FDA Authorizes First Menthol Vapor Products
SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) has given the go-ahead for four menthol vapor products to be marketed in the United States. It is the first time the agency has issued marketing granted orders for nontobacco flavored vapor products through the premarket tobacco application (PMTA) pathway.
According to the FDA, the decision to authorize NJOY LLC for four menthol-flavored e-cigarette products followed "an extensive scientific review." The PMTAs were for NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 6%.
The two authorized ACE products are sealed, prefilled, nonrefillable pods that are used with the previously authorized ACE device, and the two authorized DAILY products are disposable e-cigarettes with a prefilled, nonrefillable e-liquid reservoir.
Though it is the first-of-it's-kind decision by the FDA, the agency stressed each application is reviewed on a case-by-case basis and the actions are specific to these four products only — the authorizations do not apply to any other menthol-flavored e-cigarette products.
[Read more: NJOY Seeks FDA Approval for Access-Restricted Vapor Product]
"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 evaluates PMTAs based on a public health standard that considers, among other things, the risks and benefits of the product to the population as a whole. After reviewing the company's applications, 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, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
Specifically, the FDA said, evidence submitted by the applicant showed that these menthol-flavored products provided a benefit for adults who smoke cigarettes relative to that of the applicant's previously authorized tobacco-flavored products — in terms of complete switching — that is sufficient to outweigh the risks of the product, including youth appeal.
"We are a data driven agency and will continue to follow the science to inform our review of premarket tobacco applications," said Matthew Farrelly, director of the Office of Science in the FDA's Center for Tobacco Products. "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."
NJOY is a wholly owned subsidiary of Richmond, Va.-based Altria Group Inc., and its products are distributed by Altria Group Distribution Co. Other Altria subsidiaries include Philip Morris USA Inc., John Middleton Co., U.S. Smokeless Tobacco Co. and Helix Innovations.