FDA WARNING_LETTER - Amarillo Snuff Co. - August 11, 2023

The FDA Center for Tobacco Products issued a Warning Letter to Amarillo Snuff Company on August 11, 2023, following a review of their website, https://amarillosnuff.com. The FDA determined that the company manufactures and offers for sale or distribution in the U.S. smokeless nicotine products, including Lemon Zest, Wintergreen, and Vanilla, which are considered "tobacco products" under section 201(rr) of the FD&C Act.

These products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The FDA has not received a marketing authorization application for these products. The company is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of these products, and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.