June 2026: FDA Authorizes 20 ZYN Nicotine Pouches to Be Marketed with Specific Modified Risk Claim
The U.S. Food and Drug Administration (FDA) has issued modified risk granted orders to Philip Morris International (PMI) for 20 ZYN nicotine pouch products. This decision allows these specific products – which have been authorized for sale in the United States since January 2025 – to be marketed with the following claim:
“Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
According to the agency, the review of modified risk tobacco products (MRTP) is designed to provide adult users with science-based information regarding the relative harms of tobacco products. The authorized claim applies exclusively to the 20 specified products and does not extend to the entire ZYN portfolio, excluding ZYN Ultra line-up. Each of the following varieties received the order in both 3-milligram and 6-milligram nicotine strengths:
| ZYN Chill | ZYN Cinnamon | ZYN Citrus | ZYN Coffee | ZYN Cool Mint |
| ZYN Menthol | ZYN Peppermint | ZYN Smooth | ZYN Spearmint | ZYN Wintergreen |
The FDA determination followed a scientific review of PMI’s MRTP applications, which evaluated the relative health risks to tobacco users, consumer perception of the proposed claim, youth risk data, and overall population impact. The agency concluded that the specific risk modification claim is scientifically accurate for these products, is understood by consumers, and that marketing the products with this information benefits public health. The evaluation also incorporated recommendations from the January 22, 2026, Tobacco Products Scientific Advisory Committee meeting, public comments, and independent scientific data.
While new tobacco products can be legally sold via the standard premarket tobacco product application (PMTA) pathway, the optional MRTP pathway allows manufacturers to communicate lower disease risks directly to consumers. The FDA initially authorized these 20 products through the PMTA pathway on January 16, 2025. To date, the agency has authorized a total of 26 nicotine pouch products under the statutory public health standard.
Under the terms of the authorization, PMI must conduct post-market surveillance and studies to assess user behavior and consumer understanding of the risk-related information. The orders will expire in five years, though the company may request a renewal before that time. The FDA retains the authority to withdraw the orders if it determines that marketing the products as MRTPs no longer benefits population health, such as in the event of a significant increase in youth uptake.
April 2026: FDA Renews Authorization for Five IQOS Products to be Marketed with Exposure Modification Claims
Following scientific review, FDA issued a renewal of modified risk granted orders to Philip Morris International (PMI) 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
– IQOS 3.0 System Holder and Charger
– Marlboro Amber HeatSticks (previously Marlboro HeatSticks)
– Marlboro Green Menthol HeatSticks (previously Marlboro Smooth Menthol HeatSticks)
– Marlboro Blue Menthol HeatSticks (previously Marlboro Fresh Menthol HeatSticks)
The modified risk granted orders issued by FDA are specific to the above-mentioned products. FDA’s review found that the available new scientific evidence is generally consistent with the evidence reviewed in the original Modified Risk Tobacco Product (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.
If at any point the agency determines that, among other things, the continued marketing of the products as MRTPs no longer benefits the health of the population as a whole, the agency may withdraw the orders.
September 2025: New materials are posted for MRTP renewal applications of IQOS products
U.S. FDA previously issued modified risk granted orders (MRGOs) authorizing Philip Morris International (PMI) to market the following products with specific reduced exposure claims:
– IQOS 2.4 System Holder and Charger and HeatSticks (Authorized July 7, 2020)
– IQOS 3.0 System Holder and Charger (Authorized March 11, 2022)
These products were authorized to be marketed with the following reduced exposure information:
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.
On May 9, 2024, FDA filed for scientific review modified risk tobacco product (MRTP) renewal applications submitted by PMI for IQOS 2.4, IQOS 3.0, Marlboro Amber HeatSticks (formerly, Marlboro HeatSticks), Marlboro Green Menthol HeatSticks (formerly, Marlboro Smooth Menthol HeatSticks) and Marlboro Blue Menthol HeatSticks (formerly, Marlboro Fresh Menthol HeatSticks). The original 2020 and 2022 MRGOs are valid for the fixed time period specified in the order. PMI submitted an MRTP renewal application for FDA to determine whether the product still satisfies the requirements in section 911(g)(2) of the Federal Food, Drug, and Cosmetic Act. Renewal applications may cross-reference other applications, including an applicant’s original MRTP application as well as postmarket annual reports submitted in accordance with order requirements for both the Premarket Tobacco Application (PMTA) and MRTP application. Annual reports for MRTPs contain the cumulative results from the postmarket surveillance and studies that all companies are required to conduct as part of a modified risk granted order.
On October 7, 2025, the Tobacco Products Scientific Advisory Committee (TPSAC) will meet to discuss the MRTP renewal applications. The meeting will be open to the public. Once all materials from these MRTP renewal applications are posted, FDA will announce the closing date for the comment period, which will be no earlier than 180 days from the date of the Federal Register notice and at least 30 days from the date FDA posts the last application materials1.
June 2025: FDA initiates the scientific review for the MRTP applications of 20 ZYN variants
FDA issued a filing letter for the Modified Risk Tobacco Product (MRTP) applications of 20 ZYN nicotine pouch products. This action initiates the substantive scientific review portion of the MRTP application review process. During FDA’s review, the Agency will determine whether the applications provide the necessary evidence for ZYN to be marketed with a modified risk claim. ZYN-owner, Philip Morris International (PMI) is seeking to market the 20 ZYN nicotine pouch products with the following modified risk 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 ultimately determine whether the scientific and legal standards are met to market ZYN as a modified risk tobacco product and will issue an order letter either granting or denying the application. Recall that following an extensive scientific review of the Premarket Tobacco Product Applications (PMTAs), the FDA authorized 20 ZYN products for sale in the U.S. in January 2025.
Starting June 18, 2025, the public may submit comments on these applications on regulations.gov to FDA-2025-N-0835. FDA will post application documents, including amendments, to the CTP website. Once all materials for these applications have been made publicly available, FDA will announce a closing date for the comment period. The closing date will be no earlier than 180 days from the date of the Federal Register notice and at least 30 days from the date FDA posts the last group of application materials. In addition to the public comment, and consistent with requirements of the 2009 Family Smoking Prevention and Tobacco Control Act, FDA’s Tobacco Product Scientific Advisory Committee (TPSAC) will be convened to discuss the merits of the application.
November 2024: FDA renews the reduced-risk claim authorization for 8 General snus products
Following scientific review, FDA issued a renewal of modified risk granted orders to Philip Morris International (PMI)’s Swedish Match USA affiliate for eight General Snus products. Renewal allows Swedish Match to continue to use the following modified risk claim in marketing these products: “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 will expire on November 7, 2032 if not withdrawn by the Agency earlier due to a change in assessment (i.e. continued marketing of the products no longer benefits the health of the population as a whole).
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. 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.
This is the first renewal of modified risk granted orders issued by FDA. The above-mentioned products were originally authorized for marketing in the U.S. via the premarket tobacco product application (PMTA) pathway in 2015. In October 2019, the products were then authorized to be marketed as modified risk tobacco products (MRTP). The 2019 orders permitting marketing of General Snus products as modified risk tobacco products were valid for 5 years. To continue marketing the products after the set terms of the 2019 orders, Swedish Match USA, submitted MRTP renewal applications.
May 2024: TPSAC meeting for General snus will take place on June 26, 2024
FDA announced that a Tobacco Products Scientific Advisory Committee (TPSAC) meeting is scheduled on June 26, 2024 to discuss the renewal of risk modification order submitted by Swedish Match USA (a fully-owned affiliate of Philip Morris International) for eight General loose snus and portioned snus products:
– General Loose
– General Dry Mint Portion Original Mini
– General Portion Original Large
– General Classic Blend Portion White Large (12 ct)
– General Mint Portion White Large
– General Nordic Mint Portion White Large (12 ct)
– General Portion White Large
– General Wintergreen Portion White Large
At the TPSAC meeting, additional discussion about broader MRTP program developments, related to the conceptualization and measurement of consumer understanding, will also take place.
PMI submitted the MRTP renewal application for General Snus in July 2023 and the MRTP renewal due date is October 2024. The most critical point to watch out will be the TPSAC’s recommendation on the 4 Mint / Wintergreen variants and whether (or not) the risk modification orders will eventually be renewed for these variants.
PMI also submitted the MRTP renewal application for IQOS3 in July 2023 (- MRTP renewal due date: July 2024).
November 2023: US FDA announces the filling of MRTP renewal applications for General Snus
US FDA announced the filling of MRTP renewal applications submitted by PMI/Swedish Match (for the 8 General Snus smokeless tobacco products, including 4 Mint/Wintergreen variants) for scientific review. US FDA granted these modified risk orders in 2019 and, to continue marketing the MRTPs after the authorized five-year term, PMI/SWMA submitted an MRTP renewal application.
Starting tomorrow, the public may submit comments on these applications. Once all materials for these MRTP applications, including amendments, have been made publicly available, FDA will announce a closing date for the comment period. The closing date will be no earlier than 180 days from the date of the Federal Register notice and at least 30 days from the date FDA posts the last application materials.
PMI submitted the MRTP renewal application for IQOS3 and General Snus in July 2023. MRTP renewal due date is July 2024 for IQOS3 and October 2024 for General Snus.
Background:
A Modified Risk Tobacco Product (MRTP) application is submitted to obtain FDA modified risk order. The application must demonstrate that the product will benefit the health of the population as a whole2.
16 MRTP orders are granted so far.
– 13 of these belong to PMI: 5 for IQOS (heat-not-burn tobacco) and 8 for General Snus (owned through the Swedish Match acquisition)
– 2 belong to the 22nd Century Group for regular/menthol very low nicotine cigarettes
– In March 2023, FDA authorized Altria (UST) to market Copenhagen Classic Snuff as a MRTP with the claim: “If you smoke, consider this: Switching completely to this product from cigarettes reduces risk of lung cancer”.
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