Vape King Inc.

Warning LetterOpen

John Hannon Owner Vape King Inc. 28441 South Tamiami Trail Suite 209 Bonita Springs , FL 34134 United States vapekingecigs@gmail.comFEI 3019575510Issued Dec 15, 2022Center for Tobacco Products

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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 3019575510.

Letter Details

Firm: Vape King Inc.
Location: John Hannon Owner Vape King Inc. 28441 South Tamiami Trail Suite 209 Bonita Springs , FL 34134 United States vapekingecigs@gmail.com
FEI Number: 3019575510
Country: United States
Issue Date: December 15, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Vape King Inc. was warned that its e-liquid products are subject to FDA regulation as tobacco products under the Family Smoking Prevention and Tobacco Control Act, but the company failed to obtain required premarket authorization for these "new tobacco products" before commercial distribution. The Center for Tobacco Products determined that the company manufactured and distributed e-liquid products in the United States without complying with Federal Food, Drug, and Cosmetic Act requirements, including the mandatory premarket authorization process for products not commercially marketed prior to February 15, 2007. The inspection and submission review revealed violations of multiple FDA regulations governing electronic nicotine delivery systems and their required marketing authorization status.