FDA WARNING_LETTER - Busscatello Enterprises LLC d/b/a Route 66 Vapes - October 22, 2019

On August 22, 2019, the FDA issued a Warning Letter to Chris Bussell of Route 66 Vapes, located at 1627 Cypress Dr, Weatherford, OK 73096, United States. The letter states that the FDA's Center for Tobacco Products reviewed the website https://www.rt66vapes.com and determined that e-liquid products, specifically Route 66 Vapes Apple Pie e-liquid, are manufactured and offered for sale or distribution in the United States. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The FDA identified two primary violations: 1. **Sales to Minors:** The Route 66 Vapes Apple Pie e-liquid was sold 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 (21 U.S.C. § 387c(a)(7)(B)). 2. **Failure to Include Required Nicotine Warning Statement:** The website advertising for an e-liquid product, specifically Route 66 Apple Pie e-liquid, failed to include the required nicotine warning statement ("WARNING: This product contains nicotine