SZ Vape LLC, d/b/a Vype Vapor

Warning LetterOpen

SZ Vape LLC, d/b/a Vype Vapor 3322 East Sunset Road, Suites 120-125 Las Vegas , NV 89120 United StatesFEI 3012788522Issued May 13, 2024Center for Tobacco Products

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3012788522.

Violations1

Issue DateMay 13, 2024

Product TypeTobacco

StatusOpen

Letter Details

Firm: SZ Vape LLC, d/b/a Vype Vapor
Location: SZ Vape LLC, d/b/a Vype Vapor 3322 East Sunset Road, Suites 120-125 Las Vegas , NV 89120 United States
FEI Number: 3012788522
Country: United States
Issue Date: May 13, 2024
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

SZ Vape LLC, operating as Vype Vapor, sold electronic nicotine delivery system (ENDS) products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations requiring "new tobacco products" to receive premarket approval before legal marketing in the United States. The warning was issued following the FDA's review of inspection records determining that the company distributed these nicotine-containing products to U.S. customers without the necessary premarket authorization order in effect.

SZ Vape LLC, d/b/a Vype Vapor FDA Warning Letter, May 13, 2024