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FDA Warns Dietary Supplement Firms for Marketing Concussion Treatments

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On September 6, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to two dietary supplement companies in connection with promoting unapproved products as drugs. According to the FDA, the firms cited by the Agency, PruTect Rx and Trinity Sports Group, Inc., were targeted for the improper marketing of products labeled as dietary supplements. The FDA alleges that despite being labeled as dietary supplements, these products were labeled with a variety of claims to treat concussions and prevent concussion-related disorders. Accordingly, the FDA has found these products to be unapproved new drugs, in violation of the Federal Food,…
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FDA Warns Makers of RockStar Coffee & Energy Products

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On May 23, 2012, the U.S. Food and Drug Administration (“FDA”) issued a Warning Letter to the manufacturers of the widely popular RockStar energy products, Rockstar , Inc. (“the Company”). Found here, the Letter contains various allegations that the Company’s products are adulterated under the Federal Food, Drug and Cosmetic Act (“FFDCA”) and FDA regulations. In particular, the Company’s RockStar Roasted Coffee & Energy products, including Premium Blended Mocha Cream & Coffee, Premium Blended Latte Cream & Coffee, and Light Vanilla flavors, are allegedly adulterated under the FFDCA because of the ingredients used and the way they are marketed. Pursuant…
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Marshals Seize Misbranded Drug Products at Maine Facility per FDA’s Request

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On June 6, 2012, the U.S. Food and Drug Administration (“FDA”) announced the seizure of various drug products from a Portland, Maine facility. According to the FDA, U.S. Marshals seized the drug products upon the Agency’s request after it was discovered that the firm was making improper claims in various promotional materials, including the products’ labels and the firm’s website. The Press Release announcing the recent seizure may be accessed here. Global Biotechnologies, Inc., the firm targeted in the seizure, had been cited by the FDA before for the same type of deficiencies. In particular, the FDA issued a Warning…
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FDA Alerts Consumers of an Array of Dangers Associated with Reumofan Plus Supplement

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On June 1, 2012, the U.S. Food and Drug Administration (“FDA”) issued an alert to consumers on the product Reumofan Plus. Purportedly marketed as a dietary supplement, Reumofan Plus is manufactured in Mexico by the company Riger Naturals. According to the Agency the product poses a risk to consumers and those currently taking the product should cease use and contact a health professional immediately. The alert issued by the FDA may be accessed here. The FDA warned of several deficiencies it found with the product. In particular, the FDA noted that the label, which appears solely in Spanish, identifies the…
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FTC May Have Won Battle with POM Wonderful but Industry Appears to Have Won the War

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On May 21, 2012, the Federal Trade Commission (“FTC”) announced that it has prevailed in its claim against POM Wonderful LLC (“The Company”) pursuant to a recent ruling by Chief Administrative Law Judge (“ALJ”), D. Michael Chappell. In an Order dated May 17, 2012, Judge Chappell directed the juice giant to refrain from making statements that POM Wonderful 100% Pomegranate Juice and POMx supplements can prevent or treat heart disease, erectile dysfunction and prostate cancer unless the Company has “competent and reliable scientific evidence” to substantiate these claims. Although the FTC is largely heralding the ALJ’s order as a victory,…
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FDA Notifies Consumers of Supplement Recall after Discovery of Undeclared Drug Ingredients

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On May 18, 2012, the U.S. Food and Drug Administration (“FDA”) published a press release announcing the voluntary recall of certain dietary supplements marketed as male enhancements. West Coast Nutritionals, Ltd., the firm responsible for the supplements, initiated the recall after an FDA laboratory analysis uncovered the presence of undeclared Tadalafil in an assortment of the Company’s products. Tadalafil is the active ingredient in Cialis, the popular drug approved by the FDA to treat Erectile Dysfunction (“ED”). Because of the presence of the undeclared pharmaceutical ingredient, the FDA warns that the Company’s products are considered unapproved new drugs under the…
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FDA Warns Companies Marketing Supplements Containing DMAA

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On April 27, 2012, the U.S. Food and Drug Administration (“FDA”) issued warning letters to several dietary supplement manufacturers in connection with their alleged improper marketing of supplements containing dimethylamylamine (“DMAA”). DMAA, also referred to as geranium extract, is an ingredient found in many dietary supplements and is frequently marketed as a natural stimulant. As discussed in the FDA’s announcement, the Agency considers the marketing of products containing DMAA improper because the ingredient has not been proven to be safe for consumers. Accordingly, these products are considered adulterated under the Federal Food, Drug and Cosmetic Act (“FFDCA”). Under the FDA’s…
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