Southeast Distro Inc.

Warning LetterOpen

Southeast Distro Inc. 3463 Tom Watson Drive Saltillo , MS 38866 United StatesFEI 3031026693Issued Sep 25, 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 3031026693.

Violations1

Issue DateSep 25, 2024

Product TypeTobacco

StatusOpen

Letter Details

Firm: Southeast Distro Inc.
Location: Southeast Distro Inc. 3463 Tom Watson Drive Saltillo , MS 38866 United States
FEI Number: 3031026693
Country: United States
Issue Date: September 25, 2024
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Southeast Distro Inc. was cited for selling and distributing electronic nicotine delivery system (ENDS) products without required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA jurisdiction over tobacco products containing nicotine from any source, which expanded under 2022 legislation to include synthetic nicotine products. As a distributor of ENDS products, the company was required to ensure these "new tobacco products" obtained marketing authorization before being legally sold in the United States.

Southeast Distro Inc. FDA Warning Letter, September 25, 2024