FDA authorizes non-tobacco flavored e-cigarette products for the first time

Key takeaways:

• Although the products can now be legally marketed, the FDA warned that it does not mean they are safe.
• The authorization includes marketing restrictions to prevent risks to youth.

After “an extensive scientific review,” the FDA announced that it has authorized the marketing of four menthol-flavored e-cigarette products through its premarket tobacco product application pathway.

The four products are manufactured by NJOY. They are the NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5% and NJOY DAILY EXTRA Menthol 6%.

The two ACE products are nonrefillable pods that can be used with a previously authorized ACE device, and the two DAILY products are disposable e-cigarettes that come with a nonrefillable e-liquid reservoir, according to an FDA press release.

This is the first time the FDA has authorized non-tobacco flavored e-cigarette products, the agency said. Although these products can now be legally marketed, the FDA warned that “it does not mean these tobacco products are safe.”

When examining premarket tobacco product applications, the FDA said it considers the risks and benefits of the product to the general population. After reviewing NJOY’s applications, the FDA determined that the benefits of these products for adults who want to switch from tobacco products outweigh the risks, “including youth appeal,” the release said.

“We are a data-driven agency and will continue to follow the science to inform our review of premarket tobacco applications,” Matthew Farrelly, PhD, the director of the Office of Science in the FDA’s Center for Tobacco Products, said in the release. “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."

Still, the FDA said it “remains concerned about the risk of youth use of all e-cigarettes — particularly flavored products that are more appealing to youth.” Therefore, the authorization includes restrictions to prevent youth exposure and access, according to the release. If the FDA identifies “a notable increase” in the use of these products among children, adolescents or former smokers, the agency said it may suspend or withdraw its authorization.

Earlier this month, the FDA reversed its marketing denial orders on Juul vaping devices, in part because of new case law and further review, the agency said. At the time, the FDA stressed that the reversal was not an authorization, and e-cigarette products can only be legally marketed if they receive FDA authorization.