FDA WARNING_LETTER - The Juice Bar - October 20, 2023

The FDA issued a Warning Letter to The Juice Bar on October 20, 2023, following a review of inspection records. The FDA determined that The Juice Bar 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 from any source and being intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. Specifically, the products "THE JUICE BAR Fairy Blood 0PG 100VG 6MG" and "THE JUICE BAR Red 40PG 60VG 4MG" were found to be new tobacco products, as they were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions.

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notices or information were not provided under section 905(j). Prohibited acts include holding for sale adulterated/misbranded products (section 301(k)) and failing to provide required reports (section 301(p)).

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