FDA Posts PMTA List

NACS pushed the agency to let retailers know which vaping products they can legally market.

May 21, 2021

Woman refilling an e-cigarette

WASHINGTON—In response to a request from NACS and other groups, the U.S. Food and Drug Administration yesterday posted the list of deemed new tobacco products for which manufacturers submitted a premarket application to the agency via the Premarket Tobacco Product Application (PMTA) pathway by Sept. 9, 2020. The list includes more than six million products.

In February, the FDA posted the list of deemed new tobacco products with timely applications submitted to FDA via the Substantial Equivalence (SE) and Exemption from SE Request (EX REQ) pathways. At the time, the PMTA list was still being compiled.

The FDA required makers of e-cigarettes to submit premarket applications by Sept. 9, 2020, and retailers are allowed to keep selling these products for a year from the date of the deadline while the FDA reviews applications, or until the agency takes a negative action. If vaping companies missed the deadline last September, then their products must be pulled from the market. For this reason, NACS has been pushing for the FDA to publish the full PMTA list, which is critical to support compliance across the tobacco trade channel, helping to inform distributors, wholesalers and retailers which vapor products are being marketed legally in accordance with the agency’s compliance policy.

In August, NACS joined 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 a letter to the FDA on this request.

The FDA said the process is now complete for the deemed new tobacco products with timely applications submitted through the PMTA pathway, and updates to the SE and EX REQ lists have been made to reflect final actions taken since their initial posting. Now, all lists of deemed new tobacco products with timely submitted applications are available. The agency will be updating these lists regularly as it issues positive or negative actions on these products. 

Not a NACS Magazine or NACS Daily subscriber? Subscribe to NACS Magazine in a print and/or digital format to read the latest insights from industry thought leaders each month. Subscribe to NACS Daily to receive a roundup of industry news and trends in your inbox each weekday. Subscriptions to NACS Magazine and NACS Daily are complimentary for readers in the convenience retailing industry—you just need to sign up!