Ecig Charleston LLC

Warning LetterOpen

United StatesIssued Jul 2, 2024Center for Tobacco Products

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

Letter Details

Firm: Ecig Charleston LLC
Location: United States
FEI Number: N/A
Country: United States
Issue Date: July 02, 2024
Issuing Office: Center for Tobacco Products
Product Type: Tobacco
Status: Open

Summary

Ecig Charleston LLC, a manufacturer and distributor of e-liquid tobacco products, was cited for failing to obtain required premarket authorization orders before marketing its products in the United States. The company's e-liquid products, which contain nicotine from any source, fall under FDA jurisdiction as tobacco products and must comply with the Federal Food, Drug, and Cosmetic Act, including obtaining marketing authorization for any products not commercially marketed as of February 15, 2007. The warning was issued by the Center for Tobacco Products following an FDA inspection review that determined the company was selling these unapproved tobacco products in violation of section 910 of the FD&C Act.