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Tag: MRTP

  • FDA Posts New Materials for IQOS Renewal Applications

    FDA Posts New Materials for IQOS Renewal Applications

    The U.S. Food and Drug Administration announced today that its Tobacco Products Scientific Advisory Committee (TPSAC) will convene October 7, to evaluate the renewal applications of Philip Morris Products S.A. for its IQOS 2.4 and IQOS 3.0 heated-tobacco systems and associated HeatSticks. These devices were originally granted Modified Risk Tobacco Product (MRTP) orders in 2020 and 2022, allowing the marketing of reduced-exposure claims—specifically, that heating (not burning) tobacco significantly lowers exposure to harmful chemicals.

    The renewal will hinge on whether PMI can demonstrate that post-market evidence continues to support those claims under section 911(g)(2) of the Food, Drug, and Cosmetic Act.  The FDA has republished redacted application materials and opened a public comment period; speakers at the TPSAC meeting may submit data supporting or critiquing PMI’s dossier.

    “A vital mission of FDA is to make tobacco-related disease and death a part of America’s past,” officials from PMI said in a statement. “Smoke-free products, like IQOS, play a critical role in helping achieve that mission and provide adults who smoke with a real opportunity to change. IQOS, when marketed with the reduced-exposure claim, promotes complete switching and reduction in cigarette consumption.”

    Should the renewal be approved, PMI would retain authority to market IQOS with MRTP claims; if rejected, those claims could expire, undermining the company’s “reduced-exposure” positioning in the U.S. market.

    The outcome will not only be of interest for PMI, but for the broader heated tobacco and smoke-free sectors looking for regulatory precedents.

  • 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.

  • FDA Renews MRTPs for General Snus

    FDA Renews MRTPs for General Snus

    After a scientific review, the U.S. Food and Drug Administration issued a renewal of modified risk granted orders to Swedish Match USA, Inc., for eight General Snus products.

    With the renewal, the products may continue to be marketed – as they have been authorized to do so since 2019 – with the following modified risk claim: “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” 

    The products receiving modified risk granted orders are: General Loose, General Dry Mint Portion Original Mini, General Portion Original Large, General Classic Blend Portion White Large-12ct, General Mint Portion White Large, General Nordic Mint Portion White Large-12ct, General Portion White Large, and General Wintergreen Portion White Large.

    The modified risk granted orders issued by FDA are specific to the products as mentioned above and expire Nov. 7, 2032. If the agency determines that, among other things, the continued marketing of the products no longer benefits the health of the population as a whole, the agency may withdraw the orders.

    “The FDA’s review determined that this modified risk claim is supported by scientific evidence, that consumers understand the claim, and that consumers appropriately perceive the relative risk of these products compared to cigarettes,” the FDA stated in a release. “FDA found that these modified risk products, as actually used by consumers, will significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole.

    “In particular, the available scientific evidence, including long-term epidemiological studies, shows that relative to cigarette smoking, exclusive use of these products poses lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis. The available evidence does not indicate significant youth initiation of these products.”

    The modified risk granted order does 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 the agency deems the products to be safe for use by consumers.

  • Swedish Match Presents to FDA on General Snus

    Swedish Match Presents to FDA on General Snus

    Image: Tobacco Reporter archive

    Experts from Swedish Match USA, an affiliate of Philip Morris International, presented to the Tobacco Products Scientific Advisory Committee on June 26, 2024, according to a PMI press release. The committee, comprising independent scientific researchers, provides regulatory guidance to the U.S. Food and Drug Administration’s Center for Tobacco Products.

    The half-day meeting was part of the FDA’s review of Swedish Match’s request to continue marketing General Snus products in the U.S. as modified-risk tobacco products (MRTPs) and to expand permitted use of the reduced-risk claim to reach, and transition, more legal-age smokers away from cigarettes.

    Initially granted by the FDA in October 2019, Swedish Match can communicate to legal-age consumers that “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.” Currently, that message is accessible only on the General Snus website.

    Swedish Match presented to the committee real-world evidence showing the claim is delivering on its promise to reduce harm to individual tobacco users and benefit the health of the population and should be renewed.

    In its renewal submission, Swedish Match is seeking to expand use to additional lawful marketing channels, such as point-of-sale display and direct mail to age-verified consumers.

    “As FDA’s Center for Tobacco Products Director Brian King said when unveiling its new five-year strategic plan, this is a critical moment in the history of tobacco product regulation,” Gerry Roerty, general counsel for Swedish Match, said to committee members. The center’s mission is to make smoking-related disease and death a part of America’s past, and “today, together, we can meaningfully advance that goal,” Roerty told committee members.

    During the meeting, representatives from Swedish Match 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 evidence and research demonstrating low levels of use by unintended populations.

    General Snus is a smokeless tobacco product, traditionally produced in Sweden, that is nonfermented and air cured. The modified-risk products submitted for renewal include eight General Snus varieties that have been made available in the U.S. for more than a decade: General Snus Original (pouch); General Snus Original (loose); General Snus White (pouch); General Snus Mint (pouch); General Snus Wintergreen (pouch); General Snus Mini Mint (pouch); General Snus Classic Blend (pouch); and General Snus Nordic Mint (pouch).

    “We are understandably proud of our commitment to a cigarette-free America, which is achievable much faster if policy is guided by science,” said Stacey Kennedy, president of the Americas region and CEO of PMI’s U.S. business. “America’s 28 million adult smokers have been bombarded with misinformation about smoke-free products, which can cause confusion and prolong the most harmful form of nicotine consumption—smoking. We look forward to continuing dialogue with the FDA as it continues to consider renewal of this modified-risk authorization.”

    The General Snus products were first authorized as “appropriate for the protection of the public health” through the premarket tobacco product application (PMTA) process in 2015 following a PMTA submission earlier that same year.

    Since then, Swedish Match USA has submitted eight annual reports over as many years, the last four of which were combined with MRTP annual reporting.

  • MRTP Renewal Filed for General Snus

    MRTP Renewal Filed for General Snus

    On Nov. 30, 2023, the U.S. Food and Drug Administration filed for scientific review modified-risk tobacco product (MRTP) renewal applications submitted by Swedish Match USA for General Snus smokeless tobacco products, including:

    • General Loose;
    • General Dry Mint Portion Original Mini;
    • General Portion Original Large;
    • General Classic Blend Portion White Large, 12 count;
    • General Mint Portion White Large;
    • General Nordic Mint Portion White Large, 12 count;
    • General Portion White Large; and
    • General Wintergreen Portion White Large.

    In 2019, the FDA issued modified-risk granted orders for eight smokeless tobacco products made by Swedish Match USA. These orders expire in 2024. To continue marketing the MRTPs after the authorized five-year term, the company submitted an MRTP renewal application to the FDA.

    Starting Dec. 1, the public may submit comments on these applications on regulations.gov.

  • FDA Updates Reynolds MRTP

    FDA Updates Reynolds MRTP

    Courtesy: US FDA

    The U.S. Food and Drug Administration has added the redacted “September 14, 2020 Amendment: Timing to Respond to September 1, 2020, FDA Deficiency Letter” to R.J. Reynolds Tobacco Company’s modified-risk tobacco product (MRTP) applications.

    On Dec. 18, 2017, the FDA filed for substantive scientific review of six MRTP applications from R.J. Reynolds Tobacco Company for the following smokeless tobacco products: Camel Snus Frost, Camel Snus Frost Large, Camel Snus Mellow, Camel Snus Mint, Camel Snus Robust and Camel Snus Winterchill.

    On Oct. 25, 2022, R.J. Reynolds Tobacco Company requested to withdraw these applications from FDA review.

  • Reduced-Exposure Claim for IQOS 3

    Reduced-Exposure Claim for IQOS 3

    Photo: PMI

    The U.S. Food and Drug Administration has issued a modified-risk granted order authorizing Philip Morris Products to market the IQOS 3 system holder and charger with the following reduced-exposure information:

    • 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.
    • This reduced-exposure information is the same as the information previously authorized by FDA in July 2020 for an earlier version of the device.

    Today’s action follows the FDA’s review of a new modified-risk tobacco product (MRTP) application submitted by the company for the IQOS 3 system holder and charger. This MRTP application primarily cross-referenced the supplemental premarket tobacco product application for this device, which was authorized for legal sale and distribution in the United States in December 2020, as well as the MRTP application for the previous version of the device.

    The IQOS 3 device is similar in design to the previous version (with mainly aesthetic changes), uses the same tobacco source, and the company requested to use the same exposure reduction claim as authorized for the previous version of the device. Given these similarities, FDA largely relied on its past evaluations of the IQOS 3 device and previous version of the device in determining that the IQOS 3 device meets the authorization criteria to be marketed as an MRTP.

    Headquartered in Switzerland, Philip Morris is currently banned from importing the product into the United States following an adverse ruling in a patent dispute with BAT’s Reynolds American subsidiary.

    In an interview with Bloomberg, PMI CEO Jack Olczak said the company plans to manufacture IQOS in the U.S. to get around the import ban.