FDA WARNING_LETTER - Elec-cigs.co.uk

The FDA's Center for Tobacco Products issued a Warning Letter to elec-cigs.co.uk after reviewing their website and determining that e-liquid products were offered for sale to U.S. customers. The FDA classifies these e-liquids as tobacco products under section 201(rr) of the FD&C Act, making them subject to FDA jurisdiction.

The primary violation identified was the sale of "Zombie Juice Jam on Toast" 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 retailers from selling covered tobacco products, including e-liquids, to minors.

The FDA requires immediate correction of this violation and similar issues, emphasizing the company's responsibility to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all sales and advertising platforms. Failure to comply may result in further FDA action, including 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 dates of discontinued violative sales and a plan for maintaining compliance, is required within 15 working