The White House has missed its own deadline to publish a rule banning menthol cigarettes, raising ire among public health advocates that the policy will be indefinitely delayed by election year politics.
In an effort to force the administration to act, three anti-tobacco public health groups on Tuesday sued the Food and Drug Administration and its parent agency the Department of Health and Human Services.
“Because of Defendants’ inaction, tobacco companies have continued to use menthol cigarettes to target youth, women, and the Black community — all to the detriment of public health,” the groups said in their complaint, which was filed in the Northern District of California.
Health officials initially targeted last August to publish the rule to ban menthol. But at the end of last year, the Biden administration delayed the ban until March 2024, after fierce lobbying from critics — including the tobacco industry — seemingly spooked the White House that such a move could anger Black smokers and harm President Biden’s reelection chances.
“There is absolutely no reason to further delay a policy that has been studied for more than 12 years, is supported by overwhelming scientific evidence, and will save hundreds of thousands of lives. Make no mistake: delays cost lives, especially Black lives,” Yolonda Richardson, president and CEO, of the Campaign for Tobacco-Free Kids, said in a joint statement with Derrick Johnson, president and CEO of the NAACP.
Public health advocates say the ban would reinforce the administration’s commitment to health equity and Biden’s Cancer Moonshot initiative.
“I think that the president is walking backwards from his promise to always follow the science,” said Erika Sward, an assistant vice president at the National Lung Association. “I cannot think of a public health issue or a health issue that has more repercussions and more significance than tobacco.”
The March deadline was a regulatory one rather than legislative or legal, which experts said means there’s no real pressure on the administration to act right away.
The Office of Management and Budget (OMB) has been holding meetings with stakeholders for months, including tobacco industry lobbyists, public health advocates, industry-adjacent organizations, and civil rights groups.
There is one more meeting regarding the rule on the OMB public calendar, scheduled with lobbying firm Forbes Tate Partners on April 2. Forbes Tate counts tobacco industry giant Altria among its clients.
OMB declined to comment on a rule that’s still under review.
Carol McGruder, a co-chair of the African American Tobacco Control Leadership, one of the groups that’s a party to the lawsuit, said it’s aimed at letting the administration know that tobacco companies are not the only voices.
“We want the Biden administration to know, we want our people to know, that we are continuing to move forward. We’re here. We’re not going anywhere, and we will be vigilant to keep it moving until we get a rule passed,” McGruder said.
A potential ban on menthol cigarettes has been discussed across multiple administrations for more than a decade.
Congress banned flavored cigarettes as part of the 2009 law giving the FDA authority to regulate tobacco products, but a loophole exempted menthol. It was left up to the FDA to make a further decision.
The same three groups first sued the agency over menthol in 2020, saying FDA had “unreasonably delayed” action on a ban. The lawsuit specifically asked the court to compel the FDA to decide whether to add menthol to the list of prohibited flavors.
The groups voluntarily dismissed the lawsuit when the FDA finally proposed a rule in 2022, which estimated that banning menthol could prevent 300,000 to 650,000 smoking deaths over several decades, mostly among Black Americans.
Public health groups were optimistic, but kept their options open.
“It had been 12 years since the FDA was supposed to take action on menthol. So we were cognizant that just because the FDA said they do it … that wouldn’t necessarily mean we would get a rule that could actually ban menthol from the market. So, we left it in such a way that we could refile a new lawsuit on the same lines,” said Chris Bostic, policy director for Action on Smoking and Health.
When the March deadline passed, the groups decided they needed to act.
“We’re extremely disappointed to be forced to file this second lawsuit against the FDA in support of protecting Americans from menthol cigarettes,” ASH Executive Director Laurent Huber said in a statement. “The FDA’s own research confirms that a menthol ban would save lives; there is no scientific reason to delay finalizing this rule.”
The complaint said FDA and HHS have known menthol’s risks since 2011 but have refused to act, engaging “in a series of half-measures, doublespeak, and foot-dragging.”
Opponents of the ban have argued it will expand an illicit, unregulated marketplace of menthol cigarettes and will lead to more over-policing in communities of color, similar to the war on drugs campaign of the 1980s and 1990s.
But the policy would only apply to companies that manufacture, distribute or sell menthol cigarettes, not individuals who possess or use them.
If the White House decides to wait until after the election, advocates are concerned that a potential GOP-controlled Congress and second Trump administration could undo the rules through the Congressional Review Act.
The law allows Congress to overturn agency rules within 60 congressional session days of when a regulation is finalized.
But anti-tobacco advocates don’t want it to get that far.
“It is very rare that the president on his own, without Congress, without having to maneuver through any sort of legislative process, can do something that’s going to save hundreds of thousands of lives and prevent another generation from becoming addicted to tobacco products. But that’s where we are,” National Lung Association’s Sward said.
