FDA WARNING_LETTER - Hookah Cousins LLC - February 18, 2020

On February 6, 2020, the FDA issued a Warning Letter to Hatem Alami and Tarik Ansari, owners of hookahcousins.com, for misbranded waterpipe tobacco products. The FDA's review of their website revealed that several waterpipe tobacco products, including Starbuzz Sex on the Beach, Alchemist Straight Blueberry, and Social Smoke Sex Panther, were advertised and offered for sale in the U.S. without adequately displaying the required nicotine warning statement.

Under section 201(rr) of the FD&C Act, these products are considered tobacco products. The violation stems from the failure to comply with 21 C.F.R. § 1143.3(b)(2), which mandates that advertisements for such products conspicuously display the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This warning must be surrounded by a rectangular border and occupy at least 20 percent of the advertisement area.

The FDA cited section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), stating that tobacco products are misbranded if sold or distributed in violation of regulations under section 906(d), including 21 C.F.R. Part 1143. The letter requires immediate corrective action, including discontinuing violative