FDA’s Advanced Notice of Proposed Rulemaking: Tobacco Product Standard for Nicotine Level of Combusted Cigarettes

June 12, 2018

David Zorn

Download this Public Interest Comment (PDF)


FDA’s plan to restrict nicotine to very low levels in combusted cigarettes in order to reduce smokers’ addiction to cigarettes is a novel and creative approach to promote public health. Although such an approach was suggested decades ago, 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.

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. But FDA’s proposed plan makes no definitive statements about any plans the agency might have for noncombustible sources of nicotine.

After briefly describing the issues raised in the advanced notice of proposed rulemaking (ANPRM) and the relationship of nicotine to combustible cigarettes, this comment addresses some of FDA’s questions regarding the scope of future rulemaking, analytical testing method, technical achievability, possible countervailing effects, and other considerations.