According to a recent CDC report, nicotine pouches (NPs) like Zyn have become the second most-used nicotine product in the U.S., behind only traditional cigarettes. Their rapid rise in popularity has sparked widespread concern, reminiscent of the anxiety and controversy that surrounded the surge in vaping nearly a decade ago.
Ironically, only last month, the manufacturer of Zyn – Swedish Match North America (SMNA), agreed to pay $1.2 million to settle claims of violating Washington D.C.’s flavoured tobacco ban. The D.C. attorney general alleged SMNA allowed online sales of flavoured Zyn nicotine pouches in the district until June 30, 2024, despite the ban starting on October 1, 2022.
As part of the settlement, PMI must perform quarterly monitoring to ensure distributors comply with the ban. Earlier, PMI had suspended online sales following a subpoena and subsequently had halted sales of flavoured Zyn products through its official website and associated platforms.
Regulated products lead to safer accessibilty
Hence, the news that the FDA has granted marketing authorization to 20 Zyn nicotine pouch products, some of which are flavoured, has come as a welcome surprise. Marking the first approval of its kind, the authorization allows NPs to be legally sold, it does not permit reduced-risk claims, with the agency emphasizing that the products are not risk free.
A clear indication that the FDA considers NPs as offering more health benefits than risks
However, Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products (CTP), did highlight that in order to grant marketing authorizations, the FDA must be in possession of evidence indicating that the products in question offer more health benefits than risks. Available in 3mg and 6mg strengths, the approved products include flavours such as Citrus, Coffee, and Cool Mint. The FDA determined these pouches pose lower health risks than cigarettes and smokeless tobacco, as they contain fewer harmful substances.ce
Moreover, despite many media reports claiming the contrary, youth usage remains low, with 1.8% of U.S. middle and high school students reporting use. To prevent underage access, the FDA has imposed strict marketing restrictions and will monitor compliance. Data have also shown that many adult smokers and smokeless tobacco users switched completely to these products.
Finding the right balance
Nicotine pouches remain a controversial product, as authorities are still struggling to balance their potential harm reduction benefits with concerns over addiction and youth appeal. While their popularity grows, skepticism persists due to limited long-term research. However, the FDA’s authorization of Zyn pouches marks a significant step in regulating the industry, ensuring these products meet public health standards. By imposing strict marketing guidelines and requiring evidence of reduced harm, this move could help build consumer trust and reinforce responsible use. However, continued oversight is essential to prevent misuse and ensure that nicotine pouches remain a viable alternative for adult smokers rather than a risk for new users.
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