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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 Warns Consumers About Dietary Supplement Containing Synthetic Steroids

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On December 23, 2013, the U.S. Food and Drug Administration (“FDA”) issued an announcement warning consumers about the serious health risks associated with using “Mass Destruction,” a product marketed as a dietary supplement for muscle growth. This product is manufactured for Blunt Force Nutrition in North Carolina and is sold in retail stores, gyms, and on the internet. The FDA alleges that despite being labeled as a dietary supplement, Mass Destruction contains synthetic anabolic steroids, which makes it an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”). The FDA’s announcement may be found here.…
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FDA Seeks to Review Safety and Effectiveness of Antibacterial Soaps

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On December 16, 2013, the U.S. Food & Drug Administration (FDA) issued a proposed rule, “Safety and Effectiveness of Consumer Antiseptics,” that would require manufacturers of over-the-counter (OTC) antibacterial soaps and body washes to provide the FDA with data demonstrating that the products are safe for long-term use and effective in preventing illness and infection. You can read the FDA’s announcement here. The proposed rule is part of the FDA’s ongoing review of the safety and effectiveness of the active ingredients in antibacterial soaps and related products, which are not found in non-antibacterial, or plain, soap. Further, as noted above,…
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U.S. Marshals Seize Dietary Supplements Containing DMAA from Georgia Company

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On November 12, 2013, the U.S. Marshals, at the request of the U.S. Food and Drug Administration (FDA), seized dietary supplements manufactured and held by Hi-Tech Pharmaceutical, Inc., located in Georgia. According to the FDA, the dietary supplements are adulterated because they contain Dimethylamylamine (DMAA), a new dietary ingredient, in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). DMAA is an amphetamine derivative that is considered unsafe under federal law because it is associated with serious health risks. You can read the FDA’s announcement here. In October 2013, during an inspection at the Hi-Tech facility, FDA investigators found…
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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 Seeks Permanent Injunction against Oregon Dietary Supplement Company

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On October 21, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it is seeking a permanent injunction against James G. Cole, a dietary supplement manufacturer based in Oregon, along with the company’s president, James G. Cole, and general manager, Julie D. Graves. The complaint was filed on the FDA’s behalf by the U.S Department of Justice. If granted, the permanent injunction would prohibit James G. Cole from marketing and distributing its products until it complies with Current Good Manufacturing Practice (“cGMP”) requirements for dietary supplements and removes all unapproved drug claims from its product labels and websites. You…
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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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