Public Health Groups Sue FDA Again Over Delayed Menthol Ban

April 3, 2024 by and

Public health groups sued US regulators a second time for failing to follow through on a plan to ban menthol-flavored tobacco products.

The lawsuit filed Tuesday in a federal court in Northern California claims that the Food and Drug Administration has unreasonably and unlawfully delayed regulations that would save lives. The agency has repeatedly missed deadlines to take action on menthol, the latest of which came and went at the end of March.

“If past practice is any indication of future performance, they’re going to sit on their hands again,” said Phillip Gardiner, co-chair of the African American Tobacco Control Leadership Council, one of the groups that is suing.

More than 10 million Americans started smoking because of menthol cigarettes between 1980 and 2018, and around 378,000 people died prematurely, according to the Centers for Disease Control and Prevention. Menthol is especially popular among Black smokers due to tobacco companies’ aggressive marketing in Black neighborhoods and sponsorship of events like jazz concerts. Roughly 40% of excess deaths due to menthol cigarette smoking in the US were African Americans.

Menthol helps to make nicotine addictive due to its cooling and throat-soothing effects. In 2021, sales of menthol-flavored cigarettes made up 37% of all cigarette sales in the US, according to the CDC.

All cigarette flavors other than menthol were banned under a 2009 law that gave the FDA power to regulate tobacco products. The agency was instructed at the time to review whether menthol cigarettes were more of a health risk than regular cigarettes. That review was originally expected to take just a few years.

Public health groups had previously sued the FDA in 2020 over its lack of action. The lawsuit was dismissed when the FDA announced two draft proposals in April 2022 to end the sale of menthol cigarettes and flavored cigars.

The agency set a deadline for publishing its final ruling on menthol by August 2023. That was delayed in December and then rescheduled for March 2024.

“The FDA really has run out of procedural reasons not to pass a rule,” said Kelsey Romeo-Stuppy, managing attorney with Action on Smoking and Health, another one of the groups that is suing.

The lawsuit says the agency’s lack of action on menthol fits a pattern of being slow to act even when public health is at risk, including in the opioid crisis and with contaminated baby formula.

For Altria Group Inc., which sells Marlboro cigarettes in the US., a menthol ban would “present a major risk” to its earnings and dividend, Garrett Nelson, an analyst at CFRA Research, said in a note earlier this year.

Cigarette companies globally are finding fewer places to sell menthol, which has been banned in the EU since 2020 and in Canada since 2017. California, Massachusetts and dozens of US counties have also imposed local bans.

The case is African American Tobacco Control Leadership Council vs. US Department of Health and Human Services, 4:24-cv-01992, US District Court, Northern District of California.