The Food and Drug Administration (FDA) has issued 119 warning letters and filed 41 civil money penalty complaints against brick and mortar retailers for the underage sale of ZYN nicotine pouches.
The agency 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.
The FDA cited data from the 2023 National Youth Tobacco Survey, which showed that approximately 1.5% of youth reported currently using nicotine pouches, and use has remained unchanged among youth in recent years. However, the FDA noted that it has received reports about the potential increased popularity of these products among youth, and the products are also allegedly a popular topic on social media among youth and 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 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.”
In order for a new tobacco product to be legally marketed in the U.S., FDA stated, it must receive authorization from the FDA. To receive authorization, 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 U.S.
FDA’s Warning Letters
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, the 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.
“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,” the FDA wrote in a statement. “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.”
The agency also mentioned that today’s actions reflect its continued efforts to address the marketing and sale of unauthorized 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.