FDA WARNING_LETTER - Black Axis Juice Company LLC - October 29, 2019

The FDA Center for Tobacco Products issued a Warning Letter to Jonathan Deutsch of Black Axis Juice on September 27, 2019, following a review of their website, https://www.blackaxisjuice.com. The FDA determined that the company's e-liquid products are tobacco products subject to FDA jurisdiction and found multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations, rendering several products misbranded. Specifically, Black Axis Juice sold its "Subversion" e-liquid to a minor, violating 21 C.F.R. § 1140.14(b) and misbranding the product under section 903(a)(7)(B) of the FD&C Act. Additionally, product packages, including "Subversion," failed to include the required nicotine warning statement, violating 21 C.F.R. § 1143.3(a) and section 903(a)(7)(B). The company's website advertising for several e-liquid products also lacked this mandatory nicotine warning, violating 21 C.F.R. § 1143.3(b) and misbranding products under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act due to misleading advertising. The FDA requires immediate corrective actions, including discontinuing violative sales, labeling, and advertising, and submitting a written response within 15 working days detailing these actions and a plan for future compliance. Failure to comply could result in further FDA actions such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction.