Following a scientific review, the Food and Drug Administration (FDA) has issued a renewal of modified risk granted orders to Philip Morris International (PMI) for five Iqos products. Iqos is an electronic device that heats tobacco-filled sticks wrapped in paper to generate a nicotine-containing aerosol.
The products are:
- Iqos 2.4 system holder and charger
- Iqos 3.0 system holder and charger
- Marlboro Amber HeatSticks (previously Marlboro HeatSticks)
- Marlboro Green Menthol HeatSticks (previously Marlboro Smooth Menthol HeatSticks)
- Marlboro Blue Menthol HeatSticks (previously Marlboro Fresh Menthol HeatSticks)
The Iqos 2.4 system holder and charger, as well as the HeatSticks, were originally authorized for marketing in the U.S. via the premarket tobacco product application (PMTA) pathway in 2019. In July 2020, the products were then authorized to be marketed as modified risk tobacco products (MRTP), the agency said.
The Iqos 3.0 system holder and charger was authorized for marketing later in 2020 and then authorized to be marketed as an MRTP in 2022.
The modified risk granted orders issued by FDA are specific to these products.
“The modified risk granted order does not permit the company to market the product with any other modified risk claim that conveys or could mislead consumers into believing that the products are endorsed or approved by FDA, or that FDA deems the products to be safe for use by consumers,” the agency said. “There is no safe tobacco product, and those who do not use tobacco products should not start.”
If at any point the agency determines that, among other things, the continued marketing of the products as modified risk tobacco products (MRTPs) no longer benefits the health of the population as a whole, the agency may withdraw the orders.
The agency concluded that renewing the authorizations are “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 2025, PMI started selling the cigarette maker’s heated tobacco device in Austin, Texas, to further its smoking alternatives in the United States.
“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 of 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.”
PMI is based in Stamford, Connecticut.
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