Health Law Daily New FDA tobacco plan will focus on lowering nicotine to non-addictive levels
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Monday, July 31, 2017

New FDA tobacco plan will focus on lowering nicotine to non-addictive levels

By Harold Bishop, J.D.

A new comprehensive plan that puts nicotine, and the issue of addiction, at the center of the FDA’s tobacco regulatory efforts has been announced by the agency. The FDA’s new plan will focus on: (1) lowering nicotine in cigarettes to non-addictive levels; (2) extending timelines to submit tobacco product review applications for newly regulated products to encourage innovations that will make notable public health differences; and (3) opening up public comment through Advance Notice of Proposed Rulemaking (ANPRM) and other methods of communication with industry and the public.

Lowering nicotine to non-addictive levels. The FDA plans to begin a public dialogue about lowering nicotine levels in combustible cigarettes to non-addictive levels through achievable product standards. To do so, the FDA intends to issue an ANPRM to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes. According to recent remarks by FDA Commissioner Scott Gottlieb, M.D.: "The overwhelming amount of the death and disease attributable to tobacco is caused by addiction to cigarettes. Cigarettes are the only legal consumer product that, when used as intended, will kill half of all long-term users." The FDA believes that lowering nicotine levels could decrease the likelihood that future generations become addicted to cigarettes and allow more currently addicted to quit.

Extending timelines to encourage innovations. The FDA intends to extend timelines to submit tobacco product review applications for newly-regulated products that were on the market as of August 8, 2016. Under the revised timelines, applications to market newly-regulated:

  • combustible products, such as cigars, pipe tobacco, and hookah tobacco, would be submitted by August 8, 2021; and
  • non-combustible products, such as electronic nicotine delivery systems (ENDS) or e-cigarettes, would be submitted by August 8, 2022.

All other compliance deadlines for manufacturers will remain the same. The anticipated new enforcement policy does not affect any current requirements from the FDA’s deeming rule (81 FR 28973) that have already passed (see FDA clears the air, ‘deems’ e-cigarettes, hookah tobacco, cigars worthy of regulation, May 10, 2016). For example, mandatory age and photo-ID checks to prevent illegal sales to minors remain in effect and subject to enforcement by the FDA.

The revised timelines will give the FDA time to explore clear and meaningful measures to make tobacco products less toxic, appealing, and addictive. For example, the FDA intends to develop product standards:

  • to protect against known public health risks such as electronic nicotine delivery systems (ENDS) battery issues; and
  • about children's exposure to liquid nicotine.

Specifically, the FDA intends to issue regulations outlining what information it 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.

Public comment opportunities. To obtain public input and ensure that the FDA has the proper science-based policies in place to meaningfully reduce the damage caused by tobacco use, the FDA plans to issue an ANPRM to seek:

  • public comment on the role that flavors in tobacco products (including menthol) play in attracting youth, as well as the role they may play in helping some smokers switch to potentially less harmful forms of nicotine delivery; and
  • additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars.

The FDA also plans to examine actions to increase access and use of FDA-approved medicinal nicotine products, and work with sponsors to determine what steps can be taken under the safety and efficacy standard for products intended to help smokers quit.

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