SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) issued its first denials for marketing applications for about 55,000 flavored electronic nicotine delivery system (ENDS) products. And while these marketing denial orders (MDOs) prevent these flavored tobacco products from being sold, the FDA said it is continuing to review whether other flavored ENDS products will be allowed to stay on the market.
The MDOs were issued to three applicants—JD Nova Group LLC, Great American Vapes and Vapor Salon—because they lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the “well-documented, alarming levels of youth use of such products,” the FDA said Thursday in a press release. The products subject to this action are non-tobacco-flavored ENDS, including varieties like Apple Crumble, Dr. Cola and Cinnamon Toast Cereal, the FDA said.
The MDOs do not include all ENDS products for which the companies submitted applications, but products subject to an MDO for a premarket application must be removed from the market. The FDA had previously contacted JD Nova Group because their premarket tobacco product applications (PMTAs) did not meet filling requirements.
Although the FDA has issued other negative actions for some products submitted through the PMTA process, this is the first set of MDOs the agency issued for applications that have reached the substantive scientific review portion of the premarket review. The FDA received applications from more than 500 companies covering more than 6.5 million tobacco products by the Sept. 9, 2020, deadline. It has until Sept. 9, 2021, to review these applications.
Companies that want to market flavored ENDS products must have robust and reliable evidence showing their products’ potential benefit for adult smokers outweighs the significant risk to youth, said Mitch Zeller, the FDA’s Center for Tobacco Products (CTP) director.
“The burden is on the applicant to provide evidence to demonstrate that the marketing of their product meets the statutory standard of ‘appropriate for the protection of the public health.’ If this evidence is lacking or not sufficient, the FDA intends to issue a marketing denial order, which requires the product to be taken off or not introduced to market,” Zeller said.
That evidence would likely be in the form of a randomized controlled trial or longitudinal cohort study, Zeller said, although it’s a possibility other types of evidence could be adequate. If the applications contain the right evidence, the FDA will conduct further in-depth scientific evaluation to determine whether the evidence satisfies the statutory standard for authorization.
The scientific review of menthol ENDS products raises unique considerations, the agency said.
“Although menthol-flavored ENDS are not included in the decisions described above, the FDA notes that its reviews will similarly examine whether the evidence in the application demonstrates a benefit to existing adult users that outweighs the known youth use of such products,” the press release said.
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