FDA WARNING_LETTER - Bulk E-Juice Enterprise Inc d/b/a Bulk E-Juice - April 07, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Misty Shipp and Bryan Shipp concerning e-liquid tobacco products advertised and sold on bulkejuice.com. The FDA determined that several e-liquid products are misbranded under sections 903(a)(7)(B) and 903(a)(7)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The primary violation identified is the failure of the website advertising to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R. § 1143.3(b). This omission renders the advertising non-compliant and the products misbranded. The letter emphasizes that all tobacco products, including e-liquids, are subject to FDA jurisdiction and regulations. The company is required to immediately correct these violations and ensure all advertising across all platforms complies with the FD&C Act and implementing regulations. A written response detailing corrective actions, dates of discontinuation of violative activities, and a compliance plan must be submitted within 15 working days. Failure to comply could lead to severe enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.