The FDA’s proposals to ban menthol cigarettes and flavored cigars will test its authority to create new product standards for the tobacco industry.
The Food and Drug Administration issued two long-awaited draft standards targeting menthol and other flavored tobacco products that can make smoking harder to quit. The proposals have already deepened tensions between the agency and tobacco manufacturers, who oppose the FDA’s plans.
As the agency works to finalize the proposals—which are then likely to face an industry challenge—it should weigh the public health standard it uses, and analyze the potential for more tobacco products to enter the black market, attorneys who specialize in tobacco control policy say.
The FDA “has authority to implement tobacco product standards based on a finding that those standards are appropriate for the protection of public health,” said Bryan Haynes, a partner with Troutman Pepper. That authority, however, is “not without limits,” he said.
The agency will finalize the proposals after a public comment period that ends July 5. Major tobacco and vaping companies that would be impacted by a menthol ban, including
‘Arbitrary and Capricious’
Attorneys say the FDA needs to provide a reasonable amount of time for public input, and evidence that the standards wouldn’t unreasonably stretch the agency’s authority.
Under federal law, the FDA can issue tobacco product standards deemed “appropriate for the protection of the public health.” Marc Scheineson, a former agency official, said the FDA “can’t be arbitrary and capricious” in proposing new standards.
“They have to get real public input, they have to give the public time to respond, and they have to consider the public record that gets created,” said Scheineson, who now leads Alston & Bird’s Food & Drug Law Team. He said the tobacco industry may push the FDA to extend the comment period “to give time for thorough and thoughtful responses.”
The FDA has argued that banning menthol in cigarettes and flavors in cigars would help reduce the likelihood that young people who start using menthol cigarettes will keep doing so. The agency has also said the proposed product standards would help advance health equity by targeting products disproportionately used by Black and other minority groups.
Haynes said that a question likely to come up during the comment period is whether FDA has provided an “appropriate off ramp from combusted products to non-combusted products” for adult smokers.
The FDA has authorized some electronic nicotine delivery system (ENDS) products, citing manufacturer data indicating the products could potentially benefit combusted cigarette users who switch.
But Joelle Lester, director of Commercial Tobacco Control Programs at Mitchell Hamline School of Law’s Public Health Law Center, argued that ensuring other products are on the market to serve as less harmful alternatives to menthol cigarettes or flavored cigars isn’t part of the FDA’s mandate.
“That’s an argument for people who favor products that they promote as less harmful,” Lester said.
Public Health Standard
The FDA also faces disagreement among tobacco policy attorneys over whether it has enough evidence that its proposals would benefit public health.
In 2019, 1.15 million US middle and high school students reported smoking a cigarette in the previous month, according to the FDA. The agency said that roughly 46%, or 530,000, of youth smokers used a menthol cigarette in that month.
Data from the 2020 National Youth Tobacco Survey also showed that roughly 58% of youth cigar smokers reported using a flavored cigar during the previous 30 days.
Scheineson argued that to better prevent youth use, the FDA could have proposed a flavor product standard more focused on those that attract youth, noting that overall rates of combustible product use are at an all-time low. Banning menthol in cigars in addition to cigarettes rests on the assumption that youth will switch to cigars from cigarettes, but that doesn’t track with user patterns, he said.
While declines in menthol cigarette use were observed among non-Hispanic White youth from 2011 to 2018, the same couldn’t be said for non-Hispanic Black or Hispanic youth.
The sensory effects of menthol and other flavors can make smoking more appealing to youth, and studies show that youth menthol smokers are more physically dependent on nicotine than youth who use non-menthol cigarettes, the agency said in an email.
The leading U.S. tobacco companies are amplifying concerns that US bans on the manufacture and sale of menthol cigarettes and flavored cigars would allow illicit market sellers to flourish.
“Taking these products out of the legal marketplace will push them into unregulated, criminal markets that don’t follow any regulations and ignore minimum age laws,” Altria said in a statement.
The FDA has the authority to take enforcement actions and other steps in response to the sale and distribution of illicit tobacco products, including by issuing warning letters. The agency routinely surveys sales, distribution, marketing, and advertising of tobacco products and takes corrective action in response to violations, it said in an email.
But the FDA has opted to not take enforcement action against
“When you already have a whole host of unauthorized products on the market that FDA is doing very little to nothing to take enforcement action against,” it drives concern that “with a menthol or flavored cigar ban that they’ll penalize responsible companies and drive this activity into the black market,” Haynes said.
The FDA cited a 2015 National Academy of Sciences report that suggested that changes to conventional cigarette regulations would result in minimal trade on the illegal market. Evidence, including FDA-cited studies conducted in Canada, the US and England suggest that the proposed rules wouldn’t significantly impact the illicit market, the agency said in an email.