The Food and Drug Administration on Thursday said it had issued 119 warning letters and filed 41 complaints for civil money penalties (CMPs) against brick-and-mortar retailers who between October 2023 and February 2024 sold Zyn nicotine pouches to people under 21 years old. The agency is seeking more than $55,000 in total for the CMPs filed.
Of the warning letters announced, three were issued to online retailers for selling unauthorized flavored Zyn nicotine pouches including Espressino, Black Cherry, Lemon Spritz and Cucumber Lime, the agency said.
Any new tobacco product, or a product not commercially marketed in the U.S. as of Feb. 15, 2007, must be authorized by the FDA through the premarket tobacco product application (PMTA) process. So far, the only oral tobacco products the FDA has authorized are four varieties of Altria's discontinued brand Verve.
Swedish Match, a subsidiary of Philip Morris International (PMI), manufactures Zyn nicotine pouches. To date, the FDA said it has not authorized any Zyn product for sale in the United States.
Swedish Match did not respond by posting time to a CSP request for comment. The company said on its website that it submitted PMTA applications for all of its Zyn products in 2020.
Data from the 2023 National Youth Tobacco Survey show about 1.5% of youth reported currently using nicotine pouches, and that has remained unchanged among youth in recent years. However, the FDA said it has received reports about the potential increased popularity of nicotine pouches among youth, and the products are a popular topic on social media among youth and social media influencers.
“Although currently available data do not show that youth use of nicotine pouches has increased, FDA remains concerned about any tobacco product that may be appealing to youth and we will continue to closely monitor youth use of these products,” said Brian King, director of the CTP. “There is no excuse for selling tobacco products to any underage person, and FDA will hold retailers accountable for those violations—especially those who continue to do so after being warned.”
It is illegal for a retailer to sell any tobacco product—including cigarettes, e-cigarettes, cigars, and nicotine pouches—to anyone under 21, the FDA said.
The retailers that received warning letters have 15 working days to respond with how they will correct the violation and prevent future ones.
As of Thursday, the agency has issued more than 550 warning letters to and filed more than 100 civil money penalty complaints against retailers for the sale of unauthorized tobacco products.
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