FDA WARNING_LETTER - Aroma Ejuice LLC - July 09, 2019

The FDA issued a Warning Letter to Aroma Ejuice LLC on March 6, 2019, following a review of their mobile website, http://www.aromaejuice.com. The FDA determined that Aroma Ejuice LLC's e-liquid products are tobacco products under the FD&C Act.

The company was cited for two primary violations: 1. **Sales to Minors:** Aroma Ejuice LLC sold "Beatle Juice" e-liquid 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 e-liquid products, including "Beatle Juice," "RY 4," and "Sahara," lacked the mandatory warning statement "WARNING: This product contains nicotine. Nicotine is an addictive chemical" on their labeling and/or advertising, as required by 21 C.F.R. § 1143.3. This misbrands the products under sections 903(a)(7)(B), 903(a)(1), and/or 903(a)(7)(A) of the FD&C Act, as the omission of this material fact makes the