FDA WARNING_LETTER - mynicco.com - July 22, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to the company behind the website https://mynicco.com on July 18, 2025, regarding the sale of nicotine pouch products in the United States. The FDA"s Center for Tobacco Products determined that these products, including Zyn Slim Apple Mint and Zyn Slim Violet Licorice, are marketed without the necessary premarket authorization, violating the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Under the FD&C Act, products containing nicotine from any source are classified as tobacco products and require compliance with FDA regulations. The nicotine pouches in question are considered "new tobacco products" because they were not commercially marketed in the U.S. before February 15, 2007, and lack the required marketing authorization. Consequently, these products are deemed adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act.

The FDA has requested that the company take immediate action to address these violations, including ceasing the sale and distribution of the non-compliant products and submitting a written response within 15 working days. The response should detail the actions taken to rectify the situation and ensure future compliance with the FD&C Act. Failure to comply may result in enforcement actions such as civil penalties, product seizure, or injunctions. The company is urged to consult the FDA"s Searchable Tobacco Products Database for information on legally marketed products.