secretion and increased the cytosolic Ca 2+ concentration of islet cells by augmenting extracellular Ca 2+ influx and its release from the endoplasmic reticulum. Alternatively, there was a decline in the cellular insulin level and reactivity to sulfonylurea after prolonged exposure. The insulin depletion was greater than that produced by other fluoroquinolones. 2) The elution of di(2-ethylhexyl)phthalate (DEHP) from the infusion set could be associated with the solubilizers in the injection medicines. The package inserts of several products containing polysorbate or ethanol had no warning about DEHP. Although there was a slight correlation between polysorbate content and descriptions on package inserts, the use of DEHP-containing devices was prohibited for some products, even with limited amounts of polysorbate. Therefore, the package insert statements should be reviewed to reflect appropriately the extent of DEHP elution. 3) Risk management plan consists of strategies to minimize the potential risks of medicines. One approach could be to introduce reminders on package inserts; however, of 268 potential risks associated with 81 products, 56 were not mentioned in package inserts. Because most postmarketing pharmacovigilance plans depend on spontaneous reporting by healthcare personnel, the descriptions on package inserts should be reexamined.

  15. 21 CFR 111.160 - What requirements apply to packaging and labels received?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

  16. 21 CFR 111.160 - What requirements apply to packaging and labels received?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

  17. 21 CFR 111.160 - What requirements apply to packaging and labels received?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

  18. 21 CFR 111.160 - What requirements apply to packaging and labels received?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.160 What requirements apply to packaging and labels... labels before you use them in the manufacture of a dietary supplement until: (1) You collect...

  19. Seal welded cast iron nuclear waste container

    DOEpatents

    Filippi, Arthur M.; Sprecace, Richard P.

    1987-01-01

    This invention identifies methods and articles designed to circumvent metallurgical problems associated with hermetically closing an all cast iron nuclear waste package by welding. It involves welding nickel-carbon alloy inserts which are bonded to the mating plug and main body components of the package. The welding inserts might be bonded in place during casting of the package components. When the waste package closure weld is made, the most severe thermal effects of the process are restricted to the nickel-carbon insert material which is far better able to accommodate them than is cast iron. Use of nickel-carbon weld inserts should eliminate any need for pre-weld and post-weld heat treatments which are a problem to apply to nuclear waste packages. Although the waste package closure weld approach described results in a dissimilar metal combination, the relative surface area of nickel-to-iron, their electrochemical relationship, and the presence of graphite in both materials will act to prevent any galvanic corrosion problem.

  20. Chinese regulation of off-label use of drugs.

    PubMed

    Ma, Feng; Lou, Nan

    2013-01-01

    China has significant gaps and weaknesses in its regulatory oversight of the off-label use of drugs. As in the United States, the off-label prescribing of drugs is not prohibited in China if there is a sound scientific basis. Physicians are allowed to prescribe off-label drugs based on their medical judgment if they follow certain requirements. There is some constraint on the right to prescribe by the imposition of malpractice liability if patients are harmed from improper off-label prescribing. However, damages awarded to successful plaintiffs are usually insignificant compared to malpractice damage awards in the U.S. Advertisement of off-label use is prohibited in China. All drug advertisements in China are subject to pre-approval, and must be based on information included in the approved package insert. However, the term "advertisement" is poorly defined. As a result, non-advertisement promotion of drugs for on-label or off-label use exist in a unregulated gray area. To better address the problem of inappropriate off-label promotion and use, China should (i) regulate both drug advertisements and non-advertisement promotion under a standard requiring off-label use to have a sound scientific basis, (ii) introduce harsher regulatory penalties, and (iii) increase compensation available for victims of medical malpractice. Such reform would not only discourage improper off-label use by introducing penalties (or increasing existing penalties) for improper promotion, but would also provide reasonable compensation for victims harmed by off-label use.

  1. 21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

  2. 21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

  3. 21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

  4. 21 CFR 111.165 - What requirements apply to a product received for packaging or labeling as a dietary supplement...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier..., PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System... as a Dietary Supplement § 111.165 What requirements apply to a product received for packaging or...

  5. 27 CFR 31.212 - Labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...

  6. 27 CFR 31.212 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...

  7. 27 CFR 31.212 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...

  8. 27 CFR 31.212 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...

  9. 27 CFR 31.212 - Labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Labeling. Every dealer packaging alcohol for industrial use must affix to each package filled a label... label other appropriate statements; however, such statements must not obscure or contradict the data...

  10. Nutrition labelling, marketing techniques, nutrition claims and health claims on chip and biscuit packages from sixteen countries.

    PubMed

    Mayhew, Alexandra J; Lock, Karen; Kelishadi, Roya; Swaminathan, Sumathi; Marcilio, Claudia S; Iqbal, Romaina; Dehghan, Mahshid; Yusuf, Salim; Chow, Clara K

    2016-04-01

    Food packages were objectively assessed to explore differences in nutrition labelling, selected promotional marketing techniques and health and nutrition claims between countries, in comparison to national regulations. Cross-sectional. Chip and sweet biscuit packages were collected from sixteen countries at different levels of economic development in the EPOCH (Environmental Profile of a Community's Health) study between 2008 and 2010. Seven hundred and thirty-seven food packages were systematically evaluated for nutrition labelling, selected promotional marketing techniques relevant to nutrition and health, and health and nutrition claims. We compared pack labelling in countries with labelling regulations, with voluntary regulations and no regulations. Overall 86 % of the packages had nutrition labels, 30 % had health or nutrition claims and 87 % displayed selected marketing techniques. On average, each package displayed two marketing techniques and one health or nutrition claim. In countries with mandatory nutrition labelling a greater proportion of packages displayed nutrition labels, had more of the seven required nutrients present, more total nutrients listed and higher readability compared with those with voluntary or no regulations. Countries with no health or nutrition claim regulations had fewer claims per package compared with countries with regulations. Nutrition label regulations were associated with increased prevalence and quality of nutrition labels. Health and nutrition claim regulations were unexpectedly associated with increased use of claims, suggesting that current regulations may not have the desired effect of protecting consumers. Of concern, lack of regulation was associated with increased promotional marketing techniques directed at children and misleadingly promoting broad concepts of health.

  11. 21 CFR 501.3 - Identity labeling of animal food in package form.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...

  12. 21 CFR 501.3 - Identity labeling of animal food in package form.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...

  13. 21 CFR 501.3 - Identity labeling of animal food in package form.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...

  14. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...

  15. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...

  16. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...

  17. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION... with labeling and packaging PET drug products? (a) A PET drug product must be suitably labeled and...

  18. 21 CFR 211.122 - Materials examination and usage criteria.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... differentiated by size, shape, or color. (g) If cut labeling is used, packaging and labeling operations shall.... (e) Obsolete and outdated labels, labeling, and other packaging materials shall be destroyed. (f) Use...

  19. Effect on moisture permeability of typewriting on unit dose package surfaces.

    PubMed

    Rackson, J T; Zellhofer, M J; Birmingham, P H

    1984-10-01

    The effects of typewriting on labels of two unit dose packages with respect to moisture permeability were examined. Using an electric typewriter, a standard label format was imprinted on two different types of class A unit dose packages: (1) a heat-sealed paper-backed foil and cellofilm strip pouch, and (2) a copolyester and polyethylene multiple-cup blister with a heat-sealed paper-backed foil and cellofilm cover. The labels were typed at various typing-element impact settings. The official USP test for water permeation was then performed on typed packages and untyped control packages. The original untyped packages were confirmed to be USP class A quality. The packages for which successively harder impact settings were used showed a corresponding increase in moisture permeability. This resulted in a lowering of USP package ratings from class A to class B and D, some of which would be unsuitable for use in any unit dose system under current FDA repackaging standards. Typing directly onto the label of a unit dose package before it is sealed will most likely damage the package and possibly make it unfit for use. Pharmacists who must type labels for the unit dose packages studied should use the lowest possible typewriter impact setting and test for damage using the USP moisture-permeation test.

  20. Packaging and Labeling of Pharmaceutical Products Obtained from the Internet

    PubMed Central

    2011-01-01

    Background For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product’s identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. Objective The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. Methods During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Results Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products’ packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Conclusions Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety. PMID:21324833

  1. Packaging and labeling of pharmaceutical products obtained from the internet.

    PubMed

    Veronin, Michael

    2011-02-15

    For patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container should be comparable to that which manufacturers use to package drug products and should preserve a product's identity, strength, quality, and purity and prevent contamination. Safety features such as a child-resistant closure should be provided. Pharmaceutical products purchased from international online pharmacies are not approved by the Food and Drug Administration (FDA) and may not meet US guidelines for labeling and packaging. The study objective was to determine whether commonly purchased pharmaceutical products obtained from international online pharmacies are comparable to products dispensed in the United States with regard to labeling and packaging. During March 2006 through January 2007, 41 pharmaceutical oral dosage form samples were obtained from international Internet pharmacy websites for evaluation: 18 generic simvastatin samples, 18 generic amlodipine samples, and 5 generic sildenafil samples. Contents for each package were observed and recorded and comparison of the prescription labeling and packaging of these products was made with prescription labeling and packaging requirements in the United States. Of the 41 drug products obtained from online pharmacies from 12 different countries, only 1 product (from Canada) would meet both labeling and packaging guidelines for products dispensed in the United States. Of those not meeting the requirements, 7 were dispensed in paper envelopes with label affixed that was either handwritten or typed and contained missing information such as name and address of dispenser, name of prescriber, name of patient, and directions for use. Another 3 products did not have a label affixed to the drug product, but information was printed on a paper document enclosed in the shipping package, while 28 products did not have labels affixed to the drug product. In all, 39 of the 41 drug products' packaging would not meet the US guidelines. Aside from the Canadian product, only 1 product from Mexico was dispensed in a container that would meet guidelines established in the United States. In total, 35 products were not dispensed in plastic vials but were dispensed in unit dose packages, paper envelopes with loose dosage forms, blister packs of drugs held together with rubber bands, or a combination of these packaging forms. Results suggest that labeling and packaging standards for international generic drug products are not equivalent to labeling and packaging standards in the United States. This suggests dissimilar and substandard distribution processes compared with those in the United States, which in turn presents a challenge to patient comprehension and health literacy and may affect patient adherence to drug treatment regimens. These findings have strong implications for drug product quality, patient outcomes, therapeutic effectiveness, and safety.

  2. 21 CFR 801.437 - User labeling for devices that contain natural rubber.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... User labeling for devices that contain natural rubber. (a) Data in the Medical Device Reporting System... of the device packaging, the outside package, container or wrapper, and the immediate device package... panel of the device packaging, the outside package, container or wrapper, and the immediate device...

  3. 21 CFR 801.437 - User labeling for devices that contain natural rubber.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... User labeling for devices that contain natural rubber. (a) Data in the Medical Device Reporting System... of the device packaging, the outside package, container or wrapper, and the immediate device package... panel of the device packaging, the outside package, container or wrapper, and the immediate device...

  4. 21 CFR 801.437 - User labeling for devices that contain natural rubber.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... User labeling for devices that contain natural rubber. (a) Data in the Medical Device Reporting System... of the device packaging, the outside package, container or wrapper, and the immediate device package... panel of the device packaging, the outside package, container or wrapper, and the immediate device...

  5. 21 CFR 801.437 - User labeling for devices that contain natural rubber.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... User labeling for devices that contain natural rubber. (a) Data in the Medical Device Reporting System... of the device packaging, the outside package, container or wrapper, and the immediate device package... panel of the device packaging, the outside package, container or wrapper, and the immediate device...

  6. 21 CFR 801.437 - User labeling for devices that contain natural rubber.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... User labeling for devices that contain natural rubber. (a) Data in the Medical Device Reporting System... of the device packaging, the outside package, container or wrapper, and the immediate device package... panel of the device packaging, the outside package, container or wrapper, and the immediate device...

  7. 21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

  8. 21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

  9. 21 CFR 111.20 - What design and construction requirements apply to your physical plant?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... use in the manufacture, packaging, labeling, or holding of dietary supplements must: (a) Be suitable... dietary supplements during manufacturing, packaging, labeling, or holding; (c) Permit the use of proper...

  10. 21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

  11. 21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ..., dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Holding and Distributing § 111.455 What requirements apply to holding components, dietary supplements...

  12. 21 CFR 111.20 - What design and construction requirements apply to your physical plant?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Physical Plant and Grounds... use in the manufacture, packaging, labeling, or holding of dietary supplements must: (a) Be suitable... dietary supplements during manufacturing, packaging, labeling, or holding; (c) Permit the use of proper...

  13. 16 CFR 305.15 - Labeling for lighting products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... surface of the fluorescent lamp ballast. (3) Package labeling. For purposes of labeling under this section...” on packages containing fluorescent lamp ballasts or the luminaires into which they are incorporated must appear conspicuously, in color-contrasting ink, on the surface of the package on which printing or...

  14. 16 CFR 305.15 - Labeling for lighting products.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... surface of the fluorescent lamp ballast. (3) Package labeling. For purposes of labeling under this section...” on packages containing fluorescent lamp ballasts or the luminaires into which they are incorporated must appear conspicuously, in color-contrasting ink, on the surface of the package on which printing or...

  15. 16 CFR 305.15 - Labeling for lighting products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... surface of the fluorescent lamp ballast. (3) Package labeling. For purposes of labeling under this section...” on packages containing fluorescent lamp ballasts or the luminaires into which they are incorporated must appear conspicuously, in color-contrasting ink, on the surface of the package on which printing or...

  16. 16 CFR 305.15 - Labeling for lighting products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... surface of the fluorescent lamp ballast. (3) Package labeling. For purposes of labeling under this section...” on packages containing fluorescent lamp ballasts or the luminaires into which they are incorporated must appear conspicuously, in color-contrasting ink, on the surface of the package on which printing or...

  17. Utility and importance of animal data in drug product labels.

    PubMed

    Baldrick, Paul

    2014-08-01

    Information on the use and safety of medicines to assist prescription by healthcare professionals occurs in drug labels (Summary of Product Characteristics in Europe and Package Insert in the USA). Animal data (notably genotoxicity, reproduction toxicity and carcinogenicity and/or repeat dose toxicity testing) comprise an important component of the information (having a vital role in giving assurance that an extensive safety assessment for the medicinal product has occurred) and regulatory guidance is available to help inform on its input into drug labels. However, an evaluation of animal data for the 27 new drugs approved in the USA in 2013 (and the same drugs if available in Europe) shows great variability in detail and level of information presented within and across regions and/or the possibility of confusion on interpretation of some of the presented animal study findings. It is concluded that it may be time to revisit what animal data are presented in drug product labels (although bearing in mind current regional regulatory guidance requirements), not only to allow within and across region consistency on information given but to present it in a way that fully assists healthcare professions when prescribing a medicine. Copyright © 2014 Elsevier Inc. All rights reserved.

  18. 21 CFR 111.410 - What requirements apply to packaging and labels?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

  19. 21 CFR 111.410 - What requirements apply to packaging and labels?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

  20. 21 CFR 111.410 - What requirements apply to packaging and labels?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

  1. 21 CFR 111.410 - What requirements apply to packaging and labels?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

  2. 21 CFR 111.410 - What requirements apply to packaging and labels?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to packaging and labels? 111.410 Section 111.410 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufacturing history and control of the packaged and labeled dietary supplement through distribution. ...

  3. 21 CFR 801.40 - Form of a unique device identifier.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Automatic identification and data capture (AIDC) technology. (b) The UDI must include a device identifier... evident upon visual examination of the label or device package, the label or device package must disclose... label and device packages is deemed to meet all requirements of subpart B of this part. The UPC will...

  4. 16 CFR 1702.13 - Labeling and packaging samples.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 16 Commercial Practices 2 2014-01-01 2014-01-01 false Labeling and packaging samples. 1702.13 Section 1702.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION...

  5. 16 CFR 1702.13 - Labeling and packaging samples.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Labeling and packaging samples. 1702.13 Section 1702.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION...

  6. 16 CFR 1702.13 - Labeling and packaging samples.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 2 2011-01-01 2011-01-01 false Labeling and packaging samples. 1702.13 Section 1702.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION...

  7. 16 CFR 1702.13 - Labeling and packaging samples.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Labeling and packaging samples. 1702.13 Section 1702.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION...

  8. Searching for flavor labels in food products: the influence of color-flavor congruence and association strength.

    PubMed

    Velasco, Carlos; Wan, Xiaoang; Knoeferle, Klemens; Zhou, Xi; Salgado-Montejo, Alejandro; Spence, Charles

    2015-01-01

    Prior research provides robust support for the existence of a number of associations between colors and flavors. In the present study, we examined whether congruent (vs. incongruent) combinations of product packaging colors and flavor labels would facilitate visual search for products labeled with specific flavors. The two experiments reported here document a Stroop-like effect between flavor words and packaging colors. The participants were able to search for packaging flavor labels more rapidly when the color of the packaging was congruent with the flavor label (e.g., red/tomato) than when it was incongruent (e.g., yellow/tomato). In addition, when the packaging color was incongruent, those flavor labels that were more strongly associated with a specific color yielded slower reaction times and more errors (Stroop interference) than those that were less strongly tied to a specific color. Importantly, search efficiency was affected both by color/flavor congruence and association strength. Taken together, these results therefore highlight the role of color congruence and color-word association strength when it comes to searching for specific flavor labels.

  9. 21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

  10. 21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

  11. 21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

  12. 21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

  13. 16 CFR 502.100 - “Cents-off” representations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... of the “cents-off” representation imprinted on the commodity package or label. (3) Each “cents-off” representation imprinted on the package or label is limited to a phrase which reflects that the price marked by..., designated as the “regular price”, clearly and conspicuously on the package or label of the commodity or on a...

  14. 21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... dietary supplement that is rejected for distribution? 111.425 Section 111.425 Food and Drugs FOOD AND DRUG... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... requirements apply to a packaged and labeled dietary supplement that is rejected for distribution? You must...

  15. 21 CFR 501.3 - Identity labeling of animal food in package form.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in... affect the required declarations of identity under definitions and standards for foods promulgated...

  16. 21 CFR 501.3 - Identity labeling of animal food in package form.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Identity labeling of animal food in package form... § 501.3 Identity labeling of animal food in package form. (a) The principal display panel of a food in... affect the required declarations of identity under definitions and standards for foods promulgated...

  17. 16 CFR § 1702.13 - Labeling and packaging samples.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 16 Commercial Practices 2 2013-01-01 2013-01-01 false Labeling and packaging samples. § 1702.13 Section § 1702.13 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION POISON PREVENTION PACKAGING ACT OF 1970 REGULATIONS PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS...

  18. [A comparative analysis of inner wrapping and package inserts for medicines containing Panax ginseng C. A. Meyer].

    PubMed

    Auricchio, Mariangela Tirico; Batistic-Longatto, Mônica Arcon; Nicoletti, Maria Aparecida

    2007-10-01

    The information provided on package inserts and inner wrapping of eight products containing Panax ginseng from different manufacturers was compared internally and checked against data from the scientific literature. The inserts included extensive text, containing abundant information on indications for use, but no scientific evidence in humans. All the inserts lacked information on potential adverse effects and drug interaction. There was no standardization as to dose regimens, particularly in relation to the dried extract and ginsenoside concentration. The eight inserts thus showed no concern over standardization, indication for usage, or possible side effects and drug interactions.

  19. Sensitivity for Diagnosing Group A Streptococcal Pharyngitis from Manufacturers is 10% Higher than Reported in Peer-Reviewed Publications.

    PubMed

    Vachhani, Raj; Patel, Toral; Centor, Robert M; Estrada, Carlos A

    2017-01-01

    Meta-analyses based on peer-reviewed publications report a sensitivity of approximately 85% for rapid antigen streptococcus tests to diagnose group A streptococcal (GAS) pharyngitis. Because these meta-analyses excluded package inserts, we examined the test characteristics of rapid antigen streptococcal tests and molecular methods that manufacturers report in their package inserts. We included tests available in the US market (Food and Drug Administration, period searched 1993-2015) and used package insert data to calculate pooled sensitivity and specificity. To examine quality, we used the Quality Assessment of Diagnostic Accuracy Studies-2. We excluded 26 tests having different trade names but identical methods and data. The study design was prospective in 41.7% (10 of 24). The pooled sensitivity of the most commonly used method, lateral flow/immunochromatographic, was 95% (95% confidence interval [CI] 94-96) and the pooled specificity was 98% (96-98); 7108 patients. The pooled sensitivity of the polymerase chain reaction or molecular methods was 98% (95% CI 96-98) and the pooled specificity was 96% (95% CI 95-97); 5685 patients. Package inserts include sponsored studies that overestimate the sensitivity of rapid tests to diagnose GAS pharyngitis by approximately 10%. Physicians should understand that package inserts overestimate diagnostic test utility; a negative test cannot be used to exclude GAS pharyngitis.

  20. 7 CFR 205.303 - Packaged products labeled “100 percent organic” or “organic.”

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ..., verifying organic certification of the operations producing such ingredients, and: Provided further, That... (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL ORGANIC PROGRAM Labels, Labeling, and Market Information § 205.303 Packaged products labeled “100 percent organic” or “organic.” (a) Agricultural products...

  1. Reactions of Chinese adults to warning labels on cigarette packages: A survey in Jiangsu Province

    PubMed Central

    2011-01-01

    Background To compare reactions to warning labels presented on cigarette packages with a specific focus on whether the new Chinese warning labels are better than the old labels and international labels. Methods Participants aged 18 and over were recruited in two cities of Jiangsu Province in 2008, and 876 face-to-face interviews were completed. Participants were shown six types of warning labels found on cigarette packages. They comprised one old Chinese label, one new label used within the Chinese market, and one Chinese overseas label and three foreign brand labels. Participants were asked about the impact of the warning labels on: their knowledge of harm from smoking, giving cigarettes as a gift, and quitting smoking. Results Compared with the old Chinese label, a higher proportion of participants said the new label provided clear information on harm caused by smoking (31.2% vs 18.3%). Participants were less likely to give cigarettes with the new label on the package compared with the old label (25.2% vs 20.8%). These proportions were higher when compared to the international labels. Overall, 26.8% of participants would quit smoking based on information from the old label and 31.5% from the new label. When comparing the Chinese overseas label and other foreign labels to the new Chinese label with regard to providing knowledge of harm warning, impact of quitting smoking and giving cigarettes as a gift, the overseas labels were more effective. Conclusion Both the old and the new Chinese warning label are not effective in this target population. PMID:21349205

  2. 9 CFR 112.6 - Packaging biological products.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING... Disease Vaccine. (2) Poultry vaccines administered to individual birds using automatic vaccinating..., unless each final container bears, or is packaged in a carton with, complete and approved labeling which...

  3. 9 CFR 112.6 - Packaging biological products.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING... Disease Vaccine. (2) Poultry vaccines administered to individual birds using automatic vaccinating..., unless each final container bears, or is packaged in a carton with, complete and approved labeling which...

  4. 9 CFR 112.6 - Packaging biological products.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING... Disease Vaccine. (2) Poultry vaccines administered to individual birds using automatic vaccinating..., unless each final container bears, or is packaged in a carton with, complete and approved labeling which...

  5. 16 CFR 300.15 - Labeling of containers or packaging of wool products.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 16 Commercial Practices 1 2011-01-01 2011-01-01 false Labeling of containers or packaging of wool products. 300.15 Section 300.15 Commercial Practices FEDERAL TRADE COMMISSION REGULATIONS UNDER SPECIFIC ACTS OF CONGRESS RULES AND REGULATIONS UNDER THE WOOL PRODUCTS LABELING ACT OF 1939 Labeling § 300.15...

  6. 21 CFR 310.515 - Patient package inserts for estrogens.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Patient package inserts for estrogens. 310.515 Section 310.515 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE NEW DRUGS Requirements for Specific New Drugs or Devices § 310.515 Patient...

  7. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Patient package inserts for oral contraceptives. 310.501 Section 310.501 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the requirements of this section is misbranded under section 502 of the Federal Food, Drug, and...

  8. 21 CFR 310.501 - Patient package inserts for oral contraceptives.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Patient package inserts for oral contraceptives. 310.501 Section 310.501 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... the requirements of this section is misbranded under section 502 of the Federal Food, Drug, and...

  9. Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls. Final rule.

    PubMed

    2012-03-20

    The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs.

  10. "Doctor, are you trying to kill me?": ambivalence about the patient package insert for estrogen.

    PubMed

    Watkins, Elizabeth Siegel

    2002-01-01

    In 1976, the U.S. Food and Drug Administration proposed new requirements for patient labeling for estrogens prescribed for menopausal and postmenopausal women. This paper explores the variety of responses to this proposal from women and their husbands, feminist and consumer activists, physicians, pharmacists, and pharmaceutical manufacturers, as represented in letters written to the FDA. The drug industry and the medical profession opposed patient labeling on the grounds of cost and a resentment of governmental intrusion. Feminists and consumer advocates were in favor of the idea, but the response from current estrogen users was mixed: most women wished to be better informed, but many expressed concern that estrogen would be removed from the market. This ambivalence suggests unresolved tensions regarding conceptions of female aging, the medical management of menopause and aging, informed consent in medicine, and governmental regulation of medical practice. The debate thus represents an important moment in the history of women's health care.

  11. 21 CFR 701.11 - Identity labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Identity labeling. 701.11 Section 701.11 Food and... COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in package form shall bear as one of its principal features a statement of the identity of the commodity. (b...

  12. 21 CFR 101.3 - Identity labeling of food in packaged form.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Identity labeling of food in packaged form. 101.3 Section 101.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.3 Identity labeling of food in...

  13. 21 CFR 101.3 - Identity labeling of food in packaged form.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Identity labeling of food in packaged form. 101.3 Section 101.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.3 Identity labeling of food in...

  14. Naming, labeling, and packaging of pharmaceuticals.

    PubMed

    Kenagy, J W; Stein, G C

    2001-11-01

    The problem of medical errors associated with the naming, labeling, and packaging of pharmaceuticals is discussed. Sound-alike and look-alike drug names and packages can lead pharmacists and nurses to unintended interchanges of drugs that can result in patient injury or death. The existing medication-use system is flawed because its safety depends on human perfection. Simplicity, standardization, differentiation, lack of duplication, and unambiguous communication are human factors concepts that are relevant to the medication-use process. These principles have often been ignored in drug naming, labeling, and packaging. Instead, current methods are based on long-standing commercial considerations and bureaucratic procedures. The process for naming a marketable drug is lengthy and complex and involves submission of a new chemical entity and patent application, generic naming, brand naming, FDA review, and final approval. Drug companies seek the fastest possible approval and may believe that the incremental benefit of human factors evaluation is small. "Trade dress" is the concept that underlies labeling and packaging issues for the drug industry. Drug companies are resistant to changing trade dress and brand names. Although a variety of private-sector organizations have called for reforms in drug naming, labeling, and packaging standards have been proposed, the problem remains. Drug names, labels, and packages are not selected and designed in accordance with human factors principles. FDA standards do not require application of these principles, the drug industry has struggled with change, and private-sector initiatives have had only limited success.

  15. Evaluating Documents: The Case of Patient Package Inserts. Technical Report No. 2.

    ERIC Educational Resources Information Center

    Krug, Robert E.

    To illustrate the types of factors that must be considered in evaluating public documents, this paper analyzes a number of possible outcomes resulting from one type of document, the patient package insert (PPI) designed to provide consumers of prescription drugs with information about the drugs. It first outlines the intended sequence for a PPI:…

  16. Graphic warning labels on plain cigarette packs: will they make a difference to adolescents?

    PubMed

    McCool, Judith; Webb, Lisa; Cameron, Linda D; Hoek, Janet

    2012-04-01

    Graphic warning labels and plain cigarette packaging are two initiatives developed to increase quit behaviour among smokers. Although a little is known about how adolescents interpret graphic warning labels, very few studies have examined how plain cigarette packaging would affect adolescents' perceptions of cigarette smoking and smoking behaviour. We explored how teens interpret and respond to graphic warning labels and the plain packaging of cigarettes, to assess the potential these strategies may offer in deterring smoking initiation. Twelve focus group interviews with a sample of 80 14-16 year old students from a diverse range of schools in Auckland, New Zealand were undertaken between June and August 2009. Textual analysis revealed that graphic warning labels may influence adolescents by reiterating a negative image of smokers. Graphic warning on a plain cigarette pack increased the attention paid to graphic warning labels and the overall perceptions of harm caused by cigarette smoking, and reduced the social appeal of cigarette smoking. This research offers evidence on how adolescents are appraising and interpreting graphic warning labels, and explores how dominant appraisals may affect the role graphic warning labels play in preventing smoking. Not only would plain cigarette packaging enhance the salience and impact of graphic warning labels, but it would potentially bolster the overall message that cigarette smoking is harmful. In the context of a comprehensive tobacco control programme, graphic warning labels on plain cigarette packaging present an explicit message about the risks (to health and image) associated with cigarette smoking. Copyright © 2012 Elsevier Ltd. All rights reserved.

  17. 49 CFR 172.406 - Placement of labels.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... the package dimensions are adequate. (2) Except as provided in paragraph (e) of this section... dimensions less than those of the required label; (2) A cylinder; and (3) A package which has such an... cubic feet) or more; (2) Each non-bulk package containing a radioactive material; (3) Each DOT 106 or...

  18. 49 CFR 172.406 - Placement of labels.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... the package dimensions are adequate. (2) Except as provided in paragraph (e) of this section... dimensions less than those of the required label; (2) A cylinder; and (3) A package which has such an... cubic feet) or more; (2) Each non-bulk package containing a radioactive material; (3) Each DOT 106 or...

  19. 16 CFR 502.2 - Terms defined.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... market or trade area for a reasonably substantial period of time, i.e., a 30-day period. For consumer..., package, label, person, commerce, principal display panel, and random package have the same meaning as... person engaged in the packaging or labeling of any consumer commodity for distribution in commerce or any...

  20. Effectiveness of text versus pictorial health warning labels and predictors of support for plain packaging of tobacco products within the European Union.

    PubMed

    Agaku, Israel T; Filippidis, Filippos T; Vardavas, Constantine I

    2015-01-01

    Tobacco product warning labels are a key health communication medium with plain packaging noted as the next step in the evolution of tobacco packaging. We assessed the self-reported impact of text versus pictorial health warnings and the determinants of support for plain packaging of tobacco products in the European Union (EU). The Special Eurobarometer 385 survey was analyzed for 26,566 adults from 27 EU countries in 2012. The self-reported impact of warning labels (text or pictorial) and determinants of EU-wide support for plain packaging were assessed using multivariate logistic regression. Current smokers in countries where cigarette pictorial warnings were implemented had higher odds of reporting that health warning labels had any effect on their smoking behavior (making a quit attempt or reducing number of cigarettes smoked per day) compared to respondents in countries with text-only warning labels (adjusted odds ratio, aOR = 1.31; 95% confidence interval, 95% CI: 1.10-1.56). Population support for plain packaging of tobacco packs was higher in countries where cigarette pictorial warnings already existed (aOR = 1.17; 95% CI: 1.07-1.28). These findings indicate that the implementation of pictorial warnings at an EU level may have a positive behavioral impact among smokers and pave the way for population support for plain packaging in the EU.

  1. 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.

  2. Alcohol Warning Label Perceptions: Do Warning Sizes and Plain Packaging Matter?

    PubMed

    Al-Hamdani, Mohammed; Smith, Steven M

    2017-01-01

    There is a dearth of research on the effectiveness of stringent alcohol warning labels. Our experiment tested whether increasing the size of an alcohol health warning lowers product-based ratings. We examined whether plain packaging lowers ratings of alcohol products and the consumers who use them, increases ratings of bottle "boringness," and enhances warning recognition compared with branded packaging. A total of 440 adults (51.7% female) viewed one of three warning sizes (50%, 75%, or 90% of label surface) on either a plain or branded bottle of distilled spirits, wine, and beer. Participants also rated alcohol bottles on product-based (assessing the product itself), consumer-based (assessing perceptions of consumers of the product), and bottle boringness ratings, and then attempted to recognize the correct warning out of four choices. As expected, the size of warning labels lowered product-based ratings. Similarly, plain packaging lowered product-based and consumer-based ratings and increased bottle boringness but only for wine bottles. Further, plain packaging increased the odds of warning recognition on bottles of distilled spirits. This study shows that plain packaging and warning size (similar to the graphic warnings on cigarette packages) affect perceptions about alcohol bottles. It also shows that plain packaging increases the likelihood for correct health warning recognition, which builds the case for alcohol warning and packaging research and policy.

  3. 21 CFR 111.180 - Under this subpart G, what records must you make and keep?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.180 Under this subpart G, what records must you make and... you receive for packaging or labeling as a dietary supplement (and for distribution rather than for...

  4. 21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

  5. 21 CFR 111.180 - Under this subpart G, what records must you make and keep?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.180 Under this subpart G, what records must you make and... you receive for packaging or labeling as a dietary supplement (and for distribution rather than for...

  6. 21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

  7. 21 CFR 111.180 - Under this subpart G, what records must you make and keep?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.180 Under this subpart G, what records must you make and... you receive for packaging or labeling as a dietary supplement (and for distribution rather than for...

  8. 21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

  9. 21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

  10. 21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

  11. 21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

  12. 21 CFR 111.180 - Under this subpart G, what records must you make and keep?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.180 Under this subpart G, what records must you make and... you receive for packaging or labeling as a dietary supplement (and for distribution rather than for...

  13. 21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

  14. 21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

  15. 21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... components, packaging, and labels before use in the manufacture of a dietary supplement? 111.120 Section 111..., OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control System: Requirements for... labels before use in the manufacture of a dietary supplement? Quality control operations for components...

  16. 21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.170 What requirements apply to rejected components... a dietary supplement (and for distribution rather than for return to the supplier), that is rejected...

  17. 21 CFR 111.180 - Under this subpart G, what records must you make and keep?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.180 Under this subpart G, what records must you make and... you receive for packaging or labeling as a dietary supplement (and for distribution rather than for...

  18. 40 CFR 763.171 - Labeling requirements.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... placed for sale, shipment, or storage. If the product has more than one layer of external wrapping or packaging, the label must be attached to the innermost layer adjacent to the product. If the innermost layer... product's innermost layer of product wrapping or packaging, or a label must be attached to the next outer...

  19. Conformity of commercial oral single solid unit dose packages in hospital pharmacy practice.

    PubMed

    Thibault, Maxime; Prot-Labarthe, Sonia; Bussières, Jean-François; Lebel, Denis

    2008-06-01

    There are limited published data on the labelling of single unit dose packages in hospitals. The study was conducted in three large hospitals (two adult and one paediatric) in the metropolitan Montreal area, Quebec, Canada. The objective is to evaluate the labelling of commercial oral single solid unit dose packages available in Canadian urban hospital pharmacy practice. The study endpoint was the labelling conformity of each unit dose package for each criterion and overall for each manufacturer. Complete labelling of unit dose packages should include the following information: (1) brand name, (2) international non-proprietary name or generic name, (3) dosage, (4) pharmaceutical form, (5) manufacturer's name, (6) expiry date, (7) batch number and (8) drug identification number. We also evaluated the ease with which a single unit dose package is detached from a multiple unit dose package for quick, easy and safe use by pharmacy staff. Conformity levels were compared between brand-name and generic packages. A total of 124 different unit dose packages were evaluated. The level of conformity of each criterion varied between 19 and 50%. Only 43% of unit dose packages provided an easy-to-detach system for single doses. Among the 14 manufacturers with three or more unit dose packages evaluated, eight (57%) had a conformity level less than 50%. This study describes the conformity of commercial oral single solid unit dose packages in hospital pharmacy practice in Quebec. A large proportion of unit dose packages do not conform to a set of nine criteria set out in the guidelines of the American Society of Health-System Pharmacists and the Canadian Society of Hospital Pharmacists.

  20. Active packaging of cheese with allyl isothiocyanate, an alternative to modified atmosphere packaging.

    PubMed

    Winther, Mette; Nielsen, Per Vaeggemose

    2006-10-01

    The natural antimicrobial compound allyl isothiocyanate (AITC), found in mustard oil, is effective against cheese-related fungi both on laboratory media and cheese. Penicillium commune, Penicillium roqueforti, and Aspergillus flavus were more sensitive to AITC when it was added just after the spores had completed 100% germination and branching had started on Czapek yeast extract agar than were spores in the dormant phase. The use of 1 AITC label (Wasaouro interior labels, LD30D, 20 by 20 mm) in combination with atmospheric air in the packaging extended the shelf life of Danish Danbo cheese from 4 1/2 to 13 weeks. Two AITC labels extended the shelf life from 4 1/2 to 28 weeks. Both 1 and 2 labels in combination with modified atmosphere packaging extended the shelf life of the cheese from 18 to 28 weeks. This study showed that AITC was absorbed in the cheese, but it was not possible to detect any volatile breakdown products from AITC in the cheese. Cheese stored for up to 12 weeks with an AITC label had an unacceptable mustard flavor. The mustard flavor decreased to an acceptable level between weeks 12 and 28. Cheese stored in atmospheric air had a fresher taste without a CO2 off-flavor than did cheese stored in modified atmosphere packaging. AITC may be a good alternative to modified atmosphere packaging for cheese. The extended shelf life of cheese in the package is very desirable: the cheese can be transported longer distances, and the packaging can be used for the final maturing of the cheese. Furthermore, AITC can address problems such as pinholes and leaking seals in cheese packaging.

  1. 48 CFR 552.211-75 - Preservation, Packaging and Packing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Preservation, Packaging....211-75 Preservation, Packaging and Packing. As prescribed in 511.204(b)(2), insert the following clause: Preservation, Packaging, and Packing (FEB 1996) Unless otherwise specified, all items shall be...

  2. Labeling viral envelope lipids with quantum dots by harnessing the biotinylated lipid-self-inserted cellular membrane.

    PubMed

    Lv, Cheng; Lin, Yi; Liu, An-An; Hong, Zheng-Yuan; Wen, Li; Zhang, Zhenfeng; Zhang, Zhi-Ling; Wang, Hanzhong; Pang, Dai-Wen

    2016-11-01

    Highly efficient labeling of viruses with quantum dots (QDs) is the prerequisite for the long-term tracking of virus invasion at the single virus level to reveal mechanisms of virus infection. As one of the structural components of viruses, viral envelope lipids are hard to be labeled with QDs due to the lack of efficient methods to modify viral envelope lipids. Moreover, it is still a challenge to maintain the intactness and infectivity of labeled viruses. Herein, a mild method has been developed to label viral envelope lipids with QDs by harnessing the biotinylated lipid-self-inserted cellular membrane. Biotinylated lipids can spontaneously insert in cellular membranes of host cells during culture and then be naturally assembled on progeny Pseudorabies virus (PrV) via propagation. The biotinylated PrV can be labeled with streptavidin-conjugated QDs, with a labeling efficiency of ∼90%. Such a strategy to label lipids with QDs can retain the intactness and infectivity of labeled viruses to the largest extent, facilitating the study of mechanisms of virus infection at the single virus level. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Amino Acid Insertion Frequencies Arising from Photoproducts Generated Using Aliphatic Diazirines

    NASA Astrophysics Data System (ADS)

    Ziemianowicz, Daniel S.; Bomgarden, Ryan; Etienne, Chris; Schriemer, David C.

    2017-10-01

    Mapping proteins with chemical reagents and mass spectrometry can generate a measure of accessible surface area, which in turn can be used to support the modeling and refinement of protein structures. Photolytically generated carbenes are a promising class of reagent for this purpose. Substituent effects appear to influence surface mapping properties, allowing for a useful measure of design control. However, to use carbene labeling data in a quantitative manner for modeling activities, we require a better understanding of their inherent amino acid reactivity, so that incorporation data can be normalized. The current study presents an analysis of the amino acid insertion frequency of aliphatic carbenes generated by the photolysis of three different diazirines: 3,3'-azibutyl-1-ammonium, 3,3'-azibutan-1-ol, and 4,4'-azipentan-1-oate. Leveraging an improved photolysis system for single-shot labeling of sub-microliter frozen samples, we used EThCD to localize insertion products in a large population of labeled peptides. Counting statistics were drawn from data-dependent LC-MS2 experiments and used to estimate the frequencies of insertion as a function of amino acid. We observed labeling of all 20 amino acids over a remarkably narrow range of insertion frequencies. However, the nature of the substituent could influence relative insertion frequencies, within a general preference for larger polar amino acids. We confirm a large (6-fold) increase in labeling yield when carbenes were photogenerated in the solid phase (77 K) relative to the liquid phase (293 K), and we suggest that carbene labeling should always be conducted in the frozen state to avoid information loss in surface mapping experiments. [Figure not available: see fulltext.

  4. Labelling completeness and sodium content of packaged foods in India.

    PubMed

    Johnson, Claire; Thout, Sudhir Raj; Mohan, Sailesh; Dunford, Elizabeth; Farrand, Clare; Wu, Jason Hy; He, Feng J; Shivashankar, Roopa; Webster, Jacqui; Krishnan, Anand; Garg, Vandana; Maulik, Pallab K; Prabhakaran, Dorairaj; Neal, Bruce

    2017-11-01

    To estimate the proportion of products meeting Indian government labelling regulations and to examine the Na levels in packaged foods sold in India. Nutritional composition data were collected from the labels of all packaged food products sold at Indian supermarkets in between 2012 and 2014. Proportions of products compliant with the Food Safety Standards Authority of India (FSSAI) regulations and labelled with Na content, and mean Na levels were calculated. Comparisons were made against 2010 data from Hyderabad and against the UK Department of Health (DoH) 2017 Na targets. Eleven large chain retail stores in Delhi and Hyderabad, India. Packaged food products (n 5686) categorised into fourteen food groups, thirty-three food categories and ninety sub-categories. More packaged food products (43 v. 34 %; P<0·001) were compliant with FSSAI regulations but less (32 v. 38 %; P<0·001) reported Na values compared with 2010. Food groups with the highest Na content were sauces and spreads (2217 mg/100 g) and convenience foods (1344 mg/100 g). Mean Na content in 2014 was higher in four food groups compared with 2010 and lower in none (P<0·05). Only 27 % of foods in sub-categories for which there are UK DoH benchmarks had Na levels below the targets. Compliance with nutrient labelling in India is improving but remains low. Many packaged food products have high levels of Na and there is no evidence that Indian packaged foods are becoming less salty.

  5. 48 CFR 852.214-73 - Alternate packaging and packing.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Alternate packaging and....214-73 Alternate packaging and packing. As prescribed in 814.201-6(b)(3), insert the following provision: Alternate Packaging and Packing (JAN 2008) The bidder's offer must clearly indicate the quantity...

  6. 75 FR 18514 - Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-12

    ..., layout, use of color, use of graphics, and costs associated with designing labels. Panel 1 will address... from the general public about the design of drug and therapeutic biologic container labels, carton... packaging designs. Among these measures, FDA agreed that by the end of FY 2010, after public consultation...

  7. How four U.S. states are regulating recreational marijuana edibles.

    PubMed

    Gourdet, Camille; Giombi, Kristen C; Kosa, Katherine; Wiley, Jenny; Cates, Sheryl

    2017-05-01

    Sales of edible marijuana products have been strong in Colorado and Washington State since the legalization of recreational marijuana. Initially, these states did not have comprehensive labelling or packaging requirements in place. In response to increases in marijuana-related emergency room visits and poison control centre calls, additional regulations were implemented. Currently, Alaska, Colorado, Oregon, and Washington each have passed into law various labelling and packaging requirements for edibles. This article presents the primary legal research findings of relevant statutes and regulations for edibles in Alaska, Colorado, Oregon, and Washington. These laws were identified by using Boolean terms and connectors searches in these states' legal databases in LexisNexis. Alaska, Colorado, Oregon, and Washington vary greatly in how they regulate labelling and packaging. Colorado, Oregon and Washington require a Universal Symbol to be affixed to edibles, but only Oregon and Washington require that the use of pesticides be disclosed on the label. Only Colorado and Oregon require that the packaging for edibles bear a Nutrition Facts Panel on the label. Δ 9 -Tetrahydracannabinol (THC) in a single serving or single edible product as Alaska and Oregon. All four states prohibit the manufacture or packaging of edibles that appeal to youth. State laws governing recreational marijuana edibles have evolved since the first recreational edible products were available for sale. Alaska, Colorado, Oregon, and Washington now require edible product labels to disclose a variety of product information, including risk factors associated with consumption. However, there still remain concerns about the regulatory gaps that exist in each of these states, inherent difficulties in enforcing laws around the labelling, packaging, and manufacturing of edibles, and the outstanding question of whether these edible laws are actually informing consumers and keeping the public safe. Copyright © 2017 Elsevier B.V. All rights reserved.

  8. [WHO Framework Convention on Tobacco Control (FCTC) Article 11: packaging and labelling of tobacco products].

    PubMed

    Bekki, Kanae; Inaba, Yohei; Kunugita, Naoki

    2015-01-01

    The World Health Organization (WHO) Framework Convention on Tobacco Control (FCTC) requires member countries to implement measures aimed at reducing the demand for tobacco products. FCTC article 11 describes the important forms of health communication and packaging regulations. And this article recommends on large pictorial health warnings and encourages more effective forms of disclosure on constituents and emissions. Furthermore, article 11 recognizes the importance of the package as a promotional vehicle for tobacco companies and requires the removal of potentially misleading packaging information, including the terms "light" and "mild." The Conference of the Parties (COP) adopted guidelines for implementation of article 11 on "Packaging and labelling of Tobacco Products". Some countries, such as Canada, the U.S.A., Australia, EU countries etc. positively promoted tobacco control by implementing countermeasures such as the graphic health warning labels and plain packages. These countermeasures showed the significant effects of decreasing smoking rate and preventing smoking initiation in young people. Furthermore, these warning labels were effective for the literally challenged. However, the Japanese government has not implemented these countermeasures, and only limited texts are shown on Japanese tobacco packaging. Therefore, Japan should emulate approaches taken by other countries, and promote the tobacco control policy in accordance with FCTC.

  9. Tobacco packaging and labeling policies under the U.S. Tobacco Control Act: research needs and priorities.

    PubMed

    Hammond, David

    2012-01-01

    The Family Smoking Prevention and Tobacco Control Act (the "Act"), enacted in June 2009, gave the U.S. Food and Drug Administration authority to regulate tobacco products. The current paper reviews the provisions for packaging and labeling, including the existing evidence and research priorities. Narrative review using electronic literature search of published and unpublished sources in 3 primary areas: health warnings, constituent labeling, and prohibitions on the promotional elements of packaging. The Act requires 9 pictorial health warnings covering half of cigarette packages and 4 text warnings covering 30% of smokeless tobacco packages. The Act also prohibits potentially misleading information on packaging, including the terms "light" and "mild," and provides a mandate to require disclosure of chemical constituents on packages. Many of the specific regulatory provisions are based on the extent to which they promote "greater public understanding of the risks of tobacco." As a result, research on consumer perceptions has the potential to shape the design and renewal of health warnings and to determine what, if any, information on product constituents should appear on packages. Research on consumer perceptions of existing and novel tobacco products will also be critical to help identify potentially misleading information that should be restricted under the Act. Packaging and labeling regulations required under the Act will bring the United States in line with international standards. There is an immediate need for research to evaluate these measures to guide future regulatory action.

  10. 21 CFR 701.10 - Principal display panel.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) COSMETICS COSMETIC LABELING Package Form § 701.10 Principal display panel. The term principal display panel as it applies to cosmetics in package form and as used in this part, means the part of a label that...

  11. 21 CFR 701.10 - Principal display panel.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...) COSMETICS COSMETIC LABELING Package Form § 701.10 Principal display panel. The term principal display panel as it applies to cosmetics in package form and as used in this part, means the part of a label that...

  12. 21 CFR 701.10 - Principal display panel.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) COSMETICS COSMETIC LABELING Package Form § 701.10 Principal display panel. The term principal display panel as it applies to cosmetics in package form and as used in this part, means the part of a label that...

  13. 21 CFR 701.10 - Principal display panel.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) COSMETICS COSMETIC LABELING Package Form § 701.10 Principal display panel. The term principal display panel as it applies to cosmetics in package form and as used in this part, means the part of a label that...

  14. Young children's perceptions of health warning labels on cigarette packages: a study in six countries.

    PubMed

    Borzekowski, Dina L G; Cohen, Joanna E

    2014-01-01

    Health warning labels on cigarette packages are one way to reach youth thinking about initiating tobacco use. The purpose of this study was to examine awareness and understanding of current health warning labels among 5 and 6 year old children. Researchers conducted one-on-one interviews with urban and rural 5 and 6 year olds from Brazil, China, India, Nigeria, Pakistan, and Russia. Among the 2,423 participating children, 62 % were unaware of the health warnings currently featured on cigarette packages, with the lowest levels of awareness in India and the highest levels in Brazil. When shown the messages, the same percentage of participating children (62 %) showed no level of message understanding. While youth are receiving social and informational messages promoting tobacco use, health warning labels featured on cigarette packages are not effectively reaching young children with anti-smoking messages.

  15. 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

  16. 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...

  17. 49 CFR 174.680 - Division 6.1 (poisonous) materials with foodstuffs.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... not transport any package bearing a POISON or POISON INHALATION HAZARD label in the same car with any... by humans or animals. (b) A carrier must separate any package bearing a POISON label displaying the text “PG III,” or bearing a “PG III” mark adjacent to the POISON label, from materials marked as or...

  18. 49 CFR 174.680 - Division 6.1 (poisonous) materials with foodstuffs.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... not transport any package bearing a POISON or POISON INHALATION HAZARD label in the same car with any... by humans or animals. (b) A carrier must separate any package bearing a POISON label displaying the text “PG III,” or bearing a “PG III” mark adjacent to the POISON label, from materials marked as or...

  19. 49 CFR 174.680 - Division 6.1 (poisonous) materials with foodstuffs.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... not transport any package bearing a POISON or POISON INHALATION HAZARD label in the same car with any... by humans or animals. (b) A carrier must separate any package bearing a POISON label displaying the text “PG III,” or bearing a “PG III” mark adjacent to the POISON label, from materials marked as or...

  20. 49 CFR 174.680 - Division 6.1 (poisonous) materials with foodstuffs.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... not transport any package bearing a POISON or POISON INHALATION HAZARD label in the same car with any... by humans or animals. (b) A carrier must separate any package bearing a POISON label displaying the text “PG III,” or bearing a “PG III” mark adjacent to the POISON label, from materials marked as or...

  1. 49 CFR 174.680 - Division 6.1 (poisonous) materials with foodstuffs.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... not transport any package bearing a POISON or POISON INHALATION HAZARD label in the same car with any... by humans or animals. (b) A carrier must separate any package bearing a POISON label displaying the text “PG III,” or bearing a “PG III” mark adjacent to the POISON label, from materials marked as or...

  2. A nudge in a healthy direction. The effect of nutrition labels on food purchasing behaviors in university dining facilities.

    PubMed

    Cioffi, Catherine E; Levitsky, David A; Pacanowski, Carly R; Bertz, Fredrik

    2015-09-01

    Despite legislation that requires restaurants to post nutritional labels on their products or menu items, the scientific literature provides inconsistent support for the idea that adding labels to foods will change buying patterns. Lack of success of previous research may be that sample sizes have been too small and durations of studies too short. To assess the effect of nutrition labeling on pre-packaged food purchases in university dining facilities. Weekly sales data for a sample of pre-packaged food items were obtained and analyzed, spanning three semesters before and three semesters after nutritional labels were introduced on to the sample of foods. The labels summarized caloric content and nutrient composition information. Mean nutrient composition purchased were calculated for the sample of foods. Labeled food items were categorized as high-calorie, low-calorie, high-fat, or low-fat foods and analyzed for change as a function of the introduction of the labels. Data were obtained from all retail dining units located at Cornell University, Ithaca, NY where the pre-packaged food items were sold. Results indicated that the introduction of food labels resulted in a 7% reduction of the mean total kcals purchased per week (p < 0.001) from the labeled foods. Total fat purchased per week were also reduced by 7% (p < 0.001). Percent of sales from "low-calorie" and "low-fat" foods (p < 0.001) increased, while percent of sales from "high-calorie" and "high-fat" foods decreased (p < 0.001). The results suggest that nutrition labels on pre-packaged foods in a large university dining hall produces a small but significant reduction of labeled high calorie and high fat foods purchased and an increase in low calorie, low fat foods. Copyright © 2015 Elsevier Ltd. All rights reserved.

  3. Hazardous Material Packaging and Transportation

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

    Hypes, Philip A.

    2016-02-04

    This is a student training course. Some course objectives are to: recognize and use standard international and US customary units to describe activities and exposure rates associated with radioactive material; determine whether a quantity of a single radionuclide meets the definition of a class 7 (radioactive) material; determine, for a given single radionuclide, the shipping quantity activity limits per 49 Code of Federal Regulations (CFR) 173.435; determine the appropriate radioactive material hazard class proper shipping name for a given material; determine when a single radionuclide meets the DOT definition of a hazardous substance; determine the appropriate packaging required for amore » given radioactive material; identify the markings to be placed on a package of radioactive material; determine the label(s) to apply to a given radioactive material package; identify the entry requirements for radioactive material labels; determine the proper placement for radioactive material label(s); identify the shipping paper entry requirements for radioactive material; select the appropriate placards for a given radioactive material shipment or vehicle load; and identify allowable transport limits and unacceptable transport conditions for radioactive material.« less

  4. Watermarking spot colors in packaging

    NASA Astrophysics Data System (ADS)

    Reed, Alastair; Filler, TomáÅ.¡; Falkenstern, Kristyn; Bai, Yang

    2015-03-01

    In January 2014, Digimarc announced Digimarc® Barcode for the packaging industry to improve the check-out efficiency and customer experience for retailers. Digimarc Barcode is a machine readable code that carries the same information as a traditional Universal Product Code (UPC) and is introduced by adding a robust digital watermark to the package design. It is imperceptible to the human eye but can be read by a modern barcode scanner at the Point of Sale (POS) station. Compared to a traditional linear barcode, Digimarc Barcode covers the whole package with minimal impact on the graphic design. This significantly improves the Items per Minute (IPM) metric, which retailers use to track the checkout efficiency since it closely relates to their profitability. Increasing IPM by a few percent could lead to potential savings of millions of dollars for retailers, giving them a strong incentive to add the Digimarc Barcode to their packages. Testing performed by Digimarc showed increases in IPM of at least 33% using the Digimarc Barcode, compared to using a traditional barcode. A method of watermarking print ready image data used in the commercial packaging industry is described. A significant proportion of packages are printed using spot colors, therefore spot colors needs to be supported by an embedder for Digimarc Barcode. Digimarc Barcode supports the PANTONE spot color system, which is commonly used in the packaging industry. The Digimarc Barcode embedder allows a user to insert the UPC code in an image while minimizing perceptibility to the Human Visual System (HVS). The Digimarc Barcode is inserted in the printing ink domain, using an Adobe Photoshop plug-in as the last step before printing. Since Photoshop is an industry standard widely used by pre-press shops in the packaging industry, a Digimarc Barcode can be easily inserted and proofed.

  5. Tobacco Packaging and Labeling Policies Under the U.S. Tobacco Control Act: Research Needs and Priorities

    PubMed Central

    2012-01-01

    Introduction: The Family Smoking Prevention and Tobacco Control Act (the “Act”), enacted in June 2009, gave the U.S. Food and Drug Administration authority to regulate tobacco products. The current paper reviews the provisions for packaging and labeling, including the existing evidence and research priorities. Methods: Narrative review using electronic literature search of published and unpublished sources in 3 primary areas: health warnings, constituent labeling, and prohibitions on the promotional elements of packaging. Results: The Act requires 9 pictorial health warnings covering half of cigarette packages and 4 text warnings covering 30% of smokeless tobacco packages. The Act also prohibits potentially misleading information on packaging, including the terms “light” and “mild,” and provides a mandate to require disclosure of chemical constituents on packages. Many of the specific regulatory provisions are based on the extent to which they promote “greater public understanding of the risks of tobacco.” As a result, research on consumer perceptions has the potential to shape the design and renewal of health warnings and to determine what, if any, information on product constituents should appear on packages. Research on consumer perceptions of existing and novel tobacco products will also be critical to help identify potentially misleading information that should be restricted under the Act. Conclusion: Packaging and labeling regulations required under the Act will bring the United States in line with international standards. There is an immediate need for research to evaluate these measures to guide future regulatory action. PMID:22039072

  6. Effects of a Voluntary Front-of-Pack Nutrition Labelling System on Packaged Food Reformulation: The Health Star Rating System in New Zealand

    PubMed Central

    Eyles, Helen; Choi, Yeun-Hyang

    2017-01-01

    Interpretive, front-of-pack (FOP) nutrition labels may encourage reformulation of packaged foods. We aimed to evaluate the effects of the Health Star Rating (HSR), a new voluntary interpretive FOP labelling system, on food reformulation in New Zealand. Annual surveys of packaged food and beverage labelling and composition were undertaken in supermarkets before and after adoption of HSR i.e., 2014 to 2016. Outcomes assessed were HSR uptake by food group star ratings of products displaying a HSR label; nutritional composition of products displaying HSR compared with non-HSR products; and the composition of products displaying HSR labels in 2016 compared with their composition prior to introduction of HSR. In 2016, two years after adoption of the voluntary system, 5.3% of packaged food and beverage products surveyed (n = 807/15,357) displayed HSR labels. The highest rates of uptake were for cereals, convenience foods, packaged fruit and vegetables, sauces and spreads, and ‘Other’ products (predominantly breakfast beverages). Products displaying HSR labels had higher energy density but had significantly lower mean saturated fat, total sugar and sodium, and higher fibre, contents than non-HSR products (all p-values < 0.001). Small but statistically significant changes were observed in mean energy density (−29 KJ/100 g, p = 0.002), sodium (−49 mg/100 g, p = 0.03) and fibre (+0.5 g/100 g, p = 0.001) contents of HSR-labelled products compared with their composition prior to adoption of HSR. Reformulation of HSR-labelled products was greater than that of non-HSR-labelled products over the same period, e.g., energy reduction in HSR products was greater than in non-HSR products (−1.5% versus −0.4%), and sodium content of HSR products decreased by 4.6% while that of non-HSR products increased by 3.1%. We conclude that roll-out of the voluntary HSR labelling system is driving healthier reformulation of some products. Greater uptake across the full food supply should improve population diets. PMID:28829380

  7. Effects of a Voluntary Front-of-Pack Nutrition Labelling System on Packaged Food Reformulation: The Health Star Rating System in New Zealand.

    PubMed

    Mhurchu, Cliona Ni; Eyles, Helen; Choi, Yeun-Hyang

    2017-08-22

    Interpretive, front-of-pack (FOP) nutrition labels may encourage reformulation of packaged foods. We aimed to evaluate the effects of the Health Star Rating (HSR), a new voluntary interpretive FOP labelling system, on food reformulation in New Zealand. Annual surveys of packaged food and beverage labelling and composition were undertaken in supermarkets before and after adoption of HSR i.e., 2014 to 2016. Outcomes assessed were HSR uptake by food group star ratings of products displaying a HSR label; nutritional composition of products displaying HSR compared with non-HSR products; and the composition of products displaying HSR labels in 2016 compared with their composition prior to introduction of HSR. In 2016, two years after adoption of the voluntary system, 5.3% of packaged food and beverage products surveyed ( n = 807/15,357) displayed HSR labels. The highest rates of uptake were for cereals, convenience foods, packaged fruit and vegetables, sauces and spreads, and 'Other' products (predominantly breakfast beverages). Products displaying HSR labels had higher energy density but had significantly lower mean saturated fat, total sugar and sodium, and higher fibre, contents than non-HSR products (all p -values < 0.001). Small but statistically significant changes were observed in mean energy density (-29 KJ/100 g, p = 0.002), sodium (-49 mg/100 g, p = 0.03) and fibre (+0.5 g/100 g, p = 0.001) contents of HSR-labelled products compared with their composition prior to adoption of HSR. Reformulation of HSR-labelled products was greater than that of non-HSR-labelled products over the same period, e.g., energy reduction in HSR products was greater than in non-HSR products (-1.5% versus -0.4%), and sodium content of HSR products decreased by 4.6% while that of non-HSR products increased by 3.1%. We conclude that roll-out of the voluntary HSR labelling system is driving healthier reformulation of some products. Greater uptake across the full food supply should improve population diets.

  8. 48 CFR 1852.211-70 - Packaging, handling, and transportation.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... transportation. 1852.211-70 Section 1852.211-70 Federal Acquisition Regulations System NATIONAL AERONAUTICS AND... and Clauses 1852.211-70 Packaging, handling, and transportation. As prescribed in 1811.404-70, insert the following clause: Packaging, Handling, and Transportation (SEPT 2005) (a) The Contractor shall...

  9. 48 CFR 1852.211-70 - Packaging, handling, and transportation.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... transportation. 1852.211-70 Section 1852.211-70 Federal Acquisition Regulations System NATIONAL AERONAUTICS AND... and Clauses 1852.211-70 Packaging, handling, and transportation. As prescribed in 1811.404-70, insert the following clause: Packaging, Handling, and Transportation (SEP 2005) (a) The Contractor shall...

  10. 48 CFR 1852.211-70 - Packaging, handling, and transportation.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... transportation. 1852.211-70 Section 1852.211-70 Federal Acquisition Regulations System NATIONAL AERONAUTICS AND... and Clauses 1852.211-70 Packaging, handling, and transportation. As prescribed in 1811.404-70, insert the following clause: Packaging, Handling, and Transportation (SEP 2005) (a) The Contractor shall...

  11. 48 CFR 1852.211-70 - Packaging, handling, and transportation.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... transportation. 1852.211-70 Section 1852.211-70 Federal Acquisition Regulations System NATIONAL AERONAUTICS AND... and Clauses 1852.211-70 Packaging, handling, and transportation. As prescribed in 1811.404-70, insert the following clause: Packaging, Handling, and Transportation (SEP 2005) (a) The Contractor shall...

  12. 76 FR 28045 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-13

    ...] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for... Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements'' has been...

  13. Appalachian residents' perspectives on new U.S. cigarette warning labels.

    PubMed

    Reiter, Paul L; Broder-Oldach, Benjamin; Wewers, Mary Ellen; Klein, Elizabeth G; Paskett, Electra D; Katz, Mira L

    2012-12-01

    The U.S. Food and Drug Administration revealed new pictorial warning labels in June 2011 for cigarette packages, yet little is known about how these labels are perceived by U.S. residents. We examined the reactions to and attitudes about the new labels among residents of Appalachian Ohio, a region with a high smoking prevalence. We conducted focus groups with Appalachian Ohio residents between July and October 2011. Participants included healthcare providers (n = 30), community leaders (n = 26), parents (n = 28), and young adult men ages 18-26 (n = 18). Most participants supported the addition of the new labels to U.S. cigarette packages, though many were unaware of the labels prior to the focus groups. Participants did not think the labels would be effective in promoting smoking cessation among smokers in their communities, but they were more positive about the potential of the labels to reduce smoking initiation. Participants reported positive feedback about the more graphic labels, particularly those showing a man with a tracheal stoma or a person with severe oral disease. The labels that include a cartoon image of an ill infant and a man who quit smoking received the most negative feedback. Participants generally supported adding pictorial warning labels to U.S. cigarette packages, but only a few of labels received mostly positive feedback. Results offer early insight into how the new labels may be received if they are put into practice.

  14. An evaluation of the completeness of drug-drug interaction-related information in package inserts.

    PubMed

    Ng, Giok Qin; Sklar, Grant Edward; Chng, Hui Ting

    2017-02-01

    The project aimed to evaluate the completeness of drug-drug interaction (DDI)-related information in package inserts (PIs) and develop a systematic approach to conduct the evaluation. DDI-related information in the branded PIs of statins, macrolides, protease inhibitors and selected drugs of narrow therapeutic index (DNTI) were evaluated against the criteria distilled from the Food and Drug Administration (FDA) labelling recommendation guidance document. Decision trees were crafted and employed in the evaluation process. Scores were computed to give each PI an overall completeness score and individual criterion completeness score. The Kruskal-Wallis test and Dunn's multiple comparison test were used to assess the differences in the completeness scores. The mean overall completeness score of the 21 PIs was 35.7 ± 13.4 % (range 12.2-62 %). Eight out of the 11 individual evaluation criterion had a mean completeness score below 50 %. A subclass analysis conducted revealed that PIs from the different drug classes differed in the type of DDI-related information, such that they are more complete or less complete. The completeness score of DDI-related information in the PIs varied extensively amongst and within drug classes. A consensus between the authorities and drug companies on the type and quality of DDI-related information to be included could improve their completeness in PIs and make PIs a valuable source of DDI reference. Decision trees, albeit not validated yet, lay the groundwork for a valuable tool to evaluate DDI-related or other drug information.

  15. Impact of explained v. unexplained front-of-package nutrition labels on parent and child food choices: a randomized trial.

    PubMed

    Graham, Dan J; Lucas-Thompson, Rachel G; Mueller, Megan P; Jaeb, Melanie; Harnack, Lisa

    2017-04-01

    The present study investigated whether parent/child pairs would select more healthful foods when: (i) products were labelled with front-of-package (FOP) nutrition labels relative to packages without labels; (ii) products were labelled with colour-coded Multiple Traffic Light (MTL) FOP labels relative to monochromatic Facts up Front (FuF) FOP labels; and (iii) FOP labels were explained via in-aisle signage v. unexplained. Participants were randomly assigned to one of five conditions: (i) FuF labels with in-aisle signs explaining the labels; (ii) FuF labels, no signage; (iii) MTL labels with in-aisle signage; (iv) MTL labels, no signage; (v) control group, no labels/signage. Saturated fat, sodium, sugar and energy (calorie) content were compared across conditions. The study took place in a laboratory grocery aisle. Parent/child pairs (n 153) completed the study. Results did not support the hypothesis that MTL labels would lead to more healthful choices than FuF labels. The presence of FOP labels did little to improve the healthfulness of selected foods, with few exceptions (participants with v. without access to FOP labels selected lower-calorie cereals, participants with access to both FOP labels and in-aisle explanatory signage selected products with less saturated fat v. participants without explanatory signage). Neither MTL nor FuF FOP labels led to food choices with significantly lower saturated fat, sodium or sugar. In-aisle signs explaining the FOP labels were somewhat helpful to consumers in making more healthful dietary decisions. New FOP labelling programmes could benefit from campaigns to increase consumer awareness and understanding of the labels.

  16. 76 FR 368 - Agency Information Collection Activities; Announcement of Office of Management and Budget...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ...] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval... Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements..., Packaging, Labeling, or Holding Operations for Dietary Supplements'' has been approved by the Office of...

  17. 75 FR 40840 - Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-14

    ... Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements... regulations regarding current good manufacturing practice (CGMP) for dietary supplements. DATES: Submit either... in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements--21 CFR Part 111...

  18. 7 CFR 981.43 - Marking or labeling of containers.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... SERVICE (Marketing Agreements and Orders; Fruits, Vegetables, Nuts), DEPARTMENT OF AGRICULTURE ALMONDS... or label their containers that are used in packaging or handling of bulk almonds. For purposes of... packaging or handling of bulk almonds. [73 FR 45156, Aug. 4, 2008] Volume Regulation ...

  19. Risk management strategies in the Physicians' Desk Reference product labels for pregnancy category X drugs.

    PubMed

    Uhl, Kathleen; Kennedy, Dianne L; Kweder, Sandra L

    2002-01-01

    Drugs that carry a concern for teratogenicity are often classified as pregnancy category X in the drug label and contraindicated for use during pregnancy. Many drug labels can be found in the Physicians' Desk Reference (PDR), a widely used source of drug information by American clinicians and patients. To review product labelling in the electronic PDR for the pregnancy category X products for pregnancy prevention risk management components in labelling. The electronic version of the 2001 and 2002 PDR was searched for 'pregnancy category X' products using the full text search feature. All product labels identified were retrieved and reviewed for trade name, generic name, manufacturer and indication. Product labels were manually searched for any pregnancy prevention risk management strategies included in labelling. Those labels that had specific pregnancy prevention risk management strategies were further evaluated. One hundred and seventeen pregnancy category X products were obtained from 2249 products searched in the 2001 PDR database and 124 pregnancy category X products were obtained from the 2150 products in the 2002 PDR database. All pregnancy category X products identified were drug products. The label/package insert for each drug was reviewed to identify risk management strategies for pregnancy prevention. The majority of the labels include as the sole risk management strategy either a black box warning and/or a contraindication for use in women who are or may become pregnant. Only 13 drugs contained specific pregnancy prevention risk management strategies in the label directing the clinician and/or patient, e.g. frequency of pregnancy testing, number and type of contraception methods. Two drugs, bexarotene capsules and gel, were only included in the 2001 PDR. Three drugs, isotretinoin, acitretin, and thalidomide, have formal pregnancy prevention risk management programmes. This study demonstrates the varied risk management approaches in labelling for pregnancy prevention for pregnancy category X drugs. There is a need for consistency in the classification of pregnancy category X products and the pregnancy prevention risk management strategies utilised in the labelling for them.

  20. To See or Not to See: Do Front of Pack Nutrition Labels Affect Attention to Overall Nutrition Information?

    PubMed Central

    Bix, Laura; Sundar, Raghav Prashant; Bello, Nora M.; Peltier, Chad; Weatherspoon, Lorraine J.; Becker, Mark W.

    2015-01-01

    Background Front of pack (FOP) nutrition labels are concise labels located on the front of food packages that provide truncated nutrition information. These labels are rapidly gaining prominence worldwide, presumably because they attract attention and their simplified formats enable rapid comparisons of nutritional value. Methods Eye tracking was conducted as US consumers interacted with actual packages with and without FOP labels to (1) assess if the presence of an FOP label increases attention to nutrition information when viewers are not specifically tasked with nutrition-related goals; and (2) study the effect of FOP presence on consumer use of more comprehensive, traditional nutrition information presented in the Nutritional Facts Panel (NFP), a mandatory label for most packaged foods in the US. Results Our results indicate that colored FOP labels enhanced the probability that any nutrition information was attended, and resulted in faster detection and longer viewing of nutrition information. However, for cereal packages, these benefits were at the expense of attention to the more comprehensive NFP. Our results are consistent with a potential short cut effect of FOP labels, such that if an FOP was present, participants spent less time attending the more comprehensive NFP. For crackers, FOP labels increased time spent attending to nutrition information, but we found no evidence that their presence reduced the time spent on the nutrition information in the NFP. Conclusions The finding that FOP labels increased attention to overall nutrition information by people who did not have an explicit nutritional goal suggests that these labels may have an advantage in conveying nutrition information to a wide segment of the population. However, for some food types this benefit may come with a short-cut effect; that is, decreased attention to more comprehensive nutrition information. These results have implications for policy and warrant further research into the mechanisms by which FOP labels impact use of nutrition information by consumers for different foods. PMID:26488611

  1. 21 CFR 111.25 - What are the requirements under this subpart D for written procedures?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Equipment and Utensils § 111... dietary supplement; (b) Calibrating, inspecting, and checking automated, mechanical, and electronic... other contact surfaces that are used to manufacture, package, label, or hold components or dietary...

  2. 21 CFR 111.25 - What are the requirements under this subpart D for written procedures?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Equipment and Utensils § 111... dietary supplement; (b) Calibrating, inspecting, and checking automated, mechanical, and electronic... other contact surfaces that are used to manufacture, package, label, or hold components or dietary...

  3. 21 CFR 610.62 - Proper name; package label; legible type.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) BIOLOGICS GENERAL BIOLOGICAL PRODUCTS STANDARDS Labeling Standards § 610.62 Proper name; package... contrast in color value between the proper name and the background shall be at least as great as the color value between the trademark and trade name and the background. Typography, layout, contrast, and other...

  4. 49 CFR 175.30 - Inspecting shipments.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... part 172 of this subchapter; and (4) Labeled with a “CARGO AIRCRAFT ONLY” label (see § 172.448 of this... container, or overpack aboard an aircraft unless the package, outside container, or overpack is inspected by... carried aboard an aircraft only if, based on the inspection by the operator, the package, outside...

  5. 49 CFR 175.30 - Inspecting shipments.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... part 172 of this subchapter; and (4) Labeled with a “CARGO AIRCRAFT ONLY” label (see § 172.448 of this... container, or overpack aboard an aircraft unless the package, outside container, or overpack is inspected by... carried aboard an aircraft only if, based on the inspection by the operator, the package, outside...

  6. 49 CFR 175.30 - Inspecting shipments.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... part 172 of this subchapter; and (4) Labeled with a “CARGO AIRCRAFT ONLY” label (see § 172.448 of this... container, or overpack aboard an aircraft unless the package, outside container, or overpack is inspected by... carried aboard an aircraft only if, based on the inspection by the operator, the package, outside...

  7. 49 CFR 175.30 - Inspecting shipments.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... part 172 of this subchapter; and (4) Labeled with a “CARGO AIRCRAFT ONLY” label (see § 172.448 of this... container, or overpack aboard an aircraft unless the package, outside container, or overpack is inspected by... carried aboard an aircraft only if, based on the inspection by the operator, the package, outside...

  8. 21 CFR 701.10 - Principal display panel.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.10 Principal display panel. The term principal display panel as it applies to cosmetics in package form and as used in this part, means the part of a label that is most...

  9. The NASA Electronic Parts and Packaging (NEPP) Program: Insertion of New Electronics Technologies

    NASA Technical Reports Server (NTRS)

    LaBel, Kenneth A.; Sampson, Michael J.

    2007-01-01

    This viewgraph presentation gives an overview of NASA Electronic Parts and Packaging (NEPP) Program's new electronics technology trends. The topics include: 1) The Changing World of Radiation Testing of Memories; 2) Even Application-Specific Tests are Costly!; 3) Hypothetical New Technology Part Qualification Cost; 4) Where we are; 5) Approaching FPGAs as a More Than a "Part" for Reliability; 6) FPGAs Beget Novel Radiation Test Setups; 7) Understanding the Complex Radiation Data; 8) Tracking Packaging Complexity and Reliability for FPGAs; 9) Devices Supporting the FPGA Need to be Considered; 10) Summary of the New Electronic Technologies and Insertion into Flight Programs Workshop; and 11) Highlights of Panel Notes and Comments

  10. ProtSqueeze: simple and effective automated tool for setting up membrane protein simulations.

    PubMed

    Yesylevskyy, Semen O

    2007-01-01

    The major challenge in setting up membrane protein simulations is embedding the protein into the pre-equilibrated lipid bilayer. Several techniques were proposed to achieve optimal packing of the lipid molecules around the protein. However, all of them possess serious disadvantages, which limit their applicability and discourage the users of simulation packages from using them. In the present work, we analyzed existing approaches and proposed a new procedure of protein insertion into the lipid bilayer, which is implemented in the ProtSqueeze software. The advantages of ProtSqueeze are as follows: (1) the insertion algorithm is simple, understandable, and controllable; (2) the software can work with virtually any simulation package on virtually any platform; (3) no modification of the source code of the simulation package is needed; (4) the procedure of insertion is as automated as possible; (5) ProtSqueeze is distributed for free under a general public license. In this work, we present the architecture and the algorithm of ProtSqueeze and demonstrate its usage in case studies.

  11. 48 CFR 552.211-89 - Non-manufactured wood packaging material for export.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 4 2012-10-01 2012-10-01 false Non-manufactured wood... and Clauses 552.211-89 Non-manufactured wood packaging material for export. As prescribed in 511.204(b)(4), insert the following clause: Non-Manufactured Wood Packaging Material for Export (JAN 2010) (a...

  12. 48 CFR 552.211-89 - Non-manufactured wood packaging material for export.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 4 2014-10-01 2014-10-01 false Non-manufactured wood... and Clauses 552.211-89 Non-manufactured wood packaging material for export. As prescribed in 511.204(b)(4), insert the following clause: Non-Manufactured Wood Packaging Material for Export (JAN 2010) (a...

  13. 48 CFR 552.211-89 - Non-manufactured wood packaging material for export.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 4 2013-10-01 2013-10-01 false Non-manufactured wood... and Clauses 552.211-89 Non-manufactured wood packaging material for export. As prescribed in 511.204(b)(4), insert the following clause: Non-Manufactured Wood Packaging Material for Export (JAN 2010) (a...

  14. 48 CFR 552.211-89 - Non-manufactured wood packaging material for export.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 4 2011-10-01 2011-10-01 false Non-manufactured wood... and Clauses 552.211-89 Non-manufactured wood packaging material for export. As prescribed in 511.204(b)(4), insert the following clause: Non-Manufactured Wood Packaging Material for Export (JAN 2010) (a...

  15. 48 CFR 552.211-89 - Non-manufactured wood packaging material for export.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Non-manufactured wood... and Clauses 552.211-89 Non-manufactured wood packaging material for export. As prescribed in 511.204(b)(4), insert the following clause: Non-Manufactured Wood Packaging Material for Export (JAN 2010) (a...

  16. National Meat Case Study 2004: Product labeling information, branding, and packaging trends.

    PubMed

    Reicks, A L; Brooks, J C; Kelly, J M; Kuecker, W G; Boillot, K; Irion, R; Miller, M F

    2008-12-01

    Fresh meat retail cases in 104 supermarkets across 5 regions of the United States were audited for the use of packaging types and materials, branding, and cooking/nutritional information. Frequency means were separated for species of beef, ground beef, pork, chicken, turkey, lamb, and veal. Traditional polyvinyl chloride overwrap was used on 47.0% of packages in the fresh meat case nationwide and was the most frequent packaging type for beef, ground beef, pork, lamb, and veal. The use of modified atmosphere packaging was greatest (P < 0.001) in ground beef (33.2%) and turkey (45.1%) products. The 3 most common tray colors in the fresh meat retail case on a national level were white (39.6%), yellow (22.4%), and black (11.5%). Foam trays were used in 72.6% of all packages in the retail meat case. In 2004, 60.2% of all packages were case-ready. Chicken (94.8%) and turkey (95.6%) products utilized case-ready packaging systems more (P < 0.001) than any other species. On a national level, 50.1% of all products carried a national brand, 12.2% carried a store brand, and the remaining 37.7% of products in the fresh meat case in 2004 were not branded. Chicken was most (P < 0.001) likely to carry a natural brand label. Labels with cooking instructions were found most (P < 0.001) on pork (37.3%) and turkey products (48.1%). Chicken (20.4%) and turkey products (20.7%) were most (P < 0.001) likely to have the cooking instructions printed on the packaging material compared with all other species. Labels with nutritional information were most (P < 0.001) likely to be found on turkey products (55.7%) in the fresh meat case compared with any other species. On the national level, 6.1% of all packages reported in the fresh meat case in 2004 were value-added.

  17. [Incremental effect and mechanism of cyclosporine on blood concentration of statins and statin package insert information in Japan].

    PubMed

    Hirata-Koizumi, Mutsuko; Saito, Mitsuo; Miyake, Shinji; Hasegawa, Ryuichi

    2005-01-01

    Cyclosporine is an indispensable immunosuppressant used in organ transplant patients, who frequently manifest hyperlipidemia. Statins, which are cholesterol-lowering agents, are often combined with cyclosporine in the treatment of hyperlipidemia of organ transplant patients. Since cyclosporine is a substrate and inhibitor of CYP3A4, researchers suspect that the immunosuppressant inhibits CYP3A4-mediated metabolism of statins, leading to an increase in statin plasma concentration and infrequently resulting in rhabdomyolysis. However, a number of clinical trials have shown cyclosporine to increase the plasma concentration of all developed statins, including those not metabolized by CYP3A4. Furthemore, recent mechanistic studies have shown organic anion transporting peptides (OATP) C to mediate the uptake of some statins and cyclosporine has been shown to inhibit the uptake via OATP-C in cultured cells. Therefore, the inhibition of hepatic uptake of statins is considered to be one of the mechanisms by which cyclosporine incrementally increases statin blood concentration. However, most current Japanese package inserts of statins give no information on change in pharmacokinetic parameters such as AUC and Cmax in the combined medication with cyclosporine. Furthermore, in the Japanese package inserts, it is either stated that cyclosporine inhibits CYP3A4-mediated metabolism or no comment is made on the mechanism. The package insert should properly provide available quantitative information on the change of pharmacokinetic parameters and the probable mechanism of action.

  18. 21 CFR 111.1 - Who is subject to this part?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS General Provisions § 111.1 Who is subject to this part? (a..., package, label, or hold a dietary supplement, including: (1) A dietary supplement you manufacture but that is packaged or labeled by another person; and (2) A dietary supplement imported or offered for import...

  19. 21 CFR 111.1 - Who is subject to this part?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS General Provisions § 111.1 Who is subject to this part? (a..., package, label, or hold a dietary supplement, including: (1) A dietary supplement you manufacture but that is packaged or labeled by another person; and (2) A dietary supplement imported or offered for import...

  20. 76 FR 59504 - Intelligent Mail Package Barcode (IMpb) Implementation for Commercial Parcels

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... formats when printing an IMpb. Current standards require a different human-readable service banner text... packages must also ensure sufficient label space exists to print a longer barcode that meets specifications... service) will be used for pre-printed MRS labels (since unique serial numbers cannot be used). Response...

  1. 21 CFR 211.130 - Packaging and labeling operations.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...) Identification of the drug product with a lot or control number that permits determination of the history of the... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Packaging and labeling operations. 211.130 Section 211.130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  2. 21 CFR 226.80 - Packaging and labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Packaging and labeling. 226.80 Section 226.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Type A medicated article(s) with lot or control numbers that permit determination of the history of the...

  3. 21 CFR 211.130 - Packaging and labeling operations.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...) Identification of the drug product with a lot or control number that permits determination of the history of the... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Packaging and labeling operations. 211.130 Section 211.130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  4. 21 CFR 211.130 - Packaging and labeling operations.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...) Identification of the drug product with a lot or control number that permits determination of the history of the... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Packaging and labeling operations. 211.130 Section 211.130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  5. 21 CFR 226.80 - Packaging and labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Packaging and labeling. 226.80 Section 226.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Type A medicated article(s) with lot or control numbers that permit determination of the history of the...

  6. 21 CFR 211.130 - Packaging and labeling operations.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...) Identification of the drug product with a lot or control number that permits determination of the history of the... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Packaging and labeling operations. 211.130 Section 211.130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES...

  7. 21 CFR 226.80 - Packaging and labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Packaging and labeling. 226.80 Section 226.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Type A medicated article(s) with lot or control numbers that permit determination of the history of the...

  8. 21 CFR 226.80 - Packaging and labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Packaging and labeling. 226.80 Section 226.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Type A medicated article(s) with lot or control numbers that permit determination of the history of the...

  9. 76 FR 52862 - Time for Payment of Certain Excise Taxes, and Quarterly Excise Tax Payments for Small Alcohol...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-24

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

  10. 21 CFR 226.80 - Packaging and labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Packaging and labeling. 226.80 Section 226.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS... Type A medicated article(s) with lot or control numbers that permit determination of the history of the...

  11. 49 CFR 175.30 - Inspecting shipments.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... an aircraft only if, based on the inspection by the operator, the package, outside container, or... part 172 of this subchapter; and (4) Labeled with a “CARGO AIRCRAFT ONLY” label (see § 172.448 of this... (d) of this section, no person may carry a hazardous material in a package, outside container, or...

  12. 21 CFR 111.415 - What requirements apply to filling, assembling, packaging, labeling, and related operations?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to filling, assembling, packaging, labeling, and related operations? 111.415 Section 111.415 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD...

  13. 21 CFR 111.455 - What requirements apply to holding components, dietary supplements, packaging, and labels?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to holding components, dietary supplements, packaging, and labels? 111.455 Section 111.455 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD...

  14. 21 CFR 111.160 - What requirements apply to packaging and labels received?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to packaging and labels received? 111.160 Section 111.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  15. 21 CFR 820.130 - Device packaging.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Device packaging. 820.130 Section 820.130 Food and... QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.130 Device packaging. Each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the...

  16. Alcohol consumers' attention to warning labels and brand information on alcohol packaging: Findings from cross-sectional and experimental studies.

    PubMed

    Kersbergen, Inge; Field, Matt

    2017-01-26

    Alcohol warning labels have a limited effect on drinking behavior, potentially because people devote minimal attention to them. We report findings from two studies in which we measured the extent to which alcohol consumers attend to warning labels on alcohol packaging, and aimed to identify if increased attention to warning labels is associated with motivation to change drinking behavior. Study 1 (N = 60) was an exploratory cross-sectional study in which we used eye-tracking to measure visual attention to brand and health information on alcohol and soda containers. In study 2 (N = 120) we manipulated motivation to reduce drinking using an alcohol brief intervention (vs control intervention) and measured heavy drinkers' attention to branding and warning labels with the same eye-tracking paradigm as in study 1. Then, in a separate task we experimentally manipulated attention by drawing a brightly colored border around health (or brand) information before measuring participants' self-reported drinking intentions for the subsequent week. Study 1 showed that participants paid minimal attention to warning labels (7% of viewing time). Participants who were motivated to reduce drinking paid less attention to alcohol branding and alcohol warning labels. Results from study 2 showed that the alcohol brief intervention decreased attention to branding compared to the control condition, but it did not affect attention to warning labels. Furthermore, the experimental manipulation of attention to health or brand information did not influence drinking intentions for the subsequent week. Alcohol consumers allocate minimal attention to warning labels on alcohol packaging and even if their attention is directed to these warning labels, this has no impact on their drinking intentions. The lack of attention to warning labels, even among people who actively want to cut down, suggests that there is room for improvement in the content of health warnings on alcohol packaging.

  17. Low-profile fiber connector for co-packaged optics

    NASA Astrophysics Data System (ADS)

    Brusberg, Lars; DeJong, Michael; Butler, Douglas L.; Clark, Jeffrey S.; Sutton, Clifford G.

    2018-02-01

    We developed a small form factor connector that can be assembled on all four sides of a high-data switch package for fiber connectivity. This paper discusses a novel connector approach that has the potential to meet all co-packaging requirements including solder-reflow-compatibility, de-mateability, low insertion loss and state-of-the art FAU attach. The connector was attached to the PIC for performance evaluation. The average insertion loss across all eight fibers of the assembly was 1.77 dB, including the three optical interfaces: (1) MT-to-MT between connector and receptacle, (2) receptacle-to-PLC and (3) PIC-to-FAU. Also included is the propagation loss of the PIC waveguide. Optical return loss was measured to be -55 dB or lower.

  18. The science on front-of-package food labels.

    PubMed

    Hawley, Kristy L; Roberto, Christina A; Bragg, Marie A; Liu, Peggy J; Schwartz, Marlene B; Brownell, Kelly D

    2013-03-01

    The U.S. Food and Drug Administration and Institute of Medicine are currently investigating front-of-package (FOP) food labelling systems to provide science-based guidance to the food industry. The present paper reviews the literature on FOP labelling and supermarket shelf-labelling systems published or under review by February 2011 to inform current investigations and identify areas of future research. A structured search was undertaken of research studies on consumer use, understanding of, preference for, perception of and behaviours relating to FOP/shelf labelling published between January 2004 and February 2011. Twenty-eight studies from a structured search met inclusion criteria. Reviewed studies examined consumer preferences, understanding and use of different labelling systems as well as label impact on purchasing patterns and industry product reformulation. The findings indicate that the Multiple Traffic Light system has most consistently helped consumers identify healthier products; however, additional research on different labelling systems' abilities to influence consumer behaviour is needed.

  19. Do nutrition labels influence healthier food choices? Analysis of label viewing behaviour and subsequent food purchases in a labelling intervention trial.

    PubMed

    Ni Mhurchu, Cliona; Eyles, Helen; Jiang, Yannan; Blakely, Tony

    2018-02-01

    There are few objective data on how nutrition labels are used in real-world shopping situations, or how they affect dietary choices and patterns. The Starlight study was a four-week randomised, controlled trial of the effects of three different types of nutrition labels on consumer food purchases: Traffic Light Labels, Health Star Rating labels, or Nutrition Information Panels (control). Smartphone technology allowed participants to scan barcodes of packaged foods and receive randomly allocated labels on their phone screen, and to record their food purchases. The study app therefore provided objectively recorded data on label viewing behaviour and food purchases over a four-week period. A post-hoc analysis of trial data was undertaken to assess frequency of label use, label use by food group, and association between label use and the healthiness of packaged food products purchased. Over the four-week intervention, study participants (n = 1255) viewed nutrition labels for and/or purchased 66,915 barcoded packaged products. Labels were viewed for 23% of all purchased products, with decreasing frequency over time. Shoppers were most likely to view labels for convenience foods, cereals, snack foods, bread and bakery products, and oils. They were least likely to view labels for sugar and honey products, eggs, fish, fruit and vegetables, and meat. Products for which participants viewed the label and subsequently purchased the product during the same shopping episode were significantly healthier than products where labels were viewed but the product was not subsequently purchased: mean difference in nutrient profile score -0.90 (95% CI -1.54 to -0.26). In a secondary analysis of a nutrition labelling intervention trial, there was a significant association between label use and the healthiness of products purchased. Nutrition label use may therefore lead to healthier food purchases. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  20. 16 CFR 502.102 - “Economy size.”

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 16 Commercial Practices 1 2010-01-01 2010-01-01 false âEconomy size.â 502.102 Section 502.102 Commercial Practices FEDERAL TRADE COMMISSION RULES, REGULATIONS, STATEMENT OF GENERAL POLICY OR INTERPRETATION AND EXEMPTIONS UNDER THE FAIR PACKAGING AND LABELING ACT REGULATIONS UNDER SECTION 5(C) OF THE FAIR PACKAGING AND LABELING ACT Retail Sale...

  1. 21 CFR 610.62 - Proper name; package label; legible type.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 7 2011-04-01 2010-04-01 true Proper name; package label; legible type. 610.62 Section 610.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES... contrast in color value between the proper name and the background shall be at least as great as the color...

  2. 21 CFR 111.127 - What quality control operations are required for packaging and labeling operations?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What quality control operations are required for packaging and labeling operations? 111.127 Section 111.127 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING...

  3. 21 CFR 111.90 - What requirements apply to treatments, in-process adjustments, and reprocessing when there is a...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS... rejected dietary supplement or treat or provide an in-process adjustment to a component, packaging, or label to make it suitable for use in the manufacture of a dietary supplement unless: (1) Quality control...

  4. 40 CFR 211.204-3 - Label location and type.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... packaging if the label complying with § 211.204-3(a)(1) is not visible at the point of ultimate purchase or...) If the protector is individually packaged and so displayed at the point of ultimate purchase or... the protector is displayed at the point of ultimate purchase or distribution to prospective users in a...

  5. 21 CFR 212.80 - What are the requirements associated with labeling and packaging PET drug products?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What are the requirements associated with labeling and packaging PET drug products? 212.80 Section 212.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR...

  6. 21 CFR 111.35 - Under this subpart D, what records must you make and keep?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ..., and any other contact surfaces that are used to manufacture, package, label, or hold components or... current software is not able to retrieve such records) and of data entered into computer systems that you use to manufacture, package, label, or hold dietary supplements. (i) Your backup file (e.g., a hard...

  7. 21 CFR 111.35 - Under this subpart D, what records must you make and keep?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ..., and any other contact surfaces that are used to manufacture, package, label, or hold components or... current software is not able to retrieve such records) and of data entered into computer systems that you use to manufacture, package, label, or hold dietary supplements. (i) Your backup file (e.g., a hard...

  8. 21 CFR 111.35 - Under this subpart D, what records must you make and keep?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ..., and any other contact surfaces that are used to manufacture, package, label, or hold components or... current software is not able to retrieve such records) and of data entered into computer systems that you use to manufacture, package, label, or hold dietary supplements. (i) Your backup file (e.g., a hard...

  9. 21 CFR 701.12 - Name and place of business of manufacturer, packer, or distributor.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.12 Name and place of business of manufacturer, packer, or distributor. (a) The label of a cosmetic in package form shall specify..., the name under which the business is conducted shall be used. (c) Where the cosmetic is not...

  10. 21 CFR 701.12 - Name and place of business of manufacturer, packer, or distributor.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.12 Name and place of business of manufacturer, packer, or distributor. (a) The label of a cosmetic in package form shall specify..., the name under which the business is conducted shall be used. (c) Where the cosmetic is not...

  11. 21 CFR 701.12 - Name and place of business of manufacturer, packer, or distributor.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.12 Name and place of business of manufacturer, packer, or distributor. (a) The label of a cosmetic in package form shall specify..., the name under which the business is conducted shall be used. (c) Where the cosmetic is not...

  12. 21 CFR 701.13 - Declaration of net quantity of contents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.13 Declaration of net quantity of contents. (a) The label of a cosmetic in package form shall bear a declaration of the net quantity of contents. This... weight or measure. The statement shall be in terms of fluid measure if the cosmetic is liquid or in terms...

  13. 21 CFR 701.12 - Name and place of business of manufacturer, packer, or distributor.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.12 Name and place of business of manufacturer, packer, or distributor. (a) The label of a cosmetic in package form shall specify..., the name under which the business is conducted shall be used. (c) Where the cosmetic is not...

  14. 21 CFR 701.12 - Name and place of business of manufacturer, packer, or distributor.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.12 Name and place of business of manufacturer, packer, or distributor. (a) The label of a cosmetic in package form shall specify..., the name under which the business is conducted shall be used. (c) Where the cosmetic is not...

  15. Graphic warnings and text warning labels on cigarette packages in Riyadh Kingdom of Saudi Arabia: Awareness and perceptions

    PubMed Central

    Jradi, Hoda; Saddik, Basema

    2018-01-01

    BACKGROUND: Graphic warning labels have been shown to be effective in smoking initiation and cessation and were implemented in Saudi Arabia in 2012. To date, no study has assessed the effectiveness of these labels and the Saudi population's perceptions on the effectiveness of cigarette health warning labels. METHODS: We used a cross-sectional qualitative study comprising of nine focus groups among 3 different community group members including health-care workers, adult women and adult men. We conducted in-depth interviews among community leaders. Both focus groups and interviews assessed awareness levels and elicited perceptions about health warning labels on cigarette boxes currently used in the Kingdom of Saudi Arabia. RESULTS: While most participants in the study were aware and supported the use of graphic warning labels on cigarette packages, the awareness of the specific details on the labels was low. Participants perceived the effectiveness of current labels somewhat vague in smoking cessation and advocated for stronger and more aggressive graphics. Community leaders, however, preferred text-only labels and did not support aggressive labels which were deemed culturally and religiously inappropriate. CONCLUSIONS: The study suggests that while graphic warning labels are perceived as necessary on cigarette packages the currently used messages are not clear and therefore do not serve their intended purposes. Measures should be undertaken to ensure that pictorial cigarette labels used in Saudi Arabia are culturally and ethnically appropriate and are rotated on a regular basis to ensure salience among smokers and nonsmokers alike. PMID:29387252

  16. Commercial portion-controlled foods in research studies: how accurate are label weights?

    PubMed

    Conway, Joan M; Rhodes, Donna G; Rumpler, William V

    2004-09-01

    The purpose of this study was to evaluate the reliability of label weights as surrogates for actual weights in commercial portion-controlled foods used in a research setting. Actual weights of replicate samples of 82 portion-controlled food items and 17 discrete units of food from larger packaging were determined over time. Comparison was made to the package label weights for the portion-controlled food items and the per-serving weights for the discrete units. The study was conducted at the US Department of Agriculture's Beltsville Human Nutrition Research Center's Human Study Facility, which houses a metabolic kitchen and human nutrition research facility. The primary outcome measures were the actual and label weights of 99 food items consumed by human volunteers during controlled feeding studies. Statistical analyses performed The difference between label and actual weights was tested by the paired t test for those data that complied with the assumptions of normality. The Wilcoxon signed rank test was used for the remainder of the data. Compliance with federal guidelines for packaged weights was also assessed. There was no statistical difference between actual and label weights for only 37 food items. The actual weights of 15 portion-controlled food items were 1% or more less than label weights, making them potentially out of compliance with federal guidelines. With advance planning and continuous monitoring, well-controlled feeding studies could incorporate portion-controlled food items and discrete units, especially beverages and confectionery products. Dietetics professionals should encourage individuals with diabetes and others on strict dietary regimens to check actual weights of portion-controlled products carefully against package weights.

  17. Pictorial health warning labels on cigarette packages: an investigation on opinions of male smokers.

    PubMed

    Shojaezadeh, Davoud; Peyman, Nooshin; Shakeri, Mohammad Taghi; Nedjat, Saharnaz; Mohaddes Hakkak, Abbas; Taghdisi, Mohammad Hossein; Mohaddes Hakkak, Hamid Reza; Shariati, Keivan; Taghipour, Ali

    2014-03-01

    Health warning labels on cigarette packages are among the most straightforward and important tools to communicate with smokers and various studies have illustrated their efficacy. The current study aimed to investigate the opinions of male smokers in Mashhad city about the efficacy of health warning labels printed on cigarette packages on the smoking status of smokers. This cross-sectional descriptive study was conducted in 2013 using a questionnaire. The research population included the male smokers of Mashhad. The participants were selected from the customers referring to the newsstands for cigarettes. The obtained data were analyzed employing SPSS software Version 16, and the statistical tests including Kruskal-Wallis, Spearman, and correlation coefficient of Pearson, Chi Square, Mann-Whitney, and Bonferroni correction were used in this regard. In this research, there were 500 participants with the average age of 25 years. The initiation age of smoking was eight years while the maximum age was reported as 45 years. Results of this research about the effect of these labels on decreasing cigarette consumption rate showed that almost half of the participants believed that these labels were ineffective for them (52.2%) and other smokers (53.8%).Furthermore, significant relationship was found between the age and opinion of the smokers about the influence of these labels on reducing their cigarette consumption (P < 0.001). To promote the effect of printed images on cigarette packages, it is recommended to consider the suitability of labels in the targeted culture. In addition, to be more effective consultation sites to quit smoking should be introduced under the images.

  18. Cigarette package inserts can promote efficacy beliefs and sustained smoking cessation attempts: A longitudinal assessment of an innovative policy in Canada

    PubMed Central

    Thrasher, James F.; Swayampakala, Kamala; Cummings, K. Michael; Hammond, David; Anshari, Dien; Krugman, Dean M.; Hardin, James W.

    2016-01-01

    Background In June 2012, Canada implemented new pictorial warnings on cigarette packages, along with package inserts with messages to promote response efficacy (i.e., perceived quitting benefits) and self-efficacy (i.e., confidence to quit). This study assessed smokers’ attention towards warnings and inserts and its relationship with efficacy beliefs, risk perceptions and cessation at follow-up. Methods Data were analysed in 2015 from a prospective online consumer panel of adult Canadian smokers surveyed every four months between September 2012 and September 2014. Generalized Estimating Equation models assessed associations between reading inserts, reading warnings and efficacy beliefs (self-efficacy, response efficacy), risk perceptions, quit attempts of any length, and sustained quit attempts (i.e., 30 days or more) at follow-up. Models adjusted for socio-demographics, smoking-related variables, and time-in-sample effects. Results Over the study period, reading warnings significantly decreased (p<0.0001) while reading inserts increased (p=0.004). More frequent reading of warnings was associated independently with stronger response efficacy (Boften/very often vs never=0.28, 95% CI: 0.11–0.46) and risk perceptions at follow-up (Boften/very often vs never=0.31, 95% CI: 0.06–0.56). More frequent reading of inserts was associated independently with stronger self-efficacy to quit at follow-up (Btwice or more vs none=0.30, 95% CI: 0.14–0.47), quit attempts (ORtwice or more vs none= 1.68, 95% CI: 1.28–2.19), and quit attempts lasting 30 days or longer (ORtwice or more vs none=1.48, 95% CI: 1.01 – 2.17). Conclusions More frequent reading of inserts was associated with self-efficacy to quit, quit attempts, and sustained quitting at follow-up, suggesting that inserts complement pictorial HWLs. PMID:26970037

  19. Comparing five front-of-pack nutrition labels' influence on consumers' perceptions and purchase intentions.

    PubMed

    Gorski Findling, Mary T; Werth, Paul M; Musicus, Aviva A; Bragg, Marie A; Graham, Dan J; Elbel, Brian; Roberto, Christina A

    2018-01-01

    In 2011, a National Academy of Medicine report recommended that packaged food in the U.S. display a uniform front-of-package nutrition label, using a system such as a 0-3 star ranking. Few studies have directly compared this to other labels to determine which best informs consumers and encourages healthier purchases. In 2013, we randomized adult participants (N=1247) in an Internet-based survey to one of six conditions: no label control; single traffic light; multiple traffic light; Facts Up Front; NuVal; or 0-3 star ranking. We compared groups on purchase intentions and accuracy of participants' interpretation of food labels. There were no differences in the nutritional quality of hypothetical shopping baskets across conditions (p=0.845). All labels improved consumers' abilities to judge the nutritional quality of foods relative to no label, but the best designs varied by outcomes. NuVal and multiple traffic light labels led to the greatest accuracy identifying the healthier of two products (p<0.001), while the multiple traffic light also led to the most accurate estimates of saturated fat, sugar, and sodium (p<0.001). The single traffic light outperformed other labels when participants compared nutrient levels between similar products (p<0.03). Single/multiple traffic light and Facts Up Front labels led to the most accurate calories per serving estimations (p<0.001). Although front-of-package labels helped participants more accurately assess products' nutrition information relative to no label, no conditions shifted adults' purchase intentions. Results did not point to a clearly superior label design, but they suggest that a 3-star label might not be best for educating consumers. Copyright © 2017 Elsevier Inc. All rights reserved.

  20. 40 CFR 60.431 - Definitions and notations.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 6 2011-07-01 2011-07-01 false Definitions and notations. 60.431 Section 60.431 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS..., package inserts, book jackets, market circulars, magazine inserts, and shopping news, Newspapers, magazine...

  1. 40 CFR 60.431 - Definitions and notations.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 7 2012-07-01 2012-07-01 false Definitions and notations. 60.431 Section 60.431 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS..., package inserts, book jackets, market circulars, magazine inserts, and shopping news, Newspapers, magazine...

  2. 40 CFR 60.431 - Definitions and notations.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 7 2014-07-01 2014-07-01 false Definitions and notations. 60.431 Section 60.431 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS..., package inserts, book jackets, market circulars, magazine inserts, and shopping news, Newspapers, magazine...

  3. 40 CFR 60.431 - Definitions and notations.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 6 2010-07-01 2010-07-01 false Definitions and notations. 60.431 Section 60.431 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS..., package inserts, book jackets, market circulars, magazine inserts, and shopping news, Newspapers, magazine...

  4. 40 CFR 60.431 - Definitions and notations.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 7 2013-07-01 2013-07-01 false Definitions and notations. 60.431 Section 60.431 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS..., package inserts, book jackets, market circulars, magazine inserts, and shopping news, Newspapers, magazine...

  5. Adverse-drug-event data provided by pharmaceutical companies.

    PubMed

    Cudny, Magdalena E; Graham, Angie S

    2008-06-01

    Pharmaceutical company drug information center (PCDIC) responses to queries about adverse drug events (ADEs) were studied to determine whether PCDICs search sources other than the prescribing information on the package insert (PI) and whether the PCDICs' approach differs according to whether an ADE is listed in the PI (labeled) or not (unlabeled). Companies were selected from a list of PCDICs in the Physicians' Desk Reference. One oral or injectable prescription drug from each company was selected. For each drug, a labeled ADE and an unlabeled ADE about which to query the PCDICs were randomly selected from the index of an annual publication on ADEs. The investigators telephoned the PCDICs with an open-ended inquiry about the incidence, timing, and management of the ADE as reported in the literature and the company's internal data; they clarified that the request did not concern a specific patient. Whether or not information was provided, the source searched was recorded (PI, literature, internal database), and the percentages of PCDICs that used each source for labeled and for unlabeled ADEs were analyzed. Results were obtained from 100 companies to questions about 100 drugs (200 ADEs). For ADEs overall, 80% used the PI, 50% the medical literature, and 38% internal data. For labeled versus unlabeled ADEs, respectively, the PI was used by 84% and 76%; literature, both 50%; and internal data, 35% and 41%. The PCDIC specialists referencing the PI did not always provide accurate or up-to-date information. Some specialists, when asked to query internal databases, said that was not an option. For both labeled and unlabeled ADEs, the PI was the primary source used by PCDICs to answer safety questions about their products, and internal data were the least-used source. Most resources used by PCDICs are readily available to practicing pharmacists.

  6. The Labelling of Chemicals.

    ERIC Educational Resources Information Center

    Education in Science, 1979

    1979-01-01

    Describes the impact on chemistry laboratories and teachers in the United Kingdom of the Packaging and Labelling of Dangerous Substances Regulations 1978. These regulations require suppliers to label containers in particular ways. (HM)

  7. Conformity of package inserts information to regulatory requirements among selected branded and generic medicinal products circulating on the East African market.

    PubMed

    Sillo, Hiiti B; Masota, Nelson E; Kisoma, Sunday; Rago, Lembit; Mgoyela, Veronica; Kaale, Eliangiringa A

    2018-01-01

    Availability of correct and adequate information about medicines is an important aspect in ensuring rational use of medicines and hence facilitating safety and expected efficacy of medicines during therapy. Package inserts have proven to be a good source of information to the prescribers and patients whereby they have been useful in highlighting important information pertaining proper use and handling of the medicines. The present study was aimed at establishing the extent to which package inserts of medicines circulating on the markets of the East African Community (EAC) Partner States conform to medicines information requirements as established in the harmonized guidelines as well as national guidelines. A total of 99 package inserts from six (6) types of medicines namely Albendazole, Artemether/Lumefantrine (ALu), Ciprofloxacin, Paracetamol, Amoxicillin and Metronidazole were purposefully collected from three EAC Partner States: Kenya, Tanzania and Uganda. The medicines were selected based on their indications as first line treatments, high rates of utilization within the medicines supply system and their positions in treatment of diseases of public importance across EAC Partner States. The inserts were evaluated on the availability of information regarding fifteen (15) parameters as extracted from the EAC harmonized guidelines for registration of medicines. Moreover, comparisons were made between the percentage conformity of the branded versus generic products, markets from which the samples were collected, origin of the manufacturer and type of medicine. Majority (93.9-100%) of the medicines' package inserts highly conformed to the inclusion of the information regarding the description and composition of the medications, indications, dosage and methods of administration, warnings and precautions, contraindications and storage conditions. However, the information on handling and disposal, container package description, excipients used, clinical pharmacology of the medicines, and directions regarding overdose ranked the least in conformance with conformity ranging from 13.1-52.5%. The parameter with the lowest observed percentage conformity among the branded products scored 50% as compared to 10.8% among the generic products. Moreover, there was no significant difference (P<0.05) in the percentage conformity of the package inserts collected from each of the three Partner States as compared to the average from studied medicines. A generally good conformity was observed among medicines manufactured by European based manufacturers as compared to those based in Asia and EAC Partner States. In addition, PIs of Albendazole, Ciprofloxacin, Amoxicillin and Artemether/Lumefantrine did show overall high conformity across most of the product information requirements. Our study revealed the existence of a significant number of medicinal products circulating on the markets of EAC Partner States without necessary compliance with all product information requirements. We therefore recommend that NMRAs ensure thorough pre-market assessment of product information as well as strengthening their post marketing surveillance to ensure that medicines circulating on the market comply to medicines information requirements at all times. Emphasis should also be given to manufacturers on the importance of inclusion of appropriate and adequate product information for the safety of patients, including advocating for inclusion of patient-friendly and easy to understand medicines information.

  8. 21 CFR 820.130 - Device packaging.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device packaging. 820.130 Section 820.130 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.130 Device packaging. Each manufacturer...

  9. 21 CFR 640.94 - Labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Plasma Protein Fraction (Human) § 640.94 Labeling. In addition... package labels shall contain the following information: (a) The osmotic equivalent in terms of plasma, and...

  10. 21 CFR 640.94 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Plasma Protein Fraction (Human) § 640.94 Labeling. In addition... package labels shall contain the following information: (a) The osmotic equivalent in terms of plasma, and...

  11. 21 CFR 640.94 - Labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Plasma Protein Fraction (Human) § 640.94 Labeling. In addition... package labels shall contain the following information: (a) The osmotic equivalent in terms of plasma, and...

  12. 21 CFR 640.94 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Plasma Protein Fraction (Human) § 640.94 Labeling. In addition... package labels shall contain the following information: (a) The osmotic equivalent in terms of plasma, and...

  13. 21 CFR 640.94 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS Plasma Protein Fraction (Human) § 640.94 Labeling. In addition... package labels shall contain the following information: (a) The osmotic equivalent in terms of plasma, and...

  14. The interactive electrode localization utility: software for automatic sorting and labeling of intracranial subdural electrodes

    PubMed Central

    Tang, Wei; Peled, Noam; Vallejo, Deborah I.; Borzello, Mia; Dougherty, Darin D.; Eskandar, Emad N.; Widge, Alik S.; Cash, Sydney S.; Stufflebeam, Steven M.

    2018-01-01

    Purpose Existing methods for sorting, labeling, registering, and across-subject localization of electrodes in intracranial encephalography (iEEG) may involve laborious work requiring manual inspection of radiological images. Methods We describe a new open-source software package, the interactive electrode localization utility which presents a full pipeline for the registration, localization, and labeling of iEEG electrodes from CT and MR images. In addition, we describe a method to automatically sort and label electrodes from subdural grids of known geometry. Results We validated our software against manual inspection methods in twelve subjects undergoing iEEG for medically intractable epilepsy. Our algorithm for sorting and labeling performed correct identification on 96% of the electrodes. Conclusions The sorting and labeling methods we describe offer nearly perfect performance and the software package we have distributed may simplify the process of registering, sorting, labeling, and localizing subdural iEEG grid electrodes by manual inspection. PMID:27915398

  15. 16 CFR 460.12 - Labels.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.12 Labels. If you are a manufacturer, you must label all packages of your insulation. The labels must contain: (a) The type of insulation. (b) A chart showing these items: (1) For batts and blankets of any...

  16. 16 CFR 460.12 - Labels.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.12 Labels. If you are a manufacturer, you must label all packages of your insulation. The labels must contain: (a) The type of insulation. (b) A chart showing these items: (1) For batts and blankets of any...

  17. 16 CFR 460.12 - Labels.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.12 Labels. If you are a manufacturer, you must label all packages of your insulation. The labels must contain: (a) The type of insulation. (b) A chart showing these items: (1) For batts and blankets of any...

  18. 16 CFR 460.12 - Labels.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.12 Labels. If you are a manufacturer, you must label all packages of your insulation. The labels must contain: (a) The type of insulation. (b) A chart showing these items: (1) For batts and blankets of any...

  19. 16 CFR 460.12 - Labels.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Practices FEDERAL TRADE COMMISSION TRADE REGULATION RULES LABELING AND ADVERTISING OF HOME INSULATION § 460.12 Labels. If you are a manufacturer, you must label all packages of your insulation. The labels must contain: (a) The type of insulation. (b) A chart showing these items: (1) For batts and blankets of any...

  20. 48 CFR 52.247-65 - F.o.b. Origin, Prepaid Freight-Small Package Shipments.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 2 2010-10-01 2010-10-01 false F.o.b. Origin, Prepaid... Text of Provisions and Clauses 52.247-65 F.o.b. Origin, Prepaid Freight—Small Package Shipments. As prescribed in 47.303-17(f), insert the following clause: F.o.b. Origin Prepaid Freight—Small Package...

  1. 9 CFR 317.24 - Packaging materials.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Packaging materials. 317.24 Section... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS General § 317.24 Packaging materials... packaging materials must be safe for their intended use within the meaning of section 409 of the Federal...

  2. Packaging double-helical DNA into viral capsids.

    PubMed

    LaMarque, Jaclyn C; Le, Thuc-Vy L; Harvey, Stephen C

    2004-02-15

    DNA packaging in bacteriophage P4 has been examined using a molecular mechanics model with a reduced representation containing one pseudoatom per turn of the double helix. The model is a discretized version of an elastic continuum model. The DNA is inserted piecewise into the model capsid, with the structure being reoptimized after each piece is inserted. Various optimization protocols were investigated, and it was found that molecular dynamics at a very low temperature (0.3 K) produces the optimal packaged structure. This structure is a concentric spool, rather than the coaxial spool that has been commonly accepted for so many years. This geometry, which was originally suggested by Hall and Schellman in 1982 (Biopolymers Vol. 21, pp. 2011-2031), produces a lower overall elastic energy than coaxial spooling. Copyright 2003 Wiley Periodicals, Inc.

  3. Investigating the Correlation Between Pharmacy Student Performance on the Health Science Reasoning Test and a Critical Thinking Assignment.

    PubMed

    Nornoo, Adwoa O; Jackson, Jonathan; Axtell, Samantha

    2017-03-25

    Objective. To determine whether there is a correlation between pharmacy students' scores on the Health Science Reasoning Test (HSRT) and their grade on a package insert assignment designed to assess critical thinking. Methods. The HSRT was administered to first-year pharmacy students during a critical-thinking course in the spring semester. In the same semester, a required package insert assignment was completed in a pharmacokinetics course. To determine whether there was a relationship between HSRT scores and grades on the assignment, a Spearman's rho correlation test was performed. Results. A very weak but significant positive correlation was found between students' grades on the assignment and their overall HSRT score (r=0.19, p <0.05), as well as deduction (a scale score of the HSRT; r=0.26, p <0.01). Conclusion. Based on a very weak but significant correlation to HSRT scores, this study demonstrated the potential of a package insert assignment to be used as one of the components to measure critical-thinking skills in pharmacy students.

  4. Investigating the Correlation Between Pharmacy Student Performance on the Health Science Reasoning Test and a Critical Thinking Assignment

    PubMed Central

    Jackson, Jonathan; Axtell, Samantha

    2017-01-01

    Objective. To determine whether there is a correlation between pharmacy students’ scores on the Health Science Reasoning Test (HSRT) and their grade on a package insert assignment designed to assess critical thinking. Methods. The HSRT was administered to first-year pharmacy students during a critical-thinking course in the spring semester. In the same semester, a required package insert assignment was completed in a pharmacokinetics course. To determine whether there was a relationship between HSRT scores and grades on the assignment, a Spearman’s rho correlation test was performed. Results. A very weak but significant positive correlation was found between students’ grades on the assignment and their overall HSRT score (r=0.19, p<0.05), as well as deduction (a scale score of the HSRT; r=0.26, p<0.01). Conclusion. Based on a very weak but significant correlation to HSRT scores, this study demonstrated the potential of a package insert assignment to be used as one of the components to measure critical-thinking skills in pharmacy students. PMID:28381884

  5. 21 CFR 201.50 - Statement of identity.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

  6. 21 CFR 201.50 - Statement of identity.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

  7. 21 CFR 201.50 - Statement of identity.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

  8. 21 CFR 201.50 - Statement of identity.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

  9. 21 CFR 201.50 - Statement of identity.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.50 Statement of identity. (a) The label of prescription and insulin-containing drugs in package form shall bear as one of...

  10. 30 CFR 47.92 - Exemptions from labeling.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... COMMUNICATION (HazCom) Exemptions § 47.92 Exemptions from labeling. A hazardous chemical is exempt from subpart... Chemicals Exempt from Labeling Exemption Conditions for exemption Chemical substance, consumer product, hazardous substance, or pesticide When kept in its manufacturer's or supplier's original packaging labeled...

  11. 30 CFR 47.92 - Exemptions from labeling.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... COMMUNICATION (HazCom) Exemptions § 47.92 Exemptions from labeling. A hazardous chemical is exempt from subpart... Chemicals Exempt from Labeling Exemption Conditions for exemption Chemical substance, consumer product, hazardous substance, or pesticide When kept in its manufacturer's or supplier's original packaging labeled...

  12. 30 CFR 47.92 - Exemptions from labeling.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... COMMUNICATION (HazCom) Exemptions § 47.92 Exemptions from labeling. A hazardous chemical is exempt from subpart... Chemicals Exempt from Labeling Exemption Conditions for exemption Chemical substance, consumer product, hazardous substance, or pesticide When kept in its manufacturer's or supplier's original packaging labeled...

  13. 30 CFR 47.92 - Exemptions from labeling.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... COMMUNICATION (HazCom) Exemptions § 47.92 Exemptions from labeling. A hazardous chemical is exempt from subpart... Chemicals Exempt from Labeling Exemption Conditions for exemption Chemical substance, consumer product, hazardous substance, or pesticide When kept in its manufacturer's or supplier's original packaging labeled...

  14. 21 CFR 1302.04 - Location and size of symbol on label and labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Location and size of symbol on label and labeling. 1302.04 Section 1302.04 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.04 Location and size of symbol on label...

  15. 21 CFR 1302.04 - Location and size of symbol on label and labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 9 2011-04-01 2011-04-01 false Location and size of symbol on label and labeling. 1302.04 Section 1302.04 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.04 Location and size of symbol on label...

  16. 21 CFR 1302.04 - Location and size of symbol on label and labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Location and size of symbol on label and labeling. 1302.04 Section 1302.04 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.04 Location and size of symbol on label...

  17. Nutrition labelling and the choices logo in Israel: positions and perceptions of leading health policy makers.

    PubMed

    Gesser-Edelsburg, A; Endevelt, R; Tirosh-Kamienchick, Y

    2014-02-01

    Based on the Social Marketing approach and Diffusion of Innovations Theory that indicates the importance of opinion leaders with respect to the spreading of new ideas, concepts or practices within a community, the present study aimed to examine positions and perceptions of Israeli leading dietitians and health officials regarding nutrition labelling and the Choices logo, before it was launched in Israel in February 2011, as well as how they would communicate it to the public as agents of influence. The study involved in-depth face-to-face and telephone interviews with 15 senior dietitians and Health Ministry officials using semi-structured protocols including questions about nutrition labelling and the Choices logo. The respondents considered that the nutrition facts panels usually found on the backs of packages are too complicated for the average consumer. Simiularly, fronts of packages are cluttered with advertisements and health claims, causing confusion. The study participants would like to see an integrative label on the front of the package to facilitate consumers' decisions. However, the Choices logo raises ethical and social questions about the conflict between corporate interests and public health: (i) the label's relativity versus objectivity; (ii) the consumer's responsibility to create a balanced diet; (iii) the label's credibility; and (iv) bias against companies, products and audiences. The results of the present study highlight the importance of a need for an integrated programme of nutrition promotion, including the use of social marketing based on a cooperative effort between the food industry, regulators and professionals, to recommend changes and adjustments in nutritional front of package labelling with the aim of promoting healthier nutrition consumption. © 2013 The Authors Journal of Human Nutrition and Dietetics © 2013 The British Dietetic Association Ltd.

  18. Pictorial Health Warning Labels on Cigarette Packages: An Investigation on Opinions of Male Smokers

    PubMed Central

    Shojaezadeh, Davoud; Peyman, Nooshin; Shakeri, Mohammad Taghi; Nedjat, Saharnaz; Mohaddes Hakkak, Abbas; Taghdisi, Mohammad Hossein; Mohaddes Hakkak, Hamid Reza; Shariati, Keivan; Taghipour, Ali

    2014-01-01

    Background: Health warning labels on cigarette packages are among the most straightforward and important tools to communicate with smokers and various studies have illustrated their efficacy. Objectives: The current study aimed to investigate the opinions of male smokers in Mashhad city about the efficacy of health warning labels printed on cigarette packages on the smoking status of smokers. Patients and Methods: This cross-sectional descriptive study was conducted in 2013 using a questionnaire. The research population included the male smokers of Mashhad. The participants were selected from the customers referring to the newsstands for cigarettes. The obtained data were analyzed employing SPSS software Version 16, and the statistical tests including Kruskal-Wallis, Spearman, and correlation coefficient of Pearson, Chi Square, Mann-Whitney, and Bonferroni correction were used in this regard. Results: In this research, there were 500 participants with the average age of 25 years. The initiation age of smoking was eight years while the maximum age was reported as 45 years. Results of this research about the effect of these labels on decreasing cigarette consumption rate showed that almost half of the participants believed that these labels were ineffective for them (52.2%) and other smokers (53.8%).Furthermore, significant relationship was found between the age and opinion of the smokers about the influence of these labels on reducing their cigarette consumption (P < 0.001). Conclusions: To promote the effect of printed images on cigarette packages, it is recommended to consider the suitability of labels in the targeted culture. In addition, to be more effective consultation sites to quit smoking should be introduced under the images. PMID:24829777

  19. POISON POLITICS: A Contentious History of Consumer Protection Against Dangerous Household Chemicals in the United States

    PubMed Central

    Benrubi, Isidore Daniel

    2013-01-01

    The history of consumer protection against household poisons presents a key case study of the uniquely American struggle to balance public health and safety with the interests of business. By the late 19th century, package designs, warning labels, and state statutes had formed an uneven patchwork of protective mechanisms against accidental poisonings. As household chemicals proliferated in the early 20th century, physicians concerned with childhood poisonings pressured the federal government to enact legislation mandating warning labels on packaging for these substances. Manufacturers of household chemicals agreed to labeling requirements for caustic poisons but resisted broader regulation. Accidental poisonings of children continued to increase until the enactment of broad labeling and packaging legislation in the 1960s and 1970s. This history suggests that voluntary agreements between government agencies and manufacturers are inadequate to protect consumers against household poisonings and that, in the United States, protective household chemical regulation proceeds in a reactive rather than a precautionary manner. PMID:23488510

  20. Poison politics: a contentious history of consumer protection against dangerous household chemicals in the United States.

    PubMed

    Jones, Marian Moser; Benrubi, Isidore Daniel

    2013-05-01

    The history of consumer protection against household poisons presents a key case study of the uniquely American struggle to balance public health and safety with the interests of business. By the late 19th century, package designs, warning labels, and state statutes had formed an uneven patchwork of protective mechanisms against accidental poisonings. As household chemicals proliferated in the early 20th century, physicians concerned with childhood poisonings pressured the federal government to enact legislation mandating warning labels on packaging for these substances. Manufacturers of household chemicals agreed to labeling requirements for caustic poisons but resisted broader regulation. Accidental poisonings of children continued to increase until the enactment of broad labeling and packaging legislation in the 1960s and 1970s. This history suggests that voluntary agreements between government agencies and manufacturers are inadequate to protect consumers against household poisonings and that, in the United States, protective household chemical regulation proceeds in a reactive rather than a precautionary manner.

  1. 7 CFR 205.308 - Agricultural products in other than packaged form at the point of retail sale that are sold...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... the point of retail sale that are sold, labeled, or represented as â100 percent organicâ or âorganic.â... Information § 205.308 Agricultural products in other than packaged form at the point of retail sale that are... name of the product in retail display, labeling, and display containers: Provided, That, the term...

  2. 7 CFR 205.308 - Agricultural products in other than packaged form at the point of retail sale that are sold...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... the point of retail sale that are sold, labeled, or represented as â100 percent organicâ or âorganic.â... Information § 205.308 Agricultural products in other than packaged form at the point of retail sale that are... name of the product in retail display, labeling, and display containers: Provided, That, the term...

  3. 7 CFR 205.308 - Agricultural products in other than packaged form at the point of retail sale that are sold...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... the point of retail sale that are sold, labeled, or represented as â100 percent organicâ or âorganic.â... Information § 205.308 Agricultural products in other than packaged form at the point of retail sale that are... name of the product in retail display, labeling, and display containers: Provided, That, the term...

  4. Effects of plain packaging, warning labels, and taxes on young people's predicted sugar-sweetened beverage preferences: an experimental study.

    PubMed

    Bollard, Tessa; Maubach, Ninya; Walker, Natalie; Ni Mhurchu, Cliona

    2016-09-01

    Consumption of sugar-sweetened beverages (SSBs) is associated with increased risk of obesity, diabetes, heart disease and dental caries. Our aim was to assess the effects of plain packaging, warning labels, and a 20 % tax on predicted SSB preferences, beliefs and purchase probabilities amongst young people. A 2 × 3 × 2 between-group experimental study was conducted over a one-week period in August 2014. Intervention scenarios were delivered, and outcome data collected, via an anonymous online survey. Participants were 604 New Zealand young people aged 13-24 years who consumed soft drinks regularly. Participants were randomly allocated using a computer-generated algorithm to view one of 12 experimental conditions, specifically images of branded versus plain packaged SSBs, with either no warning, a text warning, or a graphic warning, and with or without a 20 % tax. Participant perceptions of the allocated SSB product and of those who might consume the product were measured using seven-point Likert scales. Purchase probabilities were measured using 11-point Juster scales. Six hundred and four young people completed the survey (51 % female, mean age 18 (SD 3.4) years). All three intervention scenarios had a significant negative effect on preferences for SSBs (plain packaging: F (6, 587) = 54.4, p <0.001; warning label: F (6, 588) = 19.8, p <0.001; 20 % tax: F (6, 587) = 11.3, p <0.001). Plain packaging and warning labels also had a significant negative impact on reported likelihood of purchasing SSB's (p = <0.001). A 20 % tax reduced participants' purchase probability but the difference was not statistically significant (p = 0.2). Plain packaging and warning labels significantly reduce young people's predicted preferences for, and reported probability of purchasing, SSBs.

  5. 21 CFR 820.120 - Device labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Device labeling. 820.120 Section 820.120 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES QUALITY SYSTEM REGULATION Labeling and Packaging Control § 820.120 Device labeling. Each manufacturer...

  6. Influence of packaging information on consumer liking of chocolate milk.

    PubMed

    Kim, M K; Lopetcharat, K; Drake, M A

    2013-08-01

    Chocolate milk varies widely in flavor, color, and viscosity, and liking is influenced by these properties. Additionally, package labels (declared fat content) and brand are some of the extrinsic factors that may influence consumer perception. The objective of this study was to evaluate the effects of packaging labels and brand name on consumer liking and purchase intent of chocolate milk. A consumer acceptance test, conjoint analysis survey, and Kano analysis were conducted. One hundred eight consumers evaluated 7 chocolate milks with and without brand or package information in a 2-d crossover design. A conjoint analysis survey and Kano analysis were conducted after the consumer acceptance test. Results were evaluated by 2-way ANOVA and multivariate analyses. Declared fat content and brand influenced overall liking and purchase intent for chocolate milks to differing degrees. A subsequent conjoint analysis (n=250) revealed that fat content was a driver of choice for purchasing chocolate milk followed by sugar content and brand. Brand name was less important for purchase intent of chocolate milk than fat or sugar content. Among fat content of chocolate milk, 2 and 1% fat level were most appealing to consumers, and reduced sugar and regular sugar were equally important for purchase intent. Kano analysis confirmed that fat content (whole milk, 1, or 2% fat chocolate milk) was an attractive attribute for consumer satisfaction, more so than brand. Organic labeling did not affect the purchase decision of chocolate milk; however, Kano results revealed that having an organic label on a package positively influenced consumer satisfaction. Findings from this study can help chocolate milk producers as well as food marketers better target their product labels with attributes that drive consumer choice of chocolate milk. Copyright © 2013 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

  7. Characteristics of illegal and legal cigarette packs sold in Guatemala.

    PubMed

    Arevalo, Rodrigo; Corral, Juan E; Monzon, Diego; Yoon, Mira; Barnoya, Joaquin

    2016-11-25

    Guatemala, as a party to the Framework Convention on Tobacco Control (FCTC), is required to regulate cigarette packaging and labeling and eliminate illicit tobacco trade. Current packaging and labeling characteristics (of legal and illegal cigarettes) and their compliance with the FCTC is unknown. We sought to analyze package and label characteristics of illegal and legal cigarettes sold in Guatemala. We visited the 22 largest traditional markets in the country to purchase illegal cigarettes. All brands registered on tobacco industry websites were purchased as legal cigarettes. Analysis compared labeling characteristics of illegal and legal packs. Most (95%) markets and street vendors sold illegal cigarettes; 104 packs were purchased (79 illegal and 25 legal). Ten percent of illegal and none of the legal packs had misleading terms. Half of the illegal packs had a warning label covering 26 to 50% of the pack surface. All legal packs had a label covering 25% of the surface. Illegal packs were more likely to have information on constituents and emissions (85% vs. 45%, p < 0.001) and were less expensive than legal ones (USD 0.70 ± 0.7 and 1.9 ± 1.8, p < 0.001). In Guatemala, neither illegal nor legal cigarette packs comply with FCTC labeling mandates. Urgent implementation and enforcement of the FCTC is necessary to halt the tobacco epidemic.

  8. Packaging of pharmaceuticals: still too many dangers but several encouraging initiatives.

    PubMed

    2007-06-01

    (1) In 2006 in France, several drugs sold in poorly designed packaging exposed patients to a risk of serious adverse effects. (2) In 2006, Prescrire used a standardised methodology to examine the packaging of all new pharmaceutical products (656 different boxes) assessed in the New Products section of our French edition, la revue Prescrire. About 75% of these boxes contained tablets or capsules, mostly in blister packs. (3) Poor labelling remains a major problem. The international nonproprietary names (INN) is hard to spot on most boxes of patented brand-name drugs and is often overshadowed by the brand name. The primary packaging of many products does not even include the INN. (4) Two particularly ambiguous types of labelling are becoming more common on blister packs: pre-cut multiple-unit blister packs on which the labelling is truncated when a unit blister is removed; and blister packs on which the labelling spans two blisters, creating a risk of overdose. (5) The use of colours is frequently inappropriate. In particular, irrelevant information is often highlighted unnecessarily, while other, important information is barely visible. (6) Too many devices for oral administration create a risk of misuse. Very few are graduated in units of weight. Most are graduated in millilitres, obliging caregivers to use conversion charts and thus creating a risk of dosing errors. Devices graduated in kg bodyweight can also lead to dosing errors. (7) The labelling of some injectable drugs is barely legible. The various models of plastic ampoules, that are gradually replacing glass ampoules, can represent a danger because they resemble other plastic ampoules containing products administered by different routes. Packaging that does not provide a syringe or needle can cause problems for caregivers and represents another potential source of error. (8) Many of the patient information leaflets examined in 2006 had the same flaws as previously observed, i.e. uneven information quality, discrepancies between different sections, and out-of-date information. More and more French leaflets now include insets offering "Health Advice". There are better and worse examples, but there is no guarantee that they have been properly reviewed by the regulatory agency. (9) Increasingly drug boxes include pictograms, even though several studies have shown they are often difficult to interpret. And most boxes of generics also now include standard dosing schedules that are not always appropriate and may create a risk of dosing errors with potentially serious consequences. (10) 67 multidose bottles examined in 2006 had no childproof safety cap. Some contained psychotropics, which can have life-threatening effects if accidentally consumed in large amounts. (11) Some manufacturers have adopted realistic solutions to these problems. In particular, generics manufacturers again improved product labelling in 2006 (emphasis on the INN), appropriate use of colours for dose differentiation, and, encouragingly, far more Braille labels. (12) In 2006, the French regulatory agency introduced several measures aimed at improving the labelling of ampoules containing some injectable drugs. The impact of these measures was visible on several products marketed in 2006, including plastic vials of solutions for nebulization. (13) Several other examples of well-designed packaging were seen: safety devices on prefilled syringes; a childproof safety device; a tamperproof ring; unit-dose blister packs; clearly written patient leaflets; and the use of clear and appropriate symbols and pictograms. (14) In practice, in view of the large number of incidents recorded in 2006, and the plethora of packaging designs, caregivers should take time to analyse and discuss drug packaging. In this way, they will be in a position to distinguish between good and bad drug packaging, and to anticipate the risks associated with poorly designed packaging. (15) There are many ways in which drug regulatory authorities can help to ensure that drugs are sold in safe packaging. The French regulatory agency's work on the labelling of injectable drugs is an encouraging step. European Directive 2004/27/EC on medicines for human use provides for improvements in labelling (e.g. Braille) and patient information leaflets. Transposition of these measures into French law should lead to a number of improvements, provided the relevant regulations and guidelines place patients' interests first.

  9. Pilot Fullerton uses water dispenser kit gun to rehydrate food package

    NASA Image and Video Library

    1982-03-30

    STS003-26-254 (30 March 1982) --- Astronaut Gordon Fullerton, STS-3 pilot, wearing communications kit assembly (ASSY) mini-headset (HDST), inserts the JSC water dispenser kit water gun in rehydratable plastic food (cereal) package to fill it with hot water. Photo credit: NASA

  10. A study of the nonprescription drug consumer's understanding of the ranitidine product label and actual product usage patterns in the treatment of episodic heartburn.

    PubMed

    Ciociola, A A; Sirgo, M A; Pappa, K A; McGuire, J A; Fung, K

    2001-01-01

    A study of the consumer's understanding of the product label instructions and the resulting product use were conducted to support the switch of a product from prescription to nonprescription status. H2 receptor antagonists have recently been approved for nonprescription use. This study evaluated the consumer's understanding of the product label for ranitidine hydrochloride (Zantac 75) and the product usage pattern in the treatment of episodic heartburn. Our objectives were to evaluate each aspect of the communication of labeled indications, contraindications, and directions for use of two label formats (old and new) for a new nonprescription preparation of ranitidine (Zantac) and to evaluate nonprescription consumers' use of ranitidine 75-mg tablets (as Zantac 75) in a medically unsupervised, at-home setting to observe whether these consumers used the product appropriately and followed directions as written on the package label. Adult male and female consumers (n = 1405) in a shopping mall environment who were attracted to a poster asking, "Do you have stomach problems?" were recruited for the label comprehension phase (two different label formats) and the 3-week usage phase if after reading the Zantac 75 package label they decided the product was appropriate for them. No instructions regarding the use of Zantac 75 were provided beyond what was printed on the package label. Subjects recorded use in a diary and tablet counts were performed at the end of the study period. A medical history was also taken at this time and an assessment of product use was performed by a physician. In at least 84% of all subjects, both formats were effective in the communication of label objectives for the contraindication against concurrent prescription stomach ulcer medication, maximum daily dose, and maximum duration of dosing at maximum daily doses. The direction to take one tablet per dose was adhered to by 90% of consumers, and 90% of consumers followed the instructions to take no more than two tablets in 24 hours. Ninety-six percent of consumers complied with the direction not to take the maximum daily dose for more than 14 consecutive days. Notably, the maximum daily dose was taken for < or =3 consecutive days by 79% of consumers. The most frequently reported adverse events were headache, acute nasopharyngitis, upper respiratory tract infection, diarrhea, nausea, and menstrual cramps. The study demonstrated that the vast majority of a large sample of unsupervised consumers understood the package label and fully complied with the package directions by not exceeding the maximum daily dosage and length of use. Nonprescription consumers safely used Zantac 75 without medical supervision.

  11. Comparison of two front-of-package nutrition labeling schemes, and their explanation, on consumers' perception of product healthfulness and food choice.

    PubMed

    Lundeberg, Pamela J; Graham, Dan J; Mohr, Gina S

    2018-06-01

    Front-of-package (FOP) nutrition labels are increasingly used to present nutritional information to consumers. A variety of FOP nutrition schemes exist for presenting condensed nutrition information. The present study directly compared two symbolic FOP labeling systems - traffic light and star-based schemes - with specific regard to healthfulness perception and purchase intention for a variety of products. Additionally, this study investigated which method of message framing (gain, loss, gain + loss) would best enable individuals to effectively utilize the FOP labels. College students (n = 306) viewed food packages featuring either star or traffic light FOP labels and rated the healthfulness of each product and their likelihood of purchasing the product. Within each label type, participants were presented with differently-framed instructions regarding how to use the labels. Participants who viewed the star labels rated products with the lowest healthfulness as significantly less healthful and rated products with the highest healthfulness as significantly more healthful compared to participants who viewed those same products with traffic light labels. Purchase intention did not differ by label type. Additionally, including any type of framing (gain, loss, or gain + loss) assisted consumers in differentiating between foods with mid-range vs. low nutritional value. Star-based labels led more healthful foods to be seen as even more healthful and less healthful foods to be seen as even less healthful compared to the same foods with traffic light labels. Additionally, results indicate a benefit of including framing information for FOP nutrition label instructions; however, no individual frame led to significantly different behavior compared to the other frames. While ratings of product healthfulness were influenced by the framing and the label type, purchase intention was not impacted by either of these factors. Copyright © 2018 Elsevier Ltd. All rights reserved.

  12. 76 FR 251 - Country of Origin Labeling of Packed Honey

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-04

    ...-AC89 Country of Origin Labeling of Packed Honey AGENCY: Agricultural Marketing Service, USDA. ACTION... addressing country of origin labeling for packed honey bearing any official USDA mark or statement. Also, the... origin labeling requirements are not met for packages of honey containing official USDA grade marks or...

  13. 78 FR 34565 - Modification of Mandatory Label Information for Wine

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-10

    ... advertising of wine. Section 4.10 (27 CFR 4.10) defines a brand label as the label carrying, in the usual... Advertising Requirements Under the Federal Alcohol Administration Act,'' and assigned control number 1513-0087... Advertising, Customs duties and inspection, Imports, Labeling, Packaging and containers, Reporting and...

  14. 49 CFR 172.405 - Authorized label modifications.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... subsidiary label. (b) For a package containing Oxygen, compressed, or Oxygen, refrigerated liquid, the OXIDIZER label specified in § 172.426 of this subpart, modified to display the word “OXYGEN” instead of... OXIDIZER labels. Notwithstanding the provisions of paragraph (a) of this section, the word “OXYGEN” must...

  15. 21 CFR 1302.05 - Effective dates of labeling requirements.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 9 2012-04-01 2012-04-01 false Effective dates of labeling requirements. 1302.05 Section 1302.05 Food and Drugs DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES § 1302.05 Effective dates of labeling requirements. All...

  16. 21 CFR 501.17 - Animal food labeling warning statements.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Animal food labeling warning statements. 501.17... food labeling warning statements. (a) Self-pressurized containers. (1) The label of a food packaged in... the following warning: Warning Avoid spraying in eyes. Contents under pressure. Do not puncture or...

  17. Bacterial quality and safety of packaged fresh leafy vegetables at the retail level in Finland.

    PubMed

    Nousiainen, L-L; Joutsen, S; Lunden, J; Hänninen, M-L; Fredriksson-Ahomaa, M

    2016-09-02

    Consumption of packaged fresh leafy vegetables, which are convenient ready-to-eat products, has increased during the last decade. The number of foodborne outbreaks associated with these products has concurrently increased. In our study, (1) label information, (2) O2/CO2 composition, (3) bacterial quality and (4) safety of 100 fresh leafy vegetables at the retail level were studied in Finland during 2013. Bacterial quality was studied using aerobic bacteria (AB) and coliform bacteria (CB) counts, and searching for the presence of Escherichia coli, Listeria and Yersinia. The safety was studied by the presence of Salmonella, ail-positive Yersinia, stx-positive E. coli (STEC) and Listeria monocytogenes using PCR and culturing. Important label information was unavailable on several packages originating from different companies. The packaging date was missing on all packages and the date of durability on 83% of the packages. Storage temperature was declared on 62% of the packages and 73% of the packages contained information about prewashing. The batch/lot number was missing on 29% of the packages. Very low oxygen (O2) (<1%) and elevated carbon dioxide (CO2) (2-22%) concentrations were measured in all packages labelled to contain a protective atmosphere. O2 and CO2 concentrations varied widely in the rest of the packages. AB and CB counts were high in the leafy vegetable samples varying between 6.2 and 10.6 and 4.2-8.3logcfu/g, respectively. In most of the samples, the AB and CB counts exceeded 10(8) and 10(6)cfu/g, respectively. A positive correlation was observed between the AB and CB counts. E. coli was isolated from 15% of the samples and Yersinia from 33%. L. monocytogenes was isolated from two samples and ail-positive Y. enterocolitica in one. Using PCR, STEC was detected in seven samples, and Salmonella and ail-positive Y. enterocolitica in two samples each. The AB and CB mean values of products originating from different companies varied widely. High AB and CB counts and pathogenic bacteria were detected in ready-to-eat products not needing washing before use. Our study shows that the bacterial quality and safety of packaged fresh leafy vegetables is poor and label information on the packages is inadequate. More studies are needed concerning the impact of a protective atmosphere on bacterial growth, and the impact of washing for removing bacteria. Copyright © 2016 Elsevier B.V. All rights reserved.

  18. 21 CFR 501.8 - Labeling of animal food with number of servings.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Labeling of animal food with number of servings... SERVICES (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.8 Labeling of animal food with number of servings. (a) The label of any package of a food which...

  19. Health Instruction Packages: Specific Nursing Skills.

    ERIC Educational Resources Information Center

    Bates, Clarice; And Others

    Text, illustrations, and exercises are utilized in a set of five learning modules designed to instruct nursing students in a variety of clinical skills. The first module, "Down the Tube: Insertion of a Nasogastric Tube" by Clarice Bates, describes materials and procedures used to insert a nasogastric tube through the nose and esophagus…

  20. 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.

  1. 21 CFR 501.2 - Information panel of package for animal food.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 6 2011-04-01 2011-04-01 false Information panel of package for animal food. 501... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.2 Information panel of package for animal food. (a) The term information panel as it applies to packaged food...

  2. 21 CFR 501.2 - Information panel of package for animal food.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 6 2013-04-01 2013-04-01 false Information panel of package for animal food. 501... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.2 Information panel of package for animal food. (a) The term information panel as it applies to packaged food...

  3. 21 CFR 501.2 - Information panel of package for animal food.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 6 2012-04-01 2012-04-01 false Information panel of package for animal food. 501... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.2 Information panel of package for animal food. (a) The term information panel as it applies to packaged food...

  4. 21 CFR 501.2 - Information panel of package for animal food.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 6 2014-04-01 2014-04-01 false Information panel of package for animal food. 501... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.2 Information panel of package for animal food. (a) The term information panel as it applies to packaged food...

  5. 21 CFR 501.2 - Information panel of package for animal food.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 6 2010-04-01 2010-04-01 false Information panel of package for animal food. 501... (CONTINUED) ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS ANIMAL FOOD LABELING General Provisions § 501.2 Information panel of package for animal food. (a) The term information panel as it applies to packaged food...

  6. Dual Use of Packaging on the Moon: Logistics-2-Living

    NASA Technical Reports Server (NTRS)

    Howe, A. Scott; Howard, Robert

    2010-01-01

    This paper describes a modular packaging system for logistics that can be reconfigured into internal outfitting for a lunar outpost, including desks, chairs, partitions, cabinets, and radiation shielding. Logistics include clothes, equipment, food, and other consumables needed to sustain the crew for the duration of the mission. A significant mass penalty is required for the packaging and handling of logistics for re-supply of short to long-term space missions that must be brought out of the gravity well on a launch vehicle. Once the supplies have been exhausted, the packaging material is typically of no further use and is discarded. If a scheme can be developed that reuses the logistics packaging, the mass penalty can be reduced. In this research, a modular packaging system has been devised as a kit-of-parts that can be used for both handling logistics supplies, and then reconfigured into desks, chairs, partitions, cabinets, and radiation shielding. The system is derived from a standard International Space Station (ISS)-type Cargo Transfer Bag (CTB), using soft, unfoldable box-like containers with stiff metal inserts. The empty hydrogen-impregnated CTBs can be used as-is for cabinets, opened up for use as partitions, or draped over the habitat as layers of radiation shielding. Stiff metal inserts can be reconfigured into desks and other useful outfitting.

  7. 21 CFR 347.52 - Labeling of astringent drug products.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... states “[bullet] dissolve 1 to 3 packets in [insert volume] of cool or warm water [bullet] stir until... [bullet] stir until fully dissolved; do not strain or filter. The resulting mixture contains [insert...

  8. Intra-Operative Dosimetry in Prostate Brachytherapy

    DTIC Science & Technology

    2008-04-01

    labels in the ith la - beled seed-only image. The seed region with label k in ith image is covered by ||Ωik|| seeds where ||Ω i k|| is the cardinal of...using acetol. The phantom consists of twelve slabs with thickness of 5 mm and each slab has at least a hundred holes with 5 mm spacing where seeds can be...fiducial & the needle insertion template can be pre-calibrated using a rigid mount.(a) A CAD model of the FTRAC fiducial mounted on the seed-insertion needle

  9. Reliability Technology to Achieve Insertion of Advanced Packaging (RELTECH) program

    NASA Astrophysics Data System (ADS)

    Fayette, Daniel F.; Speicher, Patricia; Stoklosa, Mark J.; Evans, Jillian V.; Evans, John W.; Gentile, Mike; Pagel, Chuck A.; Hakim, Edward

    1993-08-01

    A joint military-commercial effort to evaluate multichip module (MCM) structures is discussed. The program, Reliability Technology to Achieve Insertion of Advanced Packaging (RELTECH), has been designed to identify the failure mechanisms that are possible in MCM structures. The RELTECH test vehicles, technical assessment task, product evaluation plan, reliability modeling task, accelerated and environmental testing, and post-test physical analysis and failure analysis are described. The information obtained through RELTECH can be used to address standardization issues, through development of cost effective qualification and appropriate screening criteria, for inclusion into a commercial specification and the MIL-H-38534 general specification for hybrid microcircuits.

  10. Current oral contraceptive use instructions: an analysis of patient package inserts.

    PubMed

    Williams-Deane, M; Potter, L S

    1992-01-01

    Oral contraceptive use instructions contained in manufacturers' patient package inserts (PPIs) are often inconsistent or conflicting, both among manufacturers and among different brands and regimens from the same manufacturer. Instructions on what to do about missed pills are often incomplete or inadequate, as are instructions on backup contraceptive use when pills are missed. The format of many PPIs is confusing and makes instructions difficult to find and read. Comprehending the PPIs requires the user to read at a 10th-12th-grade level, far higher than the generally accepted 5th-6th grade level considered standard for health education materials.

  11. Reliability Technology to Achieve Insertion of Advanced Packaging (RELTECH) program

    NASA Technical Reports Server (NTRS)

    Fayette, Daniel F.; Speicher, Patricia; Stoklosa, Mark J.; Evans, Jillian V.; Evans, John W.; Gentile, Mike; Pagel, Chuck A.; Hakim, Edward

    1993-01-01

    A joint military-commercial effort to evaluate multichip module (MCM) structures is discussed. The program, Reliability Technology to Achieve Insertion of Advanced Packaging (RELTECH), has been designed to identify the failure mechanisms that are possible in MCM structures. The RELTECH test vehicles, technical assessment task, product evaluation plan, reliability modeling task, accelerated and environmental testing, and post-test physical analysis and failure analysis are described. The information obtained through RELTECH can be used to address standardization issues, through development of cost effective qualification and appropriate screening criteria, for inclusion into a commercial specification and the MIL-H-38534 general specification for hybrid microcircuits.

  12. 21 CFR 70.25 - Labeling requirements for color additives (other than hair dyes).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... suitable for coloring the human body, shall state: (1) The name of the straight color or the name of each... AND HUMAN SERVICES GENERAL COLOR ADDITIVES Packaging and Labeling § 70.25 Labeling requirements for...

  13. 21 CFR 70.25 - Labeling requirements for color additives (other than hair dyes).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... suitable for coloring the human body, shall state: (1) The name of the straight color or the name of each... AND HUMAN SERVICES GENERAL COLOR ADDITIVES Packaging and Labeling § 70.25 Labeling requirements for...

  14. 49 CFR 172.405 - Authorized label modifications.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... appear on the label. (c) For a package containing a Division 6.1, Packing Group III material, the POISON label specified in § 172.430 may be modified to display the text “PG III” instead of “POISON” or “TOXIC...

  15. 49 CFR 172.405 - Authorized label modifications.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... appear on the label. (c) For a package containing a Division 6.1, Packing Group III material, the POISON label specified in § 172.430 may be modified to display the text “PG III” instead of “POISON” or “TOXIC...

  16. 49 CFR 172.405 - Authorized label modifications.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... appear on the label. (c) For a package containing a Division 6.1, Packing Group III material, the POISON label specified in § 172.430 may be modified to display the text “PG III” instead of “POISON” or “TOXIC...

  17. 49 CFR 172.405 - Authorized label modifications.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... appear on the label. (c) For a package containing a Division 6.1, Packing Group III material, the POISON label specified in § 172.430 may be modified to display the text “PG III” instead of “POISON” or “TOXIC...

  18. 21 CFR 201.310 - Phenindione; labeling of drug preparations intended for use by man.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... in the medical literature and data accumulated by the Food and Drug Administration indicate that... label and labeling on or within the package from which the drug is to be dispensed, and any other...

  19. 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.

  20. 21 CFR 70.20 - Packaging requirements for straight colors (other than hair dyes).

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Packaging requirements for straight colors (other than hair dyes). 70.20 Section 70.20 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL COLOR ADDITIVES Packaging and Labeling § 70.20 Packaging requirements for straight colors (other than hair dyes)....

  1. Reading the Small Print – Labelling Recommendations for Orthopaedic Implants

    PubMed Central

    Haene, Roger A; Sandhu, Ranbir S; Baxandall, Richard

    2009-01-01

    INTRODUCTION There exist, currently, no clear guidelines regarding standards for surgical implant labelling. Dimensions of the laminar flow canopies in orthopaedic use fixes the distance at which implant labels can be read. Mistakes when reading the label on an implant box can pose health risks for patients, and financial consequences for medical institutions. SUBJECTS AND METHODS Using scientifically validated tools such as the Snellen Chart Formula, a theoretical minimum standard for text on implant labels was reached. This theoretical standard was then tested under real operating conditions. After discovering a minimum practical standard for implant labels, the authors then audited current labels in use on a wide range of orthopaedic implant packages. Furthermore, other non-text-related labelling problems were also noted. RESULTS There is a definite minimum standard which should be observed when implant labels are manufactured. Implants in current use bear labels on the packaging that are of an insufficient standard to ensure patient safety in theatre. CONCLUSIONS The authors have established text parameters that will increase the legibility of implant labels. In the interests of improving risk management in theatre, therefore, the authors propose a standard for orthopaedic implant labelling, and believe this will provide a useful foundation for further discussion between the orthopaedic community and implant manufacturers. PMID:19686615

  2. Packaging of microwave integrated circuits operating beyond 100 GHz

    NASA Technical Reports Server (NTRS)

    Samoska, L.; Daniel, E.; Sokolov, V.; Sommerfeldt, S.; Bublitz, J.; Olson, K.; Gilbert, B.; Chow, D.

    2002-01-01

    Several methods of packaging high speed (75-330 GHz) InP HEMT MMIC devices are discussed. Coplanar wirebonding is presented with measured insertion loss of less than 0.5dB and return loss better than -17 dB from DC to 110 GHz. A motherboard/daughterboard packaging scheme is presented which supports minimum loss chains of MMICs using this coplanar wirebonding method. Split waveguide block packaging approaches are presented in G-band (140-220 GHz) with two types of MMIC-waveguide transitions: E-plane probe andantipodal finline.

  3. 21 CFR 101.2 - Information panel of package form food.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Section 101.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.2 Information panel of package... from the size and placement requirements of this section. (ii) Soft drinks packaged in bottles shall be...

  4. 21 CFR 101.2 - Information panel of package form food.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Section 101.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.2 Information panel of package... from the size and placement requirements of this section. (ii) Soft drinks packaged in bottles shall be...

  5. 21 CFR 101.2 - Information panel of package form food.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Section 101.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.2 Information panel of package... from the size and placement requirements of this section. (ii) Soft drinks packaged in bottles shall be...

  6. 21 CFR 101.2 - Information panel of package form food.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Section 101.2 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION FOOD LABELING General Provisions § 101.2 Information panel of package... from the size and placement requirements of this section. (ii) Soft drinks packaged in bottles shall be...

  7. 9 CFR 592.340 - Supervision of marking and packaging.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Supervision of marking and packaging... § 592.340 Supervision of marking and packaging. (a) Evidence of label approval. Inspection program... product or container thereof except by an inspection program employee or under the supervision of an...

  8. 9 CFR 592.340 - Supervision of marking and packaging.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Supervision of marking and packaging... § 592.340 Supervision of marking and packaging. (a) Evidence of label approval. Inspection program... product or container thereof except by an inspection program employee or under the supervision of an...

  9. 9 CFR 592.340 - Supervision of marking and packaging.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Supervision of marking and packaging... § 592.340 Supervision of marking and packaging. (a) Evidence of label approval. Inspection program... product or container thereof except by an inspection program employee or under the supervision of an...

  10. 9 CFR 592.340 - Supervision of marking and packaging.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Supervision of marking and packaging... § 592.340 Supervision of marking and packaging. (a) Evidence of label approval. Inspection program... product or container thereof except by an inspection program employee or under the supervision of an...

  11. 9 CFR 592.340 - Supervision of marking and packaging.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Supervision of marking and packaging... § 592.340 Supervision of marking and packaging. (a) Evidence of label approval. Inspection program... product or container thereof except by an inspection program employee or under the supervision of an...

  12. 75 FR 81943 - Appliance Labeling Rule

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-29

    ....\\5\\ This substantial increase--from as many as 1,500 packaging styles per full- line bulb manufacturer in 1994 to as many as 3,500 packaging styles today--greatly increases the burden on manufacturers.... Specifically, the much larger number of packaging styles involved than in 1994, the difficulties posed by...

  13. 14 CFR 135.23 - Manual contents.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... packages that are marked or labeled as containing hazardous materials or that show signs of containing... packages that do not conform to the Hazardous Materials Regulations in 49 CFR parts 171 through 180 or that... information to ensure the following: (A) That packages containing hazardous materials are properly offered and...

  14. On the Total Edge Irregularity Strength of Generalized Butterfly Graph

    NASA Astrophysics Data System (ADS)

    Dwi Wahyuna, Hafidhyah; Indriati, Diari

    2018-04-01

    Let G(V, E) be a connected, simple, and undirected graph with vertex set V and edge set E. A total k-labeling is a map that carries vertices and edges of a graph G into a set of positive integer labels {1, 2, …, k}. An edge irregular total k-labeling λ: V(G) ∪ E(G) → {1, 2, …, k} of a graph G is a total k-labeling such that the weights calculated for all edges are distinct. The weight of an edge uv in G, denoted by wt(uv), is defined as the sum of the label of u, the label of v, and the label of uv. The total edge irregularity strength of G, denoted by tes(G), is the minimum value of the largest label k over all such edge irregular total k-labelings. A generalized butterfly graph, BFn , obtained by inserting vertices to every wing with assumption that sum of inserting vertices to every wing are same then it has 2n + 1 vertices and 4n ‑ 2 edges. In this paper, we investigate the total edge irregularity strength of generalized butterfly graph, BFn , for n > 2. The result is tes(B{F}n)=\\lceil \\frac{4n}{3}\\rceil .

  15. 21 CFR 211.125 - Labeling issuance.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

  16. 21 CFR 211.125 - Labeling issuance.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

  17. 21 CFR 211.125 - Labeling issuance.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

  18. 21 CFR 211.125 - Labeling issuance.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

  19. Frosting on the cake: pictures on food packaging bias serving size.

    PubMed

    Brand, John; Wansink, Brian; Cohen, Abby

    2016-08-01

    Food packaging often pictures supplementary extras, such as toppings or frosting, that are not listed on the nutritional labelling. The present study aimed to assess if these extras might exaggerate how many calories† are pictured and if they lead consumers to overserve. Four studies were conducted in the context of fifty-one different cake mixes. For these cake mixes, Study 1 compared the calories stated on the nutrition label with the calories of the cake (and frosting) pictured on the box. In Studies 2, 3 and 4, undergraduates (Studies 2 and 3) or food-service professionals (Study 4) were given one of these typical cake mix boxes, with some being told that cake frosting was not included on the nutritional labelling whereas others were provided with no additional information. They were then asked to indicate what they believed to be a reasonable serving size of cake. Settings Laboratory setting. Undergraduate students and food-service professionals. Study 1 showed that the average calories of cake and frosting pictured on the package of fifty-one different cake mixes exceed the calories on the nutritional label by 134 %. Studies 2 and 3 showed that informing consumers that the nutritional information does not include frosting reduces how much people serve. Study 4 showed that even food-service professionals overserve if not told that frosting is not included on the nutritional labelling. To be less misleading, packaging should either not depict extras in its pictures or it should more boldly and clearly state that extras are not included in calorie counts.

  20. 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.

  1. Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Final rule.

    PubMed

    2007-06-25

    The Food and Drug Administration (FDA) is issuing a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements that we are taking to promote and protect the public health.

  2. Method of fabricating a microelectronic device package with an integral window

    DOEpatents

    Peterson, Kenneth A.; Watson, Robert D.

    2003-01-01

    A method of fabricating a microelectronic device package with an integral window for providing optical access through an aperture in the package. The package is made of a multilayered insulating material, e.g., a low-temperature cofired ceramic (LTCC) or high-temperature cofired ceramic (HTCC). The window is inserted in-between personalized layers of ceramic green tape during stackup and registration. Then, during baking and firing, the integral window is simultaneously bonded to the sintered ceramic layers of the densified package. Next, the microelectronic device is flip-chip bonded to cofired thick-film metallized traces on the package, where the light-sensitive side is optically accessible through the window. Finally, a cover lid is attached to the opposite side of the package. The result is a compact, low-profile package, flip-chip bonded, hermetically-sealed package having an integral window.

  3. A QR code identification technology in package auto-sorting system

    NASA Astrophysics Data System (ADS)

    di, Yi-Juan; Shi, Jian-Ping; Mao, Guo-Yong

    2017-07-01

    Traditional manual sorting operation is not suitable for the development of Chinese logistics. For better sorting packages, a QR code recognition technology is proposed to identify the QR code label on the packages in package auto-sorting system. The experimental results compared with other algorithms in literatures demonstrate that the proposed method is valid and its performance is superior to other algorithms.

  4. 7 CFR 51.2927 - Marking and packing requirements.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... and packing requirements. The minimum size or numerical count of the apricots in any package shall be plainly labeled, stenciled, or otherwise marked on the package. (a) Numerical count. When the numerical...

  5. 7 CFR 51.2927 - Marking and packing requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... and packing requirements. The minimum size or numerical count of the apricots in any package shall be plainly labeled, stenciled, or otherwise marked on the package. (a) Numerical count. When the numerical...

  6. 7 CFR 51.2927 - Marking and packing requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... and packing requirements. The minimum size or numerical count of the apricots in any package shall be plainly labeled, stenciled, or otherwise marked on the package. (a) Numerical count. When the numerical...

  7. Testing Cessation Messages for Cigarette Package Inserts: Findings from a Best/Worst Discrete Choice Experiment

    PubMed Central

    Thrasher, James F.; Davis, Rachel E.; Popova, Lucy; Cho, Yoo Jin; Salloum, Ramzi G.; Louviere, Jordan; Hammond, David

    2018-01-01

    This study assessed smokers’ responses to different smoking cessation topics and imagery for cigarette package inserts. Adult smokers from Canada (n = 1000) participated in three discrete choice experiments (DCEs): DCE 1 assessed five cessation benefit topics and five imagery types; DCE 2 assessed five messages with tips to improve cessation success and five imagery types; DCE 3 assessed four reproductive health benefits of cessation topics and four imagery types. In each DCE, participants evaluated four or five sets of four inserts, selecting the most and least motivating (DCEs 1 & 3) or helpful (DCE 2) for quitting. Linear mixed models regressed choices on insert and smoker characteristics. For DCE 1, the most motivating messages involved novel disease topics and imagery of younger women. For DCE 2, topics of social support, stress reduction and nicotine replacement therapy were selected as most helpful, with no differences by imagery type. For DCE 3, imagery influenced choices more than topic, with imagery of a family or a mom and baby selected as most motivating. Statistically significant interactions for all three experiments indicated that the influence of imagery type on choices depended on the message topic. Messages to promote smoking cessation through cigarette pack inserts should consider specific combinations of message topic and imagery. PMID:29415523

  8. WCPP-THE WOLF PLOTTING AND CONTOURING PACKAGE

    NASA Technical Reports Server (NTRS)

    Masaki, G. T.

    1994-01-01

    The WOLF Contouring and Plotting Package provides the user with a complete general purpose plotting and contouring capability. This package is a complete system for producing line printer, SC4020, Gerber, Calcomp, and SD4060 plots. The package has been designed to be highly flexible and easy to use. Any plot from a quick simple plot (which requires only one call to the package) to highly sophisticated plots (including motion picture plots) can be easily generated with only a basic knowledge of FORTRAN and the plot commands. Anyone designing a software system that requires plotted output will find that this package offers many advantages over the standard hardware support packages available. The WCPP package is divided into a plot segment and a contour segment. The plot segment can produce output for any combination of line printer, SC4020, Gerber, Calcomp, and SD4060 plots. The line printer plots allow the user to have plots available immediately after a job is run at a low cost. Although the resolution of line printer plots is low, the quick results allows the user to judge if a high resolution plot of a particular run is desirable. The SC4020 and SD4060 provide high speed high resolution cathode ray plots with film and hard copy output available. The Gerber and Calcomp plotters provide very high quality (of publishable quality) plots of good resolution. Being bed or drum type plotters, the Gerber and Calcomp plotters are usually slow and not suited for large volume plotting. All output for any or all of the plotters can be produced simultaneously. The types of plots supported are: linear, semi-log, log-log, polar, tabular data using the FORTRAN WRITE statement, 3-D perspective linear, and affine transformations. The labeling facility provides for horizontal labels, vertical labels, diagonal labels, vector characters of a requested size (special character fonts are easily implemented), and rotated letters. The gridding routines label the grid lines according to user specification. Special line features include multiple lines, dashed lines, and tic marks. The contour segment of this package is a collection of subroutines which can be used to produce contour plots and perform related functions. The package can contour any data which can be placed on a grid or data which is regularly spaced, including any general affine or polar grid data. The package includes routines which will grid random data. Contour levels can be specified at any values desired. Input data can be smoothed with undefined points being acceptable where data is unreliable or unknown. Plots which are extremely large or detailed can be automatically output in parts to improve resolution or overcome plotter size limitations. The contouring segment uses the plot segment for actual plotting, thus all the features described for the plotting segment are available to the user of the contouring segment. Included with this package are two data bases for producing world map plots in Mercator projection. One data base provides just continent outlines and another provides continent outlines and national borders in great detail. This package is written in FORTRAN IV and IBM OS ASSEMBLER and has been implemented on an IBM 360 with a central memory requirement of approximately 140K of 8 bit bytes. The ASSEMBLER routines are basic plotter interface routines. The WCPP package was developed in 1972.

  9. 10 CFR 61.57 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.57 Labeling. Each package of waste must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with § 61.55. ...

  10. 10 CFR 61.57 - Labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.57 Labeling. Each package of waste must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with § 61.55. ...

  11. 10 CFR 61.57 - Labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.57 Labeling. Each package of waste must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with § 61.55. ...

  12. 10 CFR 61.57 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.57 Labeling. Each package of waste must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with § 61.55. ...

  13. 10 CFR 61.57 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... COMMISSION (CONTINUED) LICENSING REQUIREMENTS FOR LAND DISPOSAL OF RADIOACTIVE WASTE Technical Requirements for Land Disposal Facilities § 61.57 Labeling. Each package of waste must be clearly labeled to identify whether it is Class A waste, Class B waste, or Class C waste, in accordance with § 61.55. ...

  14. Automating Phase Change Lines and Their Labels Using Microsoft Excel(R).

    PubMed

    Deochand, Neil

    2017-09-01

    Many researchers have rallied against drawn in graphical elements and offered ways to avoid them, especially regarding the insertion of phase change lines (Deochand, Costello, & Fuqua, 2015; Dubuque, 2015; Vanselow & Bourret, 2012). However, few have offered a solution to automating the phase labels, which are often utilized in behavior analytic graphical displays (Deochand et al., 2015). Despite the fact that Microsoft Excel® is extensively utilized by behavior analysts, solutions to resolve issues in our graphing practices are not always apparent or user-friendly. Considering the insertion of phase change lines and their labels constitute a repetitious and laborious endeavor, any minimization in the steps to accomplish these graphical elements could offer substantial time-savings to the field. The purpose of this report is to provide an updated way (and templates in the supplemental materials) to add phase change lines with their respective labels, which stay embedded to the graph when they are moved or updated.

  15. 9 CFR 590.418 - Supervision of marking and packaging.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Supervision of marking and packaging...) Identifying and Marking Product § 590.418 Supervision of marking and packaging. (a) Evidence of label approval... container except by an inspector or under the supervision of an inspector or other person authorized by the...

  16. 9 CFR 590.418 - Supervision of marking and packaging.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Supervision of marking and packaging...) Identifying and Marking Product § 590.418 Supervision of marking and packaging. (a) Evidence of label approval... container except by an inspector or under the supervision of an inspector or other person authorized by the...

  17. 9 CFR 590.418 - Supervision of marking and packaging.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Supervision of marking and packaging...) Identifying and Marking Product § 590.418 Supervision of marking and packaging. (a) Evidence of label approval... container except by an inspector or under the supervision of an inspector or other person authorized by the...

  18. 9 CFR 590.418 - Supervision of marking and packaging.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Supervision of marking and packaging...) Identifying and Marking Product § 590.418 Supervision of marking and packaging. (a) Evidence of label approval... container except by an inspector or under the supervision of an inspector or other person authorized by the...

  19. 9 CFR 590.418 - Supervision of marking and packaging.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Supervision of marking and packaging...) Identifying and Marking Product § 590.418 Supervision of marking and packaging. (a) Evidence of label approval... container except by an inspector or under the supervision of an inspector or other person authorized by the...

  20. 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.

  1. A Review of Patents for the Smart Packaging of Meat and Muscle-based Food Products.

    PubMed

    Holman, Benjamin; Kerry, Joseph P; Hopkins, David L

    2017-10-31

    Meat packaging once acted primarily as an inert barrier to protect its contents against contamination and this function has shifted. Packaging now includes complementary functions that improve product quality, longevity and customer/retail appeal. The devices and methods applied to achieve these functions may be categorised as smart packaging, which includes intelligent packaging, devised to monitor and communicate packaged content status, and active packaging, to provide passive adjustment of in-pack conditions from its interactions with the packaged meat. Smart packaging examples already available from recent patents include antimicrobial and antioxidant packaging coatings and inserts; sensors or indicators that identify spoilage and freshness; functional engineering customisations; improvements to packaging integrity; leak or tamper detectors; and, environmentally sustainable options. Together, these inventions respond to industry and customer demands for meat packaging and are therefore the focus of this review, in which we discuss their applications and limitations in meat packaging. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  2. Consumer perceptions of specific design characteristics for front-of-package nutrition labels.

    PubMed

    Acton, R B; Vanderlee, L; Roberto, C A; Hammond, D

    2018-04-01

    An increasing number of countries are developing front-of-package (FOP) labels; however, there is limited evidence examining the impact of specific design characteristics for these labels. The current study investigated consumer perceptions of several FOP label design characteristics, including potential differences among sociodemographic sub-groups. Two hundred and thirty-four participants aged 16 years or older completed nine label rating tasks on a laptop at a local shopping mall in Canada. The rating tasks asked participants to rate five primary design characteristics (border, background presence, background colour, 'caution' symbol and government attribution) on their noticeability, readability, believability and likelihood of changing their beverage choice. FOP labels with a border, solid background and contrasting colours increased noticeability. A solid background increased readability, while a contrasting background colour reduced it. Both a 'caution' symbol and a government attribution increased the believability of the labels and the perceived likelihood of influencing beverage choice. The effect of the design characteristics was generally similar across sociodemographic groups, with modest differences in five of the nine outcomes. Label design characteristics, such as the use of a border, colour and symbols can enhance the salience of FOP nutrition labels and may increase the likelihood that FOP labels are used by consumers.

  3. The efficacy of calorie labelling formats on pre-packaged foods: An experimental study among adolescents and young adults in Canada.

    PubMed

    Acton, Rachel B; Vanderlee, Lana; White, Christine; Hammond, David

    2016-10-20

    Several countries have proposed changes to calorie labelling on nutrition facts tables (NFTs) on pre-packaged foods. As most research to date has examined general use of NFTs, there is a lack of evidence to guide specific design changes to calorie information on labels. This study examined the efficacy of various calorie labelling formats on recall, comprehension, and consumer preferences for calorie information. Experiments were conducted as part of an online survey with a national sample of 2,008 Canadians aged 16-24. In Task 1, participants were shown one of six labelling formats (e.g., %DV, Traffic Light) with calories in either small or large font, and asked to recall the amount of calories. Task 2 examined comprehension of calories in the context of recommended daily intake (RDI), using the same NFT as in Task 1. Task 3 identified participants' preferences for labelling formats. NFTs with calories in large font enhanced calorie recall (p < 0.001). When small font was displayed, the Traffic Light format performed best at improving recall (p < 0.01). With large font, the highest recall was in the Current, RDI and Traffic Light formats (all p < 0.05). Comprehension of servings per RDI was highest in the Infographic format, with no difference by font size (p < 0.001). Respondents preferred the large font calorie condition and the Infographic format (p < 0.001). Enhancements in visibility and design can improve the efficacy of calorie labelling on pre-packaged foods. The findings have direct implication for proposed changes to calorie labelling on NFTs in Canada and the United States.

  4. 50 CFR 300.161 - Alternatives and exceptions.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ..., must reflect that number or label. (4) A conveyance (truck, plane, boat, etc.) is not considered a... shipping documents; (2) Fish or shellfish contained in retail consumer packages labeled pursuant to the...

  5. 27 CFR 19.599 - Bottling and packaging records.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... proof recorded under paragraph (f) of this section); (k) Total quantity bottled, packaged, or otherwise disposed of in bulk; (l) Losses or gains of the distilled spirits product; and (m) If labeled as bottled in...

  6. 9 CFR 317.302 - Location of nutrition information.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Location of nutrition information. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.302 Location of nutrition information. (a) Nutrition information on a label of a packaged meat or meat food...

  7. 9 CFR 317.302 - Location of nutrition information.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Location of nutrition information. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.302 Location of nutrition information. (a) Nutrition information on a label of a packaged meat or meat food...

  8. 9 CFR 317.302 - Location of nutrition information.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Location of nutrition information. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.302 Location of nutrition information. (a) Nutrition information on a label of a packaged meat or meat food...

  9. 9 CFR 317.302 - Location of nutrition information.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Location of nutrition information. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.302 Location of nutrition information. (a) Nutrition information on a label of a packaged meat or meat food...

  10. 9 CFR 317.302 - Location of nutrition information.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Location of nutrition information. 317... INSPECTION AND CERTIFICATION LABELING, MARKING DEVICES, AND CONTAINERS Nutrition Labeling § 317.302 Location of nutrition information. (a) Nutrition information on a label of a packaged meat or meat food...

  11. 49 CFR 177.842 - Class 7 (radioactive) material.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... the labels on the individual packages and overpacks in the group. This provision does not apply to... Class 7 (radioactive) material bearing “RADIOACTIVE YELLOW-II” or “RADIOACTIVE YELLOW-III” labels may... transport index number determined by adding together the transport index number on the labels on the...

  12. 21 CFR 801.50 - Labeling requirements for stand-alone software.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 8 2014-04-01 2014-04-01 false Labeling requirements for stand-alone software....50 Labeling requirements for stand-alone software. (a) Stand-alone software that is not distributed... in packaged form, stand-alone software regulated as a medical device must provide its unique device...

  13. 40 CFR 156.156 - Residue removal instructions for refillable containers.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... adequate to protect human health and the environment. (2) Subject to meeting the standard in paragraph (b... (CONTINUED) PESTICIDE PROGRAMS LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Container Labeling § 156.156 Residue removal instructions for refillable containers. The label of each pesticide product packaged in a...

  14. 40 CFR 156.156 - Residue removal instructions for refillable containers.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... adequate to protect human health and the environment. (2) Subject to meeting the standard in paragraph (b... (CONTINUED) PESTICIDE PROGRAMS LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Container Labeling § 156.156 Residue removal instructions for refillable containers. The label of each pesticide product packaged in a...

  15. 40 CFR 156.156 - Residue removal instructions for refillable containers.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... adequate to protect human health and the environment. (2) Subject to meeting the standard in paragraph (b... (CONTINUED) PESTICIDE PROGRAMS LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Container Labeling § 156.156 Residue removal instructions for refillable containers. The label of each pesticide product packaged in a...

  16. 40 CFR 156.156 - Residue removal instructions for refillable containers.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... adequate to protect human health and the environment. (2) Subject to meeting the standard in paragraph (b... (CONTINUED) PESTICIDE PROGRAMS LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Container Labeling § 156.156 Residue removal instructions for refillable containers. The label of each pesticide product packaged in a...

  17. 40 CFR 156.156 - Residue removal instructions for refillable containers.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... adequate to protect human health and the environment. (2) Subject to meeting the standard in paragraph (b... (CONTINUED) PESTICIDE PROGRAMS LABELING REQUIREMENTS FOR PESTICIDES AND DEVICES Container Labeling § 156.156 Residue removal instructions for refillable containers. The label of each pesticide product packaged in a...

  18. 40 CFR 85.530 - Vehicle/engine labels and packaging labels.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... PROGRAMS (CONTINUED) CONTROL OF AIR POLLUTION FROM MOBILE SOURCES Exemption of Clean Alternative Fuel... from the tampering prohibition: (1) You must make a supplemental emission control information label for..., consistent with the requirements of this subpart. You may do this by identifying the OEM test group/engine...

  19. 40 CFR 85.530 - Vehicle/engine labels and packaging labels.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... PROGRAMS (CONTINUED) CONTROL OF AIR POLLUTION FROM MOBILE SOURCES Exemption of Clean Alternative Fuel... from the tampering prohibition: (1) You must make a supplemental emission control information label for..., consistent with the requirements of this subpart. You may do this by identifying the OEM test group/engine...

  20. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 1 2012-01-01 2012-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  1. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 1 2011-01-01 2011-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  2. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 9 Animals and Animal Products 1 2013-01-01 2013-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  3. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  4. 9 CFR 112.5 - Review and approval of labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 9 Animals and Animal Products 1 2014-01-01 2014-01-01 false Review and approval of labeling. 112.5 Section 112.5 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING...

  5. 77 FR 11547 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... Request; Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food Packages... and title ``Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food... review and clearance. Experimental Study on Consumer Responses to Whole Grain Labeling Statements on Food...

  6. 21 CFR 701.11 - Identity labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in...) Such statement of identity shall be in terms of: (1) The common or usual name of the cosmetic; or (2...

  7. 21 CFR 701.11 - Identity labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in...) Such statement of identity shall be in terms of: (1) The common or usual name of the cosmetic; or (2...

  8. 21 CFR 701.11 - Identity labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in...) Such statement of identity shall be in terms of: (1) The common or usual name of the cosmetic; or (2...

  9. 21 CFR 701.11 - Identity labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC LABELING Package Form § 701.11 Identity labeling. (a) The principal display panel of a cosmetic in...) Such statement of identity shall be in terms of: (1) The common or usual name of the cosmetic; or (2...

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

    "rsed" is an R package that contains tools for stream editing: manipulating text files by making insertions, replacements, deletions, substitutions, or commenting. It hails from the powerful Unix command, "sed". While the "rsed" package is not nearly as powerful as "see", it is much simpler to use. R programmers often write scripts that may require simple manipulation of text files. "rsed" addresses that need.

  11. Microstructure-Evolution and Reliability Assessment Tool for Lead-Free Component Insertion in Army Electronics

    DTIC Science & Technology

    2008-10-01

    provide adequate means for thermal heat dissipation and cooling. Thus electronic packaging has four main functions [1]: • Signal distribution which... dissipation , involving structural and materials consideration. • Mechanical, chemical and electromagnetic protection of components and... nature when compared to phenomenological models. Microelectronic packaging industry spends typically several months building and reliability

  12. Safe use of vaccines and vaccine compliance with food safety requirements.

    PubMed

    Grein, K; Papadopoulos, O; Tollis, M

    2007-08-01

    Advanced technologies and regulatory regimes have contributed to the availability of veterinary vaccines that have high quality and favourable safety profiles in terms of potential risks posed to the target animals, the persons who come into contact with the vaccine, the consumers of food derived from vaccinated animals and the environment. The authorisation process requires that a range of safety studies are provided to evaluate the products. The design and production of vaccines, and their safe use, are primarily assessed by using data gathered from extensive pre-marketing studies performed on target animals and specific quality tests. The current post-marketing safeguards include good manufacturing practices, batch safety testing, inspections and pharmacovigilance. In addition to hazard identification, a full benefit/risk evaluation needs to be undertaken. The outcome of that evaluation will determine options for risk management and affect regulatory decisions on the safety of the vaccine; options might, for example, include special warnings on package inserts and labels.

  13. Use of food labels by adolescents to make healthier choices on snacks: a cross-sectional study from Sri Lanka.

    PubMed

    Talagala, Ishanka A; Arambepola, Carukshi

    2016-08-08

    Unhealthy snacking is commonly seen among adolescents. Therefore, use of food labels is promoted for making healthier choices on packaged snacks. This study was conducted to assess the use of food labels in making choices on packaged snack and its associated factors among adolescents. A cross-sectional study was conducted in 2012 among 542 Grade 12 students in Sri Lanka. Eight classes were selected as 'clusters' for the study (two classes each from two schools that were selected randomly from each list of 'Girls only' and 'Boys only' schools in Colombo district). A self-administered questionnaire assessed their socio-demography, snacking behaviour, attitudes and nutrition knowledge related to food labels. Adolescents' use of labels was assessed by three practices (label reading frequency, attention paid to label contents and correct interpretation of six hypothetical labels of snacks). Based on total scores obtained for the three practices, 'satisfactory' (score ≥75(th) percentile mark) and 'unsatisfactory' (score <75(th) percentile mark) label users were identified. Using SPSS, associations were assessed at 0.05 significance level using Chi-square-test. Of the participants, 51 % were males; 61 % spent their pocket money at least once/week on packaged snacks; predominantly on biscuits (85 %) and cola-drinks (77 %) and 88 % selected snacks on their own. The majority (74.5 %) was frequent ('always' or 'most often') label readers with female predominance (p < 0.05). Over 74 % paid attention frequently to the brand name (75 %), price (85 %) and nutrition panel (81 %). Over 64 % were able to select the better food label when given a choice between two snacks, although some did it for reasons such as attractive label (63 %). The majority (84 %) had good knowledge (obtaining more than the 75(th) percentile mark) on interpreting labels. Although not statistically significant, 'unsatisfactory' label use was higher among males (73 %), purchasing power (70.4 %) and unhealthy snacking behaviour (73 %). In contrast, among the marketing strategies, identifying known brands (73.2 %) and imported products (75.8 %) as 'good' products were significantly associated with 'unsatisfactory' label use (p < 0.05). Despite having good knowledge and positive attitudes, food label use is unsatisfactory among adolescents. Skills in reading labels should be addressed in the 'School canteen policy' in Sri Lanka.

  14. Variation in commercial smoking mixtures containing third-generation synthetic cannabinoids.

    PubMed

    Frinculescu, Anca; Lyall, Catherine L; Ramsey, John; Miserez, Bram

    2017-02-01

    Variation in ingredients (qualitative variation) and in quantity of active compounds (quantitative variation) in herbal smoking mixtures containing synthetic cannabinoids has been shown for older products. This can be dangerous to the user, as accurate and reproducible dosing is impossible. In this study, 69 packages containing third-generation cannabinoids of seven brands on the UK market in 2014 were analyzed both qualitatively and quantitatively for variation. When comparing the labels to actual active ingredients identified in the sample, only one brand was shown to be correctly labelled. The other six brands contained less, more, or ingredients other than those listed on the label. Only two brands were inconsistent, containing different active ingredients in different samples. Quantitative variation was assessed both within one package and between several packages. Within-package variation was within a 10% range for five of the seven brands, but two brands showed larger variation, up to 25% (Relative Standard Deviation). Variation between packages was significantly higher, with variation up to 38% and maximum concentration up to 2.7 times higher than the minimum concentration. Both qualitative and quantitative variation are common in smoking mixtures and endanger the user, as it is impossible to estimate the dose or to know the compound consumed when smoking commercial mixtures. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  15. Do package inserts reflect symptoms experienced in practice?: assessment using an automated phone pharmacovigilance system with varenicline and zolpidem in a primary care setting.

    PubMed

    Haas, Jennifer S; Amato, Mary; Marinacci, Lucas; Orav, E John; Schiff, Gordon D; Bates, David W

    2012-08-01

    While the US FDA maintains a voluntary reporting system, postmarketing adverse drug events (ADEs) are underreported, and this case report-based system does not allow accurate determination of incidence. The aim of the study was to assess the usefulness of an automated phone pharmacovigilance system for ambulatory patients by comparing systematically collected, patient-reported symptoms to reflect possible ADEs with those reported on the package inserts of two drugs with postmarketing safety concerns, varenicline and zolpidem. English-speaking adults who received a prescription for zolpidem (n = 370) or varenicline (n = 107) from a primary care physician at one of 11 participating clinics, and who participated in the pharmacovigilance system during 2008-2010, were included in the study. Patients were called approximately 4 weeks following their visit and asked to complete a standard script that asked about adherence and pre-specified symptoms. The main outcome measures were elicited rates of pre-specified symptoms or possible ADEs. Compared with the package insert, patients taking zolpidem were significantly (p < 0.001) more likely to report fatigue (9.0% vs 1.0%), itching (4.5% vs 1.0%) and muscle aches (5.6% vs 1.0%). Elicited rates of depression and hallucination were similar to those reported in the package insert. Patients taking varenicline were significantly more likely to report confusion (1.7% vs 0.1%), depression (3.4% vs 0.1%), fatigue (6.0% vs 1.0%), hallucinations (1.7% vs 0.1%), muscle aches (6.0% vs 1.0%) and sexual dysfunction (4.3% vs 0.1%). Automated phone pharmacovigilance can provide estimates of possible ADEs in clinical practice. In the case of varenicline, these data support some of the safety concerns that have come to light postmarketing, while others such as depression and hallucination related to zolpidem were not detected. These data highlight the potential value of, and innovative ways of collecting, information about possible ADEs directly from patients.

  16. Technical Note: Computer-Manufactured Inserts for Prosthetic Sockets

    PubMed Central

    Sanders, Joan E.; McLean, Jake B.; Cagle, John C.; Gardner, David W.; Allyn, Katheryn J.

    2016-01-01

    The objective of this research was to use computer-aided design software and a tabletop 3-D additive manufacturing system to design and fabricate custom plastic inserts for trans-tibial prosthesis users. Shape quality of inserts was tested right after they were inserted into participant’s test sockets and again after four weeks of wear. Inserts remained properly positioned and intact throughout testing. Right after insertion the inserts caused the socket to be slightly under-sized, by a mean of 0.11 mm, approximately 55% of the thickness of a nylon sheath. After four weeks of wear the under-sizing was less, averaging 0.03 mm, approximately 15% of the thickness of a nylon sheath. Thus the inserts settled into the sockets over time. If existing prosthetic design software packages were enhanced to conduct insert design and to automatically generate fabrication files for manufacturing, then computer manufactured inserts may offer advantages over traditional methods in terms of speed of fabrication, ease of design, modification, and record keeping. PMID:27212209

  17. 21 CFR 1.20 - Presence of mandatory label information.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... information. The term package means any container or wrapping in which any food, drug, device, or cosmetic is...) of the Family Smoking Prevention and Tobacco Control Act (21 U.S.C. 387(13)) defining “package,” the term package means any container or wrapping in which any food, drug, device, or cosmetic is enclosed...

  18. Process Variability and Capability in Candy Production and Packaging

    ERIC Educational Resources Information Center

    Lembke, Ronald S.

    2016-01-01

    In this short, in-class activity, students use fun size packages of M&Ms to study process variability, including a real-world application of C[subscript pk]. How process variability and legal requirements force the company to put "Not Labeled for Individual Retail Sale" on each fun size package is discussed, as is the economics of…

  19. Electronic Cigarette Refill Liquids: Child-Resistant Packaging, Nicotine Content, and Sales to Minors.

    PubMed

    Buettner-Schmidt, Kelly; Miller, Donald R; Balasubramanian, Narayanaganesh

    2016-01-01

    To determine the accuracy of the labeled quantity of the nicotine content of the e-liquids sold in unlicensed vape stores, whether the packaging of e-liquids sold within the vape stores was child-resistant, whether minors were present within vape stores, and whether sales to minors occurred. This study was conducted across North Dakota prior to implementation of a new e-cigarette state law and provided a baseline assessment before enactment of the new legal requirements. We tested samples of e-liquids and performed observations in 16 stores that were selling e-cigarettes but were not legally required to be licensed for tobacco retail. The e-liquids were analyzed for nicotine content using a validated high-performance liquid chromatography method for nicotine analysis. Of the 70 collected e-liquid samples that claimed to contain nicotine, 17% contained more than the labeled quantity and 34% contained less than the labeled quantity by 10% or more, with one sample containing 172% more than the labeled quantity. Of the 94 e-liquid containers sampled, only 35% were determined to be child-resistant. Minors were present in stores, although no sales to minors occurred. Mislabeling of nicotine in e-liquids is common and exposes the user to the harmful effects of nicotine. The lack of child-resistant packaging for this potentially toxic substance is a serious public health problem. E-cigarettes should be included in the legal definition of tobacco products, child-resistant packaging and nicotine labeling laws should be enacted and strictly enforced, and vape stores should be licensed by states. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Electronic Cigarette Refill Liquids: Child-Resistant Packaging, Nicotine Content, and Sales to Minors2

    PubMed Central

    Buettner-Schmidt, Kelly; Miller, Donald R.; Balasubramanian, Narayanaganesh

    2016-01-01

    Purpose To determine the accuracy of the labeled quantity of the nicotine content of the e-liquids sold in unlicensed vape stores, whether the packaging of e-liquids sold within the vape stores was child-resistant, whether minors were present within vape stores, and whether sales to minors occurred. This study was conducted across North Dakota prior to implementation of a new e-cigarette state law and provided a baseline assessment before enactment of the new legal requirements. Design and Methods We tested samples of e-liquids and performed observations in 16 stores that were selling e-cigarettes but were not legally required to be licensed for tobacco retail. The e-liquids were analyzed for nicotine content using a validated high-performance liquid chromatography method for nicotine analysis. Results Of the 70 collected e-liquid samples that claimed to contain nicotine, 17% contained more than the labeled quantity and 34% contained less than the labeled quantity by 10% or more, with one sample containing 172% more than the labeled quantity. Of the 94 e-liquid containers sampled, only 35% were determined to be child-resistant. Minors were present in stores, although no sales to minors occurred. Conclusions Mislabeling of nicotine in e-liquids is common and exposes the user to the harmful effects of nicotine. The lack of child-resistant packaging for this potentially toxic substance is a serious public health problem. E-cigarettes should be included in the legal definition of tobacco products, child-resistant packaging and nicotine labeling laws should be enacted and strictly enforced, and vape stores should be licensed by states. PMID:27079973

  1. 7 CFR 205.308 - Agricultural products in other than packaged form at the point of retail sale that are sold...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ...) AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE (CONTINUED) ORGANIC FOODS PRODUCTION ACT PROVISIONS NATIONAL ORGANIC PROGRAM Labels, Labeling, and Market...

  2. 29 CFR 1918.99 - Retention of DOT markings, placards and labels.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR LONGSHORING General Working Conditions. § 1918.99 Retention of DOT markings, placards and labels. (a) Any employer who receives a package...

  3. 99M-Technetium labeled tin colloid radiopharmaceuticals

    DOEpatents

    Winchell, Harry S.; Barak, Morton; Van Fleet, III, Parmer

    1976-07-06

    An improved 99m-technetium labeled tin(II) colloid, size-stabilized for reticuloendothelial organ imaging without the use of macromolecular stabilizers and a packaged tin base reagent and an improved method for making it are disclosed.

  4. Color-Coded Front-of-Pack Nutrition Labels-An Option for US Packaged Foods?

    PubMed

    Dunford, Elizabeth K; Poti, Jennifer M; Xavier, Dagan; Webster, Jacqui L; Taillie, Lindsey Smith

    2017-05-10

    The implementation of a standardized front-of-pack-labelling (FoPL) scheme would likely be a useful tool for many consumers trying to improve the healthfulness of their diets. Our objective was to examine what the traffic light labelling scheme would look like if implemented in the US. Data were extracted from Label Insight's Open Access branded food database in 2017. Nutrient levels and the proportion of products classified as "Red" (High), "Amber" (Medium) or "Green" (Low) in total fat, saturated fat, total sugar and sodium for food and beverage items were examined. The proportion of products in each category that had each possible combination of traffic light colors, and met the aggregate score for "healthy" was examined. Out of 175,198 products, >50% of all US packaged foods received a "Red" rating for total sugar and sodium. "Confectionery" had the highest mean total sugar (51.9 g/100 g) and "Meat and meat alternatives" the highest mean sodium (781 mg/100 g). The most common traffic light label combination was "Red" for total fat, saturated fat and sodium and "Green" for sugar. Only 30.1% of products were considered "healthy". A wide variety ( n = 80) of traffic light color combinations were observed. A color coded traffic light scheme appears to be an option for implementation across the US packaged food supply to support consumers in making healthier food choices.

  5. 21 CFR 201.51 - Declaration of net quantity of contents.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...

  6. 21 CFR 201.51 - Declaration of net quantity of contents.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...

  7. 21 CFR 201.51 - Declaration of net quantity of contents.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...

  8. 21 CFR 201.51 - Declaration of net quantity of contents.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...

  9. 21 CFR 201.51 - Declaration of net quantity of contents.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... (CONTINUED) DRUGS: GENERAL LABELING Labeling Requirements for Prescription Drugs and/or Insulin § 201.51 Declaration of net quantity of contents. (a) The label of a prescription or insulin-containing drug in package....). A statement of the liquid measure of the contents in the case of insulin-containing drugs shall be...

  10. Nutrition Marketing on Food Labels

    ERIC Educational Resources Information Center

    Colby, Sarah E.; Johnson, LuAnn; Scheett, Angela; Hoverson, Bonita

    2010-01-01

    Objective: This research sought to determine how often nutrition marketing is used on labels of foods that are high in saturated fat, sodium, and/or sugar. Design and Setting: All items packaged with food labels (N = 56,900) in all 6 grocery stores in Grand Forks, ND were surveyed. Main Outcome Measure(s): Marketing strategy, nutrient label…

  11. 10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    .... (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (B) The...

  12. 10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... can be identified. (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS...

  13. 10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... can be identified. (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS...

  14. 10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... can be identified. (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS...

  15. 10 CFR 32.15 - Same: Quality assurance, prohibition of transfer, and labeling.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    .... (2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that: (i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (A) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (B) The...

  16. 78 FR 77656 - Aerosols and Similar Pressurized Containers-Meeting To Discuss the Method of Sale for Packages...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-24

    ..., Packaging and Labeling Regulation (UPLR) in NIST Handbook 130, ``Uniform Laws and Regulations in the Areas... permit price and quantity comparison is forbidden.'' Products using BOV technology versus traditional...

  17. Jig Aligns Shadow Mask On CCD

    NASA Technical Reports Server (NTRS)

    Matus, Carlos V.

    1989-01-01

    Alignment viewed through microscope. Alignment jig positions shadow mask on charge-coupled device (CCD) so metal film deposited on it precisely. Allows CCD package to be inserted and removed without disturbing alignment of mask. Holds CCD packages securely and isolates it electrostatically while providing electrical contact to each of its pins. When alignment jig assembled with CCD, used to move mask under micrometer control.

  18. Trick Simulation Environment 07

    NASA Technical Reports Server (NTRS)

    Lin, Alexander S.; Penn, John M.

    2012-01-01

    The Trick Simulation Environment is a generic simulation toolkit used for constructing and running simulations. This release includes a Monte Carlo analysis simulation framework and a data analysis package. It produces all auto documentation in XML. Also, the software is capable of inserting a malfunction at any point during the simulation. Trick 07 adds variable server output options and error messaging and is capable of using and manipulating wide characters for international support. Wide character strings are available as a fundamental type for variables processed by Trick. A Trick Monte Carlo simulation uses a statistically generated, or predetermined, set of inputs to iteratively drive the simulation. Also, there is a framework in place for optimization and solution finding where developers may iteratively modify the inputs per run based on some analysis of the outputs. The data analysis package is capable of reading data from external simulation packages such as MATLAB and Octave, as well as the common comma-separated values (CSV) format used by Excel, without the use of external converters. The file formats for MATLAB and Octave were obtained from their documentation sets, and Trick maintains generic file readers for each format. XML tags store the fields in the Trick header comments. For header files, XML tags for structures and enumerations, and the members within are stored in the auto documentation. For source code files, XML tags for each function and the calling arguments are stored in the auto documentation. When a simulation is built, a top level XML file, which includes all of the header and source code XML auto documentation files, is created in the simulation directory. Trick 07 provides an XML to TeX converter. The converter reads in header and source code XML documentation files and converts the data to TeX labels and tables suitable for inclusion in TeX documents. A malfunction insertion capability allows users to override the value of any simulation variable, or call a malfunction job, at any time during the simulation. Users may specify conditions, use the return value of a malfunction trigger job, or manually activate a malfunction. The malfunction action may consist of executing a block of input file statements in an action block, setting simulation variable values, call a malfunction job, or turn on/off simulation jobs.

  19. The Influence of Power and Intimacy Sexual Motives on Sexual Position Preference Among Men Who Have Sex with Men in China.

    PubMed

    Xu, Yin; Zheng, Yong

    2018-01-01

    We examined the sexual motives underlying sexual self-labels among Chinese men who have sex with men. A total of 60 bottoms, 120 versatiles, and 48 tops participated in a Web-based survey. Our results showed that tops were more likely to desire exerting power over their partners during sex, while bottoms were more likely to desire being overpowered by their partners. There were no significant sexual self-label differences in the sexual motives of wanting intimacy and the desire for pleasure. The intimacy and power ratings differed across sexual activities and sex positions. There was a tendency for sexual positions in which the performer was facing the receiver to be rated as more intimate than those in which the performer was facing away from the receiver, and for individuals who preferred to be insertive to feel more powerful in sexual positions in which their partner was kneeling down or standing than those in which their partner was sitting or lying down. Tops were significantly more likely than bottoms to engage in insertive sexual positions, while bottoms were significantly more likely to engage in receptive sexual positions. Both tops and bottoms were more likely to engage in the corresponding insertive/receptive position when the insertive position was rated as more powerful than the receptive position. Our results suggest that the concordance between sexual self-labels and sexual position preferences may rely on the power difference between the insertive and receptive positions in addition to body characteristics.

  20. Dual-process theory and consumer response to front-of-package nutrition label formats.

    PubMed

    Sanjari, S Setareh; Jahn, Steffen; Boztug, Yasemin

    2017-11-01

    Nutrition labeling literature yields fragmented results about the effect of front-of-package (FOP) nutrition label formats on healthy food choice. Specifically, it is unclear which type of nutrition label format is effective across different shopping situations. To address this gap, the present review investigates the available nutrition labeling literature through the prism of dual-process theory, which posits that decisions are made either quickly and automatically (system 1) or slowly and deliberately (system 2). A systematically performed review of nutrition labeling literature returned 59 papers that provide findings that can be explained according to dual-process theory. The findings of these studies suggest that the effectiveness of nutrition label formats is influenced by the consumer's dominant processing system, which is a function of specific contexts and personal variables (eg, motivation, nutrition knowledge, time pressure, and depletion). Examination of reported findings through a situational processing perspective reveals that consumers might prefer different FOP nutrition label formats in different situations and can exhibit varying responses to the same label format across situations. This review offers several suggestions for policy makers and researchers to help improve current FOP nutrition label formats. © The Author(s) 2017. Published by Oxford University Press on behalf of the International Life Sciences Institute. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

  1. 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

  2. 49 CFR 172.304 - Marking requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... be durable, in English and printed on or affixed to the surface of a package or on a label, tag, or... labels or attachments; and (4) Must be located away from any other marking (such as advertising) that...

  3. Using PATIMDB to Create Bacterial Transposon Insertion Mutant Libraries

    PubMed Central

    Urbach, Jonathan M.; Wei, Tao; Liberati, Nicole; Grenfell-Lee, Daniel; Villanueva, Jacinto; Wu, Gang; Ausubel, Frederick M.

    2015-01-01

    PATIMDB is a software package for facilitating the generation of transposon mutant insertion libraries. The software has two main functions: process tracking and automated sequence analysis. The process tracking function specifically includes recording the status and fates of multiwell plates and samples in various stages of library construction. Automated sequence analysis refers specifically to the pipeline of sequence analysis starting with ABI files from a sequencing facility and ending with insertion location identifications. The protocols in this unit describe installation and use of PATIMDB software. PMID:19343706

  4. Putting the genie back in the bottle? Availability and presentation of oral artemisinin compounds at retail pharmacies in urban Dar-es-Salaam

    PubMed Central

    Kachur, S Patrick; Black, Carolyn; Abdulla, Salim; Goodman, Catherine

    2006-01-01

    Background Recently global health advocates have called for the introduction of artemisinin-containing antimalarial combination therapies to help curb the impact of drug-resistant malaria in Africa. Retail trade in artemisinin monotherapies could undermine efforts to restrict this class of medicines to more theoretically sound combination treatments. Methods This paper describes a systematic search for artemisinin-containing products at a random sample of licensed pharmacies in Dar-es-Salaam, Tanzania in July 2005. Results Nineteen different artemisinin-containing oral pharmaceutical products, including one co-formulated product, one co-packaged product, and 17 monotherapies were identified. All but one of the products were legally registered and samples of each product were obtained without a prescription. Packaging and labeling of the products seldom included local language or illustrated instructions for low-literate clients. Packaging and inserts compared reasonably well with standards recommended by the national regulatory authority with some important exceptions. Dosing instructions were inconsistent, and most recommended inadequate doses based on international standards. None of the monotherapy products mentioned potential benefits of combining the treatment with another antimalarial drug. Conclusion The findings confirm the widespread availability of artemisinin monotherapies that led the World Health Organization to call for the voluntary withdrawal of these drugs in malaria-endemic countries. As the global public health community gathers resources to deploy artemisinin-containing combination therapies in Africa, planners should be mindful that these drugs will coexist with artemisinin monotherapies in an already well-established market place. In particular, regulatory authorities should be incorporated urgently into the process of planning for rational deployment of artemisinin-containing antimalarial combination therapies. PMID:16569252

  5. 49 CFR 175.630 - Special requirements for Division 6.1 (poisonous) material and Division 6.2 (infectious...

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... (infectious substances) materials. (a) A package required to bear a POISON, POISON INHALATION HAZARD, or... person may operate an aircraft that has been used to transport any package required to bear a POISON or POISON INHALATION HAZARD label unless, upon removal of such package, the area in the aircraft in which it...

  6. 49 CFR 175.630 - Special requirements for Division 6.1 (poisonous) material and Division 6.2 (infectious...

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... (infectious substances) materials. (a) A package required to bear a POISON, POISON INHALATION HAZARD, or... person may operate an aircraft that has been used to transport any package required to bear a POISON or POISON INHALATION HAZARD label unless, upon removal of such package, the area in the aircraft in which it...

  7. 49 CFR 175.630 - Special requirements for Division 6.1 (poisonous) material and Division 6.2 (infectious...

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... (infectious substances) materials. (a) A package required to bear a POISON, POISON INHALATION HAZARD, or... person may operate an aircraft that has been used to transport any package required to bear a POISON or POISON INHALATION HAZARD label unless, upon removal of such package, the area in the aircraft in which it...

  8. 49 CFR 175.630 - Special requirements for Division 6.1 (poisonous) material and Division 6.2 (infectious...

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... (infectious substances) materials. (a) A package required to bear a POISON, POISON INHALATION HAZARD, or... person may operate an aircraft that has been used to transport any package required to bear a POISON or POISON INHALATION HAZARD label unless, upon removal of such package, the area in the aircraft in which it...

  9. Cigarette packaging and health warnings: the impact of plain packaging and message framing on young smokers

    PubMed Central

    Mays, Darren; Niaura, Raymond S.; Evans, W. Douglas; Hammond, David; Luta, George; Tercyak, Kenneth P.

    2014-01-01

    Objective This study examined the impact of pictorial cigarette warning labels, warning label message framing, and plain cigarette packaging on young adult smokers’ motivation to quit. Methods Smokers ages 18–30 (n=740) from a consumer research panel were randomized to one of four experimental conditions where they viewed online images of 4 cigarette packs with warnings about lung disease, cancer, stroke/heart disease, and death, respectively. Packs differed across conditions by warning message framing (gain versus loss) and packaging (branded versus plain). Measures captured demographics, smoking behavior, covariates, and motivation to quit in response to cigarette packs. Results Pictorial warnings about lung disease and cancer generated the strongest motivation to quit across conditions. Adjusting for pre-test motivation and covariates, a message framing by packaging interaction revealed gain-framed warnings on plain packs generated greater motivation to quit for lung disease, cancer, and mortality warnings (p < 0.05), compared with loss-framed warnings on plain packs. Conclusions Warnings combining pictorial depictions of smoking-related health risks with text-based messages about how quitting reduces risks may achieve better outcomes among young adults, especially in countries considering or implementing plain packaging regulations. PMID:24420310

  10. 77 FR 31910 - Request for Comments of a Previously Approved Information Collection

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-30

    ... assist wheelchair users and other persons with limited mobility in entering and leaving a vehicle. FMVSS... certification on the owner's manual insert, the installation instructions and the lift operating instruction... insert that is placed in the vehicle owner's manual, installation instructions and one or two labels that...

  11. A Pre- and Post-Evaluation of Integrating Sustainability Curriculum by Inserting Okala Modules into an Interior Design Materials and Methods Course

    ERIC Educational Resources Information Center

    Schneiderman, Deborah; Freihoefer, Kara

    2012-01-01

    Purpose: The purpose of this paper is to examine the integration of Okala curriculum into Interior Design coursework. Okala, as a teaching package, is utilized extensively in industrial design education. However, this study examines the expansion and insertion of Okala modules in an existing interior design curriculum. The Okala modules included…

  12. Choosing front-of-package food labelling nutritional criteria: how smart were 'Smart Choices'?

    PubMed

    Roberto, Christina A; Bragg, Marie A; Livingston, Kara A; Harris, Jennifer L; Thompson, Jackie M; Seamans, Marissa J; Brownell, Kelly D

    2012-02-01

    The 'Smart Choices' programme was an industry-driven, front-of-package (FOP) nutritional labelling system introduced in the USA in August 2009, ostensibly to help consumers select healthier options during food shopping. Its nutritional criteria were developed by members of the food industry in collaboration with nutrition and public health experts and government officials. The aim of the present study was to test the extent to which products labelled as 'Smart Choices' could be classified as healthy choices on the basis of the Nutrient Profile Model (NPM), a non-industry-developed, validated nutritional standard. A total of 100 packaged products that qualified for a 'Smart Choices' designation were sampled from eight food and beverage categories. All products were evaluated using the NPM method. In all, 64 % of the products deemed 'Smart Choices' did not meet the NPM standard for a healthy product. Within each 'Smart Choices' category, 0 % of condiments, 8·70 % of fats and oils, 15·63 % of cereals and 31·58 % of snacks and sweets met NPM thresholds. All sampled soups, beverages, desserts and grains deemed 'Smart Choices' were considered healthy according to the NPM standard. The 'Smart Choices' programme is an example of industries' attempts at self-regulation. More than 60 % of foods that received the 'Smart Choices' label did not meet standard nutritional criteria for a 'healthy' food choice, suggesting that industries' involvement in designing labelling systems should be scrutinized. The NPM system may be a good option as the basis for establishing FOP labelling criteria, although more comparisons with other systems are needed.

  13. Recoil-Implantation Of Multiple Radioisotopes Towards Wear Rate Measurements And Particle Tracing In Prosthetic Joints

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

    Warner, Jacob A.; Timmers, Heiko; Smith, Paul N.

    2011-06-01

    This study demonstrates a new method of radioisotope labeling of ultra-high molecular weight polyethylene inserts in prosthetic joints for wear studies. The radioisotopes {sup 97}Ru, {sup 100}Pd, {sup 100}Rh, and {sup 101m}Rh are produced in fusion evaporation reactions induced by {sup 12}C ions in a {sup 92}Zr target foil. The fusion products recoil-implant into ultra-high molecular weight polyethylene plugs, machined to fit into the surface of the inserts. During laboratory simulations of the joint motion, a wear rate of the labeled polyethylene may be measured and the pathways of wear debris particles can be traced by detecting characteristic gamma-rays. Themore » concentration profiles of the radioisotopes extend effectively uniformly from the polyethylene surface to a depth of about 4 {mu}m. The multiplicity of labeling and the use of several gamma-ray lines aids with avoiding systematic measurement uncertainties. Two polyethylene plugs were labeled and one was fitted into the surface of the tibial insert of a knee prosthesis, which had been worn in. Actuation over close to 100,000 cycles with a 900 N axial load and a 24 deg. flexion angle removed (14{+-}1)% of the gamma-ray activity from the plug. Most of this activity dispersed into the serum lubricant identifying this as the important debris pathway. Less than 1% activity was transferred to the femoral component of the prosthesis and the measured activity on the tibial tray was insignificant. Assuming uniform wear across the superior surface of the insert, a wear rate of (12{+-}3) mm{sup 3}/Megacycle was determined. This is consistent with wear rate measurements under similar conditions using other techniques.« less

  14. 9 CFR 317.7 - Products for foreign commerce; printing labels in foreign language permissible; other deviations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Products for foreign commerce... DEVICES, AND CONTAINERS General § 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations. Labels to be affixed to packages of products for foreign commerce may be...

  15. 9 CFR 317.7 - Products for foreign commerce; printing labels in foreign language permissible; other deviations.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Products for foreign commerce... DEVICES, AND CONTAINERS General § 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations. Labels to be affixed to packages of products for foreign commerce may be...

  16. 9 CFR 317.7 - Products for foreign commerce; printing labels in foreign language permissible; other deviations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Products for foreign commerce... DEVICES, AND CONTAINERS General § 317.7 Products for foreign commerce; printing labels in foreign language permissible; other deviations. Labels to be affixed to packages of products for foreign commerce may be...

  17. 21 CFR 111.153 - What are the requirements under this subpart G for written procedures?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.153 What are the requirements under this subpart G for...

  18. 21 CFR 111.153 - What are the requirements under this subpart G for written procedures?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.153 What are the requirements under this subpart G for...

  19. 21 CFR 111.153 - What are the requirements under this subpart G for written procedures?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.153 What are the requirements under this subpart G for...

  20. 21 CFR 111.153 - What are the requirements under this subpart G for written procedures?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.153 What are the requirements under this subpart G for...

  1. 21 CFR 111.153 - What are the requirements under this subpart G for written procedures?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... or Labeling as a Dietary Supplement § 111.153 What are the requirements under this subpart G for...

  2. Mental models in risk assessment: informing people about drugs.

    PubMed

    Jungermann, H; Schütz, H; Thüring, M

    1988-03-01

    One way to communicate about the risks of drugs is through the use of package inserts. The problems associated with this medium of informing patients have been investigated by several researchers who found that people require information about drugs they are using, including extensive risk information, and that they are willing to take this information into account in their usage of drugs. But empirical results also show that people easily misinterpret the information given. A conceptual framework is proposed that might be used for better understanding the cognitive processes involved in such a type of risk assessment and communication. It is based on the idea that people develop, through experience, a mental model of how a drug works, which effects it might produce, that contraindications have to be considered, etc. This mental model is "run" when a specific package insert has been read and a specific question arises such as, for example, whether certain symptoms can be explained as normal or whether they require special attention and action. We argue that the mental model approach offers a useful perspective for examining how people understand package inserts, and consequently for improving their content and design. The approach promises to be equally useful for other aspects of risk analysis that are dependent upon human judgment and decision making, e.g., threat diagnosis and human reliability analysis.

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

    PubMed

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

    2017-09-01

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

  4. 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.

  5. Differences in consumer use of food labels by weight loss strategies and demographic characteristics.

    PubMed

    Bleich, Sara N; Wolfson, Julia A

    2015-12-22

    Little is known about national patterns in the use of fast food and packaged food labels among adults by weight loss strategies and demographic characteristics. We analyzed the Consumer Behavior Module in the National Health and Nutrition Examination Survey 2007-2010 among adults (N = 9,690). For each of the outcome variables - use of packed food and fast food menu labels - multiple logistic regressions were used to adjust for potential differences in population characteristics by weight loss activities and demographic characteristics. Overall, 69 percent of adults reported they would use fast food information and 76 percent reported using the nutrition facts panel on packaged foods. Adults trying to lose weight had a greater likelihood of reporting use of nutrition information to choose fast foods (OR = 1.72; 95 % CI: 1.29, 2.29) and using the nutrition facts panel on food labels (OR = 1.92; 95 % CI: 1.60, 2.30). Black and Hispanic adults were more likely to report using ingredients lists on packaged foods compared to Whites (White -63 %, Black/Hispanic -68 %, p < 0.05). Regardless of weight loss activities or demographic characteristics, a majority of adults report they would use fast food nutrition information.

  6. Xarray: multi-dimensional data analysis in Python

    NASA Astrophysics Data System (ADS)

    Hoyer, Stephan; Hamman, Joe; Maussion, Fabien

    2017-04-01

    xarray (http://xarray.pydata.org) is an open source project and Python package that provides a toolkit and data structures for N-dimensional labeled arrays, which are the bread and butter of modern geoscientific data analysis. Key features of the package include label-based indexing and arithmetic, interoperability with the core scientific Python packages (e.g., pandas, NumPy, Matplotlib, Cartopy), out-of-core computation on datasets that don't fit into memory, a wide range of input/output options, and advanced multi-dimensional data manipulation tools such as group-by and resampling. In this contribution we will present the key features of the library and demonstrate its great potential for a wide range of applications, from (big-)data processing on super computers to data exploration in front of a classroom.

  7. How the elderly and young adults differ in the decision making process of nonprescription medication purchases.

    PubMed

    Sansgiry, S S; Cady, P S

    1996-01-01

    The study compared elderly and young adults in their behavior and involvement in the decision making process of over-the-counter (OTC) medication purchases. Elderly subjects were more involved in the decision making process to purchase OTC medications compared to young adults. The elderly not only purchase and spend more money on medications but also read OTC labels completely. They requested help from the pharmacist more frequently than young adults. Needs of the elderly in making an OTC medication purchase were different compared to young adults. The two age groups differed on importance rating for several attributes regarding OTC medications, such as; ease of opening the package, child resistant package, side effects of medicine, manufacturer of medicine, print size on package labels, and greater choice of medicine.

  8. Responses of young adults to graphic warning labels for cigarette packages

    PubMed Central

    Cameron, Linda D.; Pepper, Jessica K.; Brewer, Noel T.

    2013-01-01

    Background In 2010, the US Food and Drug Administration (FDA) proposed a series of 36 graphic warning labels for cigarette packages. We sought to evaluate the effects of the labels on fear-related emotions about health consequences of smoking and smoking motivations of young adults. Methods We conducted an experimental study in 2010–2011 with 325 smokers and non-smokers ages 18–30 years whom we recruited through community distribution lists in North Carolina and through a national survey company. Each participant viewed 27 labels (18 of the proposed labels with graphic images and text warnings and 9 with text-only warnings) in a random order, evaluating each label on understandability and its effects on fear-related reactions and discouragement from wanting to smoke. Results Respondents found most of the proposed labels easy to understand. Of the 36 labels, 64% induced greater fear-related reactions and 58% discouraged respondents from wanting to smoke more than the corresponding text-only labels did. Labels with the greatest effects had photographs (as compared with drawings or other art graphics) or depicted diseased body parts or suffering or dead people. In almost every comparison, smokers reported lower fear-related reactions and feeling less discouraged from wanting to smoke relative to non-smokers. Conclusions Most of the proposed labels enhanced fear-related reactions about health consequences of smoking and reduced motivations to smoke relative to text-only labels, although some had larger effects than others. All but one of the nine warning labels recently adopted by the FDA enhanced fear-related reactions and reduced smoking motivations. PMID:23624558

  9. Technical note: Computer-manufactured inserts for prosthetic sockets.

    PubMed

    Sanders, Joan E; McLean, Jake B; Cagle, John C; Gardner, David W; Allyn, Katheryn J

    2016-08-01

    The objective of this research was to use computer-aided design software and a tabletop 3-D additive manufacturing system to design and fabricate custom plastic inserts for trans-tibial prosthesis users. Shape quality of inserts was tested right after they were inserted into participant's test sockets and again after four weeks of wear. Inserts remained properly positioned and intact throughout testing. Right after insertion the inserts caused the socket to be slightly under-sized, by a mean of 0.11mm, approximately 55% of the thickness of a nylon sheath. After four weeks of wear the under-sizing was less, averaging 0.03mm, approximately 15% of the thickness of a nylon sheath. Thus the inserts settled into the sockets over time. If existing prosthetic design software packages were enhanced to conduct insert design and to automatically generate fabrication files for manufacturing, then computer manufactured inserts may offer advantages over traditional methods in terms of speed of fabrication, ease of design, modification, and record keeping. Copyright © 2016 IPEM. Published by Elsevier Ltd. All rights reserved.

  10. Young adult smokers' perceptions of plain packs, numbered packs and pack inserts in Turkey: a focus group study.

    PubMed

    Mucan, Burcu; Moodie, Crawford

    2017-11-09

    The Turkish Government's 'National Tobacco Control Program 2015-2018' included plans to introduce plain packaging and also a ban on brand names on cigarette packs, allowing only assigned numbers on packs. We explored perceptions of these proposed measures, and also pack inserts with cessation messages, another novel way of using the packaging to communicate with consumers. Eight focus groups were conducted with 47 young adult smokers in Manisa and Kutahya (Turkey) in December 2016. Participants were shown three straight-edged plain cigarette packs, as required in Australia, and then three bevelled-edged plain packs, as permitted in the UK. They were then shown plain packs with numbers rather than brand names, and finally three pack inserts with messages encouraging quitting or offering tips on how to do so. Participants were asked about their perceptions of each. Plain packs were considered unappealing and off-putting, although the bevelled-edged packs were viewed more favourably than the straight-edged packs. Numbered packs were thought by some to diminish the appeal created by the brand name and potentially decrease interest among never smokers and newer smokers. Pack inserts were thought to have less of an impact than the on-pack warnings, but could potentially help discourage initiation and encourage cessation. That bevelled-edged plain packs were perceived more positively than straight-edged plain packs is relevant to countries planning to introduce plain packaging. The study provides a first insight into smokers' perceptions of a ban on brand names, which was perceived to reduce appeal among young people. © 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.

  11. Evaluation of strategies to communicate harmful and potentially harmful constituent (HPHC) information through cigarette package inserts: a discrete choice experiment.

    PubMed

    Salloum, Ramzi G; Louviere, Jordan J; Getz, Kayla R; Islam, Farahnaz; Anshari, Dien; Cho, Yoojin; O'Connor, Richard J; Hammond, David; Thrasher, James F

    2017-07-13

    The US Food and Drug Administration (FDA) has regulatory authority to use inserts to communicate with consumers about harmful and potentially harmful constituents (HPHCs) in tobacco products; however, little is known about the most effective manner for presenting HPHC information. In a discrete choice experiment, participants evaluated eight choice sets, each of which showed two cigarette packages from four different brands and tar levels (high vs low), accompanied by an insert that included between-subject manipulations (ie, listing of HPHCs vs grouping by disease outcome and numeric values ascribed to HPHCs vs no numbers) and within-subject manipulations (ie, 1 of 4 warning topics; statement linking an HPHC with disease vs statement with no HPHC link). For each choice set, participants were asked: (1) which package is more harmful and (2) which motivates them to not smoke; each with a 'no difference' option. Alternative-specific logit models regressed choice on attribute levels. 1212 participants were recruited from an online consumer panel (725 18-29-year-old smokers and susceptible non-smokers and 487 30-64-year-old smokers). Participants were more likely to endorse high-tar products as more harmful than low-tar products, with a greater effect when numeric HPHC information was present. Compared with a simple warning statement, the statement linking HPHCs with disease encouraged quit motivation. Numeric HPHC information on inserts appears to produce misunderstandings that some cigarettes are less harmful than others. Furthermore, brief narratives that link HPHCs to smoking-related disease may promote cessation versus communications that do not explicitly link HPHCs to disease. © 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.

  12. 21 CFR 201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...

  13. 21 CFR 201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...

  14. 21 CFR 201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use...

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...

  15. 21 CFR 201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use...

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...

  16. 21 CFR 201.305 - Isoproterenol inhalation preparations (pressurized aerosols, nebulizers, powders) for human use...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... immediate container label with a statement directed to pharmacists not to remove the label or (ii) by including in the package a printed warning with instructions to pharmacists to place the warning on the...

  17. Developing targets for radiation transport experiments at the Omega laser facility

    DOE PAGES

    Capelli, Deanna; Charsley-Groffman, C. A.; Randolph, Randall Blaine; ...

    2017-07-13

    Targets have been developed to measure supersonic radiation transport in aerogel foams using absorption spectroscopy. The target consists of an aerogel foam uniformly doped with either titanium or scandium inserted into an undoped aerogel foam package. This creates a localized doped foam region to provide spatial resolution for the measurement. Development and characterization of the foams is a key challenge in addition to machining and assembling the two foams so they mate without gaps. The foam package is inserted into a beryllium sleeve and mounted on a gold hohlraum. The target is mounted to a holder created using additive manufacturingmore » and mounted on a stalk. As a result, the manufacturing of the components, along with assembly and metrology of the target are described here.« less

  18. Developing targets for radiation transport experiments at the Omega laser facility

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

    Capelli, Deanna; Charsley-Groffman, C. A.; Randolph, Randall Blaine

    Targets have been developed to measure supersonic radiation transport in aerogel foams using absorption spectroscopy. The target consists of an aerogel foam uniformly doped with either titanium or scandium inserted into an undoped aerogel foam package. This creates a localized doped foam region to provide spatial resolution for the measurement. Development and characterization of the foams is a key challenge in addition to machining and assembling the two foams so they mate without gaps. The foam package is inserted into a beryllium sleeve and mounted on a gold hohlraum. The target is mounted to a holder created using additive manufacturingmore » and mounted on a stalk. As a result, the manufacturing of the components, along with assembly and metrology of the target are described here.« less

  19. Examining the conspicuousness and prominence of two required warnings on OTC pain relievers

    PubMed Central

    Bix, Laura; Bello, Nora M.; Auras, Rafael; Ranger, Jon; Lapinski, Maria K.

    2009-01-01

    The labeling of over-the-counter (OTC) drugs is critical to their safe and effective use, and certain warnings are meant to be read at the point of purchase (POP). Examples include (i) warnings that alert consumers to the fact that the package is not child-resistant and (ii) warnings that alert consumers to potential product tampering. U.S. law mandates these warnings be “conspicuous” and “prominent” so that it is likely that consumers will read them before leaving the store. Our objective was to quantify the relative prominence and conspicuousness of these warnings. Sixty-one participants reviewed the packages of 5 commercially available analgesics to evaluate the prominence and conspicuousness of these warnings. Evaluated data included (i) the time spent examining the warnings compared with other areas of the label (using a bright pupil eye tracker), (ii) the ability to recall information from the OTCs viewed, and (iii) the legibility of the warnings relative to other elements of the labels (as measured by ASTM D7298-06). Eye-tracking data indicated that warnings were viewed by fewer participants and for less time than other elements of the packages. Recall and legibility data also indicated that the warning statements compared unfavorably with other elements of the labels tested. Evidence presented in this study suggests that 2 required warnings on 5 different OTCs are not prominent or conspicuous when compared with other elements of tested labels. PMID:19332798

  20. The effect of the labelled serving size on consumption: A systematic review.

    PubMed

    Bucher, Tamara; Murawski, Beatrice; Duncanson, Kerith; Labbe, David; Van der Horst, Klazine

    2018-06-01

    Guidance for food consumption and portion control plays an important role in the global management of overweight and obesity. Carefully conceptualised serving size labelling can contribute to this guidance. However, little is known about the relationship between the information that is provided regarding serving sizes on food packages and levels of actual food consumption. The aim of this systematic review was to investigate how serving size information on food packages influences food consumption. We conducted a systematic review of the evidence published between 1980 and March 2018. Two reviewers screened titles and abstracts for relevance and assessed relevant articles for eligibility in full-text. Five studies were considered eligible for the systematic review. In three of the included studies, changes in serving size labelling resulted in positive health implications for consumers, whereby less discretionary foods were consumed, if serving sizes were smaller or if serving size information was provided alongside contextual information referring to the entire package. One study did not find significant differences between the conditions they tested and one study suggested a potentially negative impact, if the serving size was reduced. The influence of labelled serving size on consumption of non-discretionary foods remains unclear, which is partially due to the absence of studies specifically focusing on non-discretionary food groups. Studies that investigate the impact of serving size labels within the home environment and across a broad demographic cross-section are required. Copyright © 2018. Published by Elsevier Ltd.

  1. Awareness, understanding and use of sodium information labelled on pre-packaged food in Beijing:a cross-sectional study.

    PubMed

    He, Yao; Huang, Liping; Yan, Sijin; Li, Yuan; Lu, Lixin; Wang, Hongbo; Niu, Wenyi; Zhang, Puhong

    2018-04-17

    Nutrition labelling has been mandatory for pre-packaged foods since 2013 in China, and sodium is one of the nutrients required for display on the nutritional information panel (NIP). This study aimed to estimate the awareness, understanding of, and use of sodium labelling information among the population in China. A cross-sectional survey was carried out in urban Beijing in 2016 on pre-packaged foods. The researchers randomly selected 380 residents from four convenient but disconnected communities and 370 shoppers from four supermarkets owned by different companies and conducted face-to-face interviews. Questions on nutritional knowledge, health attitude, understanding and use of nutritional labels as well as other related factors were assessed. All of the 380 community residents and 308 of the 370 supermarket shoppers successfully completed the survey. Of those 688 respondents, 91.3% understood that excessive salt intake was harmful, 19.5% were aware that sodium content is listed on the NIP, 5.5% understood the meaning of NRV% (Percentage of Nutrient Reference Values), 47.7% did not know the relationship between sodium and salt, and 12.6% reported they frequently read the label when shopping. Factors for why people were more likely to choose a product because of its low level of salt shown on the label include income level and their level of awareness of the link between salt and diet. Although the participants had a good understanding of the harmful effects of salt, the awareness, understanding and use of sodium labels was very low in Beijing, and even worse nationwide. Efforts should be taken to educate the public to understand and use the NIP better and design clearer ways of displaying such information, such as front-of pack (FoP) labelling or health-related smartphone applications to improve health and help people make better food choices.

  2. Analysis of the NMI01 marker for a population database of cannabis seeds.

    PubMed

    Shirley, Nicholas; Allgeier, Lindsay; Lanier, Tommy; Coyle, Heather Miller

    2013-01-01

    We have analyzed the distribution of genotypes at a single hexanucleotide short tandem repeat (STR) locus in a Cannabis sativa seed database along with seed-packaging information. This STR locus is defined by the polymerase chain reaction amplification primers CS1F and CS1R and is referred to as NMI01 (for National Marijuana Initiative) in our study. The population database consists of seed seizures of two categories: seed samples from labeled and unlabeled packages regarding seed bank source. Of a population database of 93 processed seeds including 12 labeled Cannabis varieties, the observed genotypes generated from single seeds exhibited between one and three peaks (potentially six alleles if in homozygous state). The total number of observed genotypes was 54 making this marker highly specific and highly individualizing even among seeds of common lineage. Cluster analysis associated many but not all of the handwritten labeled seed varieties tested to date as well as the National Park seizure to our known reference database containing Mr. Nice Seedbank and Sensi Seeds commercially packaged reference samples. © 2012 American Academy of Forensic Sciences.

  3. Mitochondrial DNA transfer to the nucleus generates extensive insertion site variation in maize.

    PubMed

    Lough, Ashley N; Roark, Leah M; Kato, Akio; Ream, Thomas S; Lamb, Jonathan C; Birchler, James A; Newton, Kathleen J

    2008-01-01

    Mitochondrial DNA (mtDNA) insertions into nuclear chromosomes have been documented in a number of eukaryotes. We used fluorescence in situ hybridization (FISH) to examine the variation of mtDNA insertions in maize. Twenty overlapping cosmids, representing the 570-kb maize mitochondrial genome, were individually labeled and hybridized to root tip metaphase chromosomes from the B73 inbred line. A minimum of 15 mtDNA insertion sites on nine chromosomes were detectable using this method. One site near the centromere on chromosome arm 9L was identified by a majority of the cosmids. To examine variation in nuclear mitochondrial DNA sequences (NUMTs), a mixture of labeled cosmids was applied to chromosome spreads of ten diverse inbred lines: A188, A632, B37, B73, BMS, KYS, Mo17, Oh43, W22, and W23. The number of detectable NUMTs varied dramatically among the lines. None of the tested inbred lines other than B73 showed the strong hybridization signal on 9L, suggesting that there is a recent mtDNA insertion at this site in B73. Different sources of B73 and W23 were examined for NUMT variation within inbred lines. Differences were detectable, suggesting either that mtDNA is being incorporated or lost from the maize nuclear genome continuously. The results indicate that mtDNA insertions represent a major source of nuclear chromosomal variation.

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

    PubMed

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

    2017-08-01

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

  5. On-site detection of packaged squid freshness

    NASA Astrophysics Data System (ADS)

    Ahmad, Noor Azizah; Heng, Lee Yook; Salam, Faridah; Hanifah, Sharina Abu

    2018-04-01

    The development of indicator label for detection of total volatile basic nitrogen (TVB-N) is described. Dye extract from edible plants containing anthocyanins was immobilized onto iota-carrageenan as polymer matrix. TVB-N detection worked based on pH increase as the basic deterioration volatile amines generated in the package headspace. Results showed that the indicator label has changed color from blue to green after 12 hours of storage at ambient conditions. The TVB-N value was 38.9648 mg /100 g which is exceeded of acceptability level for seafood products. The pH value of squid flesh has also increased during storage. The colour values of L * and a * negative increases while b* negative decrease with increasing storage time. The indicator label is potentially used as freshness indicator for squid at ambient conditions.

  6. Fruit-related terms and images on food packages and advertisements affect children's perceptions of foods' fruit content.

    PubMed

    Heller, Rebecca; Martin-Biggers, Jennifer; Berhaupt-Glickstein, Amanda; Quick, Virginia; Byrd-Bredbenner, Carol

    2015-10-01

    To determine whether food label information and advertisements for foods containing no fruit cause children to have a false impression of the foods' fruit content. In the food label condition, a trained researcher showed each child sixteen different food label photographs depicting front-of-food label packages that varied with regard to fruit content (i.e. real fruit v. sham fruit) and label elements. In the food advertisement condition, children viewed sixteen, 30 s television food advertisements with similar fruit content and label elements as in the food label condition. After viewing each food label and advertisement, children responded to the question 'Did they use fruit to make this?' with responses of yes, no or don't know. Schools, day-care centres, after-school programmes and other community groups. Children aged 4-7 years. In the food label condition, χ 2 analysis of within fruit content variation differences indicated children (n 58; mean age 4·2 years) were significantly more accurate in identifying real fruit foods as the label's informational load increased and were least accurate when neither a fruit name nor an image was on the label. Children (n 49; mean age 5·4 years) in the food advertisement condition were more likely to identify real fruit foods when advertisements had fruit images compared with when no image was included, while fruit images in advertisements for sham fruit foods significantly reduced accuracy of responses. Findings suggest that labels and advertisements for sham fruit foods mislead children with regard to the food's real fruit content.

  7. 9 CFR 590.411 - Requirement of formulas and approval of labels for use in official egg products plants.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... products than for bulk packaged egg products not for sale or distribution to household consumers, label... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Requirement of formulas and approval of labels for use in official egg products plants. 590.411 Section 590.411 Animals and Animal...

  8. 9 CFR 590.411 - Requirement of formulas and approval of labels for use in official egg products plants.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... products than for bulk packaged egg products not for sale or distribution to household consumers, label... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Requirement of formulas and approval of labels for use in official egg products plants. 590.411 Section 590.411 Animals and Animal...

  9. 10 CFR 32.29 - Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name...

  10. 10 CFR 32.29 - Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name...

  11. 10 CFR 32.29 - Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name...

  12. 10 CFR 32.29 - Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... standards approved by the Commission; (b) Label or mark each detector and its point-of-sale package so that: (1) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing: (i) The following statement: “CONTAINS RADIOACTIVE MATERIAL”; (ii) The name...

  13. Attitude and Behavior Factors Associated with Front-of-Package Label Use with Label Users Making Accurate Product Nutrition Assessments.

    PubMed

    Roseman, Mary G; Joung, Hyun-Woo; Littlejohn, Emily I

    2018-05-01

    Front-of-package (FOP) labels are increasing in popularity on retail products. Reductive FOP labels provide nutrient-specific information, whereas evaluative FOP labels summarize nutrient information through icons. Better understanding of consumer behavior regarding FOP labels is beneficial to increasing consumer use of nutrition labeling when making grocery purchasing decisions. We aimed to determine FOP label format effectiveness in aiding consumers at assessing nutrient density of food products. In addition, we sought to determine relationships between FOP label use and attitude toward healthy eating, diet self-assessment, self-reported health and nutrition knowledge, and label and shopping behaviors. A between-subjects experimental design was employed. Participants were randomly assigned to one of four label conditions: Facts Up Front, Facts Up Front Extended, a binary symbol, and no-label control. One hundred sixty-one US primary grocery shoppers, aged 18 to 69 years. Participants were randomly invited to the online study. Participants in one of four label condition groups viewed three product categories (cereal, dairy, and snacks) with corresponding questions. Adults' nutrition assessment of food products based on different FOP label formats, along with label use and attitude toward healthy eating, diet self-assessment, self-reported health and nutrition knowledge, and label and shopping behaviors. Data analyses included descriptive statistics, χ 2 tests, and logistical regression. Significant outcomes were set to α=.05. Participants selected the more nutrient-dense product in the snack food category when it contained an FOP label. Subjective health and nutrition knowledge and frequency of selecting food for healthful reasons were associated with FOP label use (P<0.01 and P<0.05, respectively). Both Facts Up Front (reductive) and binary (evaluative) FOP labels appear effective for nutrition assessment of snack products compared with no label. Specific attitude and behavior factors were associated with label use. Copyright © 2018 Academy of Nutrition and Dietetics. Published by Elsevier Inc. All rights reserved.

  14. Does the Australasian "Health Star Rating" Front of Pack Nutritional Label System Work?

    PubMed

    Hamlin, Robert; McNeill, Lisa

    2016-06-01

    This article describes an experiment to measure the impact of the Australasian "Health Star Rating" front of pack nutritional label system on consumer choice behaviour. This system presents a one-half to five star rating of nutritional quality via the front facings of food product packages. While this system has been recently rolled out across Australasia, no test of its impact on food choice has been conducted. A sample of 1200 consumers was recruited on exit from supermarkets in New Zealand. A 2 × 2 factorial design was used with two levels of cold cereal product nutritional status (high, five star/low, two star) and two levels of the Health Star Rating label (present/absent). The dependent variable was revealed choice behaviour. The results indicated that the presence of the label had a significant depressive effect on consumer preference, but that this impact was not moderated in any way by the nutritional status expressed by the label. The result represents a significant functional failure of the Health Star Rating label in this research environment. The nature of the failure is consistent with the consumers processing the label in much the same way as the nominal brand cues that dominate the retail food packaging.

  15. Does the Australasian “Health Star Rating” Front of Pack Nutritional Label System Work?

    PubMed Central

    Hamlin, Robert; McNeill, Lisa

    2016-01-01

    This article describes an experiment to measure the impact of the Australasian “Health Star Rating” front of pack nutritional label system on consumer choice behaviour. This system presents a one-half to five star rating of nutritional quality via the front facings of food product packages. While this system has been recently rolled out across Australasia, no test of its impact on food choice has been conducted. A sample of 1200 consumers was recruited on exit from supermarkets in New Zealand. A 2 × 2 factorial design was used with two levels of cold cereal product nutritional status (high, five star/low, two star) and two levels of the Health Star Rating label (present/absent). The dependent variable was revealed choice behaviour. The results indicated that the presence of the label had a significant depressive effect on consumer preference, but that this impact was not moderated in any way by the nutritional status expressed by the label. The result represents a significant functional failure of the Health Star Rating label in this research environment. The nature of the failure is consistent with the consumers processing the label in much the same way as the nominal brand cues that dominate the retail food packaging. PMID:27258305

  16. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  17. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  18. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  19. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  20. 21 CFR 660.45 - Labeling.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS Hepatitis B Surface Antigen § 660.45 Labeling. In... capable of transmitting hepatitis and should be handled accordingly. (d) The package shall include a... test methods, and (3) warnings as to possible hazards, including hepatitis transmitted in handling the...

  1. New features in McStas, version 1.5

    NASA Astrophysics Data System (ADS)

    Åstrand, P.-O.; Lefmann, K.; Farhi, E.; Nielsen, K.; Skårup, P.

    The neutron ray-tracing simulation package McStas has attracted numerous users, and the development of the package continues with version 1.5 released at the ICNS 2001 conference. New features include: support for neutron polarisation, labelling of neutrons, realistic source and sample components, and interface to the Riso instrument-control software TASCOM. We give a general introduction to McStas and present the latest developments. In particular, we give an example of how the neutron-label option has been used to locate the origin of a spurious side-peak, observed in an experiment with RITA-1 at Riso.

  2. Ohio Appalachian residents' views on smoke-free laws and cigarette warning labels.

    PubMed

    Reiter, Paul L; Wewers, Mary E; Paskett, Electra D; Klein, Elizabeth G; Katz, Mira L

    2012-01-01

    Smoke-free laws and the addition of graphic warning labels to cigarette packages represent public health policies that can potentially reduce smoking and smoking-related disease. The attitudes and beliefs relating to these policies were examined among residents of Ohio Appalachia, a mostly rural region with high smoking prevalence among its residents. Focus groups were conducted with participants from Ohio Appalachia during the summer of 2007. Groups included healthcare providers (n=37), community leaders (n=31), parents (n=19), and young adult women aged 18-26 years (n=27). Most participants were female (94%), non-Hispanic White (94%), and married (65%). Participants believed that most non-smokers supported Ohio's enforced statewide comprehensive smoke-free law that began in 2007, while some smokers opposed the law due to a perceived infringement of their rights. They also reported that most residents and local businesses were abiding by and enforcing the law. Participants supported the addition of graphic warning labels to cigarette packages in the USA. They believed that such warning labels could help deter adolescents and adult non-smokers from smoking initiation, particularly if the negative aesthetic effects of smoking were emphasized. However, they felt the labels would be less effective among current smokers and older individuals living in their communities. Participants generally held positive views about both the smoke-free law and the addition of graphic warning labels to cigarette packages in the USA. These tobacco-related public health policies are promising strategies for potentially reducing smoking and its associated diseases among residents living in Appalachia. Additional research is needed to further examine support for these policies among more diverse Appalachian populations.

  3. Objective Understanding of Front-of-Package Nutrition Labels among Nutritionally At-Risk Individuals

    PubMed Central

    Ducrot, Pauline; Méjean, Caroline; Julia, Chantal; Kesse-Guyot, Emmanuelle; Touvier, Mathilde; Fezeu, Léopold K.; Hercberg, Serge; Péneau, Sandrine

    2015-01-01

    In the ongoing debate about front-of-package (FOP) nutrition labels, little data exist regarding nutritionally at-risk populations, although they are critical targets of prevention programs. This study aimed to compare the impact of FOP labels on the ability to rank products according to their nutritional quality among French adults potentially at risk of poor dietary quality (N = 14,230). Four labels were evaluated: Guideline Daily Amounts (GDA), Multiple Traffic Lights (MTL), 5-Color Nutrition Label (5-CNL), Green Tick (Tick), along with a reference without label. Mixed models were used to assess how individual characteristics and FOP labels were associated with the ability to rank products. Older participants and those with a lower educational level, income, nutritional knowledge, and likelihood of reading nutrition facts were less skilled at ranking food products according to nutritional quality. Compared with individual characteristics, nutrition labels had an increased impact on food product ranking ability. Overall, 5-CNL corresponded to the highest rate of correct responses, followed by MTL, GDA, and Tick (p < 0.0001). The strongest impact of 5-CNL was observed among individuals with no nutritional knowledge (odds ratio (OR): 20.24; 95% confidence interval (CI): 13.19–31.06). Therefore, 5-CNL appeared to be effective at informing consumers, including those who are nutritionally at-risk, about the nutritional quality of food products. PMID:26305255

  4. Objective Understanding of Front-of-Package Nutrition Labels among Nutritionally At-Risk Individuals.

    PubMed

    Ducrot, Pauline; Méjean, Caroline; Julia, Chantal; Kesse-Guyot, Emmanuelle; Touvier, Mathilde; Fezeu, Léopold K; Hercberg, Serge; Péneau, Sandrine

    2015-08-24

    In the ongoing debate about front-of-package (FOP) nutrition labels, little data exist regarding nutritionally at-risk populations, although they are critical targets of prevention programs. This study aimed to compare the impact of FOP labels on the ability to rank products according to their nutritional quality among French adults potentially at risk of poor dietary quality (N = 14,230). Four labels were evaluated: Guideline Daily Amounts (GDA), Multiple Traffic Lights (MTL), 5-Color Nutrition Label (5-CNL), Green Tick (Tick), along with a reference without label. Mixed models were used to assess how individual characteristics and FOP labels were associated with the ability to rank products. Older participants and those with a lower educational level, income, nutritional knowledge, and likelihood of reading nutrition facts were less skilled at ranking food products according to nutritional quality. Compared with individual characteristics, nutrition labels had an increased impact on food product ranking ability. Overall, 5-CNL corresponded to the highest rate of correct responses, followed by MTL, GDA, and Tick (p < 0.0001). The strongest impact of 5-CNL was observed among individuals with no nutritional knowledge (odds ratio (OR): 20.24; 95% confidence interval (CI): 13.19-31.06). Therefore, 5-CNL appeared to be effective at informing consumers, including those who are nutritionally at-risk, about the nutritional quality of food products.

  5. Food and the consumer: could labelling be the answer?

    PubMed

    Kerr, Maeve A; McCann, Mary T; Livingstone, M Barbara E

    2015-05-01

    Extensive research into the impact of nutrition labelling across Europe has shown that many consumers can effectively use a nutrition label to rank a food for healthiness. The present paper considers observational and laboratory evidence which has examined the impact of nutrition labelling (on food packaging and at point of purchase) on dietary behaviour. In addition, the potential counterproductive effects of foods bearing 'healthy' nutrition labels are examined. The observational evidence provides a useful insight into the key characteristics of nutrition label use. Those most likely to engage with nutrition labels are more likely to have a diet related disease and/or be on a weight loss diet and have a good overall diet quality. Experimental evidence, while limited, suggests that serving size information may be overlooked by consumers. In fact, there may be a tendency among consumers to overeat foods that are perceived to be healthier. The findings from the present paper suggest that if nutrition labelling is to be considered a strategy to facilitate consumers in managing their energy intake, it must coincide with salient, consistent and simple serving size information on the front of food packages and at the point of purchase. There is a clear need for more experimental research using robust methodologies, to examine the impact of nutrition information on dietary intake. In the meantime, there should be greater attention given to portion size within national dietary guidance.

  6. Assessing the Role of Shape and Label in the Misleading Packaging of Food Imitating Products: From Empirical Evidence to Policy Recommendation

    PubMed Central

    Basso, Frédéric; Bouillé, Julien; Le Goff, Kévin; Robert-Demontrond, Philippe; Oullier, Olivier

    2016-01-01

    Food imitating products are chemical consumer items used frequently in the household for cleaning and personal hygiene (e.g., bleach, soap, and shampoo), which resemble food products. Their containers replicate elements of food package design such as possessing a shape close in style to drinking product containers or bearing labels that depict colorful fruits. In marketing, these incongruent forms are designed to increase the appeal of functional products, leading to chemical consumer product embellishment. However, due to the resulting visual ambiguity, food imitating products may expose consumers to the risk of being poisoned from ingestion. Thus, from a public health perspective, food imitating products are considered dangerous chemical products that should not be sold, and may merit being recalled for the safety of consumers. To help policymakers address the hazardous presence of food imitating products, the purpose of this article is to identify the specific design features that generate most ambiguity for the consumer, and therefore increase the likelihood of confusion with foodstuffs. Among the visual elements of food packaging, the two most important features (shape and label) are manipulated in a series of three lab studies combining six Implicit Association Tests (IATs) and two explicit measures on products' drinkability and safety. IATs were administered to assess consumers' implicit association of liquid products with tastiness in a within-subject design in which the participants (N = 122) were presented with two kinds of food imitating products with a drink shape or drink label compared with drinks (experiential products with congruent form) and classic chemical products (hygiene products) (functional products with congruent form). Results show that chemical consumer products with incongruent drink shapes (but not drink labels) as an element of food package design are both implicitly associated with tastiness and explicitly judged as safe and drinkable. These results require confirmation in other studies involving different shapes and labels. Notwithstanding, due to the misleading effect of this ambiguity, public health authorities are thus well advised to focus their market surveillance on chemical products emulating a food or drink shape. PMID:27065919

  7. Responses of young adults to graphic warning labels for cigarette packages.

    PubMed

    Cameron, Linda D; Pepper, Jessica K; Brewer, Noel T

    2015-03-01

    In 2010, the US Food and Drug Administration (FDA) proposed a series of 36 graphic warning labels for cigarette packages. We sought to evaluate the effects of the labels on fear-related emotions about health consequences of smoking and smoking motivations of young adults. We conducted an experimental study in 2010-2011 with 325 smokers and non-smokers ages 18-30 years whom we recruited through community distribution lists in North Carolina and through a national survey company. Each participant viewed 27 labels (18 of the proposed labels with graphic images and text warnings and 9 with text-only warnings) in a random order, evaluating each label on understandability and its effects on fear-related reactions and discouragement from wanting to smoke. Respondents found most of the proposed labels easy to understand. Of the 36 labels, 64% induced greater fear-related reactions and 58% discouraged respondents from wanting to smoke more than the corresponding text-only labels did. Labels with the greatest effects had photographs (as compared with drawings or other art graphics) or depicted diseased body parts or suffering or dead people. In almost every comparison, smokers reported lower fear-related reactions and feeling less discouraged from wanting to smoke relative to non-smokers. Most of the proposed labels enhanced fear-related reactions about health consequences of smoking and reduced motivations to smoke relative to text-only labels, although some had larger effects than others. All but one of the nine warning labels recently adopted by the FDA enhanced fear-related reactions and reduced smoking motivations. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  8. All Natural and Clean-Label Preservatives and Antimicrobial Agents Used during Poultry Processing and Packaging.

    PubMed

    Grant, Ar'quette; Parveen, Salina

    2017-04-01

    The poultry industry is faced with compounding pressures of maintaining product safety and wholesomeness while keeping up with consumer trends of all-natural foods and label accuracy. Consumers are increasingly demanding that their foods be minimally processed and contain compounds that are easily read and recognized, i.e., products must be clean labeled. The purpose of this review is to briefly describe several natural antimicrobial agents that can be incorporated into poultry processing. These compounds and their essential oils were included in this mini-review because they are generally recognized as safe by the U.S. Food and Drug Administration and are considered clean label: thyme extract, rosemary extract, garlic, and oregano. This list of natural antimicrobial agents by no means includes all of the options available to poultry processors. Rather, this review provides a brief glance at the potential these natural antimicrobial agents have in terms of reduced pathogenicity, increased shelf stability, and sensory acceptability through direct product application or as part of the product packaging.

  9. "Plain packaging" regulations for tobacco products: the impact of standardizing the color and design of cigarette packs.

    PubMed

    Hammond, David

    2010-01-01

    Tobacco packaging and labeling policies have emerged as prominent and cost-effective tobacco control measures. Although packaging policies have primarily focused on health warnings, there is growing recognition of the importance of packaging as a marketing tool for the tobacco industry. The current paper reviews evidence on the potential impact of standardizing the color and design of tobacco packages -so called "plain" packaging. The evidence indicates three primary benefits of plain packaging: increasing the effectiveness of health warnings, reducing false health beliefs about cigarettes, and reducing brand appeal especially among youth and young adults. Overall, the research to date suggests that "plain" packaging regulations would be an effective tobacco control measure, particularly in jurisdictions with comprehensive restrictions on other forms of marketing.

  10. 7 CFR 205.309 - Agricultural products in other than packaged form at the point of retail sale that are sold...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... the point of retail sale that are sold, labeled, or represented as âmade with organic (specified... of retail sale that are sold, labeled, or represented as “made with organic (specified ingredients or... food group(s)),” to modify the name of the product in retail display, labeling, and display containers...

  11. 7 CFR 205.309 - Agricultural products in other than packaged form at the point of retail sale that are sold...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... the point of retail sale that are sold, labeled, or represented as âmade with organic (specified... of retail sale that are sold, labeled, or represented as “made with organic (specified ingredients or... food group(s)),” to modify the name of the product in retail display, labeling, and display containers...

  12. 7 CFR 205.309 - Agricultural products in other than packaged form at the point of retail sale that are sold...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... the point of retail sale that are sold, labeled, or represented as âmade with organic (specified... of retail sale that are sold, labeled, or represented as “made with organic (specified ingredients or... food group(s)),” to modify the name of the product in retail display, labeling, and display containers...

  13. 21 CFR 111.370 - What requirements apply to rejected dietary supplements?

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2013-04-01 2013-04-01 false What requirements apply to rejected dietary...

  14. 21 CFR 111.370 - What requirements apply to rejected dietary supplements?

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2014-04-01 2014-04-01 false What requirements apply to rejected dietary...

  15. 21 CFR 111.370 - What requirements apply to rejected dietary supplements?

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2011-04-01 2011-04-01 false What requirements apply to rejected dietary...

  16. 21 CFR 111.370 - What requirements apply to rejected dietary supplements?

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2012-04-01 2012-04-01 false What requirements apply to rejected dietary...

  17. 76 FR 51257 - First-Class Package Service

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-18

    ... Ground, and Bound Printed Matter prices. * * * * * * * * 2.0 Additional Physical Standards by Class of... ``PRSRT'') First-Class Package'' (or ``PKG'') must be printed as part of; directly below; or to the left... follows:] b. * * * labeling: * * * * * 2. Line 2: ``FC PARCELS 3D.'' [Revise item 4.4c2 by changing ``FCM...

  18. 21 CFR 111.370 - What requirements apply to rejected dietary supplements?

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Production and Process Control... disposition any dietary supplement that is rejected and unsuitable for use in manufacturing, packaging, or... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What requirements apply to rejected dietary...

  19. 21 CFR 101.2 - Information panel of package form food.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... identity. (2) Individual serving-size packages of food served with meals in restaurants, institutions, and...), any vignettes, designs, and other nonmandatory label information shall not be considered. If there is... designed to serve as a principal display panel, shall be exempt from the placement requirements of this...

  20. Methodology for evaluating the insect growth regulator (IGR) methoprene incorporated into packaging films

    USDA-ARS?s Scientific Manuscript database

    The insect growth regulator methoprene has been impregnated onto various packaging materials to control stored product insects, and is labeled for use in this manner in the United States. Different methodologies were utilized to evaluate efficacy towards Tribolium castaneum (Herbst), the red flour b...

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