Today (April 29), Philip Morris announced that it has received renewed Modified Risk Tobacco Product (MRTP) authorizations from the U.S. Food and Drug Administration for its IQOS heated tobacco devices and associated HEETS consumables. The renewal covers two IQOS device versions and three HEETS variants, allowing the company to continue communicating reduced-exposure information to adult smokers in the U.S. The FDA said the decision is appropriate for the protection of public health, citing evidence that switching completely from cigarettes to IQOS significantly reduces exposure to harmful chemicals.
The agency reaffirmed that available scientific evidence supports a measurable and substantial reduction in harm compared to combustible cigarettes, even without long-term epidemiological data. IQOS was first authorized through the FDA’s premarket pathway in 2019, with its initial MRTP designation granted in 2020 and expanded in subsequent years. The renewed orders maintain PMI’s position as the only company with MRTP authorizations for heated tobacco products in the U.S.
The authorization applies to the IQOS 2.4 and IQOS 3 systems, along with HEETS Amber, Green Menthol and Blue Menthol variants. PMI said the decision supports its ongoing strategy to transition adult smokers away from cigarettes, as the company continues to invest in and expand its smoke-free product portfolio while awaiting further regulatory review of newer devices.