FDA WARNING_LETTER - Apocalypse Juice, Inc. - September 22, 2020

On September 4, 2020, the FDA issued a Warning Letter to Anthony Leonardi of Apocalypse Juice, based on a review of their website, http://www.apocalypsejuice.com. The FDA determined that e-liquid tobacco products advertised and sold on the website are misbranded under sections 903(a)(7)(B) and 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B) and (A)).

The core violation is the failure of the website advertising for several e-liquid products (e.g., Blue Slushee, Psycho Vision, Vicious Hibiscus, Kandy Kane, TK4) to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This is mandated by 21 C.F.R. § 1143.3(b) for covered tobacco products. The absence of this warning renders the products misbranded because they violate regulations prescribed under section 906(d) of the FD&C Act and because the advertising is considered false or misleading by failing to reveal material facts about the product's consequences.

Apocalypse Juice is required to immediately correct these violations and submit a written response within 15 working days detailing corrective actions, including dates of discontinued violative activities and a plan