Now that our new Food & Drug Administration (FDA) Commissioner has been confirmed, he can take a look at the withdrawn menthol cigarette and cigar flavor bans. His arrival also follows the FDA’s newly proposed cap on nicotine levels in combustible tobacco products. This presents an interesting choice of rulemaking pathways beyond just another layer of tobacco control.
New FDA leadership can reroute the menthol and flavor bans to fit the policy objectives of the Trump administration. Or it can take the nicotine cap on-ramp, but only for cigarettes and some cigars. Enacting the menthol and flavor bans only makes sense if the nicotine caps don’t happen for the projected five years or longer as FDA staff cuts happen as this is written.
The third option is to simply put both proposed sets of rules on hold and let tobacco use continue its current slide. Given the ongoing decreases in tobacco category sales, and workforce reductions at the FDA Center for Tobacco Products (CTP), a good case can be made that the bans are a waste of resources. The caps on nicotine as submitted don’t address limits on vape and oral nicotine, the primary gateway to youth addiction.
In the time it has taken for the FDA to move the menthol cigarette ban to its current stage, Menthol smoking among teens has dropped below .05% (half of 1%). Regular cigarette smoking is now below 5% among 18-25-year-olds. Total cigarette usage is hovering around 11%, skewed heavily to older smokers. It declined by $2.6 billion last year, including price increases. The 24-year decrease in cigarette smoking has driven average individual use from 106 packs a year to 38, according to the Centers for Disease Control and Prevention (CDC) data.
This didn’t happen because of federal rulemaking. It’s because of growing health concerns, higher prices including increased state taxes, limited smoking venues, negative peer and social pressure and the fact that fewer teens are starting. The regulatory costs where bans are already in place include millions in state tax losses, very little real impact on reducing tobacco use, and the previously predicted increase in smuggled products. These should point the way to less costly rulemaking.
Rulemaking Wait
How long will rulemaking at the federal level have to wait?
The stated goal of the Trump Administration is to reduce the federal footprint (and budget), by pushing regulations including tobacco to the state level. It wouldn’t take much to amend the current language of the FDA’s flavor bans to begin, “Each of the several states shall enact. …” President Trump’s new Department of Health and Human Services and FDA leaders may like this approach. With a reduced staff, the FDA can continue its direct control of Market Authorizations, oversight of science, and control the import of denied products that don’t meet the standard, while transferring field enforcement to state agencies.
Much of oral nicotine’s increase is directly tied to migration from cigarettes, driven by convenience, health concerns and flavors. 2024 oral nicotine is the only tobacco segment that grew. It would need to grow 50% this year to make up the difference in combustible declines. Cigarette and cigar consumption declined $2.7 billion in 2024, and is still more than seven times greater than vape and oral nicotine combined, according to Nielsen IQ,
The data on declining tobacco use gives the FDA and the Office of Management and Budget (OMB) some extra clock to consider what fits the President’s policy. The CDC set a goal 24 years ago to reduce regular tobacco product use to 5% of the adult population. Vape and oral nicotine weren’t on the horizon, but regular teen use of cigarettes is well below 2%. Teen vape has declined by 23% since 2023. The rationale for nicotine pouches includes quitting for quite a few migraters, as low nicotine and non-nicotine brands begin to appear.
Nicotine Caps & Bans
A cap on nicotine levels would make menthol bans unnecessary.
California, Massachusetts and seven other states today have more extensive tobacco bans than the FDA. Using California’s statutes as a standard for enforcement will offer a legal template for more states to expand their bans beyond flavored vape, out of frustration as much as for alignment with federal intent. Funding from the CDC, American Cancer Society, and other NGOs provided states with more than $200 million in 2023 for anti-tobacco advocacy. Compare that to $1.13 billion for tobacco consumer marketing, net of licensed retail and wholesale incentives amid the declines.
Two years after their statewide bans, California acknowledged that non-tobacco, nicotine-free flavored and menthol smokes are legal and exempt from retail removal and fines. Kretek International, importers of Splash filtered tobacco-free menthols, met with representatives of the California Department of Justice (DOJ) to show them properly labeled menthols and flavors with no tobacco or nicotine.
Kretek’s extensive consumer research prior to their launch of Splash and non-tobacco, nicotine-free Djarum cloves concluded that without nicotine, menthol and flavored smoking would end up around 9% of current category usage. Nearly 20% said they’d be glad the nicotine was gone. Not a bad result compared to the bans.
The California DOJ response was “We’re OK with these, but we’re not listing a non-tobacco product for you.” As a result, Kretek has begun distributing its own retailer advisory explaining nicotine-free menthol benefits in terms of legal shelf status, and the benefits of reducing nicotine dependency.
Afterthoughts
The longer the new FDA and Trump White House take to reframe tobacco rulemaking, the more likely state and local rules will be enacted before the FDA’s plan gets out the door. Cigarette smoking will decline with nicotine limits. But smuggling will increase. A nicotine pouch without nicotine is pointless, but there are plenty of illicit products out there to choose from. As younger tobacco users age up into the next demographic segments, backbar strategies will need to adapt. So should the FDA.
John Geoghegan has spent the last 30 years in the tobacco business, including vice president strategic planning at General Cigar Co., U.S. manager for DjEEP Lighters, head of marketing for Kretek International Inc. and manager of LaMirada Cigar Co. He began his career 57 years ago at Procter & Gamble. Geoghegan is a graduate of the University of Cincinnati. He lives in Laguna Niguel, Calif.
