The undersigned public health and medical organizations write to urge the Food and Drug Administration (FDA) to grant the pending Citizen Petition referenced above and commence the requested rulemaking to prohibit menthol as a characterizing flavor in cigarettes.
The menthol Citizen Petition was filed over seven years ago and has yet to receive a substantive response from FDA. A lawsuit is currently pending in federal court in the Northern District of California alleging that FDA’s failure to take action on menthol cigarettes, including its failure to respond to the Citizen Petition, constitutes “unreasonable delay” in violation of the Administrative Procedure Act. In a pleading recently filed by the government in that lawsuit, it was represented that FDA’s Center for Tobacco Products “has agreed to provide a final response to Plaintiffs’ citizen petition by January 29, 2021.”
Given this announced timeline, FDA will be reaching a decision on what action to take with regard to the long pending Petition on menthol cigarettes within the next several months. If true, this decision will come at a time when FDA’s credibility as an agency guided by science has never been in greater jeopardy and under such public scrutiny. Given the strength of the scientific evidence regarding the impact of menthol cigarettes on youth initiation and adult cessation, as articulated by FDA itself, FDA’s decision in this instance will have an impact on whether FDA is perceived as an agency of integrity committed to science that resonates far beyond its decision on the pending petition. You have repeatedly assured the American people that FDA’s decision-making, on issues related to COVID-19 vaccines and therapeutics, as well as on other issues, will continue to be driven by science alone. For example, you recently promised that “every one of the decisions we have reached, has been made by FDA scientists based on science and data, not by politics.” In remarks to the Global Coalition for Regulatory Science Research, you commented that “we are committed to the principle that each of our decisions must be based on good data and sound science.” You have said, “I will fight for science. I will fight for the integrity of the agency, and I will put the interests of the American people before anything else.”
On the issue of menthol cigarettes, the science, as assessed by FDA itself, supports only one conclusion: the presence of menthol as a characterizing flavor in cigarettes is harmful to public health.
As its first order of business, and as directed by Congress in the Family Smoking Prevention and Tobacco Control Act (TCA), the Tobacco Products Scientific Advisory Committee (TPSAC) issued a report in 2011 (TPSAC Report), with two primary conclusions: (1) “Menthol cigarettes have an adverse impact on public health in the United States,” and (2) “There are no public health benefits of menthol compared to non-menthol cigarettes.” Indeed, the TPSAC Report projected the adverse impact of menthol in cigarettes from 2011 to the present day, finding that “by 2020, about 17,000 premature deaths will occur and about 2.3 million people will have started smoking, beyond what would have occurred absent availability of menthol cigarettes.” Based on these findings, TPSAC made the following “overall recommendation” to FDA: “Removal of menthol cigarettes from the marketplace would benefit the public health in the United States.”
Two years after issuance of the TPSAC Report, FDA completed its own independent, peer-review evaluation of the available science concerning menthol cigarettes. FDA evaluated the peer-reviewed literature, industry submissions and other materials provided to TPSAC and commissioned additional analyses. FDA’s Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol versus Nonmenthol Cigarettes (FDA Report) reached the overall conclusion, consistent with TPSAC’s, that it is “likely that menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes.”
FDA has never wavered in its conclusion that menthol cigarettes are adverse to public health. Indeed, less than two years ago, then-Commissioner Gottlieb announced the agency’s intention to “advance a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars . . . .,” after expressing his “deep concern” about “the availability of menthol-flavored cigarettes,” which “represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes” and “exacerbate troubling disparities in health related to race and socioeconomic status.”
Thus, as discussed in more detail below, the available science overwhelmingly supports a rule prohibiting cigarettes in which menthol is a characterizing flavor. Consistent with the long held view that all consequential decisions by FDA should be driven by science and the public health of the American people, not politics and the political fortunes of the few, there is only one possible outcome in response to the pending Citizen Petition: grant the Petition and immediately commence a tobacco product standard rulemaking process leading to a prohibition of menthol cigarettes.