FDA WARNING_LETTER - EPD International S.R.O. - April 16, 2024

The FDA issued a Warning Letter to Dino Ismet Sinanovic of snussie.com on April 3, 2024, following a review of their website, which revealed the sale and distribution of nicotine pouch products to U.S. customers. These products, including "ZYN Cucumber Lime Slim Normal" and "ZYN Espressino Mini Dry Normal," are classified as tobacco products under the FD&C Act, specifically section 201(rr), due to containing nicotine intended for human consumption.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. These products were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization or exemption. Consequently, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required information was not provided per section 905(j).

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of these products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.