The U.S. Food and Drug Administration has renewed modified risk tobacco product (MRTP) orders for several Philip Morris International IQOS devices and HeatSticks consumables, allowing the company to continue marketing the products with reduced-exposure claims. The authorization covers two IQOS device systems and three HeatStick variants, with the FDA reaffirming that available scientific evidence supports claims that switching completely from cigarettes to IQOS can significantly reduce exposure to harmful chemicals.
The products receiving modified risk granted orders are IQOS 2.4 system, IQOS 3.0 system, Marlboro Amber HeatSticks (previously Marlboro HeatSticks), Marlboro Green Menthol HeatSticks (previously Marlboro Smooth Menthol HeatSticks), and Marlboro Blue Menthol HeatSticks (previously Marlboro Fresh Menthol HeatSticks).
The agency said its latest review found new data consistent with earlier findings from initial approvals granted between 2019 and 2022. Under the renewed orders, Philip Morris can state that the IQOS system heats rather than burns tobacco, resulting in lower production of harmful substances. However, the FDA emphasized that the designation does not mean the products are safe or approved, and it restricts the company from making broader health or risk-reduction claims beyond those explicitly authorized.
The renewed MRTP status is subject to ongoing regulatory oversight, including requirements for postmarket surveillance to monitor consumer behavior and public health impact. The FDA retains the authority to withdraw the authorization if the products no longer demonstrate a net benefit to population health.
