Completely switching to menthol-flavored e-cigarette products provides a health benefit for adults who smoke cigarettes compared to tobacco-flavored products, with sufficient evidence to outweigh the risks of the product, including youth appeal, NJOY LLC reported in its marketing application, the U.S. Food and Drug Administration (FDA) said. Because the supplied evidence met FDA’s criteria, in June 2024, the agency issued marketing granted orders to NJOY LLC for four menthol-flavored products.
“We are a data-driven agency and will continue to follow the science to inform our review of premarket tobacco applications,” Matthew Farrelly, PhD, director of the FDA Center for Tobacco Products’ Office of Science, said. “Based on 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.”
Under the legal standards set in the 2009 Family Smoking Prevention and Tobacco Control Act, applicants must submit sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of public health. For the authorized applications, FDA deemed that NJOY LLC’s evidence met those criteria.
With the authorization, the FDA placed stringent marketing restrictions on the new products to prevent youth access and exposure. The FDA said it will closely monitor how the products are marketed to youth and will suspend or withdraw the authorization if the company fails to comply with requirements or if continued marketing is no longer appropriate for the protection of the public health (e.g., notable increases in the products’ use among youth or former smokers, decreases in the number of current smokers who completely switch to the products).
To date, the FDA said it has authorized 27 tobacco- and menthol-flavored e-cigarette products and devices.
Historic marketing around menthol flavoring contributed to disparities in tobacco use, particularly among Black and underage populations. In April 2024, ONS joined the healthcare community in sending a letter to the Biden-Harris administration imploring it “to finalize the FDA’s proposed rules on eliminating menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars” by the end of 2024.
In its position statement on e-cigarettes and vaping, ONS charged nurses to “advocate for e-cigarette regulation like other tobacco products until key questions are answered related to the adverse health effects of vaping, effectiveness of e-cigarettes for smoking cessation, and health advantages of e-cigarettes over traditional combustible tobacco products” and “acquire knowledge and inform consumers about evidence-based tobacco cessation alternatives and the potential harm of e-cigarettes.”
Learn more about e-cigarettes in ONS’s Tobacco, E-Cigarettes, and Vaping Learning Library, then raise your voice with policymakers and regulatory agencies. Find out how to contact your legislators and get alerts on the latest issues in the ONS Action Center.