The Juice Bar – FDA Warning Letter, Mar 30, 2021

The FDA issued a Warning Letter to The Juice Bar, identifying that their e-liquid product, "THE JUICE BAR Southern Dragon 100VG 3MG," is a new tobacco product lacking required marketing authorization. This product was not commercially marketed in the U.S. as of February 15, 2007, and does not have an FDA marketing authorization order or exemption.

Consequently, the product is deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) due to the absence of required information under section 905(j). The manufacture, sale, or distribution of such products, or the failure to provide required reports, constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The Juice Bar, a registered manufacturer with 13,882 listed products, is responsible for ensuring compliance. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation dates for the violative product, and a plan for ongoing compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction.