But in the short run, officials instructed Zeller to drop the subject.

“The day that Gottlieb resigned in 2019 was the end of FDA advancing menthol nicotine reduction,” Zeller said. “I was told by political appointees at FDA to stop talking about menthol and nicotine publicly in my speeches.”

Under former President Barack Obama, the proposal simply lacked a champion. Former FDA Commissioner Margaret Hamburg told The New York Times in 2019 that tobacco policies were hampered by delays at the Department of Health and Human Services and the White House. Zeller agreed.

“The Obama administration had an opportunity to address both menthol and nicotine and did not,” Zeller said. “And I’ll just leave it at that.”

The FDA has also apparently abandoned two other tobacco initiatives from the Obama years. In 2016, the agency sent warning letters to a number of little cigar makers, arguing they were circumventing the flavored cigarette ban by misclassifying their cigars. Manufacturers denied the allegations, but the FDA’s current proposal to ban flavored cigars would close that loophole.

Additionally, the FDA in 2017 proposed limiting the amount of a certain toxin in smokeless tobacco products but never finalized the rule.

The Biden administration is also aiming to propose limiting the amount of nicotine in cigarettes this month, though that timeline is also under doubt.

The FDA spokesperson said the agency is still working on the rule and noted that the timelines listed on the Office of Management and Budget’s website “are estimates and often change.”

Smokeless alternatives

The FDA’s current approach to e-cigarettes and other smokeless alternatives is also complicating the issue. To date, the FDA has not authorized any menthol vaping product, and has authorized just 16 total products from four manufacturers of products deemed to be less risky.

On April 11, former FDA heads Gottlieb and Mark McClellan published an op-ed calling for the FDA to make “modified risk” products a “renewed part of the US public health agenda.”

Sweanor pointed to Japan, where cigarette demand fell by more than half between 2010 and 2022, according to the Foundation for a Smoke-Free World, coinciding with the introduction of a heated tobacco product.

“There’s this tendency of people choosing to do things that are really dramatic,” he said, “rather than doing things that are really effective.”

The more dramatic proposals inevitably attract the strongest opposition. FDA Commissioner Robert Califf weathered backlash on tobacco and other issues from the House Oversight and Accountability Committee for more than four hours earlier this month.

“I would argue it is far better to get people to change behavior by informing them of the consequences of said behavior,” Florida Republican Byron Donalds told Califf, “as opposed to putting up arbitrary rules from the FDA or anywhere else.”

House Republicans also attempted to prohibit the FDA from banning menthol and flavored cigars in the most recent appropriations debate, although the language was eventually dropped.

“I think one of the really critical things for getting effective policy through on public health in the states is how do you keep it outside of a culture war?” Sweanor said. “And I’m not sure if that’s even possible.”

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