For the first time, the Food and Drug Administration will allow the marketing of non-tobacco flavored e-cigarettes, stating that the benefits outweigh the risks of the newly approved products.
The FDA granted authorization on Friday to Njoy for four menthol-flavored e-cigarette products. Njoy is a subsidiary of tobacco company Altria. This move comes as the FDA considers banning traditional menthol cigarettes and flavored cigars.
The FDA has explained that flavors are added to tobacco products to enhance taste by reducing harshness, bitterness, and astringency.
Applications are reviewed on a case-by-case basis, and in Njoy’s case, the FDA found enough evidence to support marketing authorization for the protection of public health. The approval is aimed at decreasing the number of people smoking 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,” stated 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 stressed that the authorization does not mean these products are safe or “FDA approved.” Monitoring will occur, and authorization could be revoked if there is a significant increase in youth or former smokers using the products.
The impact of this authorization on menthol cigarette smokers and vaping concerns remains to be seen. A study from the University of Pittsburgh suggested that adding menthol flavoring may produce more vapor particles and harm lung function.
“The main message that we want to put out there is for people, especially young adults, who haven’t smoked before,” said Kambez H. Benam, associate professor at the University of Pittsburgh School of Medicine. “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 expressed disapproval of the FDA’s decision on Friday.
“FDA’s decision to authorize four menthol flavored e-cigarettes – including two with nicotine levels higher than a pack of cigarettes – is highly questionable and deeply troubling,” stated 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 for the removal of all flavored tobacco products from the market.”
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