FDA Announces a Major Shake Up in Tobacco Regulatory Policy

In a stunning development, newly appointed FDA Commissioner Scott Gottlieb, M.D. held a briefing last Friday to announce a multi-year plan for tobacco and nicotine regulation.  The Commissioner’s remarks are available here, and a press release announcing the policy is available here. The Agency’s new approach places nicotine, and the issue of addiction, at the center of tobacco regulation efforts. The policy more formally embraces the notion that nicotine is delivered through products that represent a “continuum of risk,” and is most harmful when delivered through smoke particles in combustible cigarettes. Under this new plan, FDA will:

• Explore lowering nicotine levels in combustible cigarettes to non-addictive levels through product standards. The Agency will issue an Advance Notice of Proposed Rulemaking (ANPRM) to seek input on the potential public health benefits and possible adverse effects of lowering the level of nicotine in cigarettes.
• Extend timelines to submit tobacco product review applications for newly regulated tobacco products that were on the market as of Aug. 8, 2016. These timelines were already extended once (see our previous post  ), but FDA will issue a guidance extending application submission timelines for newly-regulated combustible products (such as cigars, pipe tobacco, and hookah tobacco) to August 8, 2021, and for non-combustible products (such as e-cigarettes) to August 8, 2022.
• Develop product standards to address public health risks, such as electronic nicotine delivery systems (ENDS) battery issues, and concerns about children’s exposure to liquid nicotine.
• Issue an ANPRM to seek public comment on the role that flavored tobacco products (including menthol) may play in attracting youth to consume such products, and in helping some smokers to switch to potentially less harmful forms of nicotine delivery.
• Issue an ANPRM to solicit additional comments and scientific data related to the patterns of use and resulting public health impacts from premium cigars, which were included in FDA’s 2016 deeming rule (see our previous post here).
• Examine actions to increase access and use of FDA-approved medicinal nicotine products intended to help smokers quit.
• Issue rules to make the product review process more efficient, predictable, and transparent, including regulations outlining the information the Agency expects in submissions of Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product (MRTP) applications, and reports to demonstrate Substantial Equivalence (SE).

Mitch Zeller, J.D., Director of FDA’s Center for Tobacco Products, and Anna Abram, FDA’s Deputy Commissioner for Policy, Planning, Legislation and Analysis, took questions on the new policy in a conference call. Mr. Zeller emphasized that although nicotine itself is not associated with negative health consequences, the Agency was basing its policy on a recognition that the various nicotine delivery systems fall along a “continuum of risk.” Under this continuum, combustible cigarettes are the riskiest products, and nicotine replacement products sold for smoking cessation (i.e., nicotine gums, lozenges, and patches) are at the opposite end of the spectrum. He also emphasized that the new nicotine policy was “agency wide,” and specifically mentioned the Center for Drug Evaluation and Research, which will play a role with respect to the regulation of smoking cessation products and tobacco research.

FDA’s new approach to the regulation of nicotine will have profound effects on the tobacco product industry. We will continue to monitor this bold new plan as it unfolds.