2FIRSTS | U.S. Rep. Krishnamoorthi Questions FDA Over Planned PMTA Rewrite, Seeks Communications With Altria and Reynolds
Rep. Krishnamoorthi pressed the FDA on its plan to reassess the 2021 PMTA rule and sought records of its communications with Altria and Reynolds.Summary
U.S. Rep. Raja Krishnamoorthi sent an Oct. 6 letter to Acting FDA Commissioner Kyle Diamantas questioning the agency's plan to reassess and potentially replace the 2021 PMTA regulatory framework. He asked which specific provisions the FDA may change or eliminate, what evidence supports each change, and whether any replacement framework would maintain the APPH scientific evidentiary standard. He also demanded written responses by Oct. 20, 2026, and requested records of communications since Jan. 20, 2025, with Altria, Reynolds American, their subsidiaries and other parties challenging the PMTA framework.
The inquiry follows the FDA's Sept. 28 announcement that it intends to reassess the PMTA framework, citing its experience with the 2021 rule, recent litigation in the Northern District of Texas, the widespread unauthorized market and the pace of new product introductions. Altria subsidiaries Helix Innovations and NJOY sued the FDA on Sept. 2, and Reynolds American companies filed a separate complaint on Sept. 8. Krishnamoorthi also asked how the unauthorized market relates to the scientific evidence required for marketing authorization and what additional enforcement actions the FDA plans with the DOJ and Customs and Border Protection.
The letter also links the reassessment to recent authorizations, including the Aug. 28 JUUL2 marketing orders and the May authorization of four flavored Glas ENDS products. Krishnamoorthi, co-chair of the Congressional Caucus to End Youth Vaping and leader of the 2019 congressional JUUL investigation, has consistently focused on youth vaping, flavored products, FDA premarket review standards and federal enforcement, including the 2026 PROTECT Act.
(Source：2Firsts)
