FDA WARNING_LETTER - Avalanche Distribution LLC d/b/a Avalanche Vapes - February 01, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Ethan Kasporov regarding electronic nicotine delivery system (ENDS) products sold on avalanchevapes.com. The FDA determined that products like "Nut Tobacco EB BC5000" and "Mango Kiss Funky Republic TI7000" are tobacco products under section 201(rr) of the FD&C Act, as amended to include nicotine from any source.

These ENDS 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 letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuation of sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.