FDA Reissues Marketing Permits For Five IQOS Products

On April 17, 2026, the FDA announced that, after a rigorous scientific review, the agency renewed the risk authorization orders for two IQOS devices and chargers, as well as three HeatSticks cartridges, issued to Philip Morris Products Company (PMP S.A.). Following this renewal, these five products can be sold at the time of their launch with the following exposure risk modification statements:
The available evidence indicates that the IQOS system heats tobacco but does not burn it. This significantly reduces the production of harmful and potentially harmful chemicals. Scientific research shows that a complete transition from traditional cigarettes to the IQOS system can significantly reduce the opportunities for human exposure to harmful or potentially harmful chemicals.
The products with risk authorization orders include: IQOS 2.4 devices and chargers (PM0000479), IQOS 3.0 devices and chargers (PM0000634), Marlboro Amber HeatSticks (formerly Marlboro HeatSticks) (PM0000424), Marlboro Green Menthol HeatSticks (formerly Marlboro Smooth Menthol HeatSticks) (PM0000425), and Marlboro Blue Menthol HeatSticks (formerly Marlboro Fresh Menthol HeatSticks) (PM0000426).
The FDA stated that these risk authorization orders issued by the agency are only applicable to the aforementioned products with corresponding tracking numbers that have been submitted. If the agency at any time determines that continuing to market these products as modified risk tobacco products (MRTP) is no longer beneficial to the overall health of the population, the FDA can withdraw these authorization orders.
The FDA's review found that the existing new scientific evidence is largely consistent with the evidence reviewed in the initial MRTP application and continues to support the initial conclusion that the exposure risk modification statements are supported by scientific evidence and that modified risk tobacco products are expected to benefit the health of the entire population.
However, the FDA emphasized that these risk authorization orders do not allow the company to use any other modified risk statements to market the product. These statements may convey or mislead consumers, making them believe that these products have received FDA recognition or approval, or that FDA considers these products safe for consumer use. There are no safe tobacco products, and non-smokers should not start using them. Today's authorization also requires PMP S.A. to conduct post-market monitoring and research, including evaluating the behavior of MRTP users and their understanding.
The IQOS 2.4 devices and chargers, as well as HeatSticks cartridges, initially received authorization for listing in the United States through the pre-market application process for tobacco products in 2019. Subsequently, on July 2020, these products were authorized for listing as modified risk tobacco products. The IQOS 3.0 devices and chargers received listing authorization later in 2020 and were authorized as modified risk tobacco products for listing in 2022. These risk authorization orders are valid for the fixed period specified in the authorization orders.