FDA WARNING_LETTER - Inhale Hookah & Accessories - July 09, 2019

The FDA Center for Tobacco Products issued a Warning Letter to Inhale Tobacco following a review of their website, inhaletobacco.com, which revealed the manufacture and sale of waterpipe tobacco products in the U.S. These products are subject to FDA jurisdiction under the FD&C Act.

The letter identifies two primary violations: 1. **Sales to Minors:** Inhale Banana Cream Pie waterpipe tobacco was sold to a person younger than 18 years of age, violating 21 C.F.R. § 1140.14(b). This renders the product misbranded under section 903(a)(7)(B) of the FD&C Act. 2. **Failure to Include Required Nicotine Warning Statement:** Several waterpipe tobacco products (e.g., Inhale Bump’n Grind, Inhale Banana Cream Pie, Inhale Cinapple) advertised and sold on the website lacked the mandatory "WARNING: This product contains nicotine. Nicotine is an addictive chemical" statement, as required by 21 C.F.R. § 1143.3(a) and (b). This omission causes the products to be misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act, as the labeling and/or