Rep. Krishnamoorthi Presses FDA Over Planned PMTA Rewrite, Asks for Disclosures

U.S. Representative Raja Krishnamoorthi, an Illinois Democrat, has sent a letter to the Food and Drug Administration asking it to explain its plan to reassess and potentially replace the 2021 premarket tobacco product application, or PMTA, framework, and the letter seeks specifics on both what the agency intends to change and how it has been in contact with the companies and parties that challenge the rule.

The letter, which the congressman sent on October 6 and which asks the agency for a written response by October 20, asks the FDA to identify the specific provisions of the 2021 PMTA rule that it is considering changing or eliminating, and to say whether the current scientific evidentiary standards will be maintained. The request is aimed at the question of whether the rewrite would tighten the scientific bar, loosen it, or leave it in place, and it asks the agency to put that on the record in writing.

The letter also asks for the agency's communications since January 20, 2025, with Altria, Reynolds American and the other parties that have challenged the PMTA framework, and the disclosure request is framed as part of a larger oversight question about who the agency has been consulting as it plans the rewrite.

The move comes directly after the FDA's September 28 announcement that it intends to reassess the PMTA framework, citing its experience with the 2021 rule, recent litigation, the unauthorized market, and the pace of new product introductions. The letter is a direct response to that announcement, and it presses the agency to explain the substance of the change it is planning.

Krishnamoorthi has been active on e-cigarette regulation since he led a congressional investigation into JUUL and youth vaping in 2019, and the letter lands in that context. It is one of the more pointed oversight letters of the year, and it puts the agency on notice that the congressional response to the planned PMTA rewrite is being shaped now, not after the rule is out.