The FDA authorized four products based on evidence that they help adult smokers switch from traditional cigarettes, outweighing potential risks to youth.
RT’s Three Key Takeaways:
- Evidence-Based Authorization: The FDA authorized the marketing of four menthol-flavored e-cigarette products from NJOY LLC after finding sufficient evidence that they help adult smokers switch completely from traditional cigarettes, which the agency says outweighs the potential risks to youth.
- Stringent Youth Protection: To mitigate the risk of youth usage, the FDA has imposed strict marketing restrictions on these newly authorized products and will closely monitor compliance, with the possibility of suspending or withdrawing authorization if necessary.
- Public Health Consideration: The FDA’s decision is grounded in public health standards, weighing the overall risks and benefits to the population, and marks the first approval of non-tobacco flavored vaping products through this rigorous scientific review process.
The US Food and Drug Administration (FDA) has authorized the marketing of four menthol-flavored e-cigarette products, marking the first non-tobacco flavored vaping products to receive such approval.
The FDA issued marketing granted orders to NJOY LLC for four menthol-flavored 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 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.
The FDA notes in a release that while this action permits these tobacco products to be legally marketed in the United States, it does not mean these tobacco products are safe or FDA-approved.
Public Health Standards and Evaluation
The FDA reviews premarket tobacco product applications based on public health standards, weighing the risks and benefits to the population. After evaluating NJOY LLC’s applications, the FDA found enough evidence to support marketing the menthol-flavored products. The evidence indicated that these products help adult smokers switch completely from traditional cigarettes, which outweighs the potential risks, including their appeal to youth.
“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,” says Matthew Farrelly, PhD, director of the Office of Science in the FDA’s Center for Tobacco Products, in a release.
Concerns and Monitoring
The FDA emphasizes in a release that it remains concerned about youth use of e-cigarettes, particularly flavored ones. To prevent youth access, the FDA has imposed strict marketing restrictions on these newly authorized products. The agency says it will monitor their marketing closely and take action if the company does not comply with regulations. The FDA may suspend or withdraw authorization if these products lead to increased use among youth or former smokers, or if fewer current smokers switch completely to these 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,” says Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, in a release. “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.”
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