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From Health Law Daily, March 16, 2018

FDA seeks information on setting a maximum nicotine level in cigarettes

By Harold Bishop, J.D.

An advance notice of proposed rulemaking (ANPRM) to obtain information for consideration in the development of a tobacco product standard setting the maximum nicotine level for cigarettes has been published by the FDA. The FDA is considering this action to reduce the level of nicotine in cigarettes so they are minimally addictive or non-addictive, using the best available science to determine a level that is appropriate for the protection of the public health (Advance Notice of Proposed Rulemaking, 83 FR 11818, March 16, 2018).

The FDA’s goal is nicotine levels in cigarettes that do not spur or sustain addiction. It believes this could give addicted users the choice and ability to quit more easily, and it could help to prevent experimenters from initiating regular cigarette use and becoming regular smokers.

The FDA is specifically seek comments, evidence, and other information on the following topics:

  • Scope. The scope of products covered by any potential product standard, i.e., whether the standard should cover any or all of the following products: combusted cigarettes (which FDA has previously interpreted to include kreteks and bidis), cigarette tobacco, roll-your-own tobacco, some or all cigars, pipe tobacco, and water-pipe tobacco.
  • Maximum nicotine level. The FDA is particularly interested in: (1) comments about the merits of nicotine levels like 0.3, 0.4, and 0.5 milligrams nicotine per gram of tobacco filler, as well as other levels of nicotine; (2) information on additional scientific data and research which would provide information about specific groups within the general population which may have an increased sensitivity to nicotine’s reinforcing effects, or who may have otherwise not been captured in the literature on very low nicotine content cigarettes; and (3) information on additional scientific data and research relevant to the empirical basis for regulatory decisions related to a potential nicotine product standard.
  • Implementation. Whether the nicotine standard should propose either a single target (where the nicotine is reduced all at once) or a stepped-down approach (where the nicotine is reduced gradually over time through a sequence of incremental levels and implementation dates) to reach the desired maximum nicotine level.
  • Analytic testing method. Whether the product standard should specify a method for manufacturers to use to detect the level of nicotine in their products.
  • Technical achievability. Whether significant nicotine reductions in cigarettes and other combusted tobacco products can be achieved principally through: (1) tobacco blending and cross-breeding plants; (2) genetic engineering; (3) chemical extraction; (4) agricultural practices (e.g., controlled growing conditions, fertilization, and harvest); or (5) more recent, novel techniques.
  • Possible countervailing effects. Whether current smokers of tobacco products subject to a nicotine tobacco product standard will: (1) turn to other combusted tobacco products to maintain their nicotine dependence, both in combination with cigarettes (i.e., dual use) or in place of cigarettes (i.e., switching); (2) alter their smoking behaviors by increasing the number of cigarettes smoked or increasing the depth of inhalation; (3) add nicotine in liquid or other form to their combusted tobacco product; and/or (4) turn to illicit trade to obtain cigarettes that do not adhere to the nicotine standard (see Will product standards for tobacco products result in illicit trade?, available in today’s issue of Health Law Daily, discussing the FDA’s draft concept paper on illicit trade in tobacco).
  • Economic impacts. The FDA is also seeking comments, data, research results, and other information regarding economic impacts of a potential nicotine tobacco product standard.

Comments on the ANPRM are due by June 14, 2018.

The FDA also plans to issue two additional ANPRMs: one to seek comment on the role that flavors – including menthol – play in initiation, use, and cessation of tobacco products, and one to solicit additional comments and data related to premium cigars.

MainStory: TopStory Notices TobaccoNews AdulterationNews LabelingNews RiskNews SafetyNews GMPNews

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