FDA Issues Warning Letters and Civil Money Complaints Against Retailers

The agency sent 119 letters and filed 41 civil money complaints citing sale of unauthorized products.

April 08, 2024

The U.S. Food and Drug Administration announced on April 4 it issued 119 warning letters and filed 41 civil money penalty complaints against brick-and-mortar retailers that engaged in the underage sale of various flavors of nicotine pouches between October 2023 and February 2024. The 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.

“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.

For the 41 CMP complaints being announced for underage sales, FDA is seeking more than $55,000 in total.

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 said it continues to actively monitor the marketplace and enforce the law, including through surveillance, inspections and investigations.

Last month, the FDA unveiled its Searchable Tobacco Products Database, which it says is a new list of over 17,000 tobacco products—including e-cigarettes—that may be legally marketed in the United States.

However, this is an incomplete picture of what can be marketed. FDA has only approved less than two dozen e-cigarette products and that is reflected in the database. The database fails to include all categories of products that can be on the market, like products that are subject to administrative stays and review.

“We have asked FDA numerous times for complete information about what can—and cannot—be sold in stores and they have declined to provide it,” Jeff Lenard, NACS vice president of strategic initiatives, told the New York Times in an article published in March, detailing how a group of senators petitioned chief executives from top convenience retailers to end the sale of illegal flavored vapes. “It is long past time for FDA to provide that clarity and aggressively enforce the law.