STAMFORD, CT -- The U.S. Food and Drug Administration (FDA) announced that it has authorized the renewal of modified risk tobacco product (MRTP) orders previously granted to PMI for two versions of the IQOS device and three variants of the tobacco consumables, commercialized under the HEETS brand. This renewal allows PMI to continue sharing reduced-exposure information with U.S. adults 21+ who use traditional tobacco products, such as combustible cigarettes.

The agency concluded that renewing the IQOS and HEETS MRTP authorizations is appropriate to promote public health and is expected to benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.

“As the only company to have successfully secured and maintained MRTP authorizations for heated tobacco products in the U.S., we are confident that our science-based alternatives can help adult smokers transition away from combustible cigarettes,” said Stacey Kennedy, CEO, PMI U.S. “This decision from the FDA reflects both the rigorous scientific foundation supporting IQOS and our ongoing commitment to responsibly deliver smoke-free choices to adult consumers.”

In issuing the MRTP renewal orders for IQOS, the FDA reaffirmed that “the scientific evidence that is available without conducting long-term epidemiological studies demonstrates that a measurable and substantial reduction in morbidity or mortality among individual tobacco users is reasonably likely.”

The IQOS 2.4 system was the first heated tobacco product authorized via the FDA’s MRTP process in 2020 as “appropriate for the promotion of public health,” following its authorization through the premarket tobacco product application (PMTA) process in 2019. The IQOS 3 system secured MRTP authorization in 2022, following premarket authorization in 2020. The FDA continues to review PMTAs for IQOS ILUMA and given its strong application and demonstrated track record converting legal age smokers to a better alternative, PMI believes the application warrants expeditious FDA action.

PMI’s MRTP submission included an extensive body of scientific evidence indicating that the IQOS system produces aerosol with substantially lower levels of harmful and potentially harmful constituents compared with cigarette smoke. While no tobacco product is risk-free, a growing body of real-world data—including from markets such as Japan—indicates that the availability of heated tobacco products has been associated with notable reductions in combustible cigarette consumption.

Heated tobacco products, such as IQOS, heat tobacco without burning it, significantly reducing the formation of the harmful chemicals created by combustion while delivering real tobacco taste and nicotine satisfaction. The renewed authorization covers the following products:

· IQOS 2.4 System Holder and Charger
· IQOS 3.0 System Holder and Charger
· HEETS: Amber, Green Menthol, Blue Menthol

PMI U.S. is focused on providing better options than traditional tobacco products to America’s 45 million legal-age nicotine consumers—approximately 25 million of whom still smoke cigarettes, by far the most harmful way to consume nicotine.

Since 2008, PMI has invested over $16 billion globally to develop, scientifically substantiate, and commercialize innovative smoke-free products for adults who would otherwise smoke, with the goal of completely ending the sale of cigarettes.