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FDA Updates Draft Guidance on Medical Foods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On August 13, 2013, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Frequently Asked Questions about Medical Foods; Second Edition.”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 You can read the draft guidance on the FDA’s website, available here.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 Considering Rulemaking for Menthol Cigarettes

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On July 23, 2013, the U.S. Food and Drug Administration (FDA) issued an Advanced Notice of Proposed Rulemaking (ANPRM) to request information regarding the agency’s regulation of menthol cigarettes. Menthol is a common flavoring additive used in tobacco products and is currently the only flavor permitted for use in cigarettes. The FDA is considering further regulation as a way to address certain public health risks that are raised by menthol cigarettes, particularly in comparison to regular cigarettes. You can read the ANPRM here. The FDA has authority to regulate tobacco products pursuant to the Federal Food, Drug, and Cosmetic Act…
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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 Substantially Equivalent Marketing Orders for New Tobacco Products

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On June 25, 2013, the U.S. Food and Drug Administration (FDA) issued substantially equivalent (SE) marketing orders for two new tobacco products marketed by Lorillard Tobacco Company, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box. This is the first time that the FDA has approved the marketing of new tobacco products since the Family Smoking Prevention and Tobacco Control Act (FSPTCA) gave the FDA jurisdiction over the manufacturing, distribution, and marketing of tobacco products in 2009. The announcement is provided at this link, and you can read the marketing orders for the new tobacco products here and here. Pursuant…
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FDA Publishes Overview of Regulatory Requirements for Food Businesses

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On June 19, 2013, as part of Small Business Week, the U.S. Food and Drug Administration (FDA) published “How to Start a Food Business” on its website. The article provides a brief overview of the requirements that a food business must comply with under the Federal Food, Drug, and Cosmetic Act (FDCA) and other FDA regulations. You can read the article here. As the FDA explains, the Public Health Security and Bioterrorism Preparedness and Response Act amended the FDCA to require that the owner, operator, or agent of a domestic or foreign food facility, as defined by 21 CFR 1.227, where…
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FDA Issues Final Rule on Prior Notice for Imported Food

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On May 29, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule that adopts, without change, the Interim Final Rule (IFR), entitled “Information Required in Prior Notice of Imported Food,” that was published in the Federal Register (76 FR 25542) on May 5, 2011. In particular, the final rule adopts the IFR’s requirement that a prior notice of imported food for humans or animals include the name of any country to which the article has been previously refused entry. You can read the final rule here. Pursuant to section 801(m) of the Federal Food, Drug, and Cosmetic…
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FDA Issues Letter for Failure to Obtain 510(k) Clearance for Medical Mobile App

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On March 21, 2013 the U.S. Food & Drug Administration (FDA) issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited for failure to obtain 510(k) clearance for its medical mobile app, uChek Urine Analyzer. The uChek Urine Analyzer is an iPhone mobile app, intended for use with Siemens and Bayer reagent strips, which allows a mobile phone to analyze the strips and determine urine analytes. You can read the letter here. In the letter, the FDA explains that urinanalysis dipsticks are cleared only when they are interpreted by a direct visual reading. Any company intending…
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FDA Investigates the Safety of Caffeine in Food

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On May 3, 2013, the U.S. Food and Drug Administration (FDA) announced that it is currently investigating the safety of added caffeine in foods, particularly in response to a recent trend of caffeinated products. The FDA is primarily concerned with the consumption of caffeine by children and adolescents, and in turn, caffeine in food products marketed to these age groups. You can read the FDA’s article here. According to the article, the FDA will address the health effects of caffeine, especially for those at risk from excess consumption. It will also look at the appropriate products for added caffeine and…
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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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