FDA WARNING_LETTER - True Vape USA - September 10, 2019

The FDA's Center for Tobacco Products issued a Warning Letter to True Vape USA after reviewing their website, truevapeusa.com, and determining that their e-liquid products are tobacco products subject to FDA jurisdiction. The letter identifies two primary violations. First, True Vape USA sold Bazooka Sour Straws Tropical Thunder - Mango Tango Sour Straws e-liquid to a person younger than 18 years of age, which is a violation of 21 C.F.R. § 1140.14(b) and renders the product misbranded under section 903(a)(7)(B) of the FD&C Act. Second, the company's website advertising for several e-liquid products, including Joker – Cloud Nine and Sher Burst, failed to include the required nicotine warning statement ("WARNING: This product contains nicotine. Nicotine is an addictive chemical.") as mandated by 21 C.F.R. § 1143.3(b), also resulting in misbranded products under section 903(a)(7)(B) of the FD&C Act. True Vape USA is required to immediately correct these violations and submit a written response within 15 working days detailing corrective actions, including dates of discontinuance of violative activities, and a plan for future compliance. Failure to comply may lead to further FDA actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction.