FDA WARNING_LETTER - The Vapor Craft LLC, d/b/a Vapor Craft - August 31, 2021

The FDA issued a Warning Letter to The Vapor Craft LLC, d/b/a Vapor Craft, after reviewing submissions and inspection records, determining the company manufactures and distributes e-liquid products subject to FDA regulation as tobacco products. Specifically, "Vapor Craft Hyperberry - 3mg 100ml" and "Vapor Craft Crackberry - 3mg 100ml" were identified as "new tobacco products" not commercially marketed in the U.S. as of February 15, 2007. The primary violation is the manufacturing, sale, and/or distribution of these products without the required FDA marketing 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) due to the failure to provide required notice or information under section 905(j). The letter also cites prohibited acts under section 301(k) for holding adulterated/misbranded products for sale and section 301(p) for failing to provide required reports. The firm, a registered manufacturer with over 4,300 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.