Kloc Vapor, LLC d/b/a The Vapor Edge

Warning LetterOpen

Andrew Kloc Owner Kloc Vapor, LLC d/b/a The Vapor Edge 6 New Haven Road, Suite 2 Prospect , CT 06712 United States thevaporedge@gmail.comIssued Nov 9, 2021Center for Tobacco Products

View Letter

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

Violations1

Issue DateNov 9, 2021

Product TypeTobacco

StatusOpen

Letter Details

Firm: Kloc Vapor, LLC d/b/a The Vapor Edge
Location: Andrew Kloc Owner Kloc Vapor, LLC d/b/a The Vapor Edge 6 New Haven Road, Suite 2 Prospect , CT 06712 United States thevaporedge@gmail.com
FEI Number: N/A
Country: United States
Issue Date: November 09, 2021
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Kloc Vapor, LLC d/b/a The Vapor Edge, a manufacturer and distributor of e-liquid tobacco products, was cited for failing to obtain premarket authorization for "new tobacco products" as required under the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products, deemed tobacco products effective August 8, 2016, were being manufactured and offered for sale in the United States without the legally mandated premarket approval. The FDA determined that these electronic nicotine delivery system products fell under federal tobacco regulation and were in violation of sections 201(rr) and 901(b) of the FD&C Act and applicable regulations at 21 C.F.R. § 1100.1.

Kloc Vapor, LLC d/b/a The Vapor Edge FDA Warning Letter, November 9, 2021