The U.S. Food and Drug Administration has authorized 20 ZYN nicotine pouch products to be marketed in the United States with a specific modified risk claim following an extensive scientific review.
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The decision, announced on June 30, allows Philip Morris International U.S. to market the authorized products with FDA-approved language stating that using ZYN instead of cigarettes puts users at a lower risk of several smoking-related diseases.
The FDA issued Modified Risk Tobacco Product (MRTP) orders for the products after reviewing applications submitted by Swedish Match USA.
According to the agency, the authorization applies only to the 20 specific ZYN products reviewed and does not extend to all nicotine pouches or other tobacco products.
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The FDA-authorized claim states, “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.”
The FDA said it evaluated scientific evidence related to the relative health risks of the products, consumer understanding of the modified risk claim, youth-related concerns, and the potential impact on public health.
Following the review, the agency concluded that the claim is scientifically accurate for the authorized products and that adult consumers understand its meaning.
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The agency also determined that marketing the products with the authorized claim could provide a net benefit to the population by informing adult smokers about lower-risk alternatives.
The FDA noted that this is the first time it has granted MRTP orders for nicotine pouch products.
The 20 ZYN products had previously received authorization for sale in the United States through the Premarket Tobacco Product Application (PMTA) pathway in January 2025.
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In FDA press release announcing the orders, Bret Koplow, Ph.D., J.D., acting director of the U.S FDA’s Centre for Tobacco Products stated: “FDA’s review of modified risk products is intended to ensure that adult users have clear, science-based information about the relative harms of tobacco products, so they can make informed choices.”
He further stated that the “decision allows these products to be marketed with a modified risk claim that informs adults who smoke about the lower risks associated with these products.”
