FDA WARNING_LETTER - N2G2, LLC d/b/a Lavoo Tobacco - May 14, 2019

On April 26, 2019, the FDA issued a Warning Letter to Nader Marzok of Lavoo Tobacco, following a review of their website, lavootobacco.com. The FDA determined that Lavoo Tobacco's waterpipe tobacco products are subject to FDA jurisdiction.

The letter identifies two primary violations: 1. **Sales to Minors:** Lavoo Tobacco sold Lavoo Tobacco Russian Tea waterpipe tobacco 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 advertised and sold on the website, including Lavoo Tobacco Double Dark Mint, Southern Peach, and various Lavoo Heritage Reserve products, lacked the mandatory "WARNING: This product contains nicotine. Nicotine is an addictive chemical" statement. This violates 21 C.F.R. § 1143.3(a) and/or (b), causing these products to be misbranded under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act.

The FDA requires immediate corrective