FDA Issues ANPRMs on Cigarette Nicotine Product Standards and Flavors in Tobacco Products

The U.S. Food and Drug Administration (FDA) recently issued two Advance Notices of Proposed Rulemaking (ANPRM) as part of its comprehensive tobacco and nicotine regulation initiative that places addiction at the center of its approach. The first ANPRM, issued March 16, focuses on the development of a standard for the maximum level of nicotine permitted in cigarettes. Tobacco-related disease and mortality is largely the result of nicotine addiction, and according to the Agency, this proposed action aims to reduce the level of nicotine currently allowed in tobacco products to a minimally addictive or non-addictive level. The FDA plans to use the best available science to determine the appropriate nicotine level to protect public health, with the goal of easing the cessation process for addicted tobacco users and preventing experimenters from initiating regular use. In conjunction with this ANPRM, the Agency also released a draft concept paper titled, Illicit Trade in Tobacco Products after Implementation of an FDA Product Standard, to start a dialogue around the emergence of possible illicit trade following potential future rulemaking.

The second ANPRM, issued March 21, focuses on the inclusion of flavors, including menthol, in the use and cessation of tobacco products. The Agency is seeking information on how flavors attract youth to initiate tobacco use and how certain flavors could potentially transition adult smokers away from more harmful products. Regulatory actions may include standards and restrictions on the sale and distribution of flavored tobacco products.

The Agency plans to release an additional ANPRM regarding the public health impacts of premium cigars. The ACC is actively reviewing these issuances with the intention to respond.

Clinical Topics: Prevention, Smoking

Keywords: ACC Advocacy, Tobacco, Nicotine, Menthol, Public Health, United States Food and Drug Administration, Information Seeking Behavior, Tobacco Products, Tobacco Use Disorder, Flavoring Agents, Tobacco Use

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