Retailer Groups Ask FDA to Publish PMTA List for Vapor Products

8/28/2020
FDA headquarters

ALEXANDRIA, Va. — With the Sept. 9 deadline nearing for companies to file premarket tobacco applications (PMTA) for vapor products, NACS is looking to the Food and Drug Administration (FDA) to help retailers know which items can remain on the backbar.

The convenience store association joined with FMI, the Food Industry Association, the National Association of Truckstop Operators, the Petroleum Marketers Association of America, and the Society of Independent Gasoline Marketers of America to urge the agency to publish a list of electronic nicotine delivery systems (ENDS) that have PMTAs on file.

With the list in hand, retailers will know which products they can legally sell as of Sept. 10.

As the date draws closer, "the PMTA list will be critical to support compliance across the tobacco trade channel, helping inform distributors, wholesalers, and retailers which ENDS products are being marketed legally in accordance with FDA's compliance policy. Relatedly, such a list also would facilitate enforcement against those manufacturers that continue to introduce illegally marketed products without premarket authorization or, in the case of deemed, currently marketed products, without a PMTA submitted by the deadline," the groups wrote in a letter to Matthew Holman, director, Office of Science Center for Tobacco Products at the FDA.

Without a list, the "distributors, wholesalers, retailers and adult consumers will have no centralized and credible way of determining which ENDS products are being marketed in compliance with FDA policy," the groups explained.

To read the groups' letter to the FDA, click here.

Under the 2009 Family Smoking Prevention and Tobacco Control Act, the FDA must approve PMTAs for newly deemed tobacco products — including electronic cigarettes and vapor products — to remain on the market.

Several companies, including JUUL Labs, Reynolds American Inc. and E-Alternative Solutions, have already submitted PMTAs, as Convenience Store News previously reported.

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