In June of 2020, two leading public health organizations sued the U.S. Food and Drug Administration (FDA) for its inaction on removing menthol from cigarettes. The African American Tobacco Control Leadership Council and Action on Smoking and Health (“the plaintiffs”), later joined by other public health groups, filed a lawsuit in federal court seeking – among other things – to compel the FDA to act on a citizen petition filed by the Public Health Law Center and partners in 2013, which called on the FDA to prohibit menthol in cigarettes. Finally, in response to that litigation, the FDA notified the plaintiffs that it would respond to the 2013 citizen petition by January 29, 2021.

On January 12, 2021, just weeks before the FDA’s deadline, the Public Health Law Center and twenty-two public health partners supplemented the 2013 citizen petition with seventy-eight additional studies supporting a ban on menthol in cigarettes for “the protection of public health.” The FDA sought a ninety-day extension to consider the new evidence submitted by the Center and its partners.

On April 29, 2021 the FDA finally granted PHLC’s petition and said it would start the rulemaking process to removing menthol from commercial tobacco products.  However to date, the FDA has refused to commit to a specific timeline as to when this will happen. In fact, the FDA has asked the court with jurisdiction over a lawsuit in the case to dismiss the matter outright. Nevertheless, the plaintiffs have filed an additional complaint with the court asking it to retain jurisdiction of the case in order to hold the FDA’s feet to the fire. A hearing on the motion is scheduled for September 16, 2021.

Before the lawsuit, the FDA had been sitting on the citizen petition for seven years. The 2013 petition was filed two years after the FDA’s independent advisory committee concluded that there is overwhelming scientific evidence showing the catastrophic health effects of menthol -- the same conclusion reached by the FDA’s own scientists.

The 2009 Family Smoking Prevention and Tobacco Control Act gave the FDA authority to regulate tobacco products. Congress gave the FDA this unprecedented power to regulate the tobacco industry because it wanted the agency to use this power to protect public health. At the same time, the Tobacco Control Act banned all characterizing flavors in cigarettes except menthol.

With the Act, Congress asked the FDA to study menthol and take appropriate action for the protection of public health. Exempting menthol from the flavored cigarette regulation was a terrible move for public health. Menthol cigarettes make it easier to start smoking, deepen addiction, and make it harder to quit. Big Tobacco targets the marketing of menthol cigarettes to kids, African Americans, and the LGBTQ community, making it a core driver of smoking-related health disparities.

The FDA promptly set up the Tobacco Products Scientific Advisory Committee (“TPSAC”) to review the scientific evidence on menthol and hear testimony from researchers, public health advocates, and the tobacco industry for almost two years.

In July 2011, TPSAC reached conclusions that were not surprising, but no less devastating: (1) menthol cigarettes have an adverse impact on public health in the United States; (2) menthol cigarettes offer no public health benefits, compared to non-menthol cigarettes; and (3) menthol cigarettes increase the likelihood of addiction. TPSAC estimated that by 2020, 17,000 more premature deaths will occur and approximately 2.3 million more people will have started smoking, solely because of the availability of menthol cigarettes. Most striking was TPSAC’s finding that “the availability of menthol cigarettes results in a lower likelihood of smoking cessation success in African-Americans, compared to smoking non-menthol cigarettes.” In sum, the TPSAC concluded that “[r]emoval of menthol cigarettes from the marketplace would benefit public health in the United States.”

By Mike Merissa, Staff Attorney
July 28, 2021