The U.S. Food and Drug Administration renewed modified risk tobacco product authorization for Philip Morris International's IQOS heated tobacco devices and HEETS tobacco consumables, according to a company statement.

The renewal covers two IQOS device versions and three HEETS variants, allowing the company to continue marketing reduced-exposure claims to U.S. adults who use traditional tobacco products. The FDA concluded that renewing the authorizations is appropriate to promote public health.

Philip Morris received the initial modified risk authorization for IQOS 2.4 in 2020, making it the first heated tobacco product to receive such designation. The IQOS 3 system obtained similar authorization in 2022.

"Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body's exposure to harmful or potentially harmful chemicals," the FDA stated in its order.

The authorized products include IQOS 2.4 and 3.0 system holders and chargers, plus HEETS in Amber, Green Menthol, and Blue Menthol variants. Philip Morris submitted scientific evidence showing IQOS produces aerosol with substantially lower levels of harmful constituents compared to cigarette smoke.

Philip Morris entered the U.S. market in 2022 following its acquisition of Swedish Match. The company has invested over $16 billion globally since 2008 to develop smoke-free products, with smoke-free products accounting for 41.5% of total net revenues in 2025.

The FDA continues reviewing premarket applications for IQOS ILUMA products. Philip Morris operates manufacturing facilities in Kentucky and North Carolina and employs more than 3,000 people across the United States.