The FDA must stop companies from evading upcoming new tobacco rules

Early next year, the Food and Drug Administration (FDA) is expected to issue a final rule prohibiting the sale of menthol cigarettes, as well as a separate rule prohibiting the sale of flavored cigars. In October, the FDA sent these two rules, which collectively could prevent hundreds of thousands of premature deaths, to the White House for final review.

The recent announcement that these rules will not be finalized until 2024 is disappointing, particularly because these regulations are already long overdue. Indeed, the need for them was obvious back in 2009, when Congress passed the Tobacco Control Act (TCA), granting the FDA authority to regulate tobacco products.

The 2009 TCA prohibited the sale of flavored cigarettes except for menthol, which was by far the best-selling flavor. This was a political concession lacking any public health justification. Six former Department of Health and Human Services secretaries noted at the time that the menthol exemption was “a serious flaw that provides a major win for tobacco companies and abandons African Americans” who “have been targeted by marketing campaigns for menthol cigarettes.”

The TCA did, however, give the FDA authority to prohibit menthol cigarettes through the rulemaking process. In 2011, the FDA’s advisory panel issued a 249-page report finding that “removal of menthol cigarettes from the marketplace would benefit public health in the United States.” Though more new evidence has bolstered this conclusion every year since, only in 2021, and only in response to a lawsuit, did the FDA commit to prohibiting the sale of menthol cigarettes.

The TCA’s prohibition on non-menthol flavored cigarettes also did not apply to flavored cigars. Quite predictably, cigar makers sought to exploit that loophole, immediately offering new flavored products that could be smoked like cigarettes but technically qualified as cigars. In the decade following the TCA’s enactment, cigar sales grew by more than 30 percent, with virtually all of that growth coming from increased sales of flavored cigars.

As the White House and FDA prepare to finalize the two new rules, it is critical to block the tobacco industry from finding new regulatory gaps to exploit. Industry efforts to evade the regulations must be quickly and comprehensively addressed.

These concerns are particularly pressing given recent efforts by cigarette and e-cigarette companies to evade requirements imposed by both state and federal law.

For example, immediately after California became the second state to prohibit the sale of menthol cigarettes (following Massachusetts), tobacco companies launched marketing campaigns telling current menthol smokers that “we’ve got you covered” with new “crisp” and “fresh” cigarettes that provide the “same vibe” but “minus the menthol.” These new “non-menthol” cigarettes are being packaged almost identically to their menthol counterparts.

At least some of these new products contain a synthetically derived cooling agent named WS-3 that produces a cooling, soothing effect like that of menthol cigarettes. These chemicals “can mimic menthol’s actions, making tobacco products more appealing and less irritating.”

R.J. Reynolds claims that the sensation produced by WS-3 is not a “taste” and is therefore permitted under California law. The state’s attorney general thinks otherwise, resulting in an ongoing lawsuit about whether these products can legally be sold.

At the federal level, numerous FDA actions have resulted in e-cigarette companies seeking to identify and exploit regulatory gaps, prompting the need for further regulatory action. For example, when the FDA tried to crack down on youth-appealing flavored e-cigarettes like JUUL in 2020, the policy only included cartridge-based devices, leaving an opening for disposable products like Puff Bar to remain on the market and become the new preferred vape among youth. When the FDA then told Puff Bar to stop selling its product, the company claimed that it had started using synthetic (instead of tobacco-derived) nicotine and was therefore outside of the FDA’s tobacco-related jurisdiction. Congress subsequently amended the TCA to address that issue, but enforcement remains spotty.

As the FDA finalizes its new rules on menthol cigarettes and flavored cigars, these past experiences must be front of mind. We hope both final rules will explicitly include synthetic cooling agents within their scope and also carefully address other tactics the industry will likely employ, such as color coding packs, using “concept flavors,” and selling new accessories like “flavor infusion cards.”  As soon as the regulations take effect, the FDA must focus on vigorous enforcement in order to protect public health and also ensure that companies playing by the rules are not disadvantaged.

As researchers, we will continue to study synthetic cooling agents, which may pose unknown health risks, and to track industry efforts to exploit regulatory gray areas in the U.S. and abroad.

But we already know that more lives can be saved by anticipating the tobacco industry’s next moves and writing regulations accordingly. The wait for these critical regulations has been far too long; the final rules must be carefully crafted to definitely end the sale of menthol cigarettes and flavored cigars.

Micah Berman and Alayna Tackett are professors at Ohio State University and researchers at its Center for Tobacco Research.