Top Takeaways:
- FDA initiates scientific review for ZYN MRTP claims – Swedish Match USA has submitted modified risk tobacco product applications for 10 ZYN pouch flavors in two nicotine strengths, with review kicked off June 17, 2025.
- Public comment period now open – Comments can be submitted via Regulations.gov (docket FDA‑2025‑N‑0835), and the review window remains open for at least 180 days after the final dossier is posted.
- ZYN marks first U.S. nicotine pouch brand authorized under PMTA – In January 2025, FDA cleared 20 ZYN products under the PMTA pathway, with MRTP applications seeking to further enable reduced-risk claims.
The U.S. Food and Drug Administration has begun its substantive scientific review of modified risk tobacco product (MRTP) applications submitted by Swedish Match USA for its ZYN nicotine pouch line.
Sam Dashiell, Regulatory Communications with Swedish Match parent Philip Morris International U.S., told Nicotine Insider that it is a positive development that FDA is making progress with the MRTP applications.
“We hope for an expeditious review. Swedish Match has presented the agency with a substantive scientific package that the company believes supports authorizing ZYN as appropriate to promote public health, he said. “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.”
The review marks a pivotal moment for nicotine pouches, which already made regulatory history when 20 ZYN products earned premarket tobacco product application (PMTA) authorization in January 2025.
Swedish Match has submitted MRTP applications for ten ZYN flavors—Chill, Cinnamon, Citrus, Coffee, Cool Mint, Menthol, Peppermint, Smooth, Spearmint, and Wintergreen—each in 3 mg and 6 mg strengths, totaling 20 products. The public comment period begins June 18 via Regulations.gov under docket FDA‑2025‑N‑0835, and will remain open for at least 180 days after all documentation is posted.
FDA’s PMTA authorization earlier this year determined that ZYN products met the public health standard under the 2009 Tobacco Control Act, clearing the brand as the first nicotine pouches approved for U.S. sale. The subsequent MRTP filing seeks to allow Swedish Match to market ZYN with claims such as “lower risk” compared to cigarettes.
“For adults switching from cigarettes, nicotine pouches can significantly reduce exposure to harmful tobacco constituents,” said an FDA spokesperson in January, summarizing the agency’s rationale for PMTA approval.
The FDA’s review will examine whether ZYN’s flavor and nicotine strength mix supports population-level harm reduction without encouraging youth initiation. Public comments and FDA transparency—posting redacted documents as they are reviewed—will collectively shape the outcome. Once the complete submission is available, a closing deadline will be set, at least 30 days after full disclosure and not sooner than 180 days from the Federal Register notice .
Background metrics underscore ZYN’s impact: by late 2021, the brand was in over 120,000 U.S. stores and drove 60–65% of the pre-2022 nicotine pouch category.
Its bold move—aligning with Swedish Match’s 2022 acquisition by PMI U.S. and the company’s pledge to grow smoke-free revenue to 66% by 2030—reflects a broader shift in tobacco-industry strategy. ZYN’s rapid growth—384.8 million cans sold in 2023, up 62% year-over-year—fueled massive profit gains and boosted PMI’s stock, with PMI reporting a 20% rise in smoke-free revenue during Q1 2025.
Swedish Match’s president in North America, Tom Hayes, praised the FDA decisions: “The FDA’s decision recognizes the role that ZYN can play in the protection of the public health by helping people switch from cigarettes and other traditional tobacco products,” he said.
But regulatory timelines linger. The PMTA process took nearly five years, delaying MRTP authorization. Citigroup analysts warned that the unpredictability “creates a barrier to innovation.”
A favorable MRTP outcome could unlock explicit marketing claims around reduced risk, boosting ZYN’s market position. A denial, however, would intensify scrutiny on flavored nicotine products and youth access.
