FDA WARNING_LETTER - Skull and Roses Juice Co. LLC - April 05, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Kimberly Liles on December 30, 2021, after reviewing the websites https://www.skullandrosesjuiceco.com and https://www.mellowvape.com. The review determined that e-liquid products, specifically Strawberry Fields 60ml and Eat a Peach 60ml, were manufactured and offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is that these e-liquid products are "new tobacco products" that were not commercially marketed in the U.S. as of February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act because required notice or information was not provided under section 905(j).

Although the firm is a registered manufacturer with over 620 products listed, their Premarket Tobacco Product Application (PMTA) STN PM0001346, covering 487 products, received a Marketing Denial Order on September