FDA WARNING_LETTER - Damokee, LLC d/b/a Daily Dose E-Liquid and Damokee Vapor - August 25, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Jason Budler on July 31, 2020, following a review of the websites https://dailydoseeliquid.com and https://www.damokeevapor.com. The review determined that e-liquid tobacco products advertised and sold on these websites 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 primary violation is the failure to include the required nicotine warning statement in the advertising for several e-liquid products, such as Daily Dose E-Liquid-Noon and Mad Hatter – I Love Salts (Blue Raspberry). This violates 21 C.F.R. § 1143.3(b), which mandates that advertising for covered tobacco products like e-liquids must bear the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." The absence of this warning also renders the advertising false or misleading, leading to misbranding under section 903(a)(7)(A).

The letter emphasizes that it is the recipient's responsibility to ensure compliance with the FD&C Act and FDA's implementing regulations for all tobacco products, labeling, and advertising across all platforms. Failure to