First Nontobacco Flavored E-Cigarette Products Authorized by the FDA

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The FDA has authorized the marketing of 4 menthol-flavored e-cigarette products in the United States through the premarket tobacco product application pathway.

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The US Food and Drug Administration (FDA) authorized the marketing of 4 menthol-flavored e-cigarette products in the United States through the premarket tobacco product application (PMTA) pathway. These are the first nontobacco flavored e-cigarette products authorized by the FDA.1

“It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization, and the FDA has made clear what is needed to successfully achieve that outcome,” said Brian King, PhD, MPH., 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 issued marketing granted orders to NJOY LLC for their products NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 6%. The 2 authorized ACE products are sealed, prefilled, nonrefillable pods that are used with the previously authorized ACE device. The 2 authorized DAILY products are disposable e-cigarettes with a prefilled, nonrefillable e-liquid reservoir.

After reviewing the applications, the FDA determined there was sufficient evidence to demonstrate that permitting marketing of the products would protect public health. Specifically, the evidence showed that the menthol-flavored products benefitted adults who smoke cigarettes if they completely switched to them rather than the previously authorized tobacco-flavored products. Benefits outweigh the risks of the products, including youth appeal, said the FDA.

“We are a data driven agency and will continue to follow the science to inform our review of premarket tobacco applications,” said Matthew Farrelly, PhD, 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.”

According to research, curiosity is the most common reason for vaping among youth.2 Vaping may bring social benefit, like when friends use what their friends use.3 Furthermore, as vaping products are available online and in neighborhood stores, they may be perceived as both fashionable and convenient.2

The FDA shared that they remain concerned about the risk of youth using any and all e-cigarettes—particularly flavored products that are more appealing. The new products will have stringent marketing restrictions to help prevent youth access and exposure, and the FDA will closely monitor to ensure these restrictions are maintained. The FDA will act as appropriate if the company fails to comply with any regulatory requirements and may suspend or withdraw authorization if they determine that continued marketing is no longer appropriate for the protection of the public health. This includes 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.

References

1. FDA authorizes marketing of four menthol-flavored e-cigarette products after extensive scientific review. News release. June 21, 2024. https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-four-menthol-flavored-e-cigarette-products-after-extensive-scientific?utm_medium=email&utm_source=govdelivery

2. Romijnders KAGJ, van Osch L, de Vries H, Talhout R. Perceptions and reasons regarding e-cigarette use among users and non-users: a narrative literature reviewInt J Environ Res Public Health. 2018;15(6):1190.

3. Jarmul S, Aherrera A, Rule A, et al. Lost in e-cigarette clouds: a culture on the riseAm J Public Health. 2017;107(2):265-266.

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