Decades of dallying led to current delay on menthol ban

WASHINGTON — The Biden administration’s delay in finalizing a ban on menthol cigarettes is the result of decades of resistance, delays and industry lobbying, according to former officials and public health advocates.

The White House blew past a self-imposed deadline to finalize the proposal in March after missing a previous deadline in August. Advocates now worry the proposal is shelved amid President Joe Biden’s tough reelection fight against former President Donald Trump.

The Food and Drug Administration has contemplated banning menthol cigarettes since as early as 2013, but concerns around potential heavier policing on menthol smokers, particularly Black smokers, and the opportunity for a new illicit menthol market have so far foiled the proposal.

Plus, menthols are popular, especially with Black smokers. The FDA estimated that 18.5 million people smoked menthol cigarettes in 2019. In 2020, 81 percent of Black smokers used menthols, compared with 34 percent of white smokers.

“I agree that at this point, the only holdup could be the politics,” said former FDA Center for Tobacco Products Director Mitch Zeller, who now sits on the board of nicotine-replacement therapy maker Qnovia. Zeller led the FDA’s tobacco center from March 2013 to April 2022.

The potential political fallout is fueling speculation that the proposal will be delayed again, at least until after the presidential election in November. But that risks exposing the rule to a repeal from congressional Republicans should they win control of Washington.

The delay has frustrated advocates who fear the political ramifications could worsen as time goes on.

“If they hit that earlier deadline, any furor over it would have faded by now,” said Eric Lindblom, a senior scholar at the Georgetown University O’Neill Institute and former head of the FDA’s tobacco policy office from January 2011 to November 2016.

The White House has not commented on the rule.

Tobacco has long been a political flash point. Congress wasn’t able to enact a 2009 ban on flavored cigarettes until years after anti-nicotine advocate Campaign for Tobacco-Free Kids and tobacco industry giant Altria struck a deal — and the law ultimately omitted menthol.

“There’s been nobody in the White House — under Biden or under Obama, and certainly not Trump — who was interested in helping FDA get that clearance through,” Lindblom said.

Banning menthol would likely only please voters who will vote for Biden anyway, said David Sweanor, an adjunct professor at the University of Ottawa and a longtime anti-smoking advocate in both the U.S. and Canada.

“How many swing voters or potential nonvoters are going to be influenced by anything that we do?” he said of the likely thought process. “And do we risk losing Georgia?”

Polling from CTFK shows Biden maintaining a 2-point lead with voters regardless of whether he finalizes the menthol ban. But polling commissioned by Altria shows a majority of Biden’s core demographic opposed to the menthol and flavored cigar bans.

Regardless, public health advocates say the industry is stoking unnecessary fears while the media are fanning the flames.

“What’s important to the White House, what’s important and the obstacle I think right now is, how is the media coverage about this?” Lindblom said.

Black leadership divide

The issue has split civil rights and Black interest groups, with organizations like Rev. Al Sharpton’s National Action Network and the National Organization of Black Law Enforcement Executives calling on the FDA to nix the proposal.

But others are pressuring the FDA to forge ahead, including the African American Tobacco Control Leadership Council, which recently filed a lawsuit to force the FDA to finalize the rule. Supporters of the ban dismiss critics’ concerns, pointing in part to the industry money and other associations that tie groups like NOBLE and NAN to tobacco companies.

Advocates also note that the ban impacts only retailers, not individual smokers. But law enforcement groups argue they’re responsible for enforcing state laws against untaxed cigarettes, which is what menthols will become if they’re banned.

The divide exists among Black lawmakers as well.

Only around half of the Congressional Black Caucus signed on to a 2022 letter supporting the ban organized by Rep. Robin Kelly, D-Ill., although she projects support has grown with the recent elections of younger members.

Kelly recalled working in her grandparents’ Harlem, N.Y., grocery store as a child, where menthols like Salem, Kool and Newport were the most popular cigarettes.

“When I was in college, my friend at the time made a comment about, ‘Man, if Black people didn’t smoke these cigarettes, they wouldn’t be in business,’” Kelly remembered, referring to tobacco companies. “And I said, ‘Oh no, that can’t be true. That can’t be true.’

“So it’s so interesting, many years later, to come to Congress and find out that the Black community was targeted.”

ITG Brands, R.J. Reynolds and Altria, the makers of Salem and Kool, Newport and Marlboro, respectively, did not respond to the allegations of racial targeting.

“Reynolds has been clear on our position regarding banning menthol cigarettes — we strongly believe there are more effective ways to transition adult smokers away from cigarettes permanently,” a Reynolds spokesperson said, pointing to e-cigarettes.

Initiatives abandoned

Before Biden, Trump’s FDA Commissioner Scott Gottlieb proposed banning menthol cigarettes and flavored cigars in 2018. The idea stalled amid backlash, but Gottlieb believed the products’ days were ultimately numbered.

“Once we crossed the threshold and announced that policy, especially in a Republican administration, I was pretty confident that eventually it would get put in place,” he told Axios in 2021.

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.”