FDA allows Zyn pouches to be marketed as less harmful than cigarettes
The agency said 20 Zyn products can carry a lower-risk claim after finding that switching from cigarettes may reduce several major disease risks.
- On Tuesday, the Food and Drug Administration authorized Philip Morris-owned Zyn nicotine pouches to be marketed as posing "lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis" than cigarettes.
- This decision follows heavy lobbying from tobacco companies for a clearer authorization process, marking the first time the FDA granted modified-risk status to nicotine pouches following robust scientific review.
- Extensive data showed a majority of adult users reduced cigarette consumption after starting Zyn, with over half reporting no cigarette use in the past 30 days.
- The American Lung Association called the move "appalling", expressing deep concern that flavored nicotine pouches attract youth and are not approved as products to help people quit.
- Swedish Match USA must monitor consumer risk perceptions for five years, as regulators may revoke the modified-risk orders if evidence shows significant increases in youth uptake.
33 Articles
33 Articles
FDA authorizes marketing of risk modification claim on Zyn nicotine pouches
The FDA has authorized marketing of a risk modification claim on 20 Zyn nicotine pouch products that were authorized for sale in the U.S. last year.According to an FDA press release, marketing of these products can now include the modified risk claim that “using Zyn instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic
FDA to allow Zyn nicotine pouches to be marketed as less harmful than cigarettes
The Food and Drug Administration will allow Philip Morris International to market Zyn nicotine pouches as presenting a lower health risk than cigarettes. The decision announced Tuesday authorizes 20 varieties of Zyn to carry language stating that “using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” The order does not declare the products safe, but it al…
The decision of the U.S. Food and Drug Administration (FDA) to authorise the placing on the market of 20 products of ZYN nicotine bags with a ‘modified risk’ statement marks a turning point in tobacco regulation and in the overall public health strategy against smoking. For the first time, the U.S. agency allows a category of nicotine-only products to explicitly communicate that, compared to the combustion cigarette, their use reduces the risk o…
FDA allows Zyn pouches to be marketed as less harmful than cigarettes
The Food and Drug Administration (FDA) will allow Zyn nicotine pouches to be marketed as less harmful to human health than cigarettes, the agency said Tuesday. The agency allowed the company to market 10 flavors of Zyn products, which have been authorized for sale in the U.S. since January 2025. These are the first nicotine…
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