Commonwealth Vapes – FDA Warning Letter, Sep 30, 2019

The FDA issued a Warning Letter to Len Friesen of Commonwealth Vapes on September 30, 2019, following a review of their website, https://www.commonwealthvapes.com. The FDA determined that e-liquid products advertised and sold to U.S. customers are tobacco products under the FD&C Act.

The letter identifies two primary violations: 1. **Sales to Minors:** Commonwealth Vapes sold Dr. Fog Katana Elite e-liquid to a person younger than 18 years of age, 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:** The website's advertising for several e-liquid products, including Convicted Vapes Heavy Metal Ice Canada and Wacky Watermelon by Dr. Fog Classics, failed to include the required nicotine warning statement ("WARNING: This product contains nicotine. Nicotine is an addictive chemical.") as mandated by 21 C.F.R. § 1143.3(b). This misbrands the products under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C