The FDA made a special announcement this morning regarding a new comprehensive plan to focus regulatory efforts on nicotine, specifically to lower nicotine levels in combustible cigarettes through product standards and to examine the role of non-combustible tobacco products to reduce addiction to nicotine. To fully explore these issues, the FDA has stated that it will:
- Revise compliance deadlines to submit tobacco product review applications for newly deemed products that were on the market as of August 8, 2016 as follows:
- Applications for combustible products, including cigars, pipe tobacco and hookah tobacco will be due by August 8, 2021
- Applications for non-combustible products such as e-cigarettes or other vapor products will be due by August 8, 2022
- Manufacturers will be able to continue to market products while the agency reviews these product applications
- Note that the existing and upcoming deadlines for cigar warning statements, ingredient listing, health documents, HPHC testing, and removal of modified risk claims are not affected by this announcement.
- Develop product standards regarding electronic nicotine delivery systems , including battery issues and concerns about exposure to liquid nicotine.
- Issue Advanced Notice of Proposed Rulemakings (ANPRMs) to seek input on:
- reducing nicotine on combustible cigarettes
- the issue of flavored tobacco products, including whether to ban menthol and flavors in cigarettes and cigarillos altogether, and the role that flavored tobacco products may play in helping some smokers switch to potentially less harmful forms of nicotine delivery
- exploring potential exemptions and/or alternative regulatory frameworks for premium cigars
- Issue regulations outlining the information it expects to be included in tobacco product review applications (including PMTAs, MRTPs and SE Reports).
- Finalize guidance on how it intends to review PMTAs for electronic nicotine delivery systems.
- Investigate whether, from a public health and policy perspective, provisional substantial equivalence applications (for first generation regulated products such as cigarettes, RYO and smokeless tobacco products) should remain under consideration, or whether these resources could be better devoted toward other objectives.
The FDA will be issuing guidance describing this new enforcement policy.