MyVapor-Lounge LLC d/b/a Winter Garden Ecigs

Warning LetterOpen

Bogdan Gradinariu Owner MyVapor-Lounge LLC d/b/a Winter Garden Ecigs 13750 West Colonial Drive, Suite 160 Winter Garden , FL 34787 United States WINTERGARDENECIGS@GMAIL.COMIssued Mar 2, 2022Center for Tobacco Products

View Letter

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

Violations1

Issue DateMar 2, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: MyVapor-Lounge LLC d/b/a Winter Garden Ecigs
Location: Bogdan Gradinariu Owner MyVapor-Lounge LLC d/b/a Winter Garden Ecigs 13750 West Colonial Drive, Suite 160 Winter Garden , FL 34787 United States WINTERGARDENECIGS@GMAIL.COM
FEI Number: N/A
Country: United States
Issue Date: March 02, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

MyVapor-Lounge LLC d/b/a Winter Garden Ecigs was cited for manufacturing and distributing e-liquid tobacco products without obtaining required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations applicable to newly deemed tobacco products (electronic nicotine delivery systems), which have been subject to FDA jurisdiction since August 8, 2016. The warning identified that e-liquid products must meet Federal Food, Drug, and Cosmetic Act requirements, including obtaining premarket approval for "new tobacco products" not commercially marketed in the United States as of February 15, 2007.

MyVapor-Lounge LLC d/b/a Winter Garden Ecigs FDA Warning Letter, March 2, 2022