By Timothy S. Donahue
The Food and Drug Administration has announced that its Tobacco Products Scientific Advisory Committee (TPSAC) will hold a virtual meeting on January 22, 2026, to review the modified risk tobacco product (MRTP) applications submitted by Swedish Match USA, Inc., for 20 of its ZYN nicotine pouch products.
These ZYN products, which were authorized for sale in the U.S. through the PMTA pathway in January 2025, are available in two nicotine strengths (3 mg and 6 mg) and come in various flavors, including Cool Mint, Citrus, Coffee, Peppermint, and Wintergreen.
In its MRTP applications filed June 17, 2025, Swedish Match seeks permission to market ZYN 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 U.S. law, granting a modified risk order requires the product to demonstrate that its marketing will “benefit the health of the population as a whole” and reduce risks and exposures compared to continued cigarette use. TPSAC’s upcoming review will assess scientific evidence of ZYN’s relative risk, how consumers interpret the proposed claim, and the potential effects on public health.
The FDA has initiated a public comment period on docket FDA-2025-N-0835. Comments can be submitted until January 21, 2026; those received by January 7 will be forwarded directly to TPSAC. Individuals can also request oral presentation slots for the virtual meeting.
This review builds on the earlier milestone of January 16, 2025, when the FDA authorized the marketing of the same 20 ZYN nicotine pouch products under the PMTA pathway – the first nicotine pouch authorizations in the U.S. The agency noted that these authorized products contained significantly lower levels of harmful and potentially harmful constituents compared to cigarettes and most smokeless tobacco products.
Industry observers view the upcoming TPSAC meeting as a crucial point for the development of smoke-free products. A Swedish Match spokesperson told analysts. “Swedish Match has presented the agency with a substantive scientific package that the company believes supports authorizing ZYN as appropriate to promote public health,” the spokesperson said.
For stakeholders throughout the tobacco and nicotine industry, the outcome of this meeting will be significant in at least three areas: the precedent for modified-risk claims on nicotine-pouch products, the regulatory burden related to population-level health benefit assessments, and the marketing environments for adult-use smokeless alternatives.
Periodically, the FDA may revoke marketing granted orders if post-market surveillance shows that the product no longer meets public health standards. The agency warned in its January 2025 authorization that youth use remains low but will be closely monitored.
