FDA's Proposal to Regulate Nicotine Levels

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By David Zorn
June 25, 2018

The U.S. Food & Drug Administration recently published an “Advance Notice of Proposed Rulemaking, Tobacco Product Standard for Nicotine Level of Combusted Cigarettes”[1]  to invite comments and submissions of information for it to consider as it plans to develop a maximum nicotine level for cigarettes. The agency hopes to establish a standard for nicotine levels in cigarettes so that they do not initiate or perpetuate addiction to cigarettes for some portion of potential smokers. If successful, this standard may make it easier for some cigarette smokers to quit smoking, and it may also keep people from becoming regular tobacco users if they experiment with tobacco.

In a comment filed on the advanced notice, I observe that FDA’s plan is a novel and creative approach to promote public health. Although such an approach was suggested decades ago,[2] it has not been implemented in any other country. And the plan is creative because, rather than attempting to regulate the hazards out of a product that some consumers demand, the policy would reduce the appeal of a product that is laden with hazards. However, the plan is speculative and unproven, and some tests of its underlying hypothesis cast some doubt on its likelihood of success.[3]

FDA’s plan is also incomplete as it addresses only removing access to combustible sources of nicotine. That will work only if people have access to noncombustible sources of nicotine.[4] But FDA’s proposed plan makes no definitive statements about any plans the agency might have for noncombustible sources of nicotine.

FDA’s advanced notice of proposed rulemaking to establish a maximum nicotine standard for combustible cigarettes identifies an important opportunity to potentially make a significant long-term improvement in public health. Nicotine is the addictive agent in tobacco. Reducing nicotine in cigarettes to nonaddictive levels could make it much easier for smokers to successfully quit smoking. However, the policy has never been implemented anywhere and some research indicates that it may not be as successful as would be hoped. In light of both the potential benefits and the potential limitations and countervailing effects, FDA should:

  1. Initially only cover combustible cigarettes as those are the only very low nicotine products that have been produced and tested in research.
  2. Include in any rule a proposed plan for retrospective review and use the retrospective review to improve the rule as needed based on the experience with combustible cigarettes.
  3. Propose to establish one validated method that it will use to determine compliance with the nicotine standard and what degree of variation it will accept from the standard.
  4. Focus on reducing barriers to noncombustible sources of nicotine and develop a broad nicotine-access policy that will provide a robust set of alternatives to combustible products so that smokers of very low nicotine cigarettes are not driven to initiate countervailing effects.
  5. Make the taxpayer-funded data from FDA-sponsored tobacco research publicly available.
  6. Base any proposal only on scientific research for which the data and models needed to replicate the research are publicly posted.

Read the public comment (PDF)

[1]  Department of Health and Human Services, Food and Drug Administration, “Tobacco Product Standard for Nicotine Level of Combusted Cigarettes,” 83 Federal Register 11818, March 16, 2018.

[2]  Neal L. Benowitz and Jack E. Henningfield, “Establishing a Nicotine Threshold for Addiction -- The Implications for Tobacco Regulation,” New England Journal of Medicine 1994; 331:123-125.

[4]  Neal L. Benowitz, “Comprehensive Nicotine Regulation to End the Combustible Tobacco Epidemic,” Annals of Internal Medicine; 167(10):736-737 and Tracy T. Smith, et al., “Whether to Push or Pull? Nicotine Reduction and Non-Combusted Alternatives - Two Strategies for Reducing Smoking and Improving Public Health,” Preventive Medicine, in press, available online 29 March 2018.