Custom Vapors Inc. – FDA Warning Letter, Jan 25, 2024

The FDA issued a Warning Letter to Custom Vapors Inc. on January 25, 2024, based on a review of inspection records. The company manufactures and distributes e-liquid products, which are classified as 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. Specifically, the product "Custom Vapors: Red" e-liquid was found to be 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 or exemption.

This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j). Prohibited acts include holding for sale after interstate shipment resulting in adulteration/misbranding (section 301(k)) and failure to provide required reports (section 301(p)).

Custom Vapors Inc. must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or