FDA WARNING_LETTER - American Wholesale Distribution, Inc. d/b/a Lunar E-Cigs - April 14, 2020

The FDA issued a Warning Letter to David Ross on March 6, 2019, following a review of the website https://lunar-ecigs.com, which offers e-liquid products for sale in the U.S. These products are classified as tobacco products under the FD&C Act.

The letter identifies two primary violations: 1. **Sales to Minors:** The "Caramel Stardust E-Liquid" 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:** Numerous ENDS and e-liquid products advertised on the website lacked the mandatory warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This violates 21 C.F.R. § 1143.3(a) and/or (b), leading to misbranding 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 actions for these and similar violations, including discontinuing violative sales, labeling, and advertising