DEEP DIVE

The FDA has gained an unlikely ally in its plans to ban menthol cigarettes—a leading vaping trade group that wants to see smokers switch to e-cigarette products.

The agency received hundreds of thousands of comments on its effort to target menthol and other flavored tobacco products that can make smoking harder to quit. The Vapor Technology Association, which represents an industry typically known for its combative relationship with the Food and Drug Administration’s Center for Tobacco Products, says it wants to see the proposal go through, so long as the FDA authorizes more e-cigarettes as an alternative.

“Removing menthol cigarettes from the marketplace is an important step forward, presuming that the agency does what it needs to do in terms of securing and providing alternative products that are legal and authorized and getting them introduced into the marketplace,” VTA Executive Director Tony Abboud said in an interview.

One proposed rule (RIN 0910-AI60) would prohibit tobacco manufacturers and retailers from making, distributing, and selling cigarettes containing menthol as a flavor. The second (RIN 0910-AI28) would ban all characterizing flavors, including menthol, in cigars.

Public health and anti-tobacco groups say the proposals would go far in the FDA’s efforts to reduce negative health outcomes and disparities fueled by products disproportionately used by Black Americans and other minority groups. The FDA has warned that menthol can make smoking more addictive and appealing, especially among youth.

The vaping industry has long framed its products as a way for smokers to transition away from combustible tobacco. But health groups say that offering products as an off-ramp for traditional cigarette and cigar users isn’t part of the FDA’s mandate, and that there’s not enough evidence for the agency to take an official stance on e-cigarettes as a reduced-harm alternative.

The FDA has said it likely won’t be able to complete its review of tobacco-based e-cigarette marketing applications until June 30, 2023—nearly two years after a court-imposed deadline of Sept. 9, 2021. It’s so far authorized 23 electronic nicotine products and recently ordered Juul Labs Inc. to remove its products from the US market, but subsequently stayed that order pending further review.

The agency said in an email that it couldn’t comment on a specific timeline for reviewing public input on the menthol proposals, but added that it plans to “move carefully and quickly in considering all public comments received and determining next steps to protect public health.”

The FDA said it may ultimately “decide to end the rulemaking process, to issue a new proposed rule, or to issue a final rule.”

Harm Reduction

The VTA said in comments to the FDA that it supports the menthol ban in cigarettes, but that it should do more to help adult smokers.

“VTA promotes regulation that can hasten the reduction in smoking cigarettes and that focuses on the critical importance of tobacco harm reduction as an essential public policy objective,” the group said in its letter.

In addition to the proposed ban, the FDA should “simultaneously accelerate the review and approval of menthol vaping products and other flavored vaping products,” Abboud said in an interview.

“If you’re going to take away cigarettes from a large population of consumers that are addicted to those products, you must provide them alternatives,” Abboud argued.

“Otherwise, we fear the worst happens,” he added, noting 2021 research cited by the FDA that estimates nearly 46% of menthol smokers ages 35 to 54 would become non-menthol tobacco cigarette smokers after a ban.

“That is not the best public health outcome that we can have,” Abboud said. “When you think about how popular menthol cigarettes are, the goal is to get them off of cigarettes altogether.”

Youth Risks

Tobacco policy analysts say there isn’t clear evidence that e-cigarettes is a less harmful alternative, and that such benefit must be balanced with the risks that youth will become smokers through vaping.

In 2021, roughly 39% of middle- and high-school smokers in the US reported frequently using e-cigarettes, compared to 19% for cigarettes and nearly 21% for cigars, according to the Centers for Disease Control and Prevention’s annual National Youth Tobacco Survey.

The only people likely to benefit from flavored e-cigarettes as a reduced-harm alternative are current cigarette smokers, Joanna Cohen, director of Johns Hopkins University’s Institute for Global Tobacco Control, said.

“It’s not reduced harm when you’re not using any tobacco product,” said Cohen, who recently served as a voting member on the FDA’s Tobacco Product Scientific Advisory Committee.

Joelle Lester, director of Commercial Tobacco Control Programs at Mitchell Hamline School of Law’s Public Health Law Center, said that while e-cigarette companies have argued the “potential” for their products as a “harm reduction strategy or cessation strategy, they haven’t demonstrated it to the FDA.”

“We don’t have to wonder about the harm for youth initiation or the role that menthol plays, because we know a lot about that already,” Lester said. “I don’t think that those should hold equal weight.”

Health Disparities

Public health groups say that the FDA should move ahead quickly with the menthol and flavor bans as a pivotal step forward to address health disparities.

“FDA’s public health mission requires it to finalize the proposed rule to permit its life-saving benefits to be realized as quickly as possible,” the Campaign for Tobacco-Free Kids and the American Lung Association said in a joint letter to the FDA along with more than 100 other patient advocacy and medical groups.

They added that the tobacco industry “has targeted Black Americans with marketing for menthol cigarettes for decades,” and that “Black Americans suffer a disproportionate toll of the disease and death caused by menthol cigarettes.”

“By increasing cessation in these communities, the proposed rule will reduce smoking-related health disparities and increase health equity,” they added.

In a separate letter on the proposed flavored cigar ban, the groups said that these products use flavors to “help mask the harshness of cigars,” making them especially attractive among youth. They added that the tobacco industry “targets Black youth with cheap, flavored cigars,” resulting in a “disproportionate impact on underserved populations.”

Nearly 85% of non-Hispanic Black smokers report using menthol cigarettes, compared with just 30% of non-Hispanic White smokers, according to the FDA. The agency has also said that in 2020, the 30-day cigar smoking levels for non-Hispanic Black high school students were twice as high as White students.

Cohen said it’s “long overdue to get menthol cigarettes banned in this country,” as places like Canada and the European Union have already instituted similar policies.

Lester said that the FDA should also be “directing additional cessation support for whom this is an opportunity to quit smoking altogether,” especially communities of color that tobacco companies have historically targeted in their product marketing.

“It’s the FDA’s responsibility to deliver sufficient support in the same sort of targeted careful way,” Lester added. “We want to make sure we’re reaching the most affected communities.”

Michael Bloomberg has campaigned and given money in support of a ban on flavored e-cigarettes and tobacco. Bloomberg Law is operated by entities controlled by Michael Bloomberg.

(Updated with comments on the proposed cigar ban in the 26th paragraph.)

To contact the reporter on this story: Celine Castronuovo at ccastronuovo@bloombergindustry.com

To contact the editors responsible for this story: Alexis Kramer at akramer@bloomberglaw.com; Cheryl Saenz at csaenz@bloombergindustry.com

Celine Castronuovo

Reporter