FDA WARNING_LETTER - Propaganda E-Liquid LLC - December 21, 2021

The FDA's Center for Tobacco Products issued a Warning Letter to Nicholas DeNuccio and Nicholas Bull regarding e-liquid products sold on http://www.propagandaeliquid.com. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation. The primary violation is the manufacturing and offering for sale of "new tobacco products" (specifically Propaganda E-Liquid Juicy Grape and Propaganda E-Liquid Strawberries A La Mode) without the required premarket authorization order, as they were not commercially marketed before February 15, 2007. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice under section 905(j). Although a Premarket Tobacco Product Application (PMTA) was submitted, it received a Marketing Denial Order on September 8, 2021, covering 84 products. The FDA considers products without premarket authorization, especially those with MDOs, high enforcement priorities. The company must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for future compliance, to avoid further regulatory action such as civil money penalties, seizure, or injunction.