NACS Urges FDA to Publish PMTA List for ENDS

The agency should let retailers know which vaping products they can legally market.

August 28, 2020

WASHINGTON—To avoid confusion about which electronic nicotine delivery system (ENDS) products are allowed to stay on the market, NACS joined a group of retail associations in urging the U.S. Food and Drug Administration (FDA) to publish the ENDS products for which the agency has received a premarket tobacco product application (PMTA).

The PMTA list would provide retailers with needed information on which ENDS products they can legally sell.

The FDA requires makers of e-cigarettes to submit premarket applications by Sept. 9, providing data to show their products are appropriate for public consumption. Companies can then keep selling their products for a year from the date of the deadline while the FDA reviews their applications, or until the agency takes a negative action. If vaping companies miss the deadline, they must pull their unapproved products from the market.

With the Sept. 9 deadline fast approaching, “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 letter sent this week read.

Without a published PMTA list, “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 associations said. The FDA “has adequate authority to publish such a list, consistent with applicable law and long-standing policy. For these reasons, we urge FDA to promptly publish the PMTA List on its website or other appropriate public venues.”

NACS was joined in the letter by The 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.

In June, NACS sent a letter to FDA Commissioner Stephen Hahn asking for transparency in the process and highlighting that retailers could unwittingly sell products that are illegal and face regulatory penalties.

Originally, flavored cigars were also required to file PMTAs by the September 9 deadline. However, on August 19, Judge Amit P. Mehta of the U.S. District Court for the District of Columbia ruled that FDA cannot enforce its PMTA requirement for premium cigars until the agency develops a streamlined substantial equivalence process for the products.