Comment Deadline: FDA Tobacco Product Standard for Nicotine Level of Combusted Cigarettes (Advanced Notice of Proposed Rulemaking)

Update: On June 8, 2018, the FDA extended the public comment deadline from June 14, 2018 to July 16, 2018 (83 FR 26619).

The Food and Drug Administration (FDA) is issuing an advance notice of proposed rulemaking (ANPRM) to obtain information for consideration in developing a tobacco product standard to set the maximum nicotine level for cigarettes. Because tobacco-related harms ultimately result from addiction to the nicotine in such products, causing repeated use and exposure to toxicants, FDA is considering taking this action to reduce the level of nicotine in these products so they are minimally addictive or nonaddictive, using the best available science to determine a level that is appropriate for the protection of the public health.

FDA uses the term “nonaddictive” specifically in the context of a potentially nonaddictive cigarette. They acknowledge the highly addictive potential of nicotine itself depending upon the route of delivery, and acknowledge that questions remain with respect to the precise level of nicotine in cigarettes that might render them either minimally addictive or nonaddictive for specific members or segments of the population. FDA envisions the potential circumstance where nicotine levels in cigarettes do not spur or sustain addiction for some portion of potential smokers. This could give addicted users the choice and ability to quit more easily, and it could help to prevent experimenters (mainly youth) from initiating regular use and becoming regular smokers.

The scope of products covered by any potential product standard will be one issue for comment in the ANPRM. Any additional scientific data and research relevant to the empirical basis for regulatory decisions related to a nicotine tobacco product standard is another issue for comment in the ANPRM.

Members of the public may submit comments by mail or at More information is available via the Federal Register notice.

Event Date
Monday, July 16, 2018 - 5:00pm