FDA’s New Comprehensive Plan for Tobacco and Nicotine Regulation Extends Application Deadlines for ENDS & E-Cigarettes
Today, the FDA announced a new comprehensive plan for tobacco and nicotine regulation. The plan consists of a “multi-year roadmap” to address tobacco-related disease and place nicotine at the center of regulation efforts.
Specifically, the FDA will focus its efforts on lowering the amount of nicotine in cigarettes to a level that will help control addiction. This is the first time the FDA has sought to regulate the amount of nicotine in cigarettes.
Notably, as to electronic nicotine delivery systems (ENDS) or e-cigarettes, under the new plan, applications to market these newly-regulated non-combustible products would be submitted by August 8, 2022. Manufacturers would be permitted to continue to sell their products during the FDA review of applications.
This new plan will not apply to provisions of the final Deeming Regulation for which compliance deadlines already have passed (i.e. 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 plan also reveals FDA is contemplating flavor regulations that might favor e-cigarettes over traditional cigarettes. It says it will “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.”
The FDA intends to issue regulations outlining what information the agency expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications and reports to demonstrate Substantial Equivalence (SE). The FDA also plans to finalize guidance on how it intends to review PMTAs for ENDS.
This new comprehensive regulatory plan is an exciting development for the ENDS and e-cigarette industry. We will continue to keep you informed.
The e-cig/e-liquid attorneys at Brown & Charbonneau, LLP are up to date on all of the relevant issues affecting the industry and are prepared to assist you. To learn more, call us today at 714.406.4397, or e-mail firstname.lastname@example.org to set up a consultation. For more information about the e-cigarette, e-liquid and ENDS industry, please click here.
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