FDA WARNING_LETTER - snuzyn.com - December 01, 2025

On December 30, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to snuzyn.com following a review of their website. The FDA determined that snuzyn.com is offering nicotine pouch products for sale in the United States, specifically "On! Plus Watermelon Mint Regular," "On! Plus Raspberry Lemon Regular," and "On! Plus Berry Regular." These products are considered "tobacco products" under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which was recently amended to include products containing nicotine from any source.

The primary violation is that these nicotine pouch products are "new tobacco products" that lack the required premarket authorization from the FDA. Under the FD&C Act, new tobacco products must have an authorization order or be deemed substantially equivalent to a predicate product marketed before February 15, 2007. Because snuzyn.com"s products do not meet these requirements, they are considered unlawfully marketed, adulterated, and misbranded.

snuzyn.com is required to take prompt action to address these violations. They must submit a written response within 15 working days detailing their corrective actions, including when the sale and distribution of the violative products ceased, and their plan for future compliance with the FD&C Act and FDA regulations. Failure to comply may result in regulatory actions such as civil money penalties, product seizure, or injunctions.