My Vape Shack

Warning LetterOpen

My Vape Shack 240 Dawson Village Way North, Suite 120 Dawsonville , GA 30534 United StatesIssued Dec 21, 2023Center for Tobacco Products

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

Letter Details

Firm: My Vape Shack
Location: My Vape Shack 240 Dawson Village Way North, Suite 120 Dawsonville , GA 30534 United States
FEI Number: N/A
Country: United States
Issue Date: December 21, 2023
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

My Vape Shack, an e-liquid manufacturer and distributor in Georgia, was found to be producing tobacco products containing nicotine without the required premarket authorization mandated by the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA jurisdiction over e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source following the March 2022 legislative amendment. The FDA determined that the company was manufacturing and offering these products for commercial distribution in the United States without proper regulatory approval, a violation of section 910(a) of the FD&C Act requiring premarket authorization for new tobacco products.