FDA WARNING_LETTER - Invicta Sweden AB - April 04, 2024

The FDA issued a Warning Letter to Stina Maria Armalis, Erik Rosengren, and Gustav Olof Karlsson regarding nicotine pouch products offered for sale on snusdaddy.com to U.S. customers. The FDA determined these products are "tobacco products" under the FD&C Act, specifically section 201(rr), due to containing nicotine from any source and being intended for human consumption.

The core violation is the marketing of "new tobacco products" without required premarket authorization. Specifically, ZYN Mini Dry Espressino and ZYN Slim Cucumber Lime were identified as new tobacco products not commercially marketed in the U.S. as of February 15, 2007, and lacking FDA marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act for not providing required notice under section 905(j).

The letter requires a written response within 15 working days detailing actions to address violations, including discontinuation of sales/distribution and a plan for compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction, and products may be detained or refused admission into the U.S.