FDA WARNING_LETTER - Black Industries Pty Ltd d/b/a Blck Flavour - May 19, 2020

Record Details

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)(

Company: Black Industries Pty Ltd d/b/a Blck Flavour
Inspection Date: May 19, 2020
Product Type: Tobacco
Office: Center for Tobacco Products
Person: Ann Simoneau (Director)

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ID · 8c10a9f9-23b5-4568-9c0e-546acd2469c5

Violation Codes10

21 U.S.C. 321(rr)21 U.S.C. 387a(b)21 U.S.C. 387c(a)(7)(B)21 U.S.C. 387c(a)(7)(A)21 U.S.C. 321(n)21 CFR 1140.14(a)21 CFR 1140.14(b)21 CFR 1100.221 CFR 1143.3(b)21 CFR 1143.3(b)(1)

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