FDA WARNING_LETTER - EPD International S.R.O. - April 03, 2024

The FDA issued a Warning Letter to Dino Ismet Sinanovic regarding nicotine pouch products offered for sale on snussie.com to U.S. customers. The FDA determined these products, including "ZYN Cucumber Lime Slim Normal" and "ZYN Espressino Mini Dry Normal," are tobacco products under section 201(rr) of the FD&C Act, as amended on March 15, 2022, to include nicotine from any source.

The identified products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. They lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not exempt. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information under section 905(j).

The FDA requires prompt action to address these violations, including discontinuing the violative sale and distribution. A written response is required within 15 working days detailing corrective actions, including dates of discontinuation and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.