Kaleidoscope Custom Vapor Lounge, LLC d/b/a Kaleidoscope Vapor

Warning LetterOpen

Stacey Hamilton Owner Kaleidoscope Custom Vapor Lounge, LLC d/b/a Kaleidoscope Vapor 3325 Memorial Boulevard, Suite E Murfreesboro , TN 37129 United States staceycupolo@yahoo.comIssued Sep 2, 2021Center for Tobacco Products

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateSep 2, 2021

Product TypeTobacco

StatusOpen

Letter Details

Firm: Kaleidoscope Custom Vapor Lounge, LLC d/b/a Kaleidoscope Vapor
Location: Stacey Hamilton Owner Kaleidoscope Custom Vapor Lounge, LLC d/b/a Kaleidoscope Vapor 3325 Memorial Boulevard, Suite E Murfreesboro , TN 37129 United States staceycupolo@yahoo.com
FEI Number: N/A
Country: United States
Issue Date: September 02, 2021
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Kaleidoscope Custom Vapor Lounge manufactured and distributed e-liquid tobacco products without required premarket authorization, in violation of the Federal Food, Drug, and Cosmetic Act and the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as tobacco products under FDA jurisdiction since the August 2016 deeming rule, were found to be unapproved "new tobacco products" lacking the mandated premarket authorization needed for commercial distribution in the United States. The FDA determined the products were adulterated and/or misbranded under applicable tobacco product regulations.

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