ALEXANDRIA, Va.—The Food and Drug Administration (FDA) formally responded to a request from NACS and other groups that asked the agency to publish the names of vapor products for which it has taken action in their premarket tobacco application (PMTA) review. In their letters to FDA, the associations expressed the critical nature of this list for their retail members who need to know which products are legal to sell and which are not.
“Our retail members who sell ENDS products take the responsibility of compliance and operating in accordance with the law seriously. Publicly available information noting the status of individual products is the only way retailers can ensure compliance,” stated the retail association letter.
For vapor products to stay on the market, the FDA must authorize them after reviewing their PMTAs. These applications had to be submitted to the FDA by Sept. 9, 2020. By last fall, the agency had taken action on over 98% of the 6.5 million applications received and issued marketing denial orders (MDOs) for more than one million flavored vapor products. The agency did authorize the marketing of R.J. Reynolds’ Vuse vape product, which includes the Vuse Solo closed electronic nicotine delivery system (ENDS) device and accompanying tobacco-flavored e-liquid pods.
In its letter response to the associations, the FDA states that it understands the retail groups request for specific names of deemed products and that the agency is working to update the list with final actions taken on individual products, including those that received MDOs.
“Given the large number of products involved, sharing this information requires additional time and resources so that the Agency does not disclose confidential commercial information (CCI) about products that are not yet marketed,” stated the agency.
FDA’s response explains that the agency does not have the authority to disclose CCI of products that are not on the market or whose marketing status is unclear. However, FDA’s website does disclose the names of companies that have received marketing denial orders. Until the list is updated, FDA encourages retailers to contact manufacturers and/or suppliers with any questions about specific products.
NACS will notify members when FDA updates the PMTA product list with actions taken.