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 giant Altria. This authorization comes as the FDA has been contemplating a ban on 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.
The agency conducts a thorough review of applications on a case-by-case basis. In the case of Njoy’s application, the FDA found “sufficient evidence to prove that allowing the marketing of the products would be beneficial for public health.” The approval aims to decrease the number of individuals smoking traditional cigarettes.
“It is the applicant’s responsibility to present the necessary evidence for marketing authorization, and the FDA has clearly outlined the requirements for a successful outcome,” stated Brian King, director of the FDA’s Center for Tobacco Products. “This decision reinforces that authorization of an e-cigarette product is feasible when substantial scientific evidence is provided to the agency to support it.”
The FDA clarified that this authorization does not imply that the products are safe or “FDA approved.” The agency will closely monitor data and may revoke the authorization if a notable increase in product usage among youth or former smokers is observed.
It remains to be seen whether this authorization will reduce the number of menthol cigarette users or potentially increase vaping. There are also concerns that adding menthol flavoring can produce more vapor particles and have negative implications for lung function, as highlighted in a study from the University of Pittsburgh.
The American Lung Association expressed disapproval of the FDA’s decision, emphasizing the need to remove all flavored tobacco products from the market.
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