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FDA Commissioner Robert Califf is engaged in a campaign to pressure the White House to approve a rule banning menthol cigarettes. According to a Politico story published today, Califf—who was appointed by President Joe Biden—-has asked friends and health experts to “press their White House contacts over the status of the long delayed policy.”
The rule, if finalized, will ban U.S. sales of menthol cigarettes and flavored small cigars. Califf has championed the policy, claiming it will reduce youth smoking initiation and make it easier for adult smokers to quit.
According to Politico, in addition to engaging outside assistance, Califf has “enlisted senior officials at the White House and the Health and Human Services Department to help advocate for the ban,” and personally lobbied senior Biden aides.
Politico’s description of Califf’s “behind-the-scenes encouragement of outside pressure” as an “unconventional policymaking tactic” probably undersells the actions. It’s hard to imagine any occupant of the nation’s highest office reacting with anything less than extreme annoyance to backdoor lobbying by an appointed sub-cabinet agency official. Biden is already well aware of Califf’s position on the proposed ban.
FDA’s menthol cigarette ban could fall to political pressure
The FDA menthol cigarette rule has been on hold since early December 2023, when its expected date was changed from 2023 to March 2024 in the White House’s fall agenda of planned regulations. (The 2024 date is a tentative one, not a firm commitment.) The final rule was sent to the White House Office of Management and Budget (OMB) for review last October.
The OMB Office of Information and Regulatory Affairs (OIRA) reviews all agency rules before they can be finalized and eventually implemented. Between October and December, OIRA held meetings with both opponents and proponents of the menthol cigarette rule before making a final decision.
Opponents of the ban fear police enforcement actions in minority neighborhoods and the growth of illicit sales. Proponents say a menthol ban would improve public health, especially among black Americans, but dismiss fears of unwelcome police interactions and a loss of crucial votes among angry menthol smokers (not to mention loss of personal liberty and bodily autonomy).
A menthol ban will turn a regulated market worth billions over to organized crime. In fact look at the states that have already banned (MA) the illegal market is growing & a repeal of the ban has been introduced. Bill H.2406 https://t.co/vNiHrZXuAU
— DianeGoldstein (@dianemgoldstein) July 25, 2023
It was during the OIRA review period that White House staff may have been scared away from the menthol ban, after warnings about political fallout, including potentially depressed black voting in November 2024. Biden considers black voters key to his reelection chances. (Menthol cigarettes are favored by a large majority of black people who smoke.)
“We’re now in a political season, and it’s only going to get tougher for them to do it,” Campaign for Tobacco-Free Kids CEO Yolonda Richardson told Politico. “All the delays are to the benefit of the tobacco industry. That’s just more time they have to keep them on the street, that much more time to addict kids.”
But not many kids are smoking cigarettes anymore. Among middle and high school students responding to the National Youth Tobacco Survey in 2023, just 1.6 percent reported smoking cigarettes (as little as one puff) in the past 30 days—the third year in a row that number has remained under 2.0 percent.
FDA refuses to authorize menthol vapes to help smokers
The FDA announced its intention to ban menthol cigarettes in 2021—four years after President Trump’s FDA Commissioner Scott Gottlieb had included the possibility of a menthol ban in his “comprehensive” tobacco and nicotine plan. The agency issued a draft menthol cigarette rule in April 2022.
Under Biden, the FDA also planned to resurrect a major pillar of Gottlieb’s plan: a rule mandating very low nicotine content in cigarettes. But it was menthol prohibition that got the most traction, largely because tobacco control groups have been advocating for a menthol cigarette ban since the FDA Center for Tobacco Products (CTP) came into existence in 2009.
Gottlieb’s “comprehensive plan” also included the intention to authorize a variety of vaping products, which the former commissioner believed would be accepted as cigarette substitutes by many smokers. There seemed to be a belief at the FDA that menthol-flavored vapes could be a valuable tool to prevent menthol smokers from turning to the black market if their preferred cigarettes were banned.
Even during the first year of Califf’s FDA leadership under Biden—as the agency issued marketing denials for most flavored vaping products—menthol vapes and e-liquids mostly escaped the ax and remained under review.
Califf claims FDA is doing everything it can to help menthol smokers quit. Ok, then why hasn’t the FDA authorized a single menthol e-cigarette? FDA has taken no action to educate smokers about safer nicotine alternatives. https://t.co/LW4nU74reo
— Guy Bentley (@gbentley1) April 28, 2022
That changed after Califf named ex-CDC official Brian King to lead the CTP. Since King’s appointment, the FDA has treated menthol vaping products the same as other flavors, denying them based on surveys showing youth primarily use flavored products (vapers of all ages do). The agency under Califf and King no longer seems to believe that menthol smokers faced with a ban need attractive vaping alternatives.
Califf is a longtime foe of vaping. As Barack Obama’s last FDA commissioner, Califf oversaw the rollout of the 2016 Deeming Rule, which originally included an outright ban on flavored vape products. Califf later complained that the White House OMB had removed the ban from the final rule.
Before his 2021 return to the FDA, Califf advocated for a ban on all vape flavors, and even suggested a prescription-only model for vaping products.
“The regulatory trifecta,” Califf wrote in 2019, between his FDA stints, “would be to: 1) require the tobacco industry to lower the amount of nicotine in its products to subaddictive levels (if nicotine can be dialed up using irradiation and selective breeding, it can also be dialed down, even if the law forbids regulation that reduces the level to zero); 2) ban over-the-counter vaping products; and 3) support prescription vaping so that the 30 million current tobacco users do not go through acute withdrawal all at the same time.”
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