E-Cig USA Inc d/b/a Hutchinson Tobacco and Cigar

Warning LetterOpen

Jehad M. Mishal Owner E-Cig USA Inc d/b/a Hutchinson Tobacco and Cigar 725 Baltimore Avenue Southwest Hutchinson , MN 55350 United StatesIssued Mar 1, 2022Center for Tobacco Products

View Letter

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

Violations1

Issue DateMar 1, 2022

Product TypeTobacco

StatusOpen

Letter Details

Firm: E-Cig USA Inc d/b/a Hutchinson Tobacco and Cigar
Location: Jehad M. Mishal Owner E-Cig USA Inc d/b/a Hutchinson Tobacco and Cigar 725 Baltimore Avenue Southwest Hutchinson , MN 55350 United States
FEI Number: N/A
Country: United States
Issue Date: March 01, 2022
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

E-Cig USA Inc d/b/a Hutchinson Tobacco and Cigar manufactured and distributed e-liquid products without required premarket authorization as mandated under the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products were deemed tobacco products subject to FDA regulation effective August 8, 2016, yet the firm failed to obtain premarket approval required for "new tobacco products" not commercially marketed in the United States as of February 15, 2007. The violation constituted failure to comply with the Federal Food, Drug, and Cosmetic Act's requirements for tobacco product authorization and distribution.

E-Cig USA Inc d/b/a Hutchinson Tobacco and Cigar FDA Warning Letter, March 1, 2022