FDA WARNING_LETTER - Hookah Imports Inc - August 08, 2019

The FDA issued a Warning Letter to Hookah Imports, Inc. on August 8, 2019, following a review of their submissions, inspection records, and website (https://www.rortobacco.com). The letter identifies several violations related to the manufacture and distribution of ROR Tobacco hookah products.

Firstly, the FDA determined that 12 specific ROR Tobacco hookah products are "new tobacco products" that were not commercially marketed before February 15, 2007, and are being sold without required marketing authorization orders. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required premarket review and submissions under section 905(j) were not provided.

Secondly, an FDA investigation revealed that Hookah Imports, Inc. sold 10 specific hookah tobacco products to a person younger than 18 years of age via their website, violating 21 C.F.R. § 1140.14(b). These products are therefore misbranded under section 903(a)(7)(B) of the FD&C Act.

Thirdly, the labeling and/or advertising for the same 10 hookah products on their website failed to include the required nicotine warning statement ("WARNING: This product contains nicotine. Nicotine is an addictive chemical