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FDA Warning Issued Regarding Weight Loss Products

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On April 7, 2014, the U.S. Food and Drug Administration ("FDA") released an advisory, warning consumers not to use bee pollen capsule marketed under the name Zi Xiu Tang Bee Pollen. The purpose for the advisory, previously reported here, was to alert the public that the product contained potentially harmful active pharmaceutical ingredients, which had not been listed on the label for the product and was the subject of a FDA warning letter. The undeclared substances, Sibutramine Hydrochloride (sibutramine), an active ingredient in the obesity drug Meridia (pulled from the United States market in December 2010 based on increased risk…
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FDA Publishes Food Allergen Labeling Guidelines

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On May 8, 2014, the U.S. Food and Drug Administration (FDA) published its "Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications." The draft guidance represents current thinking on the topic as previously discussed through the release of the October 2006 "Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Final Guidance." The guidance provides the FDA's answers to commonly asked questions concerning the notification process for those seeking exemptions from the labeling of food allergens and updates the responses in the 2006 document. You…
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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 Halts Production at New York Cheese Company

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On April 28, 2014, the U.S. Food and Drug Administration ("FDA") prevailed in federal court in its action against Nancy Taber Richards and the company she co-founded, Trumansburg, N.Y.-based Finger Lakes Farmstead Cheese Company, LLC. In particular, the Western District of New York's U.S. District Court entered a consent decree of permanent injunction against the New York dairy manufacturer due to the detection of listeria contamination. News pertaining to the consent decree and prior warning letter can be found here. According to the consent decree, the company Finger Lakes has been prohibited from the further manufacturing, preparation, processing, packaging, storage…
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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 Advises Consumers to Avoid Using Dietary Supplements with Undeclared Drug Ingredients

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On April 7, 2014, the U.S. Food and Drug Administration (“FDA”) advised consumers to stop taking Zi Xiu Tang Bee Pollen products, which are promoted as body forming, weight loss dietary supplements. According to the FDA, the Company's dietary supplements include at least one potentially dangerous pharmaceutical ingredient that is not declared on the product label. After testing a variety of different Zi Xiu Tang Bee Pollen dietary supplements, the FDA has discovered that each product contained at least one of the listed unnamed drug ingredients: Phenolphthalein - A substance that is associated with cancer and is not a current…
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FTC Prevails Against Marketers of Medical Foods

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On March 7, 2014, the Federal Trade Commission (“FTC”) reported that the Agency had prevailed in federal court in its action against the Wellness Support Network. In particular, the U.S. District Court for the Northern District of California entered a final judgment, finding that Wellness Support Network had violated Section 5 of the Federal Trade Commission Act (“FTCA”) by making claims about its products that were considered false and/or unsupported by scientific evidence at the time the claims were made. As part of its judgment, the Court ordered the Company to pay nearly $2.2 million dollars in restitution, which will…
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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 Statement on IOM Report on Safety of Caffeine in Foods

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On January 21, 2014, the U.S. Food & Drug Administration (“FDA”) issued a Statement on the Institute of Medicine’s Report (“IOM Report”) on Caffeine in Foods. Released on January 17, 2014, the IOM Report is a culmination of the recent public workshop, which took place in August 2013 and was focused on the investigation of the continued safety of caffeine in foods and dietary supplements. The IOM Report highlights the issues surrounding the safety of caffeine in foods and concludes that continued research is necessary to determine whether caffeinated foods and dietary supplements are safe, particularly for children and adolescents.…
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