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FDA Updates Draft Guidance on Medical Foods

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On August 13, 2013, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Frequently Asked Questions about Medical Foods; Second Edition.” The first edition of this guidance was previously issued in May 2007. The draft provides the FDA’s answers to commonly asked questions concerning the definition and regulation of medical foods and updates the responses in the 2007 document. You can read the draft guidance on the FDA’s website, available here. More specifically, a medical food—defined in section 5(b)(3) of the Orphan Drug Act (ODA)—is a food “which is formulated to be consumed or administered enterally…
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FDA Publishes Final Rule on Gluten-Free Labeling

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On August 5, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule, “Food Labeling; Gluten-Free Labeling of Foods,” that defines the term “gluten-free” and adopts requirements for its voluntary use in food labeling. The regulation will particularly help those with Celiac disease to maintain a gluten-free diet. Celiac disease is an autoimmune reaction that damages the small intestine whenever gluten, a natural protein in grains such as wheat, rye, and barley, is ingested. FDA has authority to issue the rule under Section 206 of the Food Allergen and Consumer Protection Act (FALCPA) of 2004. You can read…
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FDA Issues Warning Letters to Companies Marketing Illegal Diabetes Drugs

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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

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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

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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…
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Food Seasonings Recalled Due to Undeclared Allergens

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On February 15, 2013, the DeCoty Coffee Company of San Angelo, Texas announced that it was recalling its 1.25 pound and 5.75 pound DeCoty Taco Seasoning products. Prompting this recall are labeling concerns, specifically that the products contain an undeclared ingredient, soy, and people who have allergies or sensitivity to soy may run the risk of a serious allergic or life threatening reaction if they consume this product. As of this date, no illnesses have been reported due to ingesting this product. More information about the recall may be accessed here. In 2004, Congress passed the Food Allergen Labeling and…
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FDA/FTC Issue Joint Warning Letter to Company Marketing Flu Remedy

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On January 24, 2013, the U.S. Food and Drug Administration (“FDA”) and the U.S. Federal Trade Commission (“FTC”) issued a joint warning letter to Flu & Cold Defense, LLC (“the Company”), a Florida company, for unlawfully marketing its “GermBullet” inhaler as a cold and flu remedy. The “GermBullet” is sold online as well as in small pharmacies and health food stores. You can read the warning letter here. According to the text of the Warning Letter, the FDA targeted the Company, Flu & Cold Defense, along with its managing member Todd Whidden, for marketing the “Germ Bullet” as an unapproved…
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FDA Enjoins Beverage Maker’s Operations until it Complies with the FDCA

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On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced that it has entered into a consent decree of permanent injunction with Jonlly Fruits, Inc. (“Company”) and its President, Bartolo Pérez Román. Jonlly Fruits is a frozen fruit, juice, and vegetable manufacturing company located in Puerto Rico.  Under the consent decree, signed by Judge Gustavo A. Gelpi of the U.S. District Court for the District of Puerto Rico, the Company agrees to cease all operations until it complies with the Federal Food, Drug, and Cosmetic Act (“FDCA”). This will include complying with Current Good Manufacturing Practice (“cGMP”) and Hazard…
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Court Finds FDA’s Prohibition of Off-Label Promotion Unconstitutional

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On December 3, 2012, the U.S. Court of Appeals for the Second Circuit reversed the conviction of a pharmaceutical sales representative, finding that promotion of FDA-approved drugs for unapproved uses, in and of itself, does not constitute a violation of the Federal Food, Drug and Cosmetic Act (“FDCA”). The Defendant-Appellant in the case, Alfred Caronia, appealed from his conviction in which he was found guilty of conspiracy to introduce a misbranded drug into interstate commerce, a violation of the FDCA. In particular, Caronia was charged and thereafter convicted for promoting the drug Xyrem for uses not approved by the U.S.…
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Jimmy Dean Initiates Recall for Failure to Declare Allergens

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On November 10, 2012, Jimmy Dean issued a Press Release, explaining how the Company is initiating a voluntary recall of certain of its products due to a labeling error that resulted in undeclared allergens. In particular, the Company is recalling certain lots of its French Toast & Sausage Sandwich breakfast products because the labels of such products fail to declare the presence of soy and egg. According to the Company, no other Jimmy Dean brand products are affected. Under the Food Allergen Labeling and Consumer Protection Act (“FALCPA”), all food labels must declare the presence of major food allergens. Pursuant…
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