Eonsmoke, LLC – FDA Warning Letter, Oct 24, 2019

The FDA issued a Warning Letter to Eonsmoke, LLC, based on a review of submissions, inspection records, social media accounts (Scott Disick, Mia Khalifa, Eonsmoke, LLC Twitter), and the company website (eonsmoke.com). The FDA determined Eonsmoke, LLC, advertises, imports, sells, and distributes electronic nicotine delivery system (ENDS) products and components, including e-liquids, which are classified as tobacco products.

The letter identifies three main violations: 1. **New Tobacco Products Without Required Marketing Authorization:** Eonsmoke's Salt Nicotine E-Liquid (30mg, 60mg) and Nicotine E-Liquid (30mg) were introduced into interstate commerce without premarket review or marketing authorization, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. These products were not commercially marketed before February 15, 2007. 2. **Modified Risk Tobacco Product Violations:** Eonsmoke's ENDS products are adulterated under section 902(8) because their labeling/advertising (e.g., "without the thousands of harmful chemicals and additives," "No tar… No harmful odors") implicitly or explicitly represents a lower risk or absence of substances, without an FDA order under section 9