FDA WARNING_LETTER - eCig Factory Limited

The FDA issued a Warning Letter to Ali Asgor regarding the website http://www.ecigfactory.co.uk, which offers e-liquid products for sale to U.S. customers. The FDA determined that iBreathe Exotic Mango e-liquid is a tobacco product under section 201(rr) of the FD&C Act and is subject to FDA jurisdiction.

The primary violation identified was the sale of iBreathe Exotic Mango e-liquid to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act. This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products, including e-liquids, to minors. The product is deemed a "covered tobacco product" under 21 C.F.R. § 1100.2.

The letter requires immediate correction of this violation and similar issues, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded products imported into the U.S. are subject to detention. A written response detailing corrective actions, including discontinuation dates and a compliance plan, is required within