FDA WARNING_LETTER - All Access Vapor, LLC - June 16, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Michael MacArthur, Michael Dade, and Danielle MacArthur of All Access Vapor, following a review of their website, https://www.allaccessvapor.com. The FDA determined that several e-liquid tobacco products advertised and sold on the website are misbranded. Specifically, the advertising for these e-liquid products 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). This omission renders the products misbranded under two sections of the Federal Food, Drug, and Cosmetic Act (FD&C Act): section 903(a)(7)(B) (21 U.S.C. § 387c(a)(7)(B)) for violating regulations prescribed under section 906(d), and section 903(a)(7)(A) (21 U.S.C. § 387c(a)(7)(A)) because the advertising is considered misleading due to the failure to reveal material facts about product consequences (21 U.S.C. § 321(n)). The letter requires immediate corrective actions, including discontinuing violative advertising and sales, and submitting a written response within 15 working days detailing compliance plans. Failure to comply could lead to severe enforcement actions, such as civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and refusal of admission for imported products.