FDA WARNING_LETTER - 180 Vape E-Cigs & Lounge - October 26, 2022

The FDA issued a Warning Letter to 180 Vape E-Cigs & Lounge on October 26, 2022, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, specifically the "Juicy Peach e-liquid product," for commercial distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the marketing of a "new tobacco product" without the required premarket authorization. The "Juicy Peach e-liquid product" was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the failure to provide required notice or information under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

The FDA requires the company to submit a written response within 15 working days detailing actions taken to address the violations, including dates of discontinued sales/distribution and a plan for future compliance. Failure to comply may result in regulatory actions such