FDA WARNING_LETTER - Hookah Zone - July 11, 2025

On July 10, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Hookah Zone, identifying violations related to the sale and distribution of electronic nicotine delivery system (ENDS) products. The FDA determined that Hookah Zone sells ENDS products, which are classified as tobacco products under section 201(rr) of the FD&C Act, including those containing nicotine from any source, following the March 15, 2022, amendment to the FD&C Act.

The primary violation cited is the marketing of "new tobacco products" without the required premarket authorization order. Specifically, the product "OLIT HookaLit Watermelon Ice 40 ml .35% NIC" was identified as a new tobacco product not commercially marketed in the U.S. as of February 15, 2007, and lacking an FDA marketing authorization order or exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j).

Hookah Zone is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale/distribution of non-compliant products and a plan for maintaining compliance. Failure to comply may result in regulatory actions such