The U.S. Food and Drug Administration (FDA) has renewed the modified risk tobacco product (MRTP) authorization for Philip Morris International's (PMI) IQOS heated tobacco system, as announced on May 1, 2026. This decision allows PMI to continue marketing IQOS in the United States with claims that it reduces exposure to harmful chemicals compared to traditional cigarettes.
The renewal follows a scientific review by the FDA, which concluded that the evidence supports the reduced-risk claims for IQOS. The authorization is specific to the IQOS device and its accompanying tobacco sticks, known as HeatSticks. PMI has stated that this regulatory win reinforces its commitment to a smoke-free future.
IQOS was first authorized by the FDA as a modified risk tobacco product in 2020, but the authorization was subject to periodic review. The renewal ensures that PMI can maintain its market position in the U.S., where it competes with other reduced-risk products like vaping devices and nicotine pouches.
Public health advocates have expressed mixed reactions, with some welcoming the reduced harm potential for adult smokers who switch completely, while others caution that the products are not risk-free and may appeal to youth. The FDA has emphasized that the authorization does not mean IQOS is safe, only that it poses lower risks than continued smoking.
