FDA Proposes Action On Menthol Cigarettes And Flavored Cigars

On April 28, 2022, the Food and Drug Administration (FDA) issued two highly anticipated new rules that, if finalized, would prohibit menthol in cigarettes and flavors in cigars. If these rules are implemented, they will save millions of lives and minimize health disparities that are exacerbated by menthol cigarettes and flavored cigars. This article discusses the health harms of flavored tobacco, briefly summarizes the two proposed rules, and highlights what to watch for next in this process.

The Health Harms And Regulation Of Flavored Tobacco

Tobacco is the leading cause of preventable death in the U.S., killing over 480,000 people annually. Nicotine—the identified drug in tobacco—is highly addictive, and flavors enhance nicotine’s addictive effects. Flavors significantly increase tobacco use because they enhance its appeal, especially among youth and young adults. Over 90 percent of current smokers started smoking as teenagers, and it is estimated that 80 percent of youths who used tobacco began with flavored tobacco products. Additionally, flavors, such as menthol, mask the harshness and bitterness of tobacco, sustain tobacco dependence, and hinder cessation.

Aggressive and targeted marketing of flavored tobacco products has long been a tobacco industry tactic that has lured young people into experimentation with tobacco products, addiction, and, consequently, premature death. The tobacco industry has especially targeted Black and LGBTQ communities with predatory marketing of menthol cigarettes and flavored cigars. As of 2019, the FDA found, there were 18.5 million people in the U.S. who smoked menthol cigarettes, which are disproportionately used by marginalized populations. Nearly 85 percent of African American smokers use menthol cigarettes.

An estimated 9,000 Americans die prematurely from cigar smoking each year. Additionally, an annual health care expenditure of $1.8 billion is attributed to cigar use. Flavors are critical to cigar usage. There is a greater frequency of smoking by adults who smoke flavored cigars compared to those who smoke unflavored cigars. In 2020, an estimated 960,000 youths smoked a cigar at least once in 30 days, with almost 60 percent reporting that they used flavored cigars.

Given these impacts, flavored tobacco products present a serious public health challenge, which has led some local, state, and Tribal governments to prohibit flavored tobacco products. For instance, the tobacco industry is sponsoring a referendum in California in an attempt to block a recent state law prohibiting the sale of flavored tobacco products. Additionally, the tobacco industry has aggressively challenged these flavored tobacco laws through litigation. Since 2012, the tobacco industry has unsuccessfully challenged local flavored tobacco laws in Rhode Island, New York, Illinois, California, and Minnesota, arguing that local laws that prohibit the sale of flavored tobacco products are preempted by federal law.

These efforts by state, local, and Tribal governments are critical to promoting public health. But these policies are geographically scattered, which limits their impact, and flavored tobacco products are still sold in most jurisdictions across the country. Comprehensive national policy addressing flavored tobacco policy is therefore seriously needed.

When Congress enacted the Family Smoking Prevention & Tobacco Control Act (TCA) in 2009, it established “a special rule for cigarettes” that prohibited all flavors in cigarettes, except menthol. In other words, while Congress made flavored cigarettes illegal, it is still permissible to sell menthol cigarettes. Congress also did not prohibit other flavored tobacco products, such as cigars, pipe tobacco, or smokeless tobacco. But Congress authorized the FDA to regulate all tobacco products and directed the FDA to determine whether menthol in cigarettes should be prohibited. Congress was “especially concerned about proportionately higher rates of menthol cigarette use among African American smokers.” This concern was well-placed: exempting menthol from the TCA was a huge public health inequity. Prohibiting menthol in cigarettes would have averted the premature loss of around 4,700 Black lives between 2010 and 2020. It would have also prevented about 461,000 African Americans from becoming addicted to nicotine.

Proposed Rule Prohibiting Menthol In Cigarettes       

Yet, the FDA did not take action until April 28, 2022, 13 years after Congress enacted the TCA. The FDA proposed a rule that would, if finalized, prohibit the use of menthol in cigarettes. Specifically, the proposed rule would prohibit menthol in all products that meet the definition of “cigarette” under federal law, which also includes cigarette tobacco, roll-your-own tobacco (RYO), and heated tobacco products (such as IQOS).

Menthol would also be prohibited in cigarette “components or parts.” A product is a cigarette component or part if it: (1) alters or affects the performance, composition, constituencies or characteristics of a cigarette; or (2) can be used by humans to consume a cigarette. Components or parts include products such as filters, papers, flavor cards, drops, oils, or other additives. Including components or parts in the menthol prohibition would guard against the tobacco industry—which has previously exploited regulatory loopholes—selling menthol in products that can be used with cigarettes. While the rule would prohibit the manufacture, distribution, or sale of menthol cigarettes in the U.S., the prohibition would not apply to cigarettes made for export.

The rule focuses on the supply side of the menthol cigarette market and would not prohibit individuals from using or possessing menthol cigarettes. This is important because it focuses the FDA’s limited enforcement resources on manufacturers and sellers who have an economic incentive to market these products. Put another way, the rule would in no way criminalize or penalize the use or possession of menthol cigarettes. Even so, this has not stopped critics from trying to characterize the prohibition of menthol as a criminalization of individual behavior. It is true that focusing on individual use would harm the marginalized communities involved through increased policing, penalization, and stigmatization. Nicotine is highly addictive, and sanctioning individual behavior is both ineffective and inequitable. But the proposed rule is clear that it does not prohibit purchase or use, and the FDA cannot enforce the rule against individual users.

The FDA explains that the proposed rule satisfies the TCA’s specific guidelines for the regulation of tobacco products. Under the TCA, the FDA may adopt or revise a tobacco product standard if the new standard protects public health. In making that public health determination, the FDA has to consider: (i) the proposed standard’s risks and benefits to the population as a whole; (ii) the likelihood that existing users of tobacco products will stop using those products; and (iii) the likelihood that those who do not use tobacco products will start using them.

Here, the FDA found that prohibiting menthol in cigarettes would decrease the appeal of cigarettes and ease of smoking, thus minimizing the likelihood of smoking initiation and subsequent nicotine dependence. It would also improve the health of current smokers by decreasing cigarette consumption and increase the likelihood of cessation. Consequently, this would also minimize death and disease associated with exposure to secondhand smoke. The FDA estimates that prohibiting menthol in cigarettes would prevent 654,000 premature deaths in 40 years. The FDA also found prohibiting menthol would advance health equity because menthol use is prevalent in marginalized communities, especially among African Americans, and prohibiting menthol would lessen the health harms those communities disproportionately bear. It is estimated that the menthol prohibition would prevent 238,000 premature African American deaths in 40 years.

Proposed Rule Prohibiting Flavored Cigars

The FDA also proposed a rule that would prohibit flavors (including menthol) in cigars and their components and parts. As noted above, flavors appeal to young people, and cigar flavors come in many varieties (such as spice, strawberry, grape, banana, licorice, menthol, and chocolate) that mask the harshness of cigar smoke and make cigars easier to smoke.

Similar to the proposed ban on menthol in cigarettes, this proposed rule would prohibit the manufacture, distribution, or sale of flavored cigars in the U.S. Here, too, the FDA focuses on the supply side of the market and would not prohibit individual consumers from possessing or using flavored cigars.

The proposed rule comprehensively defines cigars—which are made in different sizes and shapes—as “a roll of tobacco wrapped in leaf tobacco or any other substance containing tobacco.” This broad definition captures many tobacco products (including little cigars, cigarillos, and large cigars) and should guard against manufacturers skirting the ban by switching to other products that closely resemble other prohibited flavored tobacco products. The flavor prohibition would also apply to cigar “components or parts,” so products such as filters, blunt wraps, or tips also could not be flavored.

This comprehensive ban is important because the tobacco industry has used this strategy before. After the TCA prohibited flavored cigarettes in 2009, the tobacco industry began to heavily market flavored cigars, thus undercutting the public health benefits of the TCA’s ban on flavored cigarettes. The FDA acknowledges as much in the preamble to the rule, noting that “tobacco companies have engaged in a calculated effort to blur the line between little cigars and cigarillos to increase the appeal to cigarette smokers, and the use of flavors facilitated these efforts.”

As with menthol in cigarettes, the FDA concluded that prohibiting flavored cigars would protect public health. Prohibiting flavored cigars would decrease the appeal of cigars, consequently minimizing smoking initiation and continued cigar use. With decreased initiation and use would come less exposure to the toxins and carcinogens in cigar smoke. Prohibiting flavored cigars would also lead to cessation because the availability of flavored cigars is associated with their use. Thus, limiting their availability would improve the health of current smokers who would either smoke fewer cigars or quit. This rule would also minimize the public health burdens borne by marginalized groups, especially African Americans and individuals who identify as LGBTQ, because of their disproportionate use of flavored cigars. Consequently, the adoption of this proposed rule would go a long way to reduce tobacco-related death and disease and minimize disparities.

Flavors In Other Tobacco Products

There are flavors in a wide range of tobacco product, including smokeless tobacco, e-cigarettes, pipe tobacco, and hookah. The proposed rules would restrict flavors in only a portion of combustible tobacco products—cigarettes and cigars­­—leaving other flavored tobacco products on the market. Based on how the tobacco industry has behaved historically, it is likely that it will focus its marketing on the other flavored tobacco products that are not covered. For example, while the proposed menthol cigarette rule would prohibit menthol in RYO tobacco, if the rule is finalized the industry is likely to increase its marketing of mentholated pipe tobacco (RYO and pipe tobacco are substantially similar), which would technically not be prohibited under the proposed rule. The FDA is, however, seeking further information on how the products that are not covered might affect the proposed flavor restrictions.

The FDA is not restricting flavors in e-cigarettes, which continue to present a serious public health danger (the Surgeon General declared youth e-cigarette use an epidemic). E-cigarettes are made in many “kid-friendly flavors” and are aggressively marketed to underage persons. The tobacco industry is likely to exploit FDA’s failure to restrict flavors in e-cigarettes, thus undercutting the public health gains from the menthol and flavored cigar rules.

What Comes Next

Comments on both rules are due on July 5, 2022. From there, the FDA will likely issue final rules that will finally close the menthol loophole in the TCA and prevent the tobacco industry from simply switching to marketing of flavored cigars once menthol cigarettes are prohibited. A tobacco industry legal challenge to the rules is likely to follow.

These rules are overdue public health measures. They would not only minimize tobacco-related morbidity and mortality but also alleviate the health harms that are disproportionately borne by the African American and LGBTQ communities who are targeted by the tobacco industry.