FDA Grants ZYN Nicotine Pouches Modified Risk Status Compared to Cigarettes

The United States (US) Food and Drug Administration (FDA) on June 30, 2026, issued modified risk granted orders to Swedish Match USA for 20 ZYN nicotine pouch products, authorizing them to be marketed 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."¹ The action marks the first time a nicotine pouch product has received modified risk tobacco product (MRTP) designation — a separate regulatory pathway from the premarket tobacco product application (PMTA) approval the same 20 ZYN products received in January 2025.

The 20 products span 10 flavors — ZYN Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen — each available in 3 mg and 6 mg nicotine strengths. The orders expire in 5 years, and Swedish Match is required to conduct postmarket surveillance including ongoing assessment of user behavior and consumer understanding of the risk claim. The FDA may withdraw the orders if continued marketing no longer benefits population health — for instance, if significant youth uptake is observed.¹

What the MRTP pathway requires

Under the Family Smoking Prevention and Tobacco Control Act, an MRTP order requires a manufacturer to demonstrate that the product, as actually used by consumers, will significantly reduce individual harm and the risk of tobacco-related disease, and benefit the population as a whole — accounting for both tobacco users and nonusers. The standard is distinct from and more demanding than PMTA authorization, which establishes that a product is "appropriate for the protection of public health."¹

In its review, the FDA evaluated relative health risks of the products, consumer understanding and perception of the proposed claim, data on youth exposure risk, and the potential population-level impact of permitting the claim. The agency concluded that the claim is scientifically accurate with respect to these products, that consumers understand it, and that marketing with the claim would benefit the population as a whole.¹ The FDA also weighed recommendations from the January 22, 2026, Tobacco Products Scientific Advisory Committee (TPSAC) meeting, public comments, and other scientific information.¹

Evidentiary basis and limitations

The MRTP application did not include observational or clinical studies directly measuring long-term health outcomes in ZYN users, and the FDA's own TPSAC briefing document acknowledged that such data for nicotine pouches remain limited.² To support the proposed risk claim, Swedish Match submitted epidemiological literature from Swedish snus — a smokeless tobacco product with similar use topography, nicotine content, pH, and systemic nicotine exposure — as a proxy for ZYN's long-term risk profile, an extrapolation the FDA accepted in its 2025 PMTA review.²

The FDA's PMTA toxicology review, however, also conducted direct chemical analysis of ZYN's constituents and found the products lower in harmful and potentially harmful chemicals (HPHCs) than not only combusted cigarettes but also General Snus — the smokeless tobacco product used as the epidemiological comparator. Of 42 HPHCs analyzed, 36 were below quantifiable levels, and the products contained no detectable quantities of the carcinogenic tobacco-specific nitrosamines NNN and NNK, or the polycyclic aromatic hydrocarbon benzo[a]pyrene (B[a]P). The FDA cited the absence of measurable NNN — identified as the predominant driver of excess oral cancer risk in smokeless tobacco users — as having particular clinical relevance. ZYN also produced no genotoxic effects in nonclinical toxicology studies (Ames test, in vitro micronucleus assay), in contrast to combusted cigarettes.¹ The FDA concluded in the PMTA context that adults who smoke and switch completely to these products would be expected to experience reduced risk of cancer, respiratory toxicity, and cardiovascular toxicity.²

The absence of long-term ZYN-specific epidemiological data remains a recognized gap; whether the favorable constituent profile translates to the disease risk reductions implied by the MRTP claim will require the postmarket surveillance studies the FDA has required as a condition of the orders.¹

Clinical context

Nicotine pouches are small fiber pouches placed between the gum and lip, delivering nicotine via oral absorption without combustion or smoke. ZYN contains substantially lower levels of harmful and potentially harmful chemicals (HPHCs) than cigarettes, a finding the FDA cited in both the 2025 PMTA decision and today's MRTP orders.¹ The FDA noted that youth nicotine pouch use prevalence is currently relatively low, and that exposure to the modified risk claim did not increase intentions to use ZYN among young adults in consumer perception studies.²

The FDA emphasized that there is no safe tobacco product and that complete cessation of all tobacco and nicotine products remains the most beneficial option for health. Switching completely from cigarettes to FDA-authorized nicotine pouches — rather than dual use — may reduce exposure to many harmful chemicals found in cigarettes.¹ To date, the FDA has authorized 26 nicotine pouch products in total.¹

References

1. US Food and Drug Administration. FDA authorizes 20 ZYN nicotine pouches to be marketed with specific modified risk claim. June 30, 2026. https://www.fda.gov/tobacco-products/ctp-newsroom/fda-authorizes-20-zyn-nicotine-pouches-be-marketed-specific-modified-risk-claim

2. US Food and Drug Administration. FDA briefing document: January 22, 2026, meeting of TPSAC on Swedish Match USA, Inc. MRTPAs for 20 ZYN nicotine pouch products. https://www.fda.gov/media/190650/download