FDA WARNING_LETTER - The Plume Room LLC - October 07, 2021

The FDA Center for Tobacco Products reviewed the website https://www.theplumeroom.com and determined that e-liquid products, specifically "Magic Melon Melody 30mL," are 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 identified e-liquid product is a "new tobacco product" as it was not commercially marketed in the U.S. as of February 15, 2007. It lacks the required FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The firm is a registered manufacturer with over 800 products listed with FDA. A Premarket Tobacco Product Application (PMTA) assigned STN PM0001250, submitted on September 8, 2020, received a Marketing Denial Order on September 8, 2021, covering 446 products.

The FDA requires a written response within 15 working days detailing actions to address violations, including discontinuation dates for violative labeling, advertising, sale, and distribution, and a plan for maintaining compliance.