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FDA Seizes Topical Creams Deemed Drugs

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On May 16, 2014, the U.S. Food and Drug Administration ("FDA"), with assistance by the U.S. Attorney for the Southern District of Ohio, seized unapproved drugs valued at more than $11 million, which were marked by Ascend Laboratories of Montvale, N.J. and held by Masters Pharmaceuticals, Inc. of Cincinnati, OH. The products seized by the FDA included those marketed for the treatment of inflamed hemorrhoids, colitis and other inflammatory conditions (Hydrocortisone Acetate Suppositories, 25 mg) and skin thickening conditions such as dermatitis and eczema (Urea Cream 39%, Urea Cream 40% and Urea Lotion 40%). The FDA announcement can be found…
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FDA to Regulate New Tobacco Products, E-Cigarettes

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On April 24, 2014, the U.S Food and Drug Administration (FDA) announced its publication of newly proposed regulations pertaining to new tobacco products, as permitted by the Family Smoking Prevention and Tobacco Control Act of 2009. The products covered under the newly-proposed regulations are any tobacco related products that fall under the statutory definition of tobacco products, including presently uncontrolled, advertised products like pipe tobacco, electronic cigarettes (e-cigarettes), nicotine gels, water pipe tobacco, cigars and other related products. While some products, like electronic cigarettes, don't directly consist of tobacco, these products fall under FDA’s tobacco authority, as promulgated by Congress,…
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FDA Publishes Draft Guidance on Honey Labeling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On April 11, 2014, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled “Draft Guidance for Industry: Proper Labeling of Honey and Honey Products” (“Guidance”).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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J&J Company Pleads Guilty to Misbranding for Off-Label Marketing

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On November 4, 2013, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Justice announced that Janssen Pharmaceuticals, Inc. (JPI), a Johnson & Johnson company, pled guilty to misbranding the drug Risperdal (risperidone) in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), arising from its off-label marketing of the drug. Under the plea agreement, the Company is required to pay a $400 million criminal fine. It will also be required to pay civil penalties under a separate settlement concerning Risperdal. The cases resulting in these settlements originated from qui tam, or “whitstleblower,” lawsuits filed under…
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FDA Finalizes Rule Requiring Unique Device Identification for Medical Devices

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On September 20, 2013, the U.S. Food and Drug Administration (FDA) published a final rule that establishes the Unique Device Identification (UDI) system, finalizing the proposal first announced in July 2012. Our previous report of the proposed rule may be accessed here. In particular, the final rule will require that most medical devices distributed in the United States, with certain exceptions, bear a unique device identification on device labeling. It is also applicable to certain combination products that contain devices and to devices licensed under the Public Health Service Act. You can read the announcement here. Section 519(f) of the…
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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 Approves Botox Cosmetic for New Intended Use

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On September 11, 2013, the U.S. Food and Drug Administration (FDA) approved onabotulinumtoxin A, the drug marketed as Botox and Botox Cosmetic, for the temporary minimizing of the appearance of moderate to severe lateral canthal lines, more commonly known as crow’s feet, in adults. Botox, made from botulinum neurotixn, prevents muscles from tightening when administered via intramuscular injection. You can read the announcement here. The FDA approved Botox Cosmetic for treating crow’s feet after the drug’s safety and effectiveness for that intended use were established by two clinical studies. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA…
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