Public Health

After false start, FDA drags its feet on menthol cigarette ban

Tanya Albert Henry , Contributing News Writer

In 2009, Food and Drug Administration (FDA) officials said they had to do their own investigation into how menthol cigarettes may be harming the public’s health, despite Congress’ having already done research and consequently instructing the agency to address the issue “quickly.”

After a decade had gone by with no final action, the AMA and National Medical Association joined the African American Tobacco Control Leadership Council, and Action on Smoking and Health in suing the FDA (PDF) in 2020 to prompt them to issue a final rule banning menthol cigarettes.

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In 2021, the FDA finally agreed to ban menthol cigarettes. The AMA and others dropped their lawsuit the following year, under the impression that the FDA was going to act within a year, with the FDA saying it would make enactment of the final rule “one of the agency’s highest priorities.”

But an FDA deadline last summer went by. Then another deadline passed around year’s end. The FDA then delayed its rule until this March. That day came and went with nothing.

So now the AMA has joined the other organizations in again suing the U.S. Department of Health and Human Services (HHS), the FDA and the Center for Tobacco Products. They are asking a federal court in California to direct the agencies to promulgate the proposed regulation that would ban menthol cigarettes, publish in the Federal Register why this is appropriate to protect public health, and do these things in a reasonable timeframe.

“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. Given defendants’ seeming inability to act on this issue without prompting from this court, the plaintiffs respectfully request this court’s intervention yet again,” says the lawsuit the AMA and others filed, African American Tobacco Control Leadership Council et al. v. HHS et al.

“We are disappointed that the FDA has yet to implement a rule banning menthol-flavored cigarettes,” said AMA Immediate Past President Jesse M. Ehrenfeld, MD, MPH. “We strongly urge the FDA to take immediate action to remove these harmful products from the market and keep them out of the hands of our nation’s youth. Delaying the rule any further will only help tobacco companies continue marketing menthol cigarettes to Black people and harming Black youth.”

Two days after the AMA and others filed the lawsuit, HHS Secretary Xavier Becerra said the “rule has garnered historic attention and the public comment period has yielded an immense amount of feedback, including from various elements of the civil rights and criminal justice movement. It’s clear that there are still more conversations to have and that will take significantly more time.”

But the lawsuit tells the court that the FDA has already published its notice of the proposed rule, closed the comment period in August 2022 and determined since April 2021 that banning menthol cigarettes is “appropriate for the protection of public health.”

Every delay means more lives lost

Congress passed and President Barack Obama signed the Tobacco Control Act in 2009, banning all cigarette flavoring except menthol and tobacco. However, the 2009 law authorized the FDA to ban menthol favoring if the prohibition would be “appropriate for public health.”

The AMA adopted policy that opposed exempting menthol from the tobacco-flavor ban.

A 2011 report from the FDA found, among other things, that there was evidence that the availability of menthol cigarettes increases experimentation and smoking, increases addiction in youth smokers and lowers the likelihood of smoking cessation in Black Americans when compared to smoking non-menthol cigarettes.

The FDA’s 2022 proposed rule notes that tobacco-company marketing targeted historically marginalized Black communities and Black teens with discount offers, free samples, advertising in nightclubs and bars and lower-cost packages that contain fewer cigarettes to “encourage trial and initiation.” And the FDA projects a 15.1% drop in smoking within 40 years if the sale of menthol-flavored cigarettes is banned. That would help save hundreds of thousands of lives, with estimates ranging from 324,000 to 654,000 lives. It also predicts up to 6,000 Black lives would be saved annually.

Tobacco is the leading cause of preventable death worldwide. Smoking-related illnesses are the leading causes of death among Black people, and 85% of African Americans who smoke use menthol cigarettes.

“We are extremely disappointed at this decision to delay the ban on menthol cigarettes yet again,” said Yolanda Lawson, MD, the National Medical Association’s president. “This ban has the potential to extend and save the lives of many people and the delay shows a tremendous disregard for public health. The marketing of menthol cigarettes continues to have a devastating impact on Black and Hispanic communities.”

The lawsuit tells the court its “help is needed. Defendants’ inaction continues to harm the public health. And the defendants have repeatedly shown that they are unable to act on the issue of menthol in cigarettes without judicial intervention.”