FDA WARNING_LETTER - Cool Clouds Distribution, Inc. d/b/a Puff Bar - July 20, 2020

The FDA issued a Warning Letter to Umais Abubaker regarding the sale and distribution of Electronic Nicotine Delivery System (ENDS) products on the website https://puffbar.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation.

The primary violations identified are: 1. **New Tobacco Products Without Required Marketing Authorization**: Products like Puff Bar Plus (Mixed Berries, Cool Mint), Puff Bar (Cucumber, Mango, Blue Razz, Banana Ice, Sour Apple) are considered "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007. They lack the required FDA marketing authorization orders or exemptions, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. 2. **Modified Risk Tobacco Product Violations**: The website makes explicit or implicit claims that the ENDS products present a lower risk, reduced substance levels, or are free of certain substances, without an FDA order permitting such claims. This violates section 911(a) of the FD&C Act, making the products adulterated under section 902(8).

The FDA requires prompt corrective actions, including discontinuing the violative labeling, advertising, sale, and distribution of these products. A