FDA WARNING_LETTER - Little Brown Smoke Shack

The FDA Center for Tobacco Products reviewed the website http://www.lilbrown.com and found that smokeless tobacco products offered for sale to U.S. customers are in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, certain products (Ariva Cinnamon, Ariva Wintergreen, Ariva Mint, Ariva Citrus, Ariva Java, Stonewall Natural, and Stonewall Java) are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. These are "new tobacco products" requiring premarket review and marketing authorization under section 910(c)(1)(A)(i), which they lack, and for which required information under section 905(j) was not provided after FDA issued "not substantially equivalent" (NSE) orders on August 28, 2014.

Additionally, numerous smokeless tobacco products (e.g., Cannon Ball Plug, Skoal Apple L/C, Red Seal Natural F/C) are misbranded under section 903(a)(7)(A) of the FD&C Act because their advertisements on the website fail to include any of the required health warning label statements mandated by the Comprehensive Smokeless Tobacco Health Education Act of 1986.

The FDA requires immediate corrective actions, including discontinuing the violative promotion