FDA WARNING_LETTER - James Audi d/b/a The Broke Smoker - October 22, 2019

The FDA's Center for Tobacco Products issued a Warning Letter to James Audi, operating as The Broke Smoker, on September 27, 2019, following a review of the website https://www.thebrokesmoker.com. The FDA determined that e-liquid products sold on the website are tobacco products subject to FDA jurisdiction.

The letter identifies three primary violations: 1. **Sales to Minors:** BrokeSmoker Hawaiian Juice, BrokeSmoker Doublemint, and BrokeSmoker Sweet Tart e-liquid products were sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). This renders the products misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Failure to Include Nicotine Warning on Product Packages:** Packages for BrokeSmoker Hawaiian Juice, BrokeSmoker Doublemint, and BrokeSmoker Sweet Tart e-liquid products lacked the required nicotine warning statement ("Warning: This product contains nicotine. Nicotine is an addictive chemical.") as mandated by 21 C.F.R. § 1143.3(a). This also misbrands the products under section 903(a)(7)(B) of the FD&C Act. 3. **Failure to Include Nic