PMI says it submitted evidence to FDA panel backing ZYN bid for modified-risk status

Key Points

• PMI submitted evidence at the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) meeting to support ZYN’s application for a modified risk tobacco product (MRTP) designation, enabling communications to U.S. adult smokers aged 21 and over that fully switching may reduce certain smoking-related risks.
• The proposed MRTP claim covers risk reductions for six diseases; PMI cited FDA meeting materials saying the claim is “scientifically accurate.”
• Key evidence includes that ZYN contains substantially lower levels of harmful chemicals than cigarettes and was assessed for its ability to help smokers switch completely.
• PMI also emphasized the need to limit impacts on youth and other non-target groups.
• ZYN received FDA marketing authorization via the PMTA pathway in January 2025; the MRTP application covers multiple flavors and 3 mg/6 mg nicotine strengths.

2Firsts, January 26, 2026

According to Business Wire, Philip Morris International (PMI) said its expert team presented scientific evidence at the U.S. Food and Drug Administration’s (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) meeting, urging the committee to recommend that the FDA grant ZYN nicotine pouches a modified risk tobacco product (MRTP) designation.

If approved, the designation would allow PMI to communicate to adult smokers of legal age (21 and over) in the United States that switching completely to ZYN could reduce the risk of multiple smoking-related diseases.

PMI said the all-day meeting, held on January 22 local time, was part of the FDA’s review of an MRTP application submitted by PMI affiliate Swedish Match USA Inc. The application proposes the following reduced-risk statement: “Switching completely from cigarettes to ZYN reduces the risk of oral cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.” In its release, PMI cited FDA meeting materials stating that “the evidence demonstrates that the proposed modified risk claim is scientifically accurate.”

PMI added that data presented at the meeting indicated the proposed statement could improve audience understanding that switching from cigarettes to ZYN may reduce the six health risks listed, while consumers can also recognize that ZYN is not risk-free but poses a significantly lower risk than continuing to smoke.

The company said the evidence reviewed by the committee included findings that ZYN contains substantially lower levels of harmful chemicals than cigarettes, and data evaluating its performance in helping smokers achieve a “complete switch.” It also stressed that impacts on youth and other non-target populations should be kept low.

On regulatory progress, PMI said ZYN received FDA marketing authorization via the premarket tobacco product application (PMTA) pathway in January 2025. The MRTP submission covers the same portfolio of PMTA-authorized ZYN products, including flavors such as Cool Mint, Peppermint, Spearmint, Wintergreen, Citrus, Coffee, Cinnamon, Smooth, Chill and Menthol, and includes nicotine strengths of 3 mg and 6 mg.

Cover image source: PMI website.