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FDA Publishes Draft Guidance on Honey Labeling

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On April 11, 2014, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled “Draft Guidance for Industry: Proper Labeling of Honey and Honey Products” (“Guidance”). The Guidance provides industry with guidelines on how to properly label honey and related products in order to ensure that these products are not labeled in a misleading manner pursuant to the requirements of the Federal Food, Drug and Cosmetic Act (“FFDCA”) and accompanying FDA regulations. The Guidance sets forth the Agency’s current thinking pertaining to honey labeling. In particular, the FDA notes the proper uses of the term “honey” in…
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FDA Moves to Update Nutrition Facts Label for Foods

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On February 27, 2014, the U.S. Food and Drug Administration's ("FDA") moved to update nutrition facts labels (“Nutrition Facts Panels”) on packaged foods and dietary supplements. The proposal was prompted by recent scientific findings that suggest there is a direct correlation between excessive food intake and recurring diseases, like heart disease and obesity. In addition, the proposed labeling will replace outdated serving sizes to help deliver a better perception of actual food intake by consumers today. The proposed Nutrition Facts Panels will provide a new, unique approach that highlights certain parts of the label like serving sizes, ingredients and caloric…
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FDA Issues Guidance on Distinguishing Liquid Dietary Supplements from Beverages

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On January 16, 2014, the U.S. Food & Drug Administration (“FDA”) published a guidance document entitled “Distinguishing Liquid Dietary Supplements from Beverages” (“Guidance”). Found here, the Guidance is aimed at explaining to industry how dietary supplements and beverages differ. Beverages are considered a type of conventional food, which differ from dietary supplements in both labeling and the ingredients that are permitted. For example, beverages differ from dietary supplements in that the labels of these products bear nutrition facts panels, as opposed to supplement facts panels, and the products are also distinguished by claims made in labeling. For example, the Guidance…
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FDA Acts to Ban Trans Fat in Foods

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On November 7, 2013, the U.S. Food and Drug Administration (“FDA”) published an announcement, entitled “Tentative Determination Regarding Partially Hydrogenated Oils,” announcing its preliminary determination that Partially Hydrogenated Oils (“PHOs”), which are the primary source of trans fatty acids (trans fat) in processed foods, are not generally recognized as safe (GRAS) for any use in food. The FDA’s determination is based on evidence that the consumption of PHOs, which are commonly added to food to increase shelf life and flavor, are associated with serious health risks. Accordingly, the FDA's action signals the first steps in a move to ban trans…
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FDA’s CFSAN Announces Plan for Program Priorities

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On September 4, 2013, the Center for Food Safety and Applied Nutrition (CFSAN or the Center), a public health regulatory center in the U.S. Food and Drug Administration (FDA), published its 2013-2014 Plan for Program Priorities. The plan outlines certain goals and objectives that CFSAN intends to achieve to improve food and cosmetic safety. You can read the 2013-2014 Plan for Program Priorities on the FDA’s website, available here. More specifically, the plan lists six goals: (1) reduce foodborne illness rates and cosmetic injury rates each year; (2) establish regulations, policies, guidance, and inspection and compliance strategies based on best…
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FDA Updates Draft Guidance on Medical Foods

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On August 13, 2013, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Frequently Asked Questions about Medical Foods; Second Edition.” The first edition of this guidance was previously issued in May 2007. The draft provides the FDA’s answers to commonly asked questions concerning the definition and regulation of medical foods and updates the responses in the 2007 document. You can read the draft guidance on the FDA’s website, available here. More specifically, a medical food—defined in section 5(b)(3) of the Orphan Drug Act (ODA)—is a food “which is formulated to be consumed or administered enterally…
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FDA Publishes Final Rule on Gluten-Free Labeling

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On August 5, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule, “Food Labeling; Gluten-Free Labeling of Foods,” that defines the term “gluten-free” and adopts requirements for its voluntary use in food labeling. The regulation will particularly help those with Celiac disease to maintain a gluten-free diet. Celiac disease is an autoimmune reaction that damages the small intestine whenever gluten, a natural protein in grains such as wheat, rye, and barley, is ingested. FDA has authority to issue the rule under Section 206 of the Food Allergen and Consumer Protection Act (FALCPA) of 2004. You can read…
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FDA Publishes Overview of Regulatory Requirements for Food Businesses

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On June 19, 2013, as part of Small Business Week, the U.S. Food and Drug Administration (FDA) published “How to Start a Food Business” on its website. The article provides a brief overview of the requirements that a food business must comply with under the Federal Food, Drug, and Cosmetic Act (FDCA) and other FDA regulations. You can read the article here. As the FDA explains, the Public Health Security and Bioterrorism Preparedness and Response Act amended the FDCA to require that the owner, operator, or agent of a domestic or foreign food facility, as defined by 21 CFR 1.227, where…
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FDA Issues Final Rule on Prior Notice for Imported Food

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On May 29, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule that adopts, without change, the Interim Final Rule (IFR), entitled “Information Required in Prior Notice of Imported Food,” that was published in the Federal Register (76 FR 25542) on May 5, 2011. In particular, the final rule adopts the IFR’s requirement that a prior notice of imported food for humans or animals include the name of any country to which the article has been previously refused entry. You can read the final rule here. Pursuant to section 801(m) of the Federal Food, Drug, and Cosmetic…
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FDA Investigates the Safety of Caffeine in Food

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On May 3, 2013, the U.S. Food and Drug Administration (FDA) announced that it is currently investigating the safety of added caffeine in foods, particularly in response to a recent trend of caffeinated products. The FDA is primarily concerned with the consumption of caffeine by children and adolescents, and in turn, caffeine in food products marketed to these age groups. You can read the FDA’s article here. According to the article, the FDA will address the health effects of caffeine, especially for those at risk from excess consumption. It will also look at the appropriate products for added caffeine and…
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