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FDA Renews Authorization for Five IQOS Products to be Marketed with Exposure Modification Claims

Following FDA’s rigorous scientific review, FDA issued a renewal of modified risk granted orders to Philip Morris Products S.A. (PMP S.A.) for two IQOS system holders and chargers and three flavors of HeatSticks products. With this renewal, these five products may be marketed with the following exposure modification claim:

AVAILABLE EVIDENCE TO DATE:

  • The IQOS system heats tobacco but does not burn it.
  • This significantly reduces the production of harmful and potentially harmful chemicals.
  • 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 products receiving modified risk granted orders are:

  • IQOS 2.4 System Holder and Charger (PM0000479)
  • 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)
  • Marlboro Blue Menthol HeatSticks (previously Marlboro Fresh Menthol HeatSticks) (PM0000426)

The modified risk granted orders issued by FDA are specific to the above-mentioned products with the noted submission tracking numbers. 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.

FDA’s review found that the available new scientific evidence is generally consistent with the evidence reviewed in the original MRTP applications and continues to support the original conclusions that the exposure modification claims are supported by scientific evidence and that the MRTPs are expected to benefit the health of the population as a whole.

The modified risk granted orders do 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. There is no safe tobacco product, and those who do not use tobacco products should not start. Today’s authorization also requires PMP S.A. to conduct postmarket surveillance and studies that include an assessment of MRTP users’ behaviors and their understanding.

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 pathway in 2019. In July 2020, the products were then authorized to be marketed as modified risk tobacco products. 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. These MRGOs were valid for the fixed time period specified in the orders.

Before making a final determination on an MRTP application, FDA takes into consideration all relevant information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC). On October 7, 2025, FDA held a TPSAC meeting to discuss these renewal applications.

More information about these modified risk granted orders are available on the FDA website.
 

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