Tag Archive: Rulemaking

Jan 11

FDA “Natural” Food Labeling

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 …

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Jun 30

FDA Bans Trans Fats

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 …

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Jan 05

Overview of FDA’s Final Menu and Vending Labeling Rules

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. …

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Oct 14

Court Finds FDA Exceeded Authority in Device Reclassification

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. …

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Sep 29

FDA Releases Proposed Rules under FSMA

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 …

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Sep 08

FDA Inches Closer to New Nutrition Facts Panel Rules

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 …

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May 06

FDA to Regulate New Tobacco Products, E-Cigarettes

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 …

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Dec 19

FDA Seeks to Review Safety and Effectiveness of Antibacterial Soaps

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. …

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Jul 30

FDA Considering Rulemaking for Menthol Cigarettes

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 …

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