Foundation Vapor LLC

Warning LetterOpen

David P. Norris Owner Foundation Vapor LLC 225 South 19th Street, Suite 1 Camp Hill , PA 17011 United States fveliquid@gmail.comFEI 3013181587Issued Dec 16, 2021Center 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 3013181587.

Violations1

Issue DateDec 16, 2021

Product TypeTobacco

StatusOpen

Letter Details

Firm: Foundation Vapor LLC
Location: David P. Norris Owner Foundation Vapor LLC 225 South 19th Street, Suite 1 Camp Hill , PA 17011 United States fveliquid@gmail.com
FEI Number: 3013181587
Country: United States
Issue Date: December 16, 2021
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Foundation Vapor LLC, a manufacturer of e-liquid tobacco products, was found to be in violation of the Family Smoking Prevention and Tobacco Control Act and Federal Food, Drug, and Cosmetic Act requirements. The company manufactured and distributed e-liquid products without obtaining required premarket authorization for these "new tobacco products" as mandated under FDA regulations. As products meeting the FDA's definition of tobacco products under the August 8, 2016 deeming rule, Foundation Vapor's e-liquids were subject to FDA jurisdiction but lacked the necessary compliance documentation for legal commercial distribution in the United States.

Foundation Vapor LLC FDA Warning Letter, December 16, 2021