FDA WARNING_LETTER - Royal Vape E-Liquid - August 27, 2019

The FDA issued a Warning Letter to Joe Turner of Royal Vape Products on August 22, 2019, following a review of their website, royalvapeproducts.com. The FDA determined that e-liquid products, specifically Raspberry Custard and Raspberry Donut, were manufactured and sold to U.S. customers, qualifying them as tobacco products under the FD&C Act.

The letter identifies two primary violations: 1. **Sales to Minors:** Royal Vape Products sold Raspberry Custard and Raspberry Donut e-liquids to a person under 18 years of age, 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:** * **Product Packages:** Packages for several e-liquid products, including Raspberry Custard and Raspberry Donut, lacked the required "WARNING: This product contains nicotine. Nicotine is an addictive chemical" statement, violating 21 C.F.R. § 1143.3(a). This misbrands the products under sections 903(a)(7)(B) and 903(a)(1) of the FD&C Act. * **Website Advertising:** The website's advertising