The Food and Drug Administration said Friday that it had approved the first menthol-flavored e-cigarettes in the United States, less than two months after the Biden administration delayed a fiercely contested decision on whether to ban traditional menthol cigarettes.
The FDA said it had authorized four types of menthol-flavored e-cigarettes made by NJOY, part of tobacco company Altria, making them the first flavored e-cigarettes that can be sold legally in the United States. The FDA said that evidence indicated that they could benefit adult smokers who want to transition to a “less harmful product.”
Public health groups sharply criticized the decision, warning that e-cigarettes and flavored tobacco products were especially appealing to young people.
The Campaign for Tobacco-Free Kids pointed out that, according to the 2023 National Youth Tobacco Survey, nearly one-fourth of high school students who use e-cigarettes use illicit menthol-flavored varieties, which are often easy to find in gas stations and corner stores.
“Today’s decision is hard to understand in light of the FDA’s own repeated conclusions that flavored e-cigarettes, including menthol-flavored products, appeal to kids and have fueled the youth e-cigarette epidemic,” Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said in a statement. “What has changed?”
Harold Wimmer, president and CEO of the American Lung Association, called the FDA’s decision “highly questionable and deeply troubling,” and said two of the menthol-flavored e-cigarettes that the agency had authorized had “nicotine levels higher than a pack of cigarettes.”
“The tobacco industry has been using menthol and other flavors to attract kids for decades,” Wimmer said in a statement. “This opens up a legal pathway for NJOY to market their highly addictive products.”
The FDA said its decision does not mean the menthol e-cigarettes “are safe,” and it noted that all tobacco products are harmful and potentially addictive. The FDA said it also remained concerned that e-cigarettes and flavored tobacco products pose a particular risk to young people.
But the agency said evidence indicated that the four menthol-flavored e-cigarettes it had authorized could have some benefits for adult smokers.
“Based upon our rigorous scientific review, in this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth,” Matthew Farrelly, director of the Office of Science in the Center for Tobacco Products at the FDA, said in a statement.
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