FDA Clamps Down on Underage and Unauthorized ZYN Sales

The Federal Food & Drug Administration announced this week that it had issued an incredible 119 warning letters to and filed over 40 Civil Money Complaints (CMPs) against brick-and-mortar retailers. All of these enforcement actions concerned the sale of ZYN nicotine pouches to people under the age of 21. 

At the same time, three online retailers were warned about selling ZYN pouches in unauthorized flavors, including Black Cherry, Lemon Spritz, Espressino, and Cucumber Lime. Just as with e-liquids, flavors such as these are likely seen as attractive to young people, and preventing their sale is undoubtedly a key part of the FDA’s mission to prevent underage tobacco use. 

Even though the 2023 National Youth Tobacco Survey showed that only 1.5% of American teens had used/were using nicotine pouches, and little evidence suggests this figure is rising, there appears to be growing concern about the popularity of ZYN and other pouches on the major social media channels. 

The director of FDA’s Center for Tobacco Products, Brian King, is quoted as saying: 

“Although currently available data do not show that youth use of nicotine pouches has increased, [the] 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. 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.”

This latest announcement comes just 10 days after the FDA issued 61 warning letters to physical retailers of unauthorized e-cigarette products on March 26th, 2024. Those warnings concerned the sale of disposable vapes marketed under the Elf Bar/EB Design and Lava brand names. 

The increase in such enforcement by the federal agency and the sheer number of warnings being issued almost weekly could signal its hardening stance on unauthorized tobacco product sales. Equally, it could point to the amount of confusion there seems to be about the legality of this type of product. E-cigarettes aren’t banned, but the overwhelming majority aren’t “authorized,” potentially sending mixed signals to retailers and users alike. 

What Are Nicotine Pouches?

Nicotine pouches, such as those sold under the ZYN, VELO, and Nordic Spirit brands, are classed as Oral Tobacco Products, even though they contain no tobacco at all. They are designed to be placed in the mouth, between the users’ lips and gums, through which nicotine is absorbed into the bloodstream. 

To date, the FDA has authorized just four oral tobacco products (in 2021) that have met the necessary standard of, among other things, providing sufficient scientific evidence to demonstrate that the product meets the required public health standard required by law. As of April 2024, the FDA has not authorized any ZYN product for sale in the United States.