By Timothy S. Donahue
Top Takeaways:
- Regulatory win: FDA renews MRTP orders for five IQOS products, allowing continued exposure-reduction claims
- Scientific backing: Agency says new evidence supports earlier findings on reduced exposure to harmful chemicals
- Ongoing oversight: FDA requires post-market studies and retains authority to revoke authorization
The U.S. Food and Drug Administration has renewed its authorization for certain IQOS products to be marketed with modified risk claims, extending one of the most closely watched regulatory decisions in the nicotine category.
The agency said it issued renewed modified risk-granted orders (MRGOs) to Philip Morris Products S.A. for five products: two IQOS device systems and three Marlboro HeatSticks variants.
With the renewal, the products can continue to be marketed using exposure-modification claims stating that the IQOS system “heats tobacco but does not burn it,” that it “significantly reduces the production of harmful and potentially harmful chemicals,” and that “switching completely… significantly reduces your body’s exposure” to those chemicals.
FDA said its latest review found that “available new scientific evidence is generally consistent with the evidence reviewed in the original MRTP applications” and that this evidence continues to support the agency’s prior conclusions.
Those conclusions center on exposure—not risk elimination. “There is no safe tobacco product,” FDA said, emphasizing that the authorization does not mean the products are safe or approved, and that non-users should not start using tobacco.
The renewal applies specifically to the IQOS 2.4 and IQOS 3.0 device systems, as well as to Marlboro Amber, Marlboro Green Menthol, and Marlboro Blue Menthol HeatSticks.
The agency stressed that the authorization is limited.
The modified risk orders “do not permit the company to market the product with any other modified risk claim” that could mislead consumers into believing FDA endorsement or safety assurances, and the agency retains the authority to withdraw the orders if the products no longer meet the statutory public health standard.
Under the Tobacco Control Act, MRTP authorizations require the FDA to determine that marketing the products is “appropriate for the protection of public health,” taking into account both users and non-users of tobacco.
That standard—and how it is applied—has made MRTP decisions among the most consequential and closely scrutinized in the industry.
The IQOS products were first authorized for sale in the U.S. through the premarket tobacco product application (PMTA) pathway in 2019, with the initial MRTP authorization granted in 2020. The IQOS 3.0 system followed, receiving PMTA authorization in 2020 and MRTP authorization in 2022.
Those authorizations were time-limited, requiring periodic review and renewal based on updated scientific evidence. As part of the renewal process, FDA considered additional data, public comments, and input from the Tobacco Products Scientific Advisory Committee (TPSAC), which met in October 2025 to review the applications.
The agency also imposed ongoing requirements.
PMP S.A. must conduct postmarket surveillance and studies, including monitoring how consumers use the products and whether they understand the modified risk claims—an area regulators have increasingly focused on to assess real-world impact.
