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Industry News FDAs Science Based Approach To Nutrition Mar 2010
 

Industry News FDAs Science Based Approach To Nutrition Mar 2010

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FDA\'s Commitment to a "Science-Based" Approach to Food Labeling/Nutrition and Perspectives from Industry

FDA\'s Commitment to a "Science-Based" Approach to Food Labeling/Nutrition and Perspectives from Industry

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    Industry News FDAs Science Based Approach To Nutrition Mar 2010 Industry News FDAs Science Based Approach To Nutrition Mar 2010 Document Transcript

    • NMR News: Volume 3, Issue 3, March 2010 FDA’S COMMITMENT TO A “SCIENCE-BASED” APPROACH TO FOOD LABELING/NUTRITION & PERSPECTIVES FROM INDUSTRY By: Latesha Richards, Marketing Coordinator On March 3, 2010, FDA Commissioner Margaret Hamburg, M.D., issued an open letter to the food industry encouraging food companies to review their product labeling to ensure they are in compliance with FDA regulations, and are truthful and not misleading with their marketing claims. This came after warning letters received by seventeen (17) food companies for making unauthorized health claims and/or structure/function and nutrient content claims. A Look at a Few Labeling Mishaps The food companies recently targeted by the FDA allegedly made unauthorized and/or misleading claims for their products and in varying degrees including some nutrient-content, structure/function and health claims that would deem the product an unapproved drug. For example, two companies received warning letters for their food products that allegedly made claims of “zero grams trans-fat...” prominently displayed on the front of package label. The Center for Food Safety and Applied Nutrition (CFSAN) categorized these products as 1
    • NMR News: Volume 3, Issue 3, March 2010 misbranded and essentially misleading because the nutrition facts panel declares saturated fat levels that are considered “high” by the FDA. Further, any product with saturated fat levels over 4 g are required to “bear a disclosure statement (immediately adjacent to the claim) referring the consumer to nutrition information for those nutrients, as required in 21CFR 101.13(h)(1)…” However, their product labels failed to bear that required disclosure, according to CFSAN. Dr. Hamburg concluded in her letter to industry that “Claims that a product is free of trans fats, which imply that the product is a better choice than products without the claim, can be misleading when a product is high in saturated fat, and especially so when the claim is not accompanied by the required statement referring consumers to the more complete information on the Nutrition Facts panel.” CFSAN also issued warning letters to a manufacturer of a functional beverage and a snack food. According to the warning letters, these food manufacturers made several implied claims that their products that they can treat or cure specific diseases. From CFSAN’s view, these products were violating the Federal Food, Drug and Cosmetic Act because they made claims that reflected intended use as an unapproved drug. CFSAN also said that the scientific publications listed serve as evidence of its “intended use for the cure, mitigation, treatment or prevention of disease.” Dr. Hamburg concludes “Products that claim to treat or mitigate disease are considered to be drugs and must meet the regulatory requirements for drugs, including the requirement to prove that the product is safe and effective for its intended use.” It is for these reasons, Dr. Hamburg implies, that the FDA has been focusing on “improving the scientific accuracy and usefulness of food labeling” in efforts to “improve consumers’ ability to make nutritious choices.” The FDA will move in full steam to propose guidance for “front-of- package” labeling and nutrient information on the Nutrition Facts Panel. This will involve an extensive examination of all the different labeling systems to ensure that they provide consumers with useful and meaningful nutrition information. Coming up with this system would be 2
    • NMR News: Volume 3, Issue 3, March 2010 consistent with the promise of a “standardized, science-based approach” to all of FDA’s regulations and guidances. Perspectives on Changes on the Use of Nutrient-Content, Structure-Function, and Qualified Health Claims These types of claims described above have long been the subject of some organizational perspectives on food labeling. Among some individuals and organizations, the Center for Science in the Public Interest (CSPI or the “Center”) has been on the forefront of labeling issues and has been persistently pushing for food labeling reform. In its “Food Labeling Chaos: The Case for Reform” report, CSPI proposes a full makeover of the nutrition facts panel. They believe among other things in removing extraneous information, stating calories per serving in larger font, including daily value and % daily value for sugar content per serving, prohibiting claims such as “fat free” and “low fat” on products that are not low in sugar, and making nutrition labeling mandatory for single-ingredient meat and poultry products. CSPI’s proposal for label makeover can be found here: http://cspinet.org/new/pdf/beforeafterlabel.pdf. Aside from nutrition facts panel reform, CSPI endorse regulatory reform for nutrient-content, structure/function and health claims for foods. 3
    • NMR News: Volume 3, Issue 3, March 2010 CSPI argues that any misleading structure/function claims should be banned entirely. According to their report, structure/function claims do not have to satisfy stringent substantiation requirements that health claims do. They further argue that based on FDA research, consumers cannot differentiate between structure/function claims and health claims, so the substantiation standard should be the same for both. Therefore they conclude that same significant scientific agreement (SSA) standard for health claims should apply to structure/function claims for foods. The Center also argues that the FDA should prohibit qualified health claims altogether because the use of uncertain scientific evidence and disclaimers would not be enough to fully protect consumers. They are pushing for the FDA to refrain from giving companies approval for these claims unless they meet the rigorous SSA requirement. The CSPI argues in their case for reform report that a nutrient-content statement like “zero trans- fat” prominently displayed in “banners, large type, and exclamation points…” is grossly misleading when the food is not low in saturated fat. They propose that the use of “zero” or “no” should not be used, unless a serving of the product is low in saturated fat and cholesterol. Similarly, Nutritionists, Marion Nestle PhD, and David Ludwig, M.D., argues in a Journal of the American Medical Association commentary piece that current label practices have long been misleading to consumer and claims, typically nutrient-content claims have skewed the truth. They endorse revisions and updates to the nutrition facts panel that would help facilitate making healthier choices easier for consumers. However, unlike CSPI who wants to tighten the requirements for making claims, Nestle and Ludwig call for an outright ban of front-of-package label claims. As the FDA is now proactively following through on front-of-label reform, let’s see if the FDA follows through on CSPI’s other recommendations. Chances are they probably will. The implementation of CSPI’s other proposed reforms may not happen immediately and 4
    • NMR News: Volume 3, Issue 3, March 2010 spontaneously, but the concern that the food industry will continue in their deceptive practices, will warrant the reforms inevitable. Nutraceutical Medical Research, LLC is a full-service clinical research organization dedicated to substantiating product or ingredient claims with scientific and clinical research services for nutraceutical, natural products, dietary supplements, ingredient, cosmeceutical, food and pharmaceutical companies, using evidence-based approaches. We provide comprehensive scientific/clinical research and medical writing services. We also provide a wide range of consulting services which includes basic science investigations, clinical trial development, clinical writing, FDA/FTC questions and compliance, label review, market research, strategic planning and Statistical analysis. Disclosure: Nutraceutical Medical Research, LLC and its employees do not subscribe to or endorse any particular statement, opinion, or perspective made in this article. To access the Center of Science in the Public Interest’s Food Labeling Chaos Case for Reform Report, go to: http://cspinet.org/new/pdf/food_labeling_chaos_report.pdf To access the full list of affected food products, go here: http://www.fda.gov/Food/LabelingNutrition/ucm202859.htm 5
    • NMR News: Volume 3, Issue 3, March 2010 References: 1. Food and Drug Administration. FDA Calls on Food Companies to Correct Labeling Violations; FDA Commissioner Issues an Open Letter to the Industry Press Release. www.fda.gov.. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm202814.htm. Accessed on March 14, 2010. 2. Brandt MB, Moss J, Ellwood K, et al. Tracking Label Claims. Food Technol. 2010. Accessed on March 15, 2010 at: http://members.ift.org/NR/rdonlyres/365E0772-D840-409A-9626- 9EDC1BA7EAA9/0/0110feat_labeling.pdf 3. Food and Drug Administration. 2010. Open Letter to Industry from Dr. Hamburg. www.fda.gov. http://www.fda.gov/Food/LabelingNutrition/ucm202733.htm . Accessed on March 14, 2010. 4. Silverglade B, Heller IR; Center for Science in the Public Interest. Food Labeling Chaos: Case For Reform Report, December 2009. http://cspinet.org/new/pdf/food_labeling_chaos_report.pdf. Accessed on March 14, 2010. 5. Food and Drug Administration. Pom Wonderful warning letter. www.fda.gov. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202785.htm. Accessed on March 14, 2010. 6. Food and Drug Administration. 2010. Dreyer’s Ice Cream Inc. warning letter. www.fda.gov. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202826.htm. Accessed on March 14, 2010. 7. Food and Drug Administration. 2010. Gorton’s Inc. warning letter. www.fda.gov. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202829.htm. Accessed on March 14, 2010. 8. Food and Drug Administration. 2010. Diamond Food Inc. warning letter. www.fda.gov. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm202825.htm . Accessed on March 14, 2010. 6