FDA WARNING_LETTER - Warlock Vapes, LLC d/b/a Zuluvape - January 07, 2020

The FDA Center for Tobacco Products reviewed zuluvape.com and determined that e-liquid tobacco products advertised and sold are subject to FDA jurisdiction. The agency found that several e-liquid products, including Fairy’s Milk and Mana, are misbranded because their website advertising fails to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This omission violates 21 C.F.R. § 1143.3(b), which mandates this warning for covered tobacco products. Consequently, the products are misbranded under section 903(a)(7)(B) of the FD&C Act for violating regulations prescribed under section 906(d), and under section 903(a)(7)(A) for having advertising that is false or misleading due to the failure to reveal material facts. The FDA requires immediate corrective actions, including discontinuing violative advertising and sales, and submitting a written response within 15 working days detailing these actions and a compliance plan. Failure to comply may lead to severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.