wadina distribution llc – FDA Warning Letter, Jan 11, 2022

The FDA issued a Warning Letter to Amjad Daoud regarding Gost Vapor's e-liquid products, specifically "Parfait – The Milkhouse – Gost Vapor," sold on gostvapor.com. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The primary violation is marketing a "new tobacco product" without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. A "new tobacco product" is defined as one not commercially marketed in the U.S. as of February 15, 2007, or a modified product marketed after this date. The identified e-liquid product was not commercially marketed by the specified date and lacks an FDA marketing authorization order, making it adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The company's Premarket Tobacco Product Application (PMTA) STN PM0002560, submitted on September 9, 2020, received a Marketing Denial Order on September 9, 2021, covering 84 products. The FDA considers products with Marketing Denial Orders among its highest enforcement priorities.

The letter requires a written response within 15 working days detailing actions taken to