Wagco Distribution, Inc.

Warning LetterOpen

Wagco Distribution, Inc. 861 Old Knight Road, Suite 104 Knightdale , NC 27545 United StatesFEI 3013151527Issued Mar 21, 2024Center 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 3013151527.

Violations1

Issue DateMar 21, 2024

Product TypeTobacco

StatusOpen

Letter Details

Firm: Wagco Distribution, Inc.
Location: Wagco Distribution, Inc. 861 Old Knight Road, Suite 104 Knightdale , NC 27545 United States
FEI Number: 3013151527
Country: United States
Issue Date: March 21, 2024
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Wagco Distribution, Inc. manufactured and distributed e-liquid products containing nicotine without required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act's new tobacco product requirements. The company failed to comply with FDA jurisdiction over tobacco products, including those containing nicotine from any source following the 2022 legislative expansion of FDA authority. The products were deemed adulterated and misbranded as they lacked the legally mandated premarket approval necessary for commercial distribution in the United States.

Wagco Distribution, Inc. FDA Warning Letter, March 21, 2024