The arc of the first heated-tobacco product cleared for the U.S. market
Philip Morris International's IQOS — a device that heats tobacco rather than burning it — became the first product to receive a modified-risk tobacco product exposure-modification authorisation from the U.S. Food and Drug Administration in July 2020, permitting PMI to market it with an exposure-reduction claim. The FDA had granted IQOS a premarket tobacco product authorisation a year earlier, in April 2019. Together the two orders marked an unprecedented pair of regulatory clearances under the Family Smoking Prevention and Tobacco Control Act.
The U.S. entry was short-lived. In 2021 the U.S. International Trade Commission's exclusion order took effect barring IQOS imports after finding that the product's HeatSticks infringed patents held by R.J. Reynolds Tobacco Company — a subsidiary of British American Tobacco — covering tobacco-heating technology. The ITC docket, Investigation No. 337-TA-1199, concluded that PMI and its U.S. commercial partner Altria Group had violated Section 337 of the Tariff Act of 1930. Importation stopped; IQOS disappeared from the U.S. market by early 2022.
The proposed standard reaches the number only after hundreds of pages of preamble.
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PMI pursued parallel remedies. It contested the patent findings and simultaneously developed an updated device intended to design around the infringed claims. On the regulatory side, its PMTA and MRTP authorisations remained technically in place — the FDA had not rescinded them — meaning any compliant product could re-enter the market without repeating the full authorisation process from scratch, provided the agency determined the modifications did not raise new questions.
By late 2024, PMI had filed to resume U.S. commercialisation. The company has described the revised IQOS as non-infringing, and the ITC proceedings related to the updated version remained active into 2025. Whether that pathway produces a stable commercial return depends on both the ITC's resolution of the patent questions and whether Altria, whose partnership with PMI on IQOS formally ended in 2023, participates in any renewed distribution arrangement.
For tobacco-control researchers the episode is instructive: the first modified-risk authorisation in U.S. regulatory history was blocked not by public-health law but by intellectual-property enforcement — a reminder that the PMTA process determines what the FDA permits, while patent and trade law determines what the market actually receives.
