FDA Allows ZYN Nicotine Pouches to Claim Lower Risks Than Cigarettes but Bars Fruity Flavors

The Food and Drug Administration authorized Swedish Match USA, Inc. to market 20 ZYN nicotine pouch products with the claim that they put users at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis than cigarettes, @NBCNews reported Tuesday. Swedish Match USA is part of Philip Morris International.

The authorized flavors are Cool Mint, Citrus, Coffee and Cinnamon in both 3-milligram and 6-milligram nicotine strengths. Fruity flavors such as Black Cherry and Peach were not included. The authorization requires the company to study how customers perceive risks associated with the products for the next five years.

The FDA may reverse the decision if it sees evidence of a significant increase in youth use. In 2025, 1.7 percent of middle and high school students reported using nicotine pouches, according to the FDA National Youth Tobacco Survey. More than one in six of those students said they used the products every day.

ZYN was the most popular brand among them. Dr. Pamela Ling, director of the University of California San Francisco’s Center for Tobacco Control Research and Education, said higher nicotine levels raise concerns.

“As your brain is exposed to nicotine, you produce more and more nicotine receptors, so over time the need for more nicotine just to feel normal increases,” she said. ” Dr. Adam Goldstein, director of Tobacco Intervention Programs at University of North Carolina School of Medicine, noted that complete switching from cigarettes has not been observed.

“The majority of people using oral nicotine products are not using them to quit combustible cigarettes,” he said. Mike Seilback, assistant vice president of nationwide advocacy and state public policy at the American Lung Association, called the move appalling and urged the FDA to reverse it to protect children from lifelong nicotine addiction.