FDA Reauthorizes PMI’s IQOS as Modified Risk Tobacco Product
PMI said it is the only company that has received modified risk tobacco product authorizations for heated tobacco products.
Apr 20, 2026
The U.S. Food and Drug Administration (FDA) has authorized the renewal of modified risk tobacco product (MRTP) orders previously granted to Philip Morris International (PMI) for two versions of the IQOS device and three variants of the tobacco consumables commercialized under the HEETS brand.
According to PMI, 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
FDA said 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.”
In March 2025, PMI began selling its IQOS heated tobacco device in Austin, Texas, after a successful pilot. This was followed by the launch of IQOS Gold in December 2025, a limited-edition heated tobacco device, in select markets: Jackson, Mississippi; Austin, Texas; and the greater Fort Lauderdale, Florida area.
