FDA WARNING_LETTER - Compuzone, Inc. d/b/a Vaping Zone - October 08, 2019

The FDA issued a Warning Letter to Louay Abouassali of Vapingzone.com on September 24, 2019, following a review of their website, which advertises and sells e-liquid products in the U.S. The FDA determined these e-liquids are "tobacco products" under the FD&C Act.

The primary violation is that several e-liquid products, including Cinnamon Roll, Circus Cotton Candy, Pink Lemonade, VZ Cherry Cigar, and VZ Honey Flue Cured Tobacco, 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 violates 21 C.F.R. § 1143.3(b), which mandates this warning for covered tobacco products. Consequently, the products are misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act, as the lack of warning makes the advertising false or misleading by failing to reveal material facts.

Vapingzone.com must immediately correct these violations and ensure all tobacco products and related advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.