FDA WARNING_LETTER - Smoke Brake Vapes, LLC - July 16, 2019

The FDA issued a Warning Letter to Smoke Brake Vapes, LLC on May 18, 2019, following a review of their website, https://www.smokebrakevapes.com. The FDA determined that the e-liquid products sold are tobacco products under the FD&C Act.

The company was cited for two primary violations: 1. **Sales to Minors:** An investigation revealed that a person younger than 18 years of age purchased "Blue Raspberry" e-liquid from the website, 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 labeling and/or advertising for several e-liquid products, including "Blue Raspberry," "Pineapple Xpress," and "Silly Rabbit," among others, failed to include the mandatory warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(a) and/or (b), making the products misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD