FDA WARNING_LETTER - VC of Montgomery, LLC d/b/a Vapor Craft of Montgomery - April 06, 2023

The FDA issued a Warning Letter to VC of Montgomery, LLC d/b/a Vapor Craft of Montgomery on April 6, 2023, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically "Darth Graper e-liquid products," which are considered tobacco products under the FD&C Act, including those containing nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. "Darth Graper e-liquid products" were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j).

The FDA considers the manufacturing, sale, and/or distribution of these unauthorized products prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The company is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of non-compliant products, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure,