NACS Presses FDA Again to Release Names of Denied ENDS Products

The association asks the agency to provide transparency for retailers in its PMTA decisions.

June 01, 2023

ALEXANDRIA, Va.—NACS, along with other retail associations, has sent a letter to the Food and Drug Administration asking for more transparency from the agency on its Premarket Tobacco Product Application (PMTA) process. The associations are also seeking a publicly available list of which e-cigarettes and vape products are legal to market.

“It has been 18 months since this request and the Agency has received millions of applications and made decisions on 99 percent of them to date, yet the only list publicly available is the names of the manufacturers and not the names of the products themselves,” wrote the associations in the letter. “This is not an adequate list for our retail members who strive to comply with the law and need to know which products specifically are legal to market and which products are not.”

In October 2021, NACS and five other retail associations sent a letter to the FDA asking the agency to publish the names of vapor products for which it has taken action. 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.

The FDA formally responded in January 2022, stating that it understands the retail groups request for specific names of 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.

In its most recent letter to the FDA, the associations said they “can appreciate the immense task of reviewing millions of applications. However, there remains widespread confusion in the marketplace as to which products can remain on shelves and which need to be removed.”

“While Director Zeller encouraged retailers to contact manufacturers with any questions about products in their inventory, this is not an adequate or fair solution. It places the burden on retailers to verify the marketing status of ENDS and vape products with the manufacturers. Many of our members are small operators who do not have the resources or bandwidth to contact the manufacturers,” wrote the associations. “Moreover, manufacturers providing a list does not guarantee accuracy or give the assurance that a verified list from the Agency would give. These retailers stand to face enforcement if they are out of compliance with the law and the only way to ensure they can comply is if they have a verified list from the Agency.”

NACS will notify members when the FDA updates the PMTA product list with actions taken.