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FDA Announces Major Tobacco Regulatory Policy Shift; Will Address Lowering Nicotine to Non-Addictive Levels, Delay Marketing Application Deadlines

Posted: July 31, 2017

On July 28, 2017, the U.S. Food and Drug Administration (FDA or the Agency) announced a new, comprehensive plan for tobacco and nicotine regulation that will place nicotine, and the issue of addiction, at the center of the Agency’s tobacco regulatory efforts. While FDA Center for Tobacco Products (CTP) Director Mitch Zeller has long discussed that tobacco products represent a “continuum of risk,” until last week’s announcement, the meaning of that phrase was never fully understood. We now know that the Agency believes that, within that continuum of risk, nicotine is most harmful when delivered through smoke particles in combustible cigarettes. Although FDA did not indicate so directly in its groundbreaking announcement, this approach suggests for the first time the Agency’s assessment that e-cigarettes and vapor products are less harmful than combustible cigarettes.

Within FDA’s multi-year plan, the Agency intends to:

  • Extend timelines to submit tobacco product review applications for newly-regulated tobacco products that were on the market as of August 8, 2016 to afford FDA more time to explore clear and meaningful measures to make tobacco products less toxic, appealing, and addictive. Applications for newly-regulated combustible products, such as cigars, pipe tobacco, and hookah tobacco would be extended until August 8, 2021, and applications for non-combustible products such as electronic nicotine delivery systems (ENDS) or e-cigarettes would be delayed until August 8, 2022. Manufacturers would be able to continue to market such products until product applications for the same are required to be submitted and while FDA reviews such product applications.
  • Issue advanced notices of proposed rulemaking (ANPRMs) to: (1) to seek input on the potential public health benefits and any possible adverse effects of lowering nicotine in cigarettes; (2) 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 (3) solicit additional 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 Deeming Rule.
  • Issue foundational rules to make the tobacco product review process more efficient, predictable, and transparent for manufacturers, while upholding the Agency’s public health mission. Among other things, FDA intends to issue regulations outlining what information FDA expects to be included in Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications, and reports to demonstrate Substantial Equivalence (SE). The Agency also plans to finalize guidance on how it intends to review PMTAs for ENDS products.

While the stated purpose of FDA’s multi-year plan is to better protect kids and significantly reduce tobacco-related disease and death, the product review application delay portions of the same are a major win for ENDS, cigar, pipe tobacco, and hookah tobacco manufacturers. As we reported previously, when President Trump nominated now FDA Commissioner Scott Gottlieb, industry was hopeful that under his watch, the Agency would roll back or delay certain portions of the Deeming Rule. Industry has been lobbying hard against the Rule’s premarket requirements since they were first proposed, as they will result in major industry consolidation because of the $1 million-plus cost involved in preparing certain marketing applications. Before the announced delays, manufacturers would have had to comply with premarket review requirements starting in November 2017.

Also notable in the Agency’s announcement is its inclusion of menthol, which Congress specifically carved out of the flavored cigarette ban enacted as part of the Family Smoking Prevention and Tobacco Control Act, the legislation that gave FDA its authority to regulate tobacco products.  In July 2013, the Agency issued an ANPRM to obtain public input on menthol in cigarettes but the Agency never moved forward with regulatory action on the same, due in large part to a successful industry challenge to the menthol report issued by FDA’s Tobacco Products Scientific Advisory Committee (TPSAC).  While the U.S. Court of Appeals for the D.C. Circuit eventually upheld the Agency’s right to rely on TPSAC’s menthol report, FDA did not pursue further regulatory action.  It remains to be seen, how, if at all, the Agency will now decide to regulate menthol in cigarettes and/or other tobacco products. 

We will continue to monitor this and other industry developments and provide more information as it becomes available.