DNA Distributors, Inc.

Warning LetterOpen

Anthony Hepker Owner DNA Distributors, Inc. 1178 Flex Court Lake Zurich , IL 60047 United States anthony@dnadistributors.comFEI 3013173050Issued Oct 12, 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 3013173050.

Violations1

Issue DateOct 12, 2021

Product TypeTobacco

StatusOpen

Letter Details

Firm: DNA Distributors, Inc.
Location: Anthony Hepker Owner DNA Distributors, Inc. 1178 Flex Court Lake Zurich , IL 60047 United States anthony@dnadistributors.com
FEI Number: 3013173050
Country: United States
Issue Date: October 12, 2021
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

DNA Distributors, Inc. was warned for manufacturing and distributing e-liquid tobacco products without required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, which are classified as electronic nicotine delivery systems under FDA jurisdiction, failed to comply with FD&C Act requirements applicable to newly deemed tobacco products effective August 8, 2016. The warning was issued after FDA review of the company's submissions and inspection records revealed these products were being manufactured and offered for sale in the United States without proper regulatory approval.

DNA Distributors, Inc. FDA Warning Letter, October 12, 2021