March was an important month for tobacco control in the U.S. While historically less progressive than other countries in regulating tobacco products, three recent developments offer encouraging signs of change. They also remind us of the critical role that the U.S. Food & Drug Administration (FDA) plays in public health policymaking.
The Three ANPRMs
Last month, the FDA released three advanced notices of proposed rulemaking (ANPRM) on tobacco-related products. An ANPRM is a formal invitation for stakeholders to submit comments before a federal agency issues a proposed rule. In practical terms, an ANPRM enables stakeholders to weigh in on, and even potentially shape, a forthcoming policy by responding to specific issues for input.
Released on March 16, the first ANPRM addresses the development of a tobacco product standard for a maximum nicotine level in cigarettes. The FDA seeks comment on a number of policy design considerations including, among others: the merits of various maximum nicotine levels (e.g., 0.5mg nicotine/g); to which products a maximum nicotine level should apply (e.g., combusted cigarettes, cigars, pipe tobacco); and whether to use a stepped-down, or gradual, reduction in maximum nicotine levels.
Importantly, the FDA highlights factors that could reduce the benefits of a future policy and seeks comment on how to addresses them. For example, current smokers could switch to a tobacco product not covered under the policy or use that non-covered product in addition to the currently used (covered) product. Similarly, current smokers could increase the number of cigarettes smoked to maintain an equivalent level of nicotine overall.
Released on March 21, the second ANPRM addresses the role that flavors play in tobacco products. The FDA has previously acknowledged the role that flavored tobacco products can play in attracting new youth and young adult smokers. The ANPRM suggests that a future policy could go further than prior policies to include menthol cigarettes and other sweet-flavored tobacco products (e.g., candy-flavored little cigars). The ANPRM also seeks comments on the role that flavors may play in helping some adult smokers reduce use or switch to less harmful tobacco products, which may require the FDA to delicately balance complex issues around the use of flavors in non-combustible tobacco products (e.g., e-cigarettes).
Finally, released on March 26, the third ANPRM addresses so-called premium cigars. The FDA seeks comments, especially research and data, on how to define premium cigars, as well as their use patterns. Moreover, the FDA is interested in input from stakeholders on pubic health-related concerns, such as the health risks of premium cigars versus other cigars and required warning statements.
The FDA and Public Health Policymaking
We do not yet know what future policies might look like; although unlikely, the FDA could even choose not to move forward with future policies in any of the three areas. The mechanics of the rulemaking process suggest that full implementation would likely be years away (not accounting for litigation). Tobacco companies have long relied on lobbying and litigation to push back against unfavorable policies; according to one source, tobacco companies spent upwards of $21 million in 2017 on lobbying alone in the U.S.
Nonetheless, the ANPRMs serve as key initial steps in the FDA’s comprehensive regulatory plan to reduce tobacco-related disease and death, first announced in July 2017. Historically, the U.S. has lagged behind similarly situated countries on tobacco regulation. While others have implemented plain packaging requirements, the Federal Cigarette Labeling and Advertising Act dates to the Johnson Administration and has not been substantively changed since. The FDA did not even have the authority to comprehensively regulate tobacco products until 2009. What’s more, the U.S. has signed, but not ratified, the Framework Convention on Tobacco Control, which misses
an important opportunity to strengthen domestic policies and support tobacco control globally.
Given this inauspicious starting point, it is encouraging to see the continued acknowledgement of the public health role that the FDA plays. In his statements announcing the ANPRMs, Commissioner Gottlieb continuously referenced the key role that the FDA plays in public health policymaking. Prior commissioners have similarly acknowledged this role, which is especially important for supporting tobacco cessation efforts by the U.S. Centers for Disease Control and Prevention. The population health emphasis of public health brings renewed focus on where and how to orient exercise of the FDA’s post-2009 authority.
Additionally, it is encouraging to see the FDA’s strong commitment to rooting its tobacco-related policymaking in science-based evidence and principles. The ANPRMs seek to engage stakeholders to identify the best available science to ground future policymaking. In a time of increased politicization of science, the continued acknowledgement of the role that rigorous science and evidence plays in public health policymaking takes on special importance.