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FDA “Natural” Food Labeling

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On November 12, the U.S. Food & Drug Administration (“FDA”) announced that it is soliciting public comments on how the Agency should define the term “natural” and regulate its use in food labeling. The FDA has engaged the public’s input after receiving two Citizen Petitions requesting the agency take action on establishing a formal definition of the term “natural” for use in food labeling and one requesting asking that the agency prohibits the use of the term “natural” on food labels. The FDA also notes that this recent move is driven by recent private litigation surrounding the term “natural” in…
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FDA Bans Trans Fats

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FDA Issues Final Determination Concerning Partially Hydrogenated Oils The U.S. Food and Drug Administration (FDA) has long reacted to the public concern over trans fatty acids (also known as TFA or trans fats) found in foods as a part of Partially Hydrogenated Oils (PHOs).  FDA recently issued its final decision on how it would categorize PHOs.  Following through on an effort the FDA began in 2013, the categorization of PHOs officially changed to not generally recognized as safe (GRAS) for use in food, effectively banning trans fats.  This change in categorization now puts PHOs under the regulations that govern food…
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Overview of FDA’s Final Menu and Vending Labeling Rules

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Menu and Vending Labeling Rules On November 25, 2014, the U.S. Food and Drug Administration (FDA) finalized two rules requiring that calorie counts be listed on menus and menu boards in certain restaurants and vending machines (menu and vending labeling rules). The full text of the menu and vending labeling rules can be found here. The menu labeling rule applies to restaurants if they are part of a chain of 20 or more locations, doing business under the same name, and offering more or less the same menu items. The 1990 Nutrition Labeling and Education Act established nutrition labeling on…
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Court Finds FDA Exceeded Authority in Device Reclassification

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On September 26, 2014, The United States Court of Appeals for the District of Columbia Circuit ruled that the FDA had “short circuited” its procedural requirements, pertaining to device reclassification and formal rulemaking, when it reevaluated a medical device being sold on the market in an effort to require the device to obtain further approval. The medical device that was the subject of the controversy was an absorbable surgical mesh, designed for use in knee replacement surgeries, called the Collagen Scaffold. In 2008, the device manufacturer obtained clearance from the FDA, through the 510(k) process, to market the Collagen Scaffold.…
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FDA Releases Proposed Rules under FSMA

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On September 19, 2014, the U.S. Food and Drug Administration (FDA) released revisions to four proposed rules, opening them up for public comment. When these four rules are finalized in 2015, they will implement portions of the FDA Food Safety Modernization Act (FSMA) of 2011. The four new rules open for public comment set guidelines for the following food safety issues: Enhanced produce safety Preventative controls for human food Best practices and guidelines for animal food The foreign supplier verification program The FDA is looking towards shifting its focus under the FSMA from after-the-fact responses, or a reactionary approach, to…
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FDA Inches Closer to New Nutrition Facts Panel Rules

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On August 1, 2014, the U.S. Food and Drug Administration (FDA) closed its comment period for a proposed rule that would make significant changes to food labeling requirements, particularly nutrition facts panels. Per the Administrative Procedure Act, the FDA is currently reviewing the 264,723 comments that it received regarding the proposed rule and changes to nutrition facts panels that appear on all FDA-regulated food products. The proposed rule can be found here. As soon as the rule is finalized, it will be implemented in sixty (60) days’ time. For existing products, manufacturers will have two (2) years to comply with…
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FDA to Regulate New Tobacco Products, E-Cigarettes

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On April 24, 2014, the U.S Food and Drug Administration (FDA) announced its publication of newly proposed regulations pertaining to new tobacco products, as permitted by the Family Smoking Prevention and Tobacco Control Act of 2009. The products covered under the newly-proposed regulations are any tobacco related products that fall under the statutory definition of tobacco products, including presently uncontrolled, advertised products like pipe tobacco, electronic cigarettes (e-cigarettes), nicotine gels, water pipe tobacco, cigars and other related products. While some products, like electronic cigarettes, don't directly consist of tobacco, these products fall under FDA’s tobacco authority, as promulgated by Congress,…
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FDA Seeks to Review Safety and Effectiveness of Antibacterial Soaps

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On December 16, 2013, the U.S. Food & Drug Administration (FDA) issued a proposed rule, “Safety and Effectiveness of Consumer Antiseptics,” that would require manufacturers of over-the-counter (OTC) antibacterial soaps and body washes to provide the FDA with data demonstrating that the products are safe for long-term use and effective in preventing illness and infection. You can read the FDA’s announcement here. The proposed rule is part of the FDA’s ongoing review of the safety and effectiveness of the active ingredients in antibacterial soaps and related products, which are not found in non-antibacterial, or plain, soap. Further, as noted above,…
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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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