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FDA Warns Company for Marketing Medical Device

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On November 5, 2012, the U.S. Food and Drug Administration (“FDA”) announced recent action the Agency has taken against a Tennessee-based company in connection with the Company’s alleged violations of the Federal Food, Drug and Cosmetic Act (“FFDCA”). According to the FDA’s Press Release, found here, The Avalon Effect, Inc. (“the Company”) is in violation of the FFDCA because of several claims made on the Company’s website and other linked websites which contain claims that its light therapy device may be used to cure or treat fungal meningitis, concussions, Lyme disease and other illnesses. In addition, the FDA notes that…
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FDA Approves MS Drug, Noting Boxed Warnings

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On September 12, 2012, the U.S. Food and Drug Administration (“FDA”) announced the approval of the drug Aubagio (teriflunomide). Manufactured by Sanofi Aventis, Aubagio is a once-a-day tablet for the treatment of relapsing forms of multiple sclerosis (“MS”) in adults. The full announcement of the approval may be accessed here. As noted in the FDA’s announcement, Aubagio contains a Boxed Warning intended to alert prescribers and patients of certain risks, including liver problems and birth defects. Accordingly, prescribers are warned to refrain from prescribing Aubagio to patients who have existing liver problems. In addition, prescribers are required to verify that…
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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 Approves First At-Home HIV Test

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On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) approved the first over-the-counter (“OTC”) at-home test kit used to detect human immunodeficiency virus (“HIV”). According to the FDA’s announcement, the OraQuick In-Home HIV Test allows the user to collect an oral fluid sample by first swabbing the gums. Thereafter, the sample is placed in a vial where the results will be displayed within 20 to 40 minutes. Of course, like most other at-home tests, the FDA warns that the results of the test are not definitive in nature and that additional testing in a clinical setting should be…
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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 Releases Draft Guidance Updating Warnings for Labeling of Albumin, Highlighting Risk of Creutzfeldt Jakob Disease

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On June 11, 2012, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document, entitled Draft Guidance for Industry: Amendment to ‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products.’ Found here, the Document highlights the recommended changes to labeling in light of current scientific knowledge. Creutzfeldt-Jakob Disease (“CJD”) is a debilitating brain disorder that results in rapidly declining neurological functioning and ultimately death. Related to bovine spongiform encephalitis (“BSE” or “Mad Cow Disease”), variant Creutzfeldt-Jakob Disease (“vCJD”) is extremely rare and thought…
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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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FDA and FAAN Aim to Educate Public during Food Allergy Awareness Week

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This week (May 13 – May 19, 2012) is recognized as Food Allergy Awareness Week (“FAAW”). FAAW was created by the Food Allergy & Anaphylaxis Network (“FAAN”), a non-profit organization dedicated to promoting awareness food allergies and those who suffer from them. An annual event since 1998, FAAW began at a time when companies were not required to declare major food allergens in labeling. In 2004 Congress passed the Food Allergen Labeling and Consumer Protection Act (“FALCPA”), thereby giving the U.S. Food and Drug Administration (“FDA”) the authority to regulate in this area. Since the passage of FALCPA, the FDA…
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FDA Warns of Recall Due to Undeclared Milk Derivatives in Several Beverage Products

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On May 10, 2012, the U.S. Food and Drug Administration (“FDA”) posted a press release on its website notifying consumers of a recent recall of various fruit beverages. Jonlly Fruits Inc., the manufacturer of the beverages, opted to initiate the voluntary recall of the affected products after labeling deficiencies were uncovered during the FDA’s inspection of its facilities. According to the Company’s press release, several of its products may contain the milk derivative sodium caseinate. Under the Food Allergen Labeling and Consumer Protection Act and its corresponding FDA regulations, manufacturers and/or labelers of finished food products are required to declare…
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