Strengthening the FDA Proposed Rule on Menthol-Flavored Products

John Maa, MD and Jeffrey Wigand, PhD

We applaud the recent action by the Biden administration to restrict the sales of menthol cigarettes and flavored cigars.

In this article, we review the rationale for a ban and offer recommendations on ways to make the Food and Drug Administration’s (FDA’s) proposed rule stronger.

Menthol is used extensively in health care products due to its anesthetic and antimicrobial effects. The substance is also intentionally added by tobacco manufacturers to a tobacco blend of burley, flue-cured, and oriental tobacco with additional ingredients. Menthol reduces the irritating nature of tobacco smoke aerosol on the airways, thus promoting greater inhalation of the smoke mixture of nicotine and combustion byproducts.

Tobacco products in the marketplace are categorized into two distinct types: non-menthol cigarettes and menthol cigarettes (for example, Newport, Kool, and Salem). While the marketing of cigarettes as either menthol or non-menthol might lead some smokers to believe that these are two distinct tobacco products, the reality is that menthol is used in all tobacco products. When menthol is added at a higher concentration of 5–9 percent weight/weight (w/w) basis the product is marketed as a menthol product, whereas when menthol is added at a lower concentration (generally less than 1 percent w/w), the product is referred to as non-menthol. (The term “weight/weight basis” means that the percentage of various components in a whole is determined by weight, with volume disregarded.) The proposed FDA product rule will prohibit the industry’s use of higher levels of menthol as a characterizing flavor but allow the continued use of menthol as an additive at lower levels in the remaining cigarettes.

Uses And Applications Of Menthol

A tobacco blend goes through several manufacturing steps before menthol is sprayed on the blend. Casing operations use additives such as licorice, honey, and chocolate to smooth out the harshness of the finished product. In 1986, the Federal Cigarette Labeling and Advertising Act required tobacco manufacturers to submit annually to the Department of Health and Human Services all the additives they use in tobacco manufacturing. The listing of all the additives (600 plus) from each manufacturer are collated and presented together (in past years by the law firm Covington and Burling) to protect any proprietary information that give individual brands their distinctive flavor and aroma. Many of these additives are considered generally recognized as safe for use in food and cosmetics, although they undergo pyrolysis in a cigarette that may change their chemical structure and toxicity, and the possible health hazards afterwards remain unresolved. The Flavor and Extract Manufacturers Association supplies organic-based flavors to manufacturers that are used in final tobacco blends, but in very low concentrations.

The proposed FDA ban is also supported in extensive tobacco industry internal documents produced in tobacco litigation by the states’ attorneys general and in individual product liability suits, which reveal that the industry worked for decades to optimize menthol delivery and yields, resulting in numerous patent applications since the 1960s. The tobacco industry also harnesses the characteristic effects of menthol in novel ways other than as an intentional additive to the tobacco blend. A recent innovation is a crushable capsule containing menthol that is imbedded in the tobacco column (high menthol delivery on demand); other approaches include menthol coating of packaging components and in the cellulose acetate filters. Menthol then migrates into the tobacco rod via mass transfer. The intention behind all these methods to increase delivery of menthol is severalfold: to permit an increased puff volume and deeper inhalation into the lungs; to enhance and strengthen nicotine addiction; to facilitate the ease of initiation by children; to complicate tobacco cessation; and to allow manufacturers to use cheaper, lower-quality tobacco. Menthol does not undergo any chemical modifications in the aerosol delivery to the smoker in a combustible product and acts an independent chemical in all other types of tobacco and medical products.

Policies Affecting Menthol Use

The industry has used menthol’s attributes to target “at risk” groups, such as African Americans, women, children, and LGBTQ individuals. The science of menthol in tobacco products serves as a strong foundation for the proposed FDA ban, which has been awaited since 2011, when the FDA Tobacco Products Scientific Advisory Committee (TPSAC) concluded that “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.” The World Health Organization’s Framework Convention on Tobacco Control, the world’s first global public health treaty, recommended banning menthol tobacco products. The World Health Organization’s Framework Convention on Tobacco Control, the world’s first global public health treaty. Numerous entities—first Brazil in 2012, then the European Parliament, then Ethiopia, Moldova, Turkey, and seven provinces in Canada—moved forward with a menthol ban. The EU legislation prohibits the use of menthol as a characterizing flavor at the higher concentration but allows its continued use as an additive in lower concentration in cigarettes. The Canadian legislation is the most comprehensive, prohibiting menthol’s use at any concentration as an additive in cigarettes, most cigars, papers, and filters.

In 2016, a Federal Appeals Court ruled against a tobacco industry challenge to the FDA TPSAC recommendation, opening the door for menthol to be banned as a cigarette additive in the US. Since then, a wave of menthol bans have been adopted in cities and states around the nation, championed by the African American Tobacco Control Leadership Council. The state of Massachusetts passed a statewide menthol ban in 2019, followed by California in 2020.

Steps To Bolster Proposed Rules

First, the proposal does not address menthol use in e-cigarettes or vapor products that have great appeal to youth. Second, even if the proposed rule is adopted, a menthol cigarette smoker who wishes to continue can readily construct their own menthol products by mixing bulk cans of tobacco with commercially available United States Pharmacopeia (USP) menthol (often available as crystals). The proposed FDA rule will prohibit the manufacture, distribution, and sale of commercially available menthol drops, capsules, filter tips, or cards that can be added to roll your own tobacco. We would recommend that USP menthol marketed to be added to bulk tobacco also be included in this prohibition.

Third, evidence in Canada suggests that going further and also removing menthol as an additive at any level—not just at high-enough levels in which menthol becomes a “characterizing flavor—could be a more effective smoking cessation strategy and help smokers to quit rather than switch to “non-menthol” cigarettes that still contain menthol at a lower concentration. With this approach, menthol smokers in Ontario were more likely to make a quit attempt, be successful at quitting for six months, and did not significantly switch to other flavored tobacco products, e-cigarettes, or to contraband menthol cigarettes. Finally, the proposed FDA rule does not have a consistent approach to all uses of mentholated tobacco products—it does not disturb the agency’s previous grant of an exemption for menthol-flavored “heat not burn” products and does not include vaping devices that are still undergoing premarket tobacco product application and review. The complete ban of menthol (both as an additive and a characterizing flavor) would resolve these inconsistencies and encompass all menthol tobacco products.

John Maa, MD, is a general surgeon in San Francisco, California, and was the 2018 president of the San Francisco Marin Medical Society and previous chair of the University of California Office of the President Tobacco Related Research Program. He is on the board of directors of the American Heart Association Western States Affiliate, which supports the proposed menthol rule.

Jeffrey Wigand, PhD, is a medical biochemist and former vice president of research and development and environmental affairs at Brown & Williamson Tobacco Corporation based in Louisville, Kentucky, who worked on the development of reduced-harm cigarettes and in 1996 blew the whistle on tobacco tampering at the company.

SFMMS Election Coming Soon

Scan this code using your smartphone or visit

sfmms.org/advocacy/leadership-opportunities

to view the Slate of Candidates for the upcoming 2022 SFMMS Election. Voting begins on 10/31/22 and ends at 5pm on 11/14/22. Electronic ballots will be available at this link the day voting begins.