The U.S. Food and Drug Administration (FDA) authorized the marketing of 20 Zyn nicotine pouch products yesterday through the premarket tobacco product application (PMTA) pathway after an extensive scientific review, according to a press release from FDA. This is “the first time the agency has authorized products commonly referred to as nicotine pouches.”
The products for which the FDA issued marketing granted orders are as follows, each with two nicotine strengths (3 milligram and 6 milligram): Zyn Chill, Zyn Cinnamon, Zyn Citrus, Zyn Coffee, Zyn Cool Mint, Zyn Menthol, Zyn Peppermint, Zyn Smooth, Zyn Spearmint and Zyn Wintergreen. The FDA stated that the authorizations are specific to these products only; they do not apply to any other nicotine pouch or other Zyn products.
The FDA said it determined these products met the public health standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act, considering the risks and benefits to the population as a whole.
Among several key considerations, the agency’s evaluation found that the authorized Zyn products contain significantly lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, meaning they pose a lower risk of cancer and other serious health conditions compared to those products.
The FDA also clarified that this authorization “does not mean these tobacco products are safe, nor are they ‘FDA approved.’”
As part of its evaluation, the FDA “reviewed data regarding youth risk and found that youth use of nicotine pouches remains low despite growing sales in recent years. For example, the 2024 National Youth Tobacco Survey showed that 1.8% of U.S. middle and high school students reported currently using nicotine pouches.”
“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.”
First appeared on www.convenience.org