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FDA’s CFSAN Announces Plan for Program Priorities

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On September 4, 2013, the Center for Food Safety and Applied Nutrition (CFSAN or the Center), a public health regulatory center in the U.S. Food and Drug Administration (FDA), published its 2013-2014 Plan for Program Priorities. The plan outlines certain goals and objectives that CFSAN intends to achieve to improve food and cosmetic safety. You can read the 2013-2014 Plan for Program Priorities on the FDA’s website, available here. More specifically, the plan lists six goals: (1) reduce foodborne illness rates and cosmetic injury rates each year; (2) establish regulations, policies, guidance, and inspection and compliance strategies based on best…
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FDA Approves Botox Cosmetic for New Intended Use

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On September 11, 2013, the U.S. Food and Drug Administration (FDA) approved onabotulinumtoxin A, the drug marketed as Botox and Botox Cosmetic, for the temporary minimizing of the appearance of moderate to severe lateral canthal lines, more commonly known as crow’s feet, in adults. Botox, made from botulinum neurotixn, prevents muscles from tightening when administered via intramuscular injection. You can read the announcement here. The FDA approved Botox Cosmetic for treating crow’s feet after the drug’s safety and effectiveness for that intended use were established by two clinical studies. Under the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA…
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FDA Updates Draft Guidance on Medical Foods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On August 13, 2013, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Frequently Asked Questions about Medical Foods; Second Edition.”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 You can read the draft guidance on the FDA’s website, available here.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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