FDA WARNING_LETTER - Prime Hookah Incorporated - October 08, 2019

The FDA Center for Tobacco Products issued a Warning Letter to Prime Hookah on September 24, 2019, following a review of their website, primehookah.com. The FDA determined that Prime Hookah was advertising and offering waterpipe tobacco products for sale or distribution in the United States, which are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was that several waterpipe tobacco products, including Afzal Hookah Shisha Tobacco Pan Masala Supreme, Al Fakher Hookah Shisha Tobacco Strawberry, and Fumari Hookah Shisha Tobacco Lemon, were misbranded. This misbranding occurred because their labeling and/or advertising on the website failed to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(b), which mandates this warning for covered tobacco products.

Consequently, these products are misbranded under section 903(a)(7)(B) of the FD&C Act for violating regulations prescribed under section 906(d). Additionally, the products are misbranded under section 903(a)(1) and/or section 903(a)(7)(A) of the FD&C Act because the absence of the required warning renders their labeling and/or advertising false or misleading