RickinmortyBars – FDA Warning Letter, Sep 12, 2023

The FDA issued a Warning Letter to Kareem Walton regarding the sale of electronic nicotine delivery system (ENDS) products on the website https://rickinmortybars.com. The FDA determined these products are tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction and compliance requirements.

The primary violations identified are: 1. **Marketing of New Tobacco Products Without Authorization:** The website offers ENDS products, specifically Elfbar Kiwi Passion Fruit Guava and Esco Bars – Kiwi Dragon Berry 10 Count, which are considered "new tobacco products" as they were not commercially marketed in the U.S. before February 15, 2007. These products lack the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6). 2. **Sale to Underage Individuals:** An investigation revealed the sale of a Candy King Air - Gummy Worm 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 letter requires a written response within 15 working days detailing actions taken to