JMJL Global LLC – FDA Warning Letter, Oct 7, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Brewell MFG (2821 Saturn Street Unit B, Brea, CA 92821) after reviewing their website, https://www.brewellmfg.com. The review determined that e-liquid products manufactured and offered for sale or distribution in the U.S. are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization orders. Specifically, e-liquid products including Brewell Tobacco Series - Butterscotch #5, Brewell - Hard Strawberry #22, and Brewell - Melon Breeze #23 were found to be new tobacco products not commercially marketed before February 15, 2007, and lacking FDA marketing authorization. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Although the firm is a registered manufacturer with over 200 products listed, their Premarket Tobacco Product Applications (PMTAs) (STNs PM0001206, PM0001207, PM0001216) submitted on September 7, 2020, received Marketing Denial Order determinations on September 8, 2