FDA makes surprise announcements regarding nicotine, extends timeline for applications for newly regulated tobacco products

On an otherwise quiet Friday morning in July, FDA Commissioner Dr. Scott Gottlieb made the following significant announcements regarding FDA's regulation of tobacco and nicotine products:

• FDA will extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016, as follows:
  • Applications for cigars, pipe tobacco and hookah tobacco will be due by Aug. 8, 2021
  • Applications for non-combustible products such as ENDS or e-cigarettes will be due by Aug. 8, 2022
  • The sunset provision for marketing during FDA’s review of premarket applications will be lifted and manufacturers will be able to continue to market products while the agency reviews product applications
• FDA intends to issue Advanced Notice of Proposed Rulemakings (ANPRMs) to:
  • 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
  • Solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars
  • Seek public comment on how to make combustible products less addictive or non-addictive
• FDA 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.
• FDA plans to issue regulations outlining what information the agency expects to be included in:
  • Premarket Tobacco Applications (PMTAs),
  • Modified Risk Tobacco Product (MRTP) applications, and
  • Substantial Equivalence (SE) reports.
• FDA plans to finalize guidance on how it intends to review PMTAs for ENDS.
• Dr. Gottlieb also indicated that FDA might reconsider whether to continue to use its resources to review certain pending provisional Substantial Equivalence (SE) reports.

This announcement contains encouraging news for CDA members, as the timelines for applications for newly regulated tobacco products are extended significantly, and FDA explicitly states that  products can be marketed during the application process. FDA will be issuing ANPRMs on a number of issues, including “determining what role flavors play in attracting youth and may play in helping  smokers switch to potentially less harmful forms of nicotine delivery, and making cigarettes less or non – addictive.” In these instances, CDA will continue to monitor and report on FDA activity on regulation of tobacco and nicotine products, and will advocate on behalf of thorough, science based regulations beneficial to the Convenience Distribution industry and our industry partners. 

FDA press release: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm568923.htm

Commissioner Gottlieb’s speech  https://www.fda.gov/NewsEvents/Speeches/ucm569024.htm