APA, CPDD, and SRNT offer scientific feedback on FDA proposal
The 2009 Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration (FDA) the authority to regulate tobacco products. The act authorizes the FDA to adopt a tobacco product standard if the Secretary of Health and Human Services (HHS) finds that the standard is appropriate for the protection of the public health.
In making such a finding, the HHS Secretary must consider scientific evidence concerning: “(1) The risks and benefits of the proposed standard to the population as a whole, including users and nonusers of tobacco products; (2) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (3) the increased or decreased likelihood that those who do not use tobacco products will start using such products.”
Following that process, the FDA issued an advance notice of proposed rulemaking (ANPRM) in March 2018 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.”
Although the Tobacco Control Act prohibits the FDA from issuing a regulation that would require the reduction of nicotine yields of a tobacco product to zero, it can issue a potential product standard that would set a maximum nicotine level for cigarettes, and restrictions prohibiting the sale and distribution of any product that violates such a standard.
Three organizations – the American Psychological Association (APA), the College on Problems of Drug Dependence, and the Society for Research on Nicotine and Tobacco – have issued a joint statement providing detailed comments on the ANPRM. Organized as a set of thirteen key points, the document provides a scientific rationale for reduced nicotine tobacco products as part of a comprehensive strategy to reduce tobacco-associated morbidity and mortality. Psychologist Dorothy Hatsukami, of the University of Minnesota, who is a leading researcher on nicotine addiction and has had prominent roles in all three organizations, led the development of the statement.
The ANPRM is the first step in a long process through which the FDA gathers public input for use in making regulatory decisions. APA will continue to monitor the FDA’s regulatory activities involving tobacco products. For more information on APA’s involvement in tobacco control efforts, contact Geoff Mumford of APA’s Science Government Relations Office.