FDA Authorizes Marketing of Four NJOY Menthol E-Cigarettes

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WASHINGTON, D.C. — The U.S. Food and Drug Administration has authorized the marketing of four menthol-flavored e-cigarette products by NJOY LLC. This decision marks the first time the FDA has allowed non-tobacco flavored e-cigarettes to be sold in the United States.

Understanding the Authorization

The FDA’s decision came after an extensive scientific review of NJOY’s premarket tobacco product applications (PMTAs). The authorized products include NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 6%. The ACE products are sealed, pre-filled pods used with a previously approved device, while the DAILY products are disposable e-cigarettes with prefilled, non-refillable reservoirs.

Each application was reviewed individually. The FDA’s authorization applies only to these four specific products, not to any other menthol-flavored e-cigarettes. Companies must obtain a written marketing order from the FDA to legally sell new tobacco products in the U.S.

Not an Endorsement of Safety

Despite the authorization, the FDA emphasized that these products are not “FDA approved” and are not considered safe. “All tobacco products are harmful and potentially addictive,” the agency stated. It warned that those who do not use tobacco products should not start.

Brian King, director of the FDA’s Center for Tobacco Products, explained the responsibility of companies in this process. “It is the responsibility of the applicant to provide the necessary evidence to obtain marketing authorization,” King said. “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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Public Health Standards

The FDA uses a public health standard to evaluate PMTAs, which includes assessing the risks and benefits of the product to the entire population. In NJOY’s case, the FDA found enough evidence to show that marketing these menthol-flavored e-cigarettes would protect public health. The company’s data indicated that these products could help adult smokers completely switch from traditional cigarettes to a less harmful alternative.

Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products, highlighted the importance of scientific evidence in their decision-making. “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,” Farrelly said.

FDA’s Menthol E-Cigarette Decision

This authorization could have significant implications for the e-cigarette market and public health. By allowing these specific menthol-flavored products, the FDA acknowledges their potential to aid adult smokers in moving away from traditional cigarettes. However, the agency remains vigilant about the risks to younger populations, emphasizing that all tobacco products carry inherent dangers.

The decision also sends a clear message to other e-cigarette manufacturers: thorough scientific evidence is crucial for gaining FDA authorization. This could lead to more rigorous research and data collection efforts within the industry, ultimately resulting in better-informed decisions about product safety and public health impacts.

In summary, the FDA’s authorization of four NJOY menthol e-cigarette products represents a careful balance between potential benefits for adult smokers and the need to protect youth from tobacco-related harm. The agency’s commitment to data-driven decisions highlights the ongoing effort to navigate the complexities of tobacco regulation and public health.

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