FDA WARNING_LETTER - Nubilus Vapor LLC d/b/a VapeCity Chicago - May 19, 2020

On April 22, 2020, the FDA issued a Warning Letter to Benedict Ventura regarding e-liquid products sold on nubilusvapor.com. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act.

The primary violation is that advertising for several e-liquid products, including Nubilus Vapor Nüage Citrine, Nubilus Vapor Nebulychee, and Nubilus Vapor Nüage Pair, fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 CFR 1143.3(b) and renders the products misbranded under sections 903(a)(7)(B) and 903(a)(7)(A) of the FD&C Act. The latter section also cites the failure to reveal material facts as making advertising misleading.

The FDA requires immediate correction of these violations and any similar ones. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response is required within 15 working days, detailing corrective actions, including dates of discontinued violative activities and a plan for ongoing compliance. The reference number for the response is RW2001296.