For the first time, the Food and Drug Administration will allow for the marketing of non-tobacco flavored e-cigarettes, saying the benefits outweigh the dangers of the newly approved products.
The FDA gave its authorization on Friday to Njoy for four menthol-flavored e-cigarette products. Njoy is owned by tobacco giant Altria. The authorization comes as the FDA has considered a ban on the sale of traditional menthol cigarettes and flavored cigars.
The FDA has said the flavors are added to tobacco products to improve taste by reducing the harshness, bitterness and astringency.
The agency said that it reviews applications on a case-by-case basis and with Njoy's application, the FDA determined there was "sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health." The approval was made in hopes of reducing the number of people who smoke traditional cigarettes.
“It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization, and the FDA has made clear what’s needed to successfully achieve that outcome,” said Brian King, director of the FDA’s Center for Tobacco Products. “This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.”
The FDA added that the authorization should not be interpreted that these products are safe nor are they “FDA approved.”
The agency said it would closely review data and could suspend its authorization if a notable increase in the use of the products among youth or former smokers is measured.
Whether this authorization reduces the number of smokers who use menthol cigarettes remains to be seen. Plus, there remain concerns that it could lead to an increase in vaping.
Last year, the University of Pittsburgh released findings that indicated adding menthol flavoring produces more vapor particles and is associated with worse lung function.
“The main message that we want to put out there is for people, especially young adults, who haven’t smoked before,” Kambez H. Benam, associate professor at the University of Pittsburgh School of Medicine, said in a press release. “Switching to e-cigarettes may be a better, safer alternative for someone who is trying to quit smoking regular tobacco products. But it’s important to have full knowledge of e-cigarettes’ risks and benefits before trying them.”
The American Lung Association announced its disapproval of the FDA's decision on Friday.
"FDA's decision to authorize four menthol flavored e-cigarettes - including two that have nicotine levels higher than a pack of cigarettes - is highly questionable and deeply troubling," said Harold Wimmer, President and CEO of the American Lung Association. "The tobacco industry has been using menthol and other flavors to attract kids for decades - this opens up a legal pathway for NJOY to market their highly addictive products. The American Lung Association continues to call on the removal of all flavored tobacco products from the market."
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