FDA approves sale of Zyn nicotine pouches following extensive review

Key takeaways:

• Study data show that nicotine pouches benefit adults who switched over to them from cigarettes or other tobacco products.
• The authorization does not mean the products are safe or “FDA approved,” however.

The FDA announced it has authorized the marketing of 20 Zyn nicotine pouch products, citing their greater health benefits vs. cigarettes and other tobacco products.

It is the first time the agency has authorized the sale of nicotine pouches, but the authorization does not signify their safety.

“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” Matthew Farrelly, PhD, director of the Office of Science in the FDA’s Center for Tobacco Products, said in a press release.

He added that study data provided by the applicant, Philip Morris International, “show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”

According to the FDA, their evaluation showed that the nicotine pouches pose a lower risk for cancer and other serious health outcomes compared with similar products, like cigarettes, snus and moist snuff, due to having significantly lower amounts of harmful constituents.

The FDA also assessed data regarding the products’ use and risks among youth, finding that only 1.8% of American middle and high school students reported using nicotine pouches last year.

“It’s critical that the manufacturer market these products responsibly to prevent youth use,” Brian King, PhD, MPH, director of the FDA’s Center for Tobacco Products, said in the release.

Sales of nicotine pouch products over the last couple of years have soared, but their prevalence of use remains low, with only 2.9% of adults ever using the products in 2022 and less than 1% currently using them, according to a University of Southern California analysis.

The FDA underlined that the authorization means only that the products are permitted to be legally marketed to U.S. adults aged 21 years or older and does not mean that the products are safe or “FDA approved.”

“There is no safe tobacco product; youth should not use tobacco products and adults who do not use tobacco products should not start,” the release said.

The administration added that it will closely monitor the marketing and use of these products — which come in 3 mg and 6 mg strength and flavors like mint and coffee — while the authorization could be suspended or withdrawn if the product no longer meets the required public health standard, such as an increase in usage among youth.

“[The FDA] is committed to taking action, as appropriate, to best protect public health,” King said.

References:

• FDA authorizes marketing of 20 ZYN nicotine pouch products after extensive scientific review. Available at: https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-20-zyn-nicotine-pouch-products-after-extensive-scientific-review. Published Jan. 16, 2025. Accessed Jan. 17, 2025.
• Few U.S. adults use nicotine pouches, study finds. Available at: https://keck.usc.edu/news/few-u-s-adults-use-nicotine-pouches-study-finds/. Published July 10, 2024. Accessed Jan. 17, 2025.