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In a significant move following an extensive scientific review, the U.S. Food and Drug Administration (FDA) has authorized the marketing of four menthol-flavored e-cigarette products through the premarket tobacco product application (PMTA) pathway. NJOY LLC received marketing granted orders for NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4.5%, and NJOY DAILY EXTRA Menthol 6%. These products are the first non-tobacco flavored e-cigarette products to be authorized by the FDA.
The authorized ACE products are sealed, pre-filled, non-refillable pods compatible with the previously authorized ACE device, while the authorized DAILY products are disposable e-cigarettes with prefilled, non-refillable e-liquid reservoirs. These authorizations apply exclusively to these four products and not to any other menthol-flavored e-cigarettes.
Dr. Brian King, director of the FDA’s Center for Tobacco Products, emphasized the responsibility of applicants to provide robust scientific evidence for marketing authorization. “This action reinforces that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted,” said Dr. King.
The FDA’s evaluation of PMTAs is based on a public health standard, considering the overall population’s risks and benefits. The FDA determined that the evidence provided by NJOY LLC demonstrated that marketing these menthol-flavored products would be appropriate for public health protection. The evidence indicated a benefit for adult smokers in terms of complete switching from traditional cigarettes to these menthol-flavored products, outweighing the risks, including youth appeal.
Dr. Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products, highlighted the FDA’s commitment to data-driven decision-making. “Based on our rigorous scientific review, the evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth,” said Dr. Farrelly.
Despite these authorizations, the FDA remains vigilant about the potential risks of youth use of all e-cigarettes, particularly flavored ones. The FDA has implemented stringent marketing restrictions to prevent youth access and exposure to these new products. The agency will monitor the marketing practices of NJOY LLC and take appropriate action if statutory or regulatory requirements are violated. Authorization may be suspended or withdrawn if continued marketing is deemed inappropriate for public health protection, especially if there is a significant increase in youth use or a decrease in adult smokers switching completely.
These actions are part of the FDA’s broader efforts to ensure all new tobacco products marketed in the U.S. undergo rigorous scientific review and receive appropriate marketing authorizations. The FDA has reviewed nearly 27 million deemed product applications, making determinations on over 26 million. To date, 27 tobacco- and menthol-flavored e-cigarette products and devices have been authorized, including the four announced today.
For a comprehensive list of legally marketed e-cigarette products, visit the FDA’s new Searchable Tobacco Products Database or refer to the printable one-page flyer of authorized e-cigarette products. Those manufacturing, importing, selling, or distributing e-cigarettes without the required premarket authorization face enforcement risks.
