The U.S. Food and Drug Administration (FDA) gave marketing granted orders for four 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 authorization arrived through the premarket tobacco product application (PMTA) pathway.
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 pre-filled, non-refillable e-liquid reservoir.
Today’s authorizations mark the first non-tobacco flavored e-cigarette products to be authorized by the FDA. However, the authorizations do not apply to any other menthol-flavored e-cigarette products.
“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.”
“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 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.
Previously, the FDA had only authorized 23 tobacco-flavored e-cigarettes, making these approved menthol-flavored products a significant step in the FDA approval process. Prior to this, the FDA had most recently issued marketing denial orders for 65 disposable e-cigarettes to Shenzhen Yibo Technology Co. Ltd.
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.
