Superdragon TCM UK Ltd – FDA Warning Letter, Aug 27, 2019

On August 22, 2019, the FDA issued a Warning Letter to David Xiu and Mary Yang of vapingdirect.com, following a review of their website. The FDA determined that their e-liquid products are tobacco products subject to FDA jurisdiction.

The letter identified multiple violations: 1. **Sale to Minors:** The Tropical Burst e-liquid product was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b) and rendering the product misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Missing Nicotine Warning Statement in Advertising:** The website's advertising for e-liquid products (including Blueberry, Cherry, Cherry Cola, Double Apple, Menthol, Menthol Ice Cool, Mixed Berry, Mixed Fruit, Tobacco, and Tropical Burst) failed to include the required nicotine warning statement, violating 21 C.F.R. § 1143.3(b) and misbranding these products under section 903(a)(7)(B) of the FD&C Act. 3. **Missing Nicotine Warning Statement on Labeling:** The labeling for the Tropical Burst e-liquid product did not display the required nicotine warning statement in the manner required by 21 C.F.R. § 11