My Vape Shack – FDA Warning Letter, Dec 21, 2023

The FDA issued a Warning Letter to My Vape Shack on December 21, 2023, following a review of inspection records. The FDA determined that My Vape Shack manufactures and distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, due to containing nicotine and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the product "Vanilla Bean 18nic 120ml" 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. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided.

The letter emphasizes that failure to provide a required report under section 905(j) is a prohibited act under section 301(p). My Vape Shack is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale/distribution of non-compliant products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.