TJ's E-Cigarettes Limited – FDA Warning Letter, Dec 10, 2019

The FDA issued a Warning Letter to Terry Utting and James Utting of tj-ecigs.co.uk after reviewing their website, which advertises and sells electronic nicotine delivery system (ENDS) and e-liquid products to U.S. customers. These products are classified as tobacco products under the FD&C Act.

The FDA identified two primary violations: 1. **Sales to Minors:** The "myblu Starter Kit" ENDS product was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). This renders the product misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Failure to Include Required Nicotine Warning Statement:** Advertising for several e-liquid products (e.g., Dr Frost Cherry Ice Nic Salt, Nicotine Shot 10ml) on the website failed to include the mandatory warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as required by 21 C.F.R. § 1143.3(b). This misbrands the products under section 903(a)(7)(B) and section 903(a)(7)(A) of the FD&C Act, as the advertising is considered misleading due to the omission of material facts.