Kilo E-Liquid, Inc. – FDA Warning Letter, May 16, 2023

The FDA issued a Warning Letter to Brian Kim of Kilo E-Liquids, Inc., after reviewing their website, https://www.kiloeliquids.com, and identifying e-liquid products offered for sale in the U.S. These products, including "Kilo Revival: Brazzberry Lemonade," "Pineapple Whip," and "Dewberry Cream," are classified as tobacco products under section 201(rr) of the FD&C Act, as they contain nicotine from any source. The FDA determined these are "new tobacco products" because they were not commercially marketed before February 15, 2007, and lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required information under section 905(j). The firm must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for maintaining compliance, to avoid further regulatory actions such as civil money penalties, seizure, or injunction.