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FDA Seeks Injunction against Company for Misbranding Drug Products

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On June 25, 2014, the U.S. Department of Justice ("DOJ"), in response to a request made by the U.S. Food and Drug Administration ("FDA"), filed a complaint seeking a permanent injunction against Laclede, Inc. of Rancho Domingo California and the Company's president, Michael A. Pellico. The injunctive relief, which was sought in the U.S. District Court for the Central District of California, related to Laclede's illegal distribution of over-the-counter (OTC) vaginal drug products that did not have the required FDA approval. News pertaining to this action can be found here. The unapproved products that were subject to the complaint against…
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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On May 8, 2014, the U.S. Food and Drug Administration (FDA) published its "Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications." The draft guidance represents current thinking on the topic as previously discussed through the release of the October 2006 "Guidance for Industry: Questions and Answers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 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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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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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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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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