FDA WARNING_LETTER - Black Hills Vapors LLC - July 11, 2025

On July 10, 2025, the FDA issued a Warning Letter to Black Hills Vapors LLC for selling and distributing e-liquid products without required marketing authorization. The FDA determined that the company's "CUSTARD MONSTER Swirl Edition Creamsicle 3MG 100ML" e-liquid product is a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order.

This product is deemed adulterated under section 902(6)(A) of the FD&C Act (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) of the FD&C Act (21 U.S.C. § 387c(a)(6)) because no notice or information was provided as required by section 905(j) of the FD&C Act. The letter emphasizes that e-liquid products, now including those with nicotine from any source due to a March 15, 2022, amendment to the FD&C Act, require premarket authorization.

Black Hills Vapors LLC must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of the violative products