Steamist Vape Supply – FDA Warning Letter, Aug 2, 2022

On August 1, 2022, the FDA issued a Warning Letter to Steamist Vape Supply, identifying that their e-liquid products, specifically "290 CELSIUS BERRY CRUNCH 3MG 120ML," are tobacco products under the FD&C Act, including those with nicotine from any source as per the March 15, 2022 amendment. The FDA determined that this product is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is the manufacturing, sale, and/or distribution of this e-liquid product without the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) due to the lack of required notice or information under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Steamist Vape Supply 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 outlining a plan for maintaining compliance