FDA Issues Warning Letters to and Files Civil Money Penalty Complaints Against Retailers for Underage Sales of ZYN Nicotine Pouches

April 4, 2024

On April 4, FDA announced the issuance of 119 warning letters to, and the filing of 41 civil money penalty complaints against, brick and mortar retailers that engaged in the underage sale of various flavors of ZYN nicotine pouches between October 2023 and February 2024. FDA has also issued warning letters to three online retailers for the sale of unauthorized, flavored ZYN nicotine pouches, including Espressino, Black Cherry, Lemon Spritz, and Cucumber Lime.

Nicotine pouches are a type of tobacco product. The small pouches are intended to be held between the user’s lip and gum, where the nicotine is absorbed into the body. The products contain nicotine powder or nicotine salts—not cut, ground, powdered, or leaf tobacco itself—and do not require spitting.

Data from the 2023 National Youth Tobacco Survey show approximately 1.5 percent of youth reported currently using nicotine pouches, and use has remained unchanged among youth in recent years. However, FDA has received reports about the potential increased popularity of these products among youth, and the products are also 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, Ph.D., M.P.H., director of FDA’s Center for Tobacco Products. “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. This federal minimum age of sale applies to all retail establishments and persons with no exceptions. In order for a new tobacco product to be legally marketed in the United States, it must receive authorization from FDA. To receive authorization from FDA, an application must be submitted for the product that, among other things, provides sufficient scientific evidence to demonstrate that the product meets the necessary public health standard required by law. To date, FDA has authorized four oral tobacco products that have met the necessary standard. As of April 2024, the FDA has not authorized any ZYN product for sale in the United States.

FDA generally sends warning letters the first time an investigation or inspection reveals a violation. To achieve voluntary compliance, warning letter recipients have 15 working days to respond with the steps they will take to correct and prevent future violations. However, failure to promptly correct the violations may result in additional FDA action, including civil money penalties. For the 41 civil money penalty complaints being announced for underage sales, FDA is seeking more than $55,000 in total. Of the warning letters announced today, three are to online retailers for selling unauthorized flavored ZYN nicotine pouches including Espressino, Black Cherry, Lemon Spritz, and Cucumber Lime.

Youth use of any tobacco products, including nicotine pouches, is unsafe. These products contain nicotine, which is highly addictive, can harm adolescent brain development, and can adversely impact attention, learning, and memory. Parents, teachers, and other adults should be aware of youth use of nicotine pouches and their health risks to youth. Since these products can be used without the need to spit, they could enable youth to use these products without being noticed.

Today’s actions reflect FDA’s continued efforts across the supply chain to address the marketing and sale of unauthorized and potentially youth-appealing tobacco products. To date, the agency has issued more than 550 warning letters to and filed over 100 civil money penalty complaints against retailers for the sale of unauthorized tobacco products. The agency continues to actively monitor the marketplace and enforce the law, including through surveillance, inspections, and investigations.

 

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