FDA WARNING_LETTER - jadore enterprises, llc - June 08, 2020

The FDA issued a Warning Letter to Jadore Enterprises LLC, d/b/a Tiki Vapes, for violations related to their e-liquid products, specifically Tiki Vapes - Spearmint e-liquid. The FDA determined these products are tobacco products subject to FDA jurisdiction.

The inspection revealed several violations: 1. **Misbranded Product (Nicotine Warning):** The Tiki Vapes - Spearmint e-liquid product packages 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), rendering it misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Misbranded Product (Product Listing):** The Tiki Vapes - Spearmint e-liquid product was not included in the biannual product list required by section 905(i) of the FD&C Act, making it misbranded under section 903(a)(6). 3. **Misbranded Product (Ingredient Listing):** The company failed to provide an ingredient listing for the Tiki Vapes - Spearmint e-liquid product as required by section 904(a)(1) of the FD&C Act, resulting in misbranding under section 903(a)(10)(A). 4.