FDA WARNING_LETTER - Born Blessed Enterprises, LLC d/b/a One Stop Vape Shop - October 12, 2023

The FDA issued a Warning Letter to Born Blessed Enterprises, LLC d/b/a One Stop Vape Shop on October 12, 2023, following a review of inspection records. The company 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 e-liquid product "Banana Pudding V2" was cited as a new tobacco product that was not commercially marketed in the U.S. as of February 15, 2007, and lacks FDA marketing authorization. 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 per section 905(j).

The letter emphasizes that failure to provide a required report under section 905(j) is a prohibited act under section 301(p) of the FD&C Act, and any act resulting in adulterated or misbranded products held for sale after interstate shipment is prohibited under section 301(k).

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuation of