FDA WARNING_LETTER - Born Blessed Enterprises, LLC d/b/a One Stop Vape Shop - September 14, 2023

On September 14, 2023, the FDA issued a Warning Letter to Matthew Derek Keenlyside regarding the sale of unauthorized electronic nicotine delivery system (ENDS) products on vapingopen.com. The FDA determined that "California Grown Cali Bars Disposable Vape - Orange Soda" and "California Grown Cali Bars Disposable Vape - Mango Nectar" are tobacco products under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded jurisdiction to products containing nicotine from any source.

These ENDS products are considered "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, the products are deemed 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 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.