FDA WARNING_LETTER - Malicious Liquids Inc. - December 21, 2021

The FDA issued a Warning Letter to Erika Pearce regarding e-liquid products manufactured and sold via maliciousliquids.com, vapertreats.com, and localvape.com. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act, subject to FDA jurisdiction.

The primary violation is the marketing of "new tobacco products" without required premarket authorization. Specifically, Pixy Dip by Vaper Treats, Mr. Malts Flurry’s by Vaper Treats E-Juice, and The Cupcake Man Blueberry by Vaper Treats were identified as 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.

The firm is a registered manufacturer with over 2,500 listed products. A Premarket Tobacco Product Application (PMTA) (STN PM0001181) submitted on September 7, 2020, received a Marketing Denial Order on September 8, 2021, covering 715 products. Products with Marketing Denial Orders are high enforcement priorities.

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing violative