FDA WARNING_LETTER - 2486808 Ontario, Inc. d/b/a Mister Vapor - September 14, 2023

The FDA issued a Warning Letter to Due Thich on September 14, 2023, after reviewing the website mistervapor.ca, which offers Electronic Nicotine Delivery System (ENDS) products for sale to U.S. customers. These products 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 required premarket authorization. Specifically, the Elf Bar BC5000 Mango Peach 5000 Puffs Disposable Vape and Elf Bar BC5000 Blue Razz Ice 5000 Puffs Disposable Vape were found to be new tobacco products, not commercially marketed in the U.S. as of February 15, 2007, and lacking FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter mandates a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of non-compliant products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction. The FDA also noted that this letter does not constitute