Black Industries Pty Ltd d/b/a Blck Flavour – FDA Warning Letter, May 19, 2020

The FDA issued a Warning Letter to Rashaad Bhana of Blckvapour.co.za on April 22, 2020, following a review of their website, which advertised and sold e-liquid products to U.S. customers. The FDA determined these e-liquids are tobacco products under the FD&C Act.

The letter identified two primary violations: 1. **Sales to Minors:** Blckvapour.co.za sold "Mistyhaze Gourmet E-Liquid - Creamy Amarula" to a person younger than 18, 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:** Advertisements for several e-liquid products, including "Mistyhaze Gourmet E-Liquid - Creamy Amarula," "Prime E-Liquid - FizzApple," and others, on the website failed to display the mandatory warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as required by 21 C.F.R. § 1143.3(b). This omission misbrands the products under sections 903(a)(7)(B) and 903(a)(7)(