Key Takeaways:
- The FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) will meet Oct. 7 to evaluate whether Philip Morris can renew modified-risk status for IQOS systems.
- The review will reexamine whether post-market data justifies continued claims that heating (not burning) tobacco significantly lowers exposure under section 911(g)(2) of the FD&C Act.
- The meeting is open to public comment. Written submissions were due on Sept. 25, and oral presentations may be scheduled between 1:00 p.m. and 2:00 p.m. ET on October 7.
The U.S. Food and Drug Administration announced that its Tobacco Products Scientific Advisory Committee (TPSAC) will meet on October 7, 2025, to review renewal applications filed by Philip Morris Products S.A. for its IQOS 2.4 and IQOS 3.0 heated-tobacco systems and associated HeatSticks.
The products were originally granted Modified Risk Tobacco Product (MRTP) orders in 2020 and 2022, allowing them to be marketed with reduced-exposure claims—specifically that the IQOS system “heats tobacco but does not burn it,” thus “significantly reduces the production of harmful and potentially harmful chemicals.”
Under U.S. law, these MRTP orders are limited in duration. To retain the right to make reduced-exposure claims, Philip Morris must meet the requirements of section 911(g)(2) of the FD&C Act, demonstrating through postmarket surveillance and accumulated evidence that the claims remain scientifically valid.
The meeting will take place at FDA’s White Oak campus, in Silver Spring, MD, in a hybrid format with in-person and webcast participation.
If the renewal is approved, Philip Morris would keep the authority to market IQOS with MRTP claims in the U.S. If denied, the permission to advertise reduced exposure could expire — potentially disrupting its position in the U.S. smoke-free and heated tobacco market.
