The U.S. Food and Drug Administration has authorized the marketing of four menthol-flavored e-cigarette products through the premarket tobacco product application (PMTA) pathway: NJOY Ace Pod Menthol 2.4%, NJOY Ace Pod Menthol 5%, NJOY Daily Menthol 4.5% and NJOY Daily Extra Menthol 6%. The authorizations mark the first non-tobacco flavored e-cigarette products to be authorized by the FDA.

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.

“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 United States, 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 United States, it does not mean these tobacco products are safe nor are they ‘FDA approved,’” said the FDA’s Center for Tobacco Products in a statement.

The approval comes on the heels of a Senate Judiciary Committee oversight hearing, “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes,” during which Senators were critical of the regulatory oversight and approval process for these products. NACS sent a letter to the committee on behalf of the industry, advocating for enhanced enforcement of illegal e-cigarette sales and more clarity from FDA regarding what retailers can and cannot sell. Read the letter here.

To date, the FDA has authorized 27 tobacco- and menthol-flavored e-cigarette products and devices, including the newly authorized four NJOY products. Further information on tobacco products that may be legally marketed in the United States is available in FDA’s Searchable Tobacco Products Database.

As of April 2024, FDA has issued approximately 670 warning letters to firms for manufacturing and/or distributing illegal e-cigarette products and issued more than 550 warning letters to retailers for the sale of unauthorized e-cigarettes. The agency has also filed civil money penalty complaints against more than 50 e-cigarette manufacturers and more than 100 retailers for manufacture and/or sale of unauthorized new tobacco products, as well as complaints for permanent injunction against seven e-cigarette manufacturers.