Key Takeaways
- FDA renewed modified risk granted orders for five IQOS products from Philip Morris Products S.A.
- The renewed products include the IQOS 2.4 System Holder and Charger, IQOS 3.0 System Holder and Charger, and three Marlboro HeatSticks products.
- The products may continue to be marketed with an exposure modification claim stating that the IQOS system heats tobacco but does not burn it and significantly reduces the production of harmful and potentially harmful chemicals.
- FDA said the available new scientific evidence remained generally consistent with the evidence reviewed in the original MRTP applications.
2Firsts, April 20, 2026
According to FDA, the agency renewed modified risk granted orders for five IQOS products from Philip Morris Products S.A. following scientific review.
Five IQOS products received renewed modified risk orders
The products receiving renewed orders are the IQOS 2.4 System Holder and Charger (PM0000479), the IQOS 3.0 System Holder and Charger (PM0000634), Marlboro Amber HeatSticks, previously Marlboro HeatSticks (PM0000424), Marlboro Green Menthol HeatSticks, previously Marlboro Smooth Menthol HeatSticks (PM0000425), and Marlboro Blue Menthol HeatSticks, previously Marlboro Fresh Menthol HeatSticks (PM0000426).
The products may continue to use the exposure modification claim
Under the renewed orders, these five products may continue to be marketed with the following exposure modification claim: available evidence to date shows that the IQOS system heats tobacco but does not burn it; this significantly reduces the production of harmful and potentially harmful chemicals; and scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces the body’s exposure to harmful or potentially harmful chemicals.
FDA said new evidence continues to support the original conclusions
FDA said its review found that the available new scientific evidence was generally consistent with the evidence reviewed in the original MRTP applications and continued to support the original conclusions that the exposure modification claims are supported by scientific evidence and that the products are expected to benefit the health of the population as a whole.
The orders apply only to the specified products and claims
FDA said the renewed modified risk orders are specific to the above products and their submission tracking numbers.
The agency also said it may withdraw the orders if it later determines, among other things, that continued marketing of the products as modified risk tobacco products no longer benefits the health of the population as a whole.
FDA added that the orders do not permit the company to market the products with any other modified risk claim that could mislead consumers into believing the products are endorsed or approved by FDA, or that FDA considers them safe. FDA said there is no safe tobacco product and that people who do not use tobacco products should not start.
The company must continue postmarket studies
FDA said the authorization also requires Philip Morris Products S.A. to conduct postmarket surveillance and studies, including assessments of users’ behaviors and their understanding of the modified risk claims.
The products were previously authorized through PMTA and MRTP pathways
FDA said the IQOS 2.4 System Holder and Charger, along with the HeatSticks products, were originally authorized for marketing in the United States through the premarket tobacco product application pathway in 2019, and then authorized as modified risk tobacco products in July 2020.
The IQOS 3.0 System Holder and Charger was authorized for marketing later in 2020 and then authorized as an MRTP in 2022. FDA noted that those earlier modified risk orders were valid for the fixed period specified in the orders.
FDA previously convened TPSAC to discuss the renewal applications
FDA also said that before making a final determination on an MRTP application, it considers all relevant information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee. On October 7, 2025, FDA held a TPSAC meeting to discuss these renewal applications.
Image source: FDA
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