PM · 10-Q · 2026Q2 · Full report
FDA Product Authorizations
Philip Morris International Inc. · 2026-07-24 · Importance 47 · Surprise 60 · In source text
The FDA renewed PMI’s IQOS 2.4 and IQOS 3.0 exposure-modification orders on April 17, 2026, with expiration in April 2031. In June 2026, the FDA authorized modified-risk claims for all 20 ZYN nicotine-pouch varieties previously authorized for sale, making them the only nicotine-pouch products in the U.S. with MRTP authorization. PMI submitted bundled PMTAs and MRTPAs for IQOS ILUMA in October 2023; the FDA accepted those applications in March 2024, but review remained ongoing as of the filing. On May 8, 2026, the FDA issued final guidance indicating it would not prioritize enforcement against certain unauthorized ENDS and nicotine-pouch products that had made meaningful authorization progress.
Key facts
- On April 17, 2026 the FDA renewed the exposure modification orders with a stated expiration date in April 2031. source
- As a result of the June 2026 FDA conclusion, the 20 ZYN nicotine pouch products can be marketed with the modified risk claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” source
- General snus products received modified risk orders on October 22, 2019 and the FDA renewed those orders on November 7, 2024 with a stated expiration date in November 2032. source
- On July 7, 2020 the FDA issued an exposure modification order authorizing marketing of IQOS 2.4 and three related consumables as MRTPs with reduced exposure claims. source
- On March 11, 2022 the FDA issued an exposure modification order for IQOS 3.0. source
- On January 26, 2023 the FDA authorized the marketing of two new tobacco-flavored consumables (Marlboro Sienna HeatSticks and Marlboro Bronze HeatSticks) and a modified Marlboro Amber HeatSticks. source
- PMI submitted bundled PMTAs for IQOS ILUMA THS products together with MRTPAs on October 20, 2023 and the FDA formally accepted those bundled PMTAs and MRTPAs in March 2024. source
- On January 19, 2024 the FDA completed its review of PMI's Requests for Exemption from Substantial Equivalence for five submitted IQOS consumables and determined they were exempt from substantial equivalence requirements. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | realized | — | On April 17, 2026 the FDA renewed the exposure modification orders with a stated expiration date in April 2031. |
| revenue | positive | realized | — | As a result of the June 2026 FDA conclusion, the 20 ZYN nicotine pouch products can be marketed with the modified risk claim: “Using ZYN… |
| revenue | positive | realized | — | General snus products received modified risk orders on October 22, 2019 and the FDA renewed those orders on November 7, 2024 with a stated… |
| revenue | positive | committed | — | PMI noted the FDA issued final guidance on May 8, 2026 stating it does not intend to prioritize enforcement against certain unauthorized… |
| revenue | positive | realized | — | The FDA authorized marketing of Swedish Match's General snus and ZYN nicotine pouches and versions of PMI's IQOS devices and consumables,… |
| revenue | unclear | probable | — | PMI submitted renewal applications for MRTP authorizations for IQOS 2.4 and three related consumables and IQOS 3.0 on July 5, 2023. |
| revenue | positive | realized | — | PMI stated these 20 ZYN products are the only nicotine pouch products on the U.S. market that have been authorized as MRTPs. |
| revenue | unclear | probable | — | Swedish Match USA, Inc. submitted an application on July 17, 2023 requesting re-authorization to continue to market eight General snus… |