WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) has announced the authorization of 20 ZYN nicotine pouch products through its premarket tobacco product application (PMTA) pathway. This landmark decision marks the first time the agency has approved the marketing of nicotine pouch products, which are small synthetic fiber pouches designed to deliver nicotine when placed between a user’s gum and lip.
The authorization follows a thorough scientific review under the requirements of the 2009 Family Smoking Prevention and Tobacco Control Act, which obligates the FDA to evaluate the risks and benefits of tobacco products for the population as a whole. Evidence provided by the manufacturer, Swedish Match, demonstrated that the approved products pose significantly lower risks of cancer and other severe health conditions compared to cigarettes and most traditional smokeless tobacco products, such as moist snuff and snus.
“These nicotine pouch products meet the bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch,” said Matthew Farrelly, Ph.D., director of the Office of Science in the FDA’s Center for Tobacco Products. “To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks.”
The decision is informed in part by data showing that adult smokers and smokeless tobacco users are likely to completely switch to ZYN pouches, decreasing their exposure to the harmful chemicals found in combustible and many smokeless tobacco products. Furthermore, the FDA’s analysis reflected reassuring data regarding the low prevalence of youth use, with the 2024 National Youth Tobacco Survey reporting that only 1.8% of middle and high school students currently use nicotine pouches, despite their rising sales in recent years.
“It’s critical that the manufacturer market these products responsibly to prevent youth use,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “While current data show that youth use remains low, the FDA is closely monitoring the marketplace and is committed to taking action, as appropriate, to best protect public health.”
While these nicotine pouches are now legally permitted for sale in the U.S. to adults 21 and older, FDA officials were clear that the authorization does not imply the products are safe, nor are they “FDA approved.” The agency reaffirms that no tobacco product is safe and cautions that adults who do not currently use tobacco products should not begin.
To address concerns about youth exposure, the FDA has imposed rigorous marketing restrictions on the ZYN pouches approved under this authorization. These limitations include requirements for the manufacturer to ensure digital, TV, and radio advertisements are targeted specifically to adults 21 and older, and audience demographics are closely monitored. Additionally, Swedish Match has committed to further measures aimed at limiting youth appeal, such as refraining from mass-market advertising on radio and TV, using models and actors aged 35+ in promotional materials, and avoiding content that could directly or indirectly appeal to youth.
The FDA retains the ability to suspend or withdraw marketing orders if it determines the products are no longer meeting the established public health standard. For instance, a notable increase in youth usage could result in revised actions by the agency.
The 20 ZYN products now permitted for sale in two nicotine strengths (3 milligrams and 6 milligrams) include a variety of flavors, such as Chill, Citrus, Coffee, Cool Mint, Smooth, and Wintergreen. These actions apply only to the specific products authorized and do not extend to other nicotine pouch offerings or allow for reduced-risk marketing claims without further regulatory approval.
The FDA’s decision aims to provide a balanced effort to provide potentially less harmful alternatives for adult tobacco users while safeguarding public health and monitoring for unintended consequences, particularly among youth. The agency will continue to evaluate these products’ impact in real-world settings, ensuring their use aligns with the broader public health objectives.
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