Public health groups have filed a second lawsuit against U.S. regulators for failing to follow through on plans to ban menthol-flavored tobacco products.
The lawsuit, filed Tuesday in federal court in Northern California, alleges the Food and Drug Administration unreasonably and illegally delayed lifesaving regulations. The agency has repeatedly missed deadlines for implementing menthol measures, the most recent of which ended at the end of March.
“If past practices are any indication of future performance, they will bristling again,” said Philip Gardiner, co-president of the African American Tobacco Control Leadership Council, one of the groups filing the lawsuit. It's going to happen,” he said.
Between 1980 and 2018, more than 10 million Americans started smoking because of menthol cigarettes, and about 378,000 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 such as jazz concerts. Approximately 40% of excess deaths from menthol cigarette smoking in the United States were among African Americans.
Menthol helps make nicotine addictive due to its cooling and throat-soothing effects. According to the CDC, sales of menthol-flavored cigarettes accounted for 37% of all cigarette sales in the United States in 2021.
All cigarette flavors other than menthol were banned under a 2009 law that gave the FDA authority to regulate tobacco products. At the time, the agency was instructed to consider whether menthol cigarettes posed a higher health risk than regular cigarettes. The review was initially expected to take just a few years.
Public health groups previously sued the FDA over its failure to act in 2020. The lawsuit was dismissed in April 2022 when the FDA released two draft proposals to end the sale of menthol cigarettes and flavored cigars.
The agency had set a deadline to publish a final ruling on menthol by August 2023, but that was postponed to December and then to March 2024.
“The FDA has really run out of procedural reasons not to pass a rule,” said Kelsey Romeo Stappy, lead attorney for Action on Smoking and Health, one of the other groups suing. he said.
The agency's lack of action on menthol follows a pattern of slow response times when public health is at risk, such as the opioid crisis or contaminated infant formula, the complaint says.
For Altria Group, which sells Marlboro cigarettes in the U.S., a menthol ban would “pose a significant risk” to its earnings and dividend, CFRA Research analyst Garrett Nelson said in a note earlier this year.
Menthol has been banned in the EU since 2020 and in Canada since 2017, and cigarette companies around the world are reducing the number of places they sell it. California, Massachusetts and dozens of U.S. counties have also imposed local bans.
The case is African American Tobacco Control Leadership Council v. U.S. Department of Health and Human Services, 4:24-cv-01992, U.S. District Court for the Northern District of California.
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