Warning Letters – Page 2 – Shehadeh Giannamore, PLLC

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Permanent Injunction Sought after Cheese Manufacturer Fails to Respond to FDA Warning Letter

FDA CGMP, Enforcement, FDA, Food, Warning Letters

On August 8, 2014, the U.S. Food and Drug Administration ("FDA") filed a Complaint for Permanent Injunction against a Michigan Cheese Manufacturer and its owners under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 332. The FDA seeks to prevent S. Serra Cheese Company, based in Clinton Township, Michigan from receiving, preparing, processing, packing, holding, or distributing food until they meet FDA requirements. The Complaint for Permanent Injunction comes as a result of inspectional observations and the Company’s failure to take prompt action when notified of these observations. In particular, FDA inspected the manufacturing facility in 2013 and…

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FDA Seeks Injunction against Company for Misbranding Drug Products

FDA Disease Claims, Drug, Drugs, Enforcement, FDA, Labeling, Warning Letters

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

FDA Dietary Supplements, Drugs, Enforcement, FDA, imports, Labeling, Warning Letters

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 Halts Production at New York Cheese Company

FDA Enforcement, FDA, Listeria, Warning Letters

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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FTC Prevails Against Marketers of Medical Foods

FDA, FTC Advertising, Disease Claims, FDA, FTC, Substantiation, Warning Letters

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 Warns Consumers About Dietary Supplement Containing Synthetic Steroids

FDA Adverse Events, dietary ingredients, Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Warning Letters

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

FDA Dietary Supplements, DMAA, Enforcement, FDA, New Dietary Ingredients, Warning Letters

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 Issues Warning Letters to Companies Marketing Illegal Diabetes Drugs

FDA Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Labeling, Structure-Function Claims, Warning Letters

On July 23, 2013, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to 15 domestic and foreign companies that were deemed to be unlawfully marketing diabetes products in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and other federal laws. The products, sold online and in retail stores, include dietary supplements, over-the-counter (OTC) drugs, and unapproved prescription drugs. You can read the announcement here. Also, a list of the warning letters is available at this link. The FDA issued the warning letters as part of an initiative to remove illegal diabetes products from…

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FDA Issues Warning Letters to Online Cigarette Companies

FDA Cigarettes, FDA, Labeling, Tobacco Products, Warning Letters

In April 2013, the U.S. Food and Drug Administration (FDA) issued warning letters to certain online cigarette retailers, finding many of their products adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). One of the companies is located in Indonesia but offers its cigarettes for sale to customers in the United States. It is unclear where the other company is based, as it is an internet retailer with no available address information. You can read the warning letters by clicking here and here. The FDA sent similar warning letters to other online retailers of cigarettes…

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Company’s Operations Halted for Violating FDA Food Labeling Rules

FDA Enforcement, FDA, Food, Labeling, Misbranding, Nutrition Facts, Warning Letters

On March 13, 2013, the U.S. Food and Drug Administration (“FDA”) announced that a federal judge has signed a consent decree of permanent injunction, enjoining a New Jersey-based food company’s operations. In particular, Butterfly Bakery Inc. (“the Company”) is prohibited from processing and distributing food until it brings its operations into compliance with the Federal Food, Drug and Cosmetic Act (“FFDCA”). According to the consent decree, the Company’s products were deemed misbranded due to various labeling deficiencies, whereby the Company allegedly failed to comply with federal law and accompanying FDA food labeling rules. As noted by the FDA, the present action demonstrates…