After 12 years of discussion, the FDA today announced concrete steps to ban sales of menthol cigarettes and flavored mass-market cigars. The agency has issued a draft rule, and will accept public comment on the controversial measure from May 4 to July 5.
The FDA announced its intention to ban menthol cigarettes last spring, and said it would have a draft rule ready within a year. Last week, the White House Office of Management and Budget completed its review of the FDA’s proposed rule.
The FDA made no announcement today about authorization of menthol vaping products, which have been tied up in the agency’s review process since Premarket Tobacco Applications (PMTAs) were submitted almost 20 months ago. The FDA has issued Marketing Denial Orders (MDOs) for almost all vaping products in flavors other than tobacco and menthol, and has authorized the sale of four vape devices and tobacco-flavored refills only. But the agency has so far punted on menthol.
The FDA has not encouraged menthol smokers to switch to safer menthol-flavored vapes—an action that could not only save lives, but would greatly reduce the challenges of managing a menthol cigarette ban. If more smokers understood the truth that vaping is far less risky than smoking, and had ready access to a selection of FDA-authorized menthol e-liquids and quality prefilled devices, many would likely be inspired to quit smoking.
The FDA, however, doesn’t seem interested in smoothing the bumpy road it will soon face. As things currently stand, the agency will deal with two nicotine product black markets.
But @FDATobacco is indulging in de facto rulemaking by blocking all flavoured vape products via an unattainable PMTA standard. FDA is crushing the US vape industry while evading the disciplines of the rulemaking process and its obligation to meet the public health standard.
— Clive Bates (@Clive_Bates) April 28, 2022
“Despite the cascade of bad news, there had been some optimism that if the FDA announced a menthol cigarette ban, it would be preceded by positive news about menthol harm reduction products,” American Vaping Association President Gregory Conley told Vaping360. “Regrettably, the FDA continues to show that its supposed commitment to comprehensive nicotine and tobacco regulation was really just another excuse to ban more products.”
In today’s FDA press release, the agency said it “recognizes the importance of ensuring broad and equitable access to all the tools and resources that can help smokers quit.” The press release goes on to note that many insurance plans “cover tobacco cessation services, like medication and counseling, without any out-of-pocket cost,” and to encourage people who want to quit smoking to visit smokefree.gov.”
The FDA made no mention of harm reduction options for people who smoke. The agency faces continued lobbying from tobacco control groups to ban menthol vapes too. Truth Initiative today issued a statement congratulating the FDA on the menthol cigarette ban, and urging the agency to “expand these efforts to eliminate all flavored tobacco products from the market, especially menthol e-cigarettes—a key driver of the persistent national youth e-cigarette epidemic.”
The 2009 Tobacco Control Act banned cigarettes with “characterizing flavors”—except menthol, which Congress ordered the new FDA Center for Tobacco Products (CTP) to study. The agency concluded that banning menthol would benefit public health, and has since been under constant pressure from tobacco control groups to prohibit menthol.
Until now the FDA hasn’t had White House support for a menthol ban. When Trump’s FDA Commissioner Scott Gottlieb announced his intention to ban menthol cigarettes as part of his comprehensive overhaul of the nicotine market, the menthol ban went nowhere. When Gottlieb resigned, the FDA dropped the issue until the Biden administration decided to revive Gottlieb’s plan.
Despite my cynicism, I am often optimistic about the future.
I thought that if a menthol ban was formally proposed, the FDA would highlight the availability of menthol harm reduction products as a key reason for doing it.
With zero menthol vapes authorized, I’ll take the L. pic.twitter.com/FbYnXuUNFf
— Gregory Conley (@GregTHR) April 28, 2022
The ban is still a long way away. Following a 60-day public comment period, the agency will produce a final rule, which could take a year or more. Then the FDA will set a date to implement the new rule, which could take another year. At that point, tobacco companies will almost certainly sue the agency, which could postpone the ban further, possibly for many years.
Most observers expect aggressive legal challenges to the ban, especially from Reynolds American (a subsidiary of British American Tobacco), which makes Newport cigarettes, the leading menthol brand in the U.S. Menthol cigarettes make up half of Reynolds’ sales.
Fewer than half of Americans who smoke choose menthol cigarettes, but more than 80 percent of black smokers prefer them. Because of that, tobacco control organizations have long courted support for a menthol ban from civil rights organizations. The issue has gained steam in recent years, with some groups like the NAACP joining the fight to ban menthol as a social justice issue.
Other organizations, like the American Civil Liberties Union, disagree. They fear that the inevitable black market that will result from a menthol ban would lead to unnecessary and potentially violent interactions with police who will be tasked with enforcing sales bans.
If the FDA really wanted to improve the health of those who smoke menthol cigarettes, including disproportionate numbers of minorities, it would have authorized the sale of menthol e-cigarettes to adults– years ago– to help them switch.
— Jeff Stier (@JeffaStier) April 28, 2022
“Should cops be staking out stores for contraband menthol cigarettes and flavored vapes?” asks author Jacob Grier. “ Should street sellers be subjected to potentially violent policing? Should Americans be arrested and sentenced to years in prison for selling tobacco and nicotine to consenting adults?”
The FDA claims that it “cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars,” but only against manufacturers and sellers. But in black neighborhoods, it will be black citizens that face police—not FDA—enforcement of contraband cigarette sales, whether as store owners and employees, or as street sellers in what will likely be a massive informal market.
Tobacco control activists claim that fears of police violence and imprisonment for sales of contraband cigarettes are overblown. But in states with menthol and other flavored tobacco and vape bans, enforcement actions are already happening. A federal ban on menthol cigarettes will increase opportunities for aggressive enforcement and incarceration exponentially.