FDA WARNING_LETTER - Northerner Scandinavia, Inc.

The FDA issued a Warning Letter to Mr. Svandal regarding smokeless tobacco products sold and distributed in the U.S. via websites (northerner.com, swedish-snus.com, snusdistribution.com) and social media (Facebook, Twitter).

The FDA determined several products are adulterated and misbranded. Specifically: 1. **Premarket Review Violations:** Ariva Mint and Ariva Wintergreen smokeless tobacco products were found to be "new tobacco products" that lack required premarket marketing authorization orders under section 910(c)(1)(A)(i) of the FD&C Act, making them adulterated (section 902(6)(A)). Additionally, a notice or other information was not provided as required by section 905(j), rendering them misbranded (section 903(a)(6)). FDA had issued Non-Substantially Equivalent (NSE) orders for these products on August 28, 2014. 2. **Modified Risk Tobacco Product Violations:** Products described as "mild" (e.g., Thunder Ultra Frosted, Catch Pure Mint, Northerner Licorice/Lemon, White Bite Fresh Citrus Mint) or implying reduced substance levels/exposure (e.g., CatchDry Licorice, Jakobsson’s Fläder, Skruf Slim Fresh White) are considered "modified risk tobacco products" under section 9