EZPuff Vapor Labs, LLC – FDA Warning Letter, Jun 22, 2023

The FDA issued a Warning Letter to Paul Roger of EZPuff.com on June 16, 2023, after reviewing their website and determining that they offer "Elf Bar" electronic nicotine delivery system (ENDS) products for sale or distribution in the United States. These products, specifically "Elf Bar BC5000 Disposable Vape – Gumi" and "Elf Bar BC5000 Disposable Vape – Honeydew Pineapple Orange," are considered "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

The primary violation is that these ENDS products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided as required by section 905(j).

The FDA requires a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. The letter emphasizes the firm's responsibility to ensure all tobacco