The Juice Bar – FDA Warning Letter, Aug 11, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to The Juice Bar on August 11, 2022, following a review of submissions and inspection records. The Juice Bar manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source as of April 14, 2022.

The primary violation identified is the marketing of "The Juice Bar Strawberry Shortcake 5mg e-liquid product" without the required premarket authorization. This product is deemed a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is 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.

The letter states that manufacturing, selling, or distributing such adulterated or misbranded products, or failing to provide required reports, constitutes prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA has not received a marketing authorization application for the listed product.

The Juice Bar is required to submit a written response within 15 working days, detailing actions taken to address violations, including discontinuation dates