TobaccoReporter logo

Tag: modified risk

  • PMI Announces FDA Reauthorization of IQOS as MRTP

    PMI Announces FDA Reauthorization of IQOS as MRTP

    Today (April 29), Philip Morris announced that it has received renewed Modified Risk Tobacco Product (MRTP) authorizations from the U.S. Food and Drug Administration for its IQOS heated tobacco devices and associated HEETS consumables. The renewal covers two IQOS device versions and three HEETS variants, allowing the company to continue communicating reduced-exposure information to adult smokers in the U.S. The FDA said the decision is appropriate for the protection of public health, citing evidence that switching completely from cigarettes to IQOS significantly reduces exposure to harmful chemicals.

    The agency reaffirmed that available scientific evidence supports a measurable and substantial reduction in harm compared to combustible cigarettes, even without long-term epidemiological data. IQOS was first authorized through the FDA’s premarket pathway in 2019, with its initial MRTP designation granted in 2020 and expanded in subsequent years. The renewed orders maintain PMI’s position as the only company with MRTP authorizations for heated tobacco products in the U.S.

    The authorization applies to the IQOS 2.4 and IQOS 3 systems, along with HEETS Amber, Green Menthol and Blue Menthol variants. PMI said the decision supports its ongoing strategy to transition adult smokers away from cigarettes, as the company continues to invest in and expand its smoke-free product portfolio while awaiting further regulatory review of newer devices.

  • 22nd Century Files PMTA Renewal

    22nd Century Files PMTA Renewal

    22nd Century Group, Inc. announced it has filed a renewal application with the U.S. Food and Drug Administration for its Modified Risk Tobacco Product authorization covering VLN reduced nicotine content cigarettes. The original authorization, granted in December 2021, expires in December 2026.

    22nd Century says VLN remains the first and only combustible cigarette authorized by the FDA to reduce the health harms of smoking, with approved claims including “95% less nicotine” and statements that it helps reduce nicotine consumption and smoking frequency. The company cited decades of independent clinical research supporting VLN products, including evidence that lowering nicotine content reduces smoking rates and increases quit attempts. Company CEO Larry Firestone said the renewal builds on FDA recognition that reducing nicotine directly can alter smoking behavior and improve public health outcomes, adding that VLN products align with the FDA’s proposed low-nicotine standard issued in January 2025.

  • FDA Establishes Closing Date for Public Comments on MRTP Renewal Applications for IQOS Products

    FDA Establishes Closing Date for Public Comments on MRTP Renewal Applications for IQOS Products

    Today (November 6, 2025), FDA established the closing date for the public comment period on the modified risk tobacco product (MRTP) renewal applications submitted by Philip Morris Products S.A. for several IQOS heated tobacco products. Public comments on these applications must be submitted to the appropriate docket by 11:59 p.m. ET on December 8, 2025, to ensure they are considered by FDA:

    The application materials, redacted in accordance with applicable laws, can be found on FDA’s website. 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).

    FDA held a TPSAC meeting to discuss these renewal applications on October 7, 2025. The public was able to attend virtually and present comments to the committee. Materials from the meeting are available on FDA’s website.

    For the latest updates on any MRTP applications under scientific review, sign up to receive email alertsExternal Link Disclaimer.