FDA WARNING_LETTER - Orama Hookah Corporation - October 08, 2019

The FDA's Center for Tobacco Products issued a Warning Letter to Samih Isehak of Orama Hookah on September 24, 2019, following a review of the website https://www.oramahookah.com. The FDA determined that waterpipe tobacco products advertised and sold on the website are misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B), § 387c(a)(1), § 387c(a)(7)(A)).

The primary violation is the failure to include the required nicotine warning statement, "WARNING: This product contains nicotine. Nicotine is an addictive chemical," in the advertising for several waterpipe tobacco products, such as Al Waha After Nine, Fumari Ambrosia, and Starbuzz Blue Mist. This violates 21 C.F.R. § 1143.3(b), which mandates this warning for covered tobacco products. The absence of this warning also renders the products misbranded because the advertising is considered false or misleading by failing to reveal material facts about the product's consequences.

Orama Hookah is required to immediately correct these violations and ensure all tobacco products, labeling, and