UltraUK Group d/b/a Ultra Vape – FDA Warning Letter, Oct 8, 2019

The FDA issued a Warning Letter to Andrew James regarding e-liquid products advertised and sold on ultravape.com to U.S. customers. The FDA determined these e-liquids are tobacco products under the FD&C Act.

The letter identifies two primary violations: 1. **Sales to Minors:** Ultravape.com sold "Dragons Blood" and "nicotine booster" e-liquids to a person under 18, violating 21 C.F.R. § 1140.14(b). This renders the products misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Failure to Include Required Nicotine Warning Statement:** Several e-liquid products, including "Cherry with Nicotine Shot" and "Heisenberg Blue – Special Edition with Nicotine Shot," were advertised without the mandatory "WARNING: This product contains nicotine. Nicotine is an addictive chemical" statement, as required by 21 C.F.R. § 1143.3(b). This also misbrands the products under section 903(a)(7)(B) of the FD&C Act.

The FDA requires immediate corrective actions for these and similar violations to ensure compliance with the FD&C Act and FDA regulations. Failure to comply may result in further actions, including civil money penalties, no-tobacco-sale