E-Cig POD USA LLC d/b/a e-cig POD

Warning LetterOpen

Tom Madden Owner E-Cig POD USA LLC d/b/a e-cig POD 14645 Excelsior Boulevard Minnetonka , MN 55345 United States sales@ecigpod.comIssued Nov 9, 2022Center for Tobacco Products

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations1

Issue DateNov 9, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: E-Cig POD USA LLC d/b/a e-cig POD
Location: Tom Madden Owner E-Cig POD USA LLC d/b/a e-cig POD 14645 Excelsior Boulevard Minnetonka , MN 55345 United States sales@ecigpod.com
FEI Number: N/A
Country: United States
Issue Date: November 09, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

E-Cig POD USA LLC manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA regulations governing newly deemed tobacco products, specifically electronic nicotine delivery systems, which have been subject to FDA jurisdiction since August 8, 2016. The FDA determined that the company's e-liquid products were marketed without the legally mandated premarket review and approval required for new tobacco products under section 910(a) of the FD&C Act.

E-Cig POD USA LLC d/b/a e-cig POD FDA Warning Letter, November 9, 2022