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The U.S. Food and Drug Administration (FDA) has authorized 20 ZYN nicotine pouch products to carry a modified-risk claim that using them instead of cigarettes lowers the risk of major smoking-related diseases, including lung cancer, heart disease, stroke, and emphysema. The authorization applies only to specific products made by Swedish Match USA and does not mean nicotine pouches are safe or approved for quitting smoking.
The FDA based its decision on scientific evidence showing nicotine pouches expose users to significantly fewer toxic chemicals than combustible cigarettes. Studies also found that adult smokers who completely switch to these products can substantially reduce their exposure to harmful substances, with some reducing or quitting smoking altogether.
Swedish Match is required to conduct post-market studies and monitor consumer use and understanding of the products. The authorization is valid for five years and may be withdrawn if it no longer benefits public health, including if youth use increases. The FDA continues to emphasize that quitting all tobacco and nicotine products remains the healthiest choice.
According to the Campaign for Tobacco Free-Kids, “The FDA’s decision is deeply troubling given the extensive scientific evidence that flavored tobacco products appeal to kids and the fact that nicotine pouches were the only category of tobacco product that saw an increase in youth use last year. The FDA is sanctioning a flavored tobacco product that is already increasing in popularity with kids and repeating the mistakes it made with Juul that resulted in the youth e-cigarette epidemic.”
The ruling comes as nicotine pouches become one of the fastest-growing smoke-free nicotine products worldwide. While public health experts view them as a lower-risk alternative for adult smokers, regulators continue to caution that they are not risk-free and should not be used by people who do not already use tobacco.
The FDA continues to emphasize that quitting all tobacco and nicotine products remains the healthiest choice. However, for adults who smoke and cannot or do not quit, completely switching to FDA-authorized nicotine pouches may offer a significantly less harmful alternative to smoking.
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