FDA WARNING_LETTER - Warlock Vapes, LLC d/b/a Zuluvape - July 09, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Orit Deverell regarding e-liquid products marketed on zuluvape.com and zulufume.com. The FDA determined that these e-liquid products, including Cinna Yum, French Caramel, and Gummy Fish, are tobacco products under section 201(rr) of the FD&C Act, especially after the March 15, 2022, amendment expanding jurisdiction to products with nicotine from any source. The primary violation is the marketing of "new tobacco products" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required information under section 905(j). The letter emphasizes the firm's responsibility to ensure all tobacco products, labeling, and advertising comply with the FD&C Act and implementing regulations. The firm must submit a written response within 15 working days detailing actions to address violations, including discontinuing violative sales and a plan for future compliance, to avoid potential regulatory actions such as civil money penalties, seizure, or injunction.