Kaleidoscope Custom Vapor Lounge, LLC d/b/a Kaleidoscope Vapor – FDA Warning Letter, Sep 2, 2021

The FDA issued a Warning Letter to Kaleidoscope Custom Vapor Lounge, LLC d/b/a Kaleidoscope Vapor for manufacturing and distributing unapproved new tobacco products. The company's e-liquid products, specifically KALEIDOSCOPE Vapor 6mg nicotine e-liquid, are deemed "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007.

These products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of a required notice or information under section 905(j). The company's Premarket Tobacco Product Application (PMTA), STN No. PM0003302, covering 5,122 products, received a refusal to accept determination on May 6, 2021.

The FDA requires the company to cease the violative sale and distribution of these products and submit a written response within 15 working days detailing corrective actions and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.