FDA Denies Marketing Applications For 55,000 Flavored E-Cigarette Products

The Food and Drug Administration announced on Thursday that it denied the marketing applications for about 55,000 e-cigarette products from three applicants, citing that the applications did not have enough evidence showing the products would benefit public health. 

According to the press release, the applicants, JD Nova Group LLC, Great American Vapes, and Vapor Salon, did not show that their products “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.” As a result of this decision, these three companies will not be able to market e-cigarettes with flavors other than tobacco, and products that are already on the market are required to be removed from the market. . 

“Ensuring new tobacco products undergo an evaluation by the FDA is a critical part of our aim to reduce tobacco-related disease and death. We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed,” Acting FDA Commissioner Janet Woodcock said. 

The FDA explained that this decision addresses only some of the applications for new tobacco products received by the FDA by Sept. 9, 2020, a deadline set by the court. Over 500 companies have sent applications for over 6.5 million products, the press release said. The FDA has taken action regarding some of these applications previously, including taking products off of the market, but this is the first group of applications where the scientific review has been completed. 

The FDA cited that flavored e-cigarettes are more likely to be used by youth, and that the applicants need to show that the marketing for the product is acceptable in order to be able to be sold. Reportedly, this action follows legislation passed by Congress.  The press release specified that the FDA has not ruled out the possibility that the companies could provide enough evidence to have their flavored products remain on the market. 

“The agency is committed to working to transition the current marketplace to one in which all ENDS (electronic nicotine delivery system) products available for sale have demonstrated that they are ‘appropriate for the protection of the public health,’” the FDA said.