Key facts
- The FDA will allow Philip Morris International to market Zyn nicotine pouches as less harmful than cigarettes.
- The marketing claim states that using Zyn instead of cigarettes lowers the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.
- This authorization applies to 20 variants of Zyn products.
- Zyn is the fastest-growing nicotine product in the U.S.
- Zyn received marketing authorization from the FDA in January 2025.
The U.S. Food and Drug Administration (FDA) has authorized Philip Morris International (PMI) to market its Zyn nicotine pouches with claims that they pose a lower risk of certain diseases compared to cigarettes. This decision, reported by Reuters and Axios, allows PMI to state that using Zyn instead of cigarettes reduces the risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis for 20 variants of the product.
Zyn, a popular nicotine pouch product inserted under the lip, is the fastest-growing nicotine product in the U.S. The FDA's review process involved scientific evidence presented by PMI to its Tobacco Products Scientific Advisory Committee (TPSAC). In a preliminary review, FDA scientists indicated that the proposed modified risk claim appears to be scientifically accurate. They also noted that youth use of nicotine pouches is currently low and that viewing the claim did not increase intentions to use Zyn among young adults.
Philip Morris International's U.S. family of businesses had sought a Modified Risk Tobacco Product (MRTP) designation. The company presented data suggesting ZYN contains substantially lower levels of harmful chemicals than cigarettes and promotes complete switching from combustible products. The FDA had previously granted Zyn marketing authorization in January 2025 through the Premarket Tobacco Product Authorization (PMTA) pathway, making it the first nicotine pouch to receive such approval. Data presented also indicated that consumers understood ZYN products are not entirely risk-free but carry significantly lower risks than continuing to smoke cigarettes.