Authorization Includes Restrictions to Mitigate Youth Risk
Following an extensive scientific review, the U.S. Food and Drug Administration today authorized the marketing of four e-cigarette products in the United States through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to NJOY LLC for four menthol-flavored e-cigarette products – 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, pre-filled, non-refillable pods that are used with the previously authorized ACE device, and the two authorized DAILY products are disposable e-cigarettes with a prefilled, non-refillable e-liquid reservoir.
Today’s authorizations mark the first non-tobacco flavored e-cigarette products to be authorized by the FDA. Importantly, each application is reviewed on a case-by-case basis and today’s actions are specific to these four products only – the authorizations do not apply to any other menthol-flavored e-cigarette products. To legally market a new tobacco product in the U.S., a company must receive a written marketing order from the FDA. While this action permits these specific tobacco products to be legally marketed in the U.S., it does not mean these tobacco products are safe nor are they “FDA approved.” All tobacco products are harmful and potentially addictive. Those who do not use tobacco products shouldn’t start.
“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, Ph.D., M.P.H., 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, 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, Ph.D., 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."
The FDA remains concerned about the risk of youth use of all e-cigarettes – particularly flavored products that are more appealing to youth. Like previously authorized products, the FDA has placed stringent marketing restrictions on the new products in an effort to prevent youth access and exposure. The FDA will closely monitor how these products are marketed and will act as appropriate if the company fails to comply with any applicable statutory or regulatory requirements. The agency may suspend or withdraw authorization if the agency determines that continued marketing is no longer appropriate for the protection of the public health, including if there is a notable increase in use of the products among youth or former smokers, or a decrease in the number of current smokers who completely switch to the products.
Today’s actions are among many the FDA has taken to ensure all new tobacco products that are marketed in the U.S. undergo science-based review and have received marketing authorizations by the agency. The FDA has received applications for nearly 27 million deemed products and has made determinations on more than 26 million of these applications. To date, the FDA has authorized 27 tobacco- and menthol-flavored e-cigarette products and devices, including the four authorized today. The agency maintains a printable one-page flyer of all authorized e-cigarette products; these are the only e-cigarette products that currently may be lawfully marketed and sold in the U.S. and those manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization risk enforcement. Those seeking a list of tobacco products—including e-cigarettes—that may be legally marketed in the United States, can visit the FDA’s new Searchable Tobacco Products Database.
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