FDA WARNING_LETTER - my vapor den - March 14, 2024

The FDA Center for Tobacco Products issued a Warning Letter to Vapor Den DBA Nu Age Smoke & Vape on March 14, 2024, following a review of inspection records. The company manufactures, sells, and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, to include nicotine from any source.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the product "Papa Smurf 60ml 3% nicotine" was cited as a new tobacco product that 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 absence of required notice or information under section 905(j).

The FDA requires the company to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.