FDA WARNING_LETTER - IP Eye Limited

The FDA's Center for Tobacco Products issued a Warning Letter to http://www.cheap-eliquid.co.uk after determining their e-liquid products are offered for sale to U.S. customers and are subject to FDA jurisdiction as tobacco products under the FD&C Act.

The primary violation identified was the sale of Butterscotch 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 (21 U.S.C. § 387c(a)(7)(B)). This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquids, to minors. The FDA's investigation confirmed a minor purchased the product from the website.

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 further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco 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 15 working days.