FDA Announces it is Ready to Act on Menthol Cigarettes, but its Success is Uncertain

May 14, 2021By Faraz Siddiqui & David B. Clissold

The Food & Drug Administration (FDA) announced on April 29, 2021 that it is working towards banning menthol flavored cigarettes, committing itself to issuing a proposed product standard to prohibit menthol as a characterizing flavor in cigarettes “within the next year.” In the same announcement, FDA also shared its intent to propose a product standard that would ban flavored cigars. FDA’s announcement was supported with a matching statement by U.S. Department of Health & Human Services Secretary, Xavier Becerra.

The announcement followed a Center of Tobacco Products (CTP) response to a citizen petition originally submitted in 2013 by anti-tobacco and public health groups (including prominent African American groups like the African American Tobacco Control Leadership Council) on prohibiting menthol cigarettes. In January of this year, the petitioners submitted a supplement to the original petition with additional research on the public health impact of menthol in cigarettes. The petitioners also filed suit to compel the Agency to respond to the petition in the federal district court for the Northern District of California last year. On January 28, 2021, the judge in that case ordered the agency to respond to the petitioners by April 29, 2021.

Federal actions on menthol cigarettes

In 2009, Congress specifically exempted “tobacco or menthol” when it prohibited all other flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (TCA)’s “Special Rule for Cigarettes.” According to the legislative history of the bill, Congress recognized that “unique issues” surrounded menthol and mentholated cigarettes, including “the large number of Americans who smoke menthol, the disproportionate prevalence of menthol cigarettes among African Americans, the racial and ethnic differences in lung cancer incidence, and the uncertainty about the potentially negative consequences of an immediate menthol ban. . . .” H.R. Rep. No. 111-58, at 38-39 (2009). “Given the number of open questions related to menthol cigarettes, the legislation authorize[d] the Secretary to ban or modify the use of menthol in cigarettes based on scientific evidence.” Id. This would ensure that FDA has the scientific evidence necessary to make the best decisions to protect the public health. Id.

As enacted, the TCA had the purpose “to continue to permit the sale of tobacco products to adults in conjunction with measures to ensure that they are not sold or accessible to underage purchasers.” 21 U.S.C. § 387 (notes to statute, § 3, ¶ 7). Congress would let FDA come to its own decision based on whether menthol cigarettes posed a danger to public health. Id. § 387g(a)(1)(A). Congress would also mandate FDA to have the newly created Tobacco Product Scientific Advisory Committee (TPSAC) study and report on “the impact of the use of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities.” Id. § 387g(e).

TPSAC released a report of its findings in 2011. According to TPSAC, there was little scientific evidence to suggest that menthol cigarettes were more (or less) toxic, or contribute to more disease, compared to nonmentholated cigarettes. TPSAC also found “adequate data” to suggest that menthol use is likely associated with increased smoking initiation by youth and young people, and is likely associated with greater addiction. In sum, TPSAC concluded that “[m]enthol cigarettes have an adverse impact on public health in the United States.” Shortly thereafter, CTP published a preliminary scientific evaluation stating that “menthol cigarettes pose a public health risk above that seen with nonmenthol cigarettes.”

Yet, TPSAC did not recommend, and FDA did not take, any regulatory action based on the report, which would require rulemaking procedures that include public notice and an opportunity for public comment. But TPSAC also stated that there were “gaps in understanding of menthol cigarettes and public health that should be addressed with further research.” For example, TPSAC noted that FDA would need to assess the potential for contraband menthol cigarettes, which was required by the Act.

Thereafter, in 2013, FDA issued an advance notice of proposed rulemaking (ANPRM) to obtain more data and information regarding a number of complex questions regarding the potential regulation of menthol in cigarettes. 78 Fed. Reg. 44,484 (July 24, 2013) (Menthol ANPRM). In a meeting with the media, Mitch Zeller, Director of the CTP said that FDA could only go as far as the regulatory science will take us: “The bottom line is, we need more information. . . . We also need input from the public.”

In November 2018, amidst an aggressive campaign against flavored e-cigarettes, the Trump administration announced plans to ban menthol cigarettes. According to interviews with then Commissioner Scott Gottlieb, the proposed ban faced opposition at the Health and Human Services, the White House and by members of Congress. By the time the flavor ban was formally announced, it had been pared down to exclude both mentholated cigarettes and e-cigarettes. When asked about menthols, Gottlieb explained that excluding menthol from the bans “reflected a ‘careful balancing’ of concerns about youth and the need of adult smokers using e-cigarettes to quite [sic.] smoking.”

FDA’s citizen petition response and proposed action on menthol

FDA now believes there is “sufficient evidence in the record to support a decision to begin the rulemaking process to prohibit menthol as a characterizing flavor in cigarettes.” FDA said that it considered the evidence from the citizen petition and its supplement in its response, as well as the comments to the petition and the agency’s own independent study of the evidence related to menthol cigarettes. According to the agency’s response, “the science has evolved” since the release of the TPSAC report. In the intervening eight years, “there has been an accumulating evidence base regarding the role menthol in cigarettes plays in regard to facilitating experimentation and progression to regular use.” Also in the intervening years, both Canada and the European Union have imposed bans on menthol cigarettes, in 2017 and 2020 respectively. The FDA appears ready to use this evidence to issue a proposed rule to prohibit menthol as a characterizing flavor in cigarettes within the next year as “one of the Agency’s highest priorities.”

Not everyone is likely to agree with the FDA’s assessment regarding the sufficiency of the evidence or the public health benefit of such a ban, especially when it comes to the countervailing effects brought about by the ban such as illicit trade or enforcement. As recently as 2020, the U.S. Surgeon General concluded that evidence is “suggestive but not sufficient” that restricting the sale of certain types of tobacco products, such as menthol, will increase smoking cessation. In addition, any menthol rule would require significant public comment and could likely face litigation in federal court. It is also likely that the measures attract Congressional attention, but lawmakers are divided have been divided on the issue in the past. Others, such as Senators Richard Burr of North Carolina have vehemently opposed the ban when illegal drugs such as marijuana are being legalized.

Even the African American community is split on the issue of a menthol ban. Organizations like NAACP have long supported a menthol cigarettes ban, pointing to research that shows that the tobacco industry has specifically targeted its marketing to African Americans. Others, including prominent Black leaders like Al Sharpton and civil rights organizations like the ACLU have strongly opposed such a ban for its prospect of criminalization a product popular in the African American community. In response to this, the FDA announcement pointed out that any ban on menthol cigarettes will only address manufacturers, distributors, wholesalers, importers and retailers: “the FDA cannot and will not enforce against individual consumer possession or use of menthol cigarettes or any tobacco product.”

At least one of the authors of the citizen petition has already claimed victory, announcing on its website homepage that “FDA Bans Menthol in Cigarettes.” (Accessed May 2021). But an actual ban could still be years away, if it comes at all. For one, a product standard must be issued under formal rulemaking procedures that include public notice and an opportunity for public comment, § 387g(c), and  the FDA is only just starting the drafting of the proposed rule. In addition, FDA must consider “[i]nformation . . . regarding the technical achievability of compliance with such standard” as well as “the countervailing effects of the tobacco product standard on the health of adolescent tobacco users, adult tobacco users, or nontobacco users, such as the creation of a significant demand for contraband or other tobacco products that do not meet the requirements of [the TCA] and the significance of such demand.” § 387g(b).  Finally, any final rule must have an effective date of at least one year unless FDA can show that an earlier date “is necessary for the protection of the public health.” Id. at § 387g(d)(2).

How will the flavored cigar ban affect premium cigars?

According to 2017 research partly funded by FDA, the use of flavored cigars increased by over 50% after the TCA’s Special Rule for Cigarettes went into effect in 2009, with fruit, sweet/candy, and wine as the most popular flavors in the market (mint/menthol made up less than 3% of the market before and since TCA). Both the FDA’s announcement and the research on cigar uptake amongst youth focus on flavored, machine-manufactured, mass-produced cigars and cigarillos that can closely resemble cigarettes.It is unclear how FDA will address premium, often hand-rolled, cigars in the proposed standard that would ban “flavored” cigars, especially after the district court for D.C. ordered the FDA to develop a distinct, streamlined marketing process for premium cigars.

Premium cigar manufacturers previously articulated several reasons why regulating cigar “flavors” is fraught with uncertainty, and advocated for more specific guidance.  For example, like wine, differences in cultivation, aging, and blending techniques result in cigars with distinctive flavor profiles that cigar marketers and smokers may describe as including “notes” of certain flavors (e.g., coffee, citrus, minerals, bittersweet chocolate).  However, these products contain no additives to deliver these flavor experiences.  In addition, cigar products may also contain various non-tobacco ingredients that the manufacturer uses primarily or exclusively for non-flavoring purposes (e.g., humectants, preservatives, adhesives), but could nonetheless affect the “flavor” of the final product.  Finally, FDA must respect that the TCA “special rule” applies to “characterizing flavors” in cigarettes and their components, not necessarily every flavor.  § 387g(a)(1)(A).

FDA may be forced to examine different approaches in regulating flavored cigarettes and cigars.  In any case, we will be closely following the regulatory and policy challenges that will result from FDA’s announcement.

Categories: Tobacco