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  • FDA Releases Meeting Materials for Zyn’s MRTP Application  

    FDA Releases Meeting Materials for Zyn’s MRTP Application  

    Today (January 20), the U.S. Food and Drug Administration released meeting materials ahead of a virtual meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) to review modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc. for 20 Zyn nicotine pouch products. The materials include a draft agenda, background documents from both the applicant and the FDA, and draft questions for committee consideration, and are available on the FDA’s 2026 TPSAC Meeting Materials and Information page.

    The virtual TPSAC meeting is scheduled for January 22. FDA opened Docket No. FDA-2025-N-0835-0020  for public comments related to the meeting, with submissions due by 11:59 p.m. ET on January 21. Comments specific to the ZYN MRTP applications may also be submitted under a separate docket, Docket No. FDA-2025-N-0835-0001, which was established on June 18, 2025.

    Visit the event webpage to learn more about attending the meeting online

  • FDA Schedules TPSAC Review of ZYN Applications

    FDA Schedules TPSAC Review of ZYN Applications

    The U.S. Food and Drug Administration announced a January 22, 2026, virtual meeting of the Tobacco Products Scientific Advisory Committee (TPSAC) to review modified risk tobacco product (MRTP) applications submitted by Swedish Match USA for 20 ZYN nicotine pouch products. These products—already authorized for sale through the PMTA pathway in January 2025—include flavors such as Cool Mint, Citrus, Coffee, Peppermint, and Wintergreen, each in 3 mg and 6 mg strengths. The company is seeking permission to market the pouches with the claim: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

    Under federal law, MRTP applications must demonstrate that a product, as actually used by consumers, reduces individual health risks and benefits overall population health. TPSAC’s review will focus on scientific evidence regarding ZYN’s relative health risks, consumer comprehension of the proposed claim, and the potential public health impact of granting a modified risk order. The meeting will be held virtually, open to the public, captioned, and recorded.

    Public comments may be submitted to Docket No. FDA-2025-N-0835 through January 21, 2026, with comments received by January 7 provided directly to TPSAC. The FDA is also inviting individuals to request oral presentation slots during the meeting’s public comment period. Redacted MRTP application materials are available on the FDA’s website, and the agency will consider all public input and TPSAC recommendations before issuing a final decision.

  • Philip Morris Urges FDA TPSAC to Recommend Continued Modified-Risk Marketing of IQOS

    Philip Morris Urges FDA TPSAC to Recommend Continued Modified-Risk Marketing of IQOS

    Experts from Philip Morris International presented evidence to the Tobacco Products Scientific Advisory Committee (TPSAC), according to a PMI press release. The committee, comprised of independent scientific researchers, provides nonbinding recommendations to the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP).

    The full-day meeting on October 7 was part of the FDA’s customary review of PMI’s request to continue marketing versions of its IQOS heated-tobacco products in the U.S. as modified-risk tobacco products (MRTPs), a necessary step while FDA completes its review of pending applications for IQOS ILUMA (a later version of the IQOS models that are currently authorized by the FDA) to reach and transition even more legal-age adults away from combustible cigarettes.

    “The evidence presented at this meeting, as also noted by the FDA, further supports the agency’s original conclusions that led the FDA to authorize the IQOS system as a modified-risk tobacco product,” said Stacey Kennedy, PMI U.S.’ CEO. “We encourage the FDA to continue efforts to establish a timely scientific review process for smoke-free products—including for IQOS ILUMA, which has been pending FDA review for nearly two years and has globally shown even higher rates of legal-age adults fully switching from combustible cigarettes—that are a better choice for legal-age adults who would otherwise use traditional tobacco products, including combustible cigarettes.”

    Initially granted by the FDA in 2020, the MRTP designation for the IQOS system authorizes PMI to communicate to legal-age consumers that: “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.”

    During the meeting, representatives from PMI and committee members discussed a range of scientific, technical, and consumer-communications topics. The company provided an overview of its responsible marketing practices and presented additional evidence and research demonstrating high levels of complete switching among current legal-age smokers while maintaining low levels of use by unintended populations.

    Addressing committee members, Keagan Lenihan, VP and Chief External Affairs Officer for PMI U.S., said: “CTP’s mission is to make tobacco-related disease and death a part of America’s past. Smoke-free products, like PMI’s IQOS system, play a critical role in helping CTP achieve this mission and provide adults who smoke with a real opportunity to change. The IQOS system, when marketed with the reduced-exposure claim, promotes complete switching from combustible cigarettes.”

  • FDA Begins Review of Zyn’s Modified Risk Claim

    FDA Begins Review of Zyn’s Modified Risk Claim

    The U.S. Food and Drug Administration (FDA) has officially begun its scientific review of modified risk applications for 20 Zyn nicotine pouch products, submitted by Swedish Match USA, Inc.

    Already authorized for sale in January 2025, the company is now seeking permission to market Zyn with a health-related claim: “Using Zyn instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”

    FDA’s review will assess whether this claim is scientifically and legally justified under the Modified Risk Tobacco Product (MRTP) process. The agency will issue a final decision after reviewing scientific evidence, public comments, and recommendations from its Tobacco Product Scientific Advisory Committee (TPSAC).

    “It is a positive development that FDA is progressing the MRTP applications and we hope for an expeditious review,” a PMI spokesperson said. “Swedish Match has presented the agency with a substantive scientific package that the company believes supports authorizing ZYN as appropriate to promote public health. Providing accurate information on the relative risk of different nicotine products to America’s 45 million legal-age nicotine consumers will help accelerate switching to better alternatives than continued cigarette use—the most harmful form of nicotine consumption.”

    Public comments open June 18 at regulations.gov under docket FDA-2025-N-0835. The comment period will remain open for at least 180 days after publication of the Federal Register notice.

    TPSAC meeting details and redacted application materials will be released on a rolling basis at the FDA’s Center for Tobacco Products website.

  • Swedish Match MRTP Comments Due July 5

    Swedish Match MRTP Comments Due July 5

    The U.S. Food and Drug Administration posted the final set of application materials related to renewing existing modified-risk tobacco product (MRTP) orders for Swedish Match U.S.A.’s General Snus products.

    The agency announced a deadline for public comments. To ensure they receive consideration by FDA, the applications must be submitted to the docket by 11:59 p.m. EDT on July 5, 2024.

    The application materials, redacted in accordance with applicable laws, can be found on the FDA’s website. “Before making a final determination on an MRTP application, FDA considers all information available to the agency, including public comments and recommendations from the Tobacco Products Scientific Advisory Committee (TPSAC),” a release states.

    The FDA recently announced a TPSAC meeting to discuss these renewal applications, scheduled for June 26, 2024, which the public is able to attend in person at the FDA White Oak Campus or virtually. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

    Written submissions may be made to the contact person on or before June 20, 2024.

  • FDA Seeks Nominations for TPSAC

    FDA Seeks Nominations for TPSAC

    Image: freshidea

    The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) is requesting nominations by Oct. 11, 2023, for a nonvoting representative of the interests of the tobacco manufacturing industry to serve on the Tobacco Products Scientific Advisory Committee (TPSAC). Individuals may self-nominate or be nominated by any interested person or organization.

    In addition, the CTP is seeking any industry organizations interested in participating in the selection of this TPSAC nonvoting representative.

    Nomination materials for prospective TPSAC candidates and letters from industry organizations interested in participating in the selection process should be sent to the CTP by Oct. 11, 2023. Please see the Federal Register notice for further details on the nomination and selection procedures.

    TPSAC advises the CTP in its responsibilities related to the regulation of tobacco products. The committee reviews and evaluates safety, dependence and health issues concerning tobacco products and provides appropriate advice, information and recommendations to the FDA commissioner.

  • TPSAC Meeting Materials Available

    TPSAC Meeting Materials Available

    Credit: Postmodern Studio

    The U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) met on May 18 to discuss the “Requirements for Tobacco Product Manufacturing Practice” proposed rule. All the meeting materials, including the recording, transcript and summary minutes, are now available online.

    The proposed rule, if finalized, lays out the FDA’s requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of tobacco products.

    Comments on the proposed rule must be submitted by 11:59 p.m. Eastern Time on Sept. 6, 2023.

  • TPSAC to Discuss Proposed Rule

    TPSAC to Discuss Proposed Rule

    Image: Tobacco Reporter archive

    The Tobacco Products Scientific Advisory Committee (TPSAC) will hold a meeting to discuss the Requirements for Tobacco Product Manufacturing Practice proposed rule on May 18, 2023, from 9 a.m. to 2 p.m.

    The proposed rule is open for public comment until Sept. 6, 2023.

    The TPSAC meeting will be available via a free webcast. Electronic or written comments on the meeting must be submitted by May 11 for consideration by the committee.