FDA WARNING_LETTER - ShiVish International LTD. d/b/a Evapstore - March 10, 2020

The FDA Center for Tobacco Products issued a Warning Letter to evapstore.com on February 28, 2020, following a review of their website. The FDA determined that e-liquid products advertised and sold to U.S. customers are tobacco products under the FD&C Act.

The primary violation is that several e-liquid products, including "Whoop E Liquids Mango Sexy Multipack," "King Cloudz Green Apple," and "Golden Cream E Liquids Strawberry Milkshake Multipack," are misbranded. This is because their website advertising fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(b) and consequently misbrands the products under sections 903(a)(7)(B) and 903(a)(7)(A) of the FD&C Act. The absence of this material fact also renders the advertising misleading.

The letter requires immediate corrective actions, including discontinuing violative advertising, labeling, sale, and distribution. A written response detailing corrective actions and a plan for maintaining compliance must be submitted within 15 working days. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction, and products may be detained upon import.