FDA – Page 3 – Shehadeh Giannamore, PLLC

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FTC-FDA Warning Letter Issued to Company Marketing Ebola Cure

FDA, FTC Dietary Supplements, Disease Claims, Drugs, FDA, FTC, Labeling, Substantiation, Warning Letters

On September 23, 2014, the U.S. Food & Drug Administration ("FDA"), in conjunction with the Federal Trade Commission ("FTC"), issued a Warning Letter to Natural Solutions Foundation in Newton, New Jersey. FDA representatives allege the FDA warning letter was prompted by the certain marketing. In particular, the Company violated the Federal Food, Drug, and Cosmetic Act by promoting the use of several products to cure, treat, mitigate, or prevent disease. According to the letter, Dr. Rima Laibow promoted Nano Silver as a "natural therapy" or "cure" for the Ebola virus. Additionally, Laibow's website contained claims referring to the product as…

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FDA Inches Closer to New Nutrition Facts Panel Rules

FDA Beverages, FDA, Food, Labeling, Nutrition Facts, Rulemaking

On August 1, 2014, the U.S. Food and Drug Administration (FDA) closed its comment period for a proposed rule that would make significant changes to food labeling requirements, particularly nutrition facts panels. Per the Administrative Procedure Act, the FDA is currently reviewing the 264,723 comments that it received regarding the proposed rule and changes to nutrition facts panels that appear on all FDA-regulated food products. The proposed rule can be found here. As soon as the rule is finalized, it will be implemented in sixty (60) days’ time. For existing products, manufacturers will have two (2) years to comply with…

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Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter

FDA CGMP, dietary supplement marketing, Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Labeling, manufacturing practices, permanent injunction, Structure-Function Claims, Warning Letters

On August 8, 2014, the U.S. Food and Drug Administration ("FDA") obtained a court order from the United States District Court for the Middle District of Georgia against a dietary supplement manufacturer. The Order prohibits the manufacturer from selling dietary supplements until they comply with FDA good manufacturing regulations and other applicable, federal requirements. In addition to purported manufacturing deficiencies, the Company, BioAnue, sold dietary supplements that were marketed as treatments for common diseases, causing the FDA to deem these products to be unapproved new drugs. The FDA’s announcement can be found here. BioAnue received a warning letter from the…

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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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FDA to Regulate New Tobacco Products, E-Cigarettes

FDA e-cigarettes, FDA, imports, Labeling, Rulemaking, Tobacco Products

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

FDA Enforcement, FDA, Food, Guidance, imports, Labeling

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

FDA Adverse Events, Dietary Supplements, Enforcement, FDA

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…