FDA WARNING_LETTER - Kaleidoscope Custom Vapor Lounge, LLC - September 07, 2021

The FDA issued a Warning Letter to Kaleidoscope Custom Vapor Lounge, LLC, for manufacturing and distributing unapproved e-liquid products. The FDA determined that their e-liquid products, specifically "KALEIDOSCOPE Vapor 6mg nicotine" and "KALEIDOSCOPE Vapor C008 60ML e-liquid product," are "new tobacco products" under the FD&C Act because they were not commercially marketed in the U.S. as of February 15, 2007.

These products are being sold without the required FDA marketing authorization order, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The company's Premarket Tobacco Product Application (PMTA), STN No. PM0003302, covering 5,122 products, was refused acceptance by the FDA on May 6, 2021.

The FDA requires the company to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the non-compliant products and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.