FDA WARNING_LETTER - Vape Hut, Inc. - September 13, 2022

The FDA issued a Warning Letter to Bridgette Norris of Vape Hut on August 19, 2022, following a review of their website, vapehut.com. The FDA determined that e-liquid products, specifically "Wintergreen (Tobacco Free) by VH Blends" and "Cupcake (Tobacco Free) by VH Blends," were manufactured and offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, due to containing nicotine from any source.

The primary violation is that these e-liquid products are "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 deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because no notice or information was provided as required by section 905(j).

Vape Hut 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 the non-compliant products, and