FDA Authorizes PMI IQOS Modified Risk Product Renewal

The U.S. FDA announced that it has authorized the renewal of modified risk tobacco product 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."