FDA WARNING_LETTER - VCI Enterprise, Inc d/b/a DRIPTECH - September 19, 2023

The FDA issued a Warning Letter to Daniella Maggie Rodriguez regarding the website https://driptechs.com, which offers Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. These products are considered tobacco products under the FD&C Act, including those containing nicotine from any source, effective April 14, 2022.

The primary violations identified are: 1. **Marketing of New Tobacco Products Without Authorization:** The website offers ENDS products, specifically "Esco Bars Banana Ice," which are new tobacco products not commercially marketed before February 15, 2007, and lack the required FDA marketing authorization order. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. 2. **Sale to Underage Individuals:** An investigation revealed the sale of an "Esco Bars Banana Ice" ENDS product to an individual under 21 years of age, violating section 906(d)(5) of the FD&C Act. This makes the product misbranded under section 903(a)(7)(B).

The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or