SILVER SPRING, Md. – Last week, the U.S. Food and Drug Administration (FDA) announced a new plan for tobacco and nicotine regulation places nicotine and addiction at the center of the agency’s tobacco regulation efforts.
The FDA says that its goal is to ensure that the agency has the scientific and regulatory foundation to implement the Family Smoking Prevention and Tobacco Control Act, and make certain that it is striking an appropriate balance between regulation and encouraging innovative tobacco products that may be less dangerous than cigarettes. FDA also says that it’s providing targeted relief on some timelines described in the May 2016 final rule that extended the FDA's authority to additional tobacco products. The agency will also seek input on flavors in tobacco products.
The FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards. The agency intends to issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes.
The agency intends to extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016. The FDA says it intends to develop product standards to “protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues and concerns about children's exposure to liquid nicotine.” It also will provide manufacturers additional time to develop higher quality, more complete applications informed by additional guidance from the agency.
The agency plans to issue this guidance describing a new enforcement policy shortly. Under expected revised timelines, applications for newly-regulated combustible products, such as cigars, pipe tobacco and hookah tobacco, would be submitted by Aug. 8, 2021, and applications for non-combustible products such as ENDS or e-cigarettes would be submitted by Aug. 8, 2022. Additionally, the FDA expects that manufacturers would continue to market products while the agency reviews product applications.
The new enforcement policy will not affect any current requirements for cigarettes and smokeless tobacco, only the newly-regulated tobacco products such as cigars and e-cigarettes. This approach also will not apply to provisions of the final rule for which compliance deadlines already have passed, such as mandatory age and photo-ID checks to prevent illegal sales to minors. It also will not affect future deadlines for other provisions of the rule, including, but not limited to, required warning statements, ingredient listing, health document submissions, harmful and potentially harmful constituent reports, and the removal of modified risk claims, i.e., "light," "low," or "mild," or similar descriptors.
The agency also will seek input from the public on a variety of topics, including approaches to regulating kid-appealing flavors in e-cigarettes and cigars. The FDA intends to issue ANPRMs to: 1) seek public comment on the role that flavors (including menthol) in tobacco products play in attracting youth and may play in helping some smokers switch to potentially less harmful forms of nicotine delivery; and 2) solicit comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars, which were included in the FDA's 2016 rule. Additionally, the agency plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to consider what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.