One Stop VAPE Shop #3 - Grove – FDA Warning Letter, Nov 14, 2022

The FDA issued a Warning Letter to One Stop Vape Shop on November 14, 2022, following a review of submissions and inspection records. The FDA determined that One Stop Vape Shop manufactures and distributes e-liquid products, which are considered tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine and are intended for human consumption. This includes products with nicotine from any source, as per the Consolidated Appropriations Act, 2022.

The inspection revealed two primary violations: 1. **Unregistered Establishment:** One Stop Vape Shop failed to register its manufacturing establishment at 518 West 3rd Street, Grove, OK, as required by section 905(c) of the FD&C Act. This renders all tobacco products manufactured there misbranded under section 903(a)(6) and constitutes prohibited acts under sections 301(k) and 301(p). 2. **Unlisted Tobacco Products:** The company's tobacco products were not included in a list required by section 905(i) of the FD&C Act, which mandates biannual reporting of commercially distributed tobacco products. This also results in misbranded products under section 903(a)(6) and constitutes prohibited acts under sections 301(k) and 301(p).

One Stop Vape Shop is required