FDA WARNING_LETTER - Vapor Authority, Inc. - November 09, 2023

On November 8, 2023, the FDA issued a Warning Letter to Todd Skezas regarding electronic nicotine delivery system (ENDS) products sold on vaporauthority.com. The FDA determined that ENDS products, including "Cali Bars 2K Disposable Vape Pen – 2000 Puffs – Frozen Banana" and "Elf Bar (EB Design) Disposable Vape Pen – 5000 Puffs – Miami Mint," are offered for sale or distribution in the U.S. and are considered tobacco products under section 201(rr) of the FD&C Act.

These products are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

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