FDA WARNING_LETTER - Cool Vapes LLC - August 26, 2021

The FDA Center for Tobacco Products issued a Warning Letter to Cool Vapes, LLC, following a review of submissions and inspection records, determining the company manufactures and distributes e-liquid products, specifically Cool Vapes Fuzzy Navel 30mL .3% e-liquid. These products are deemed tobacco products subject to FDA jurisdiction and regulations, including the August 8, 2016, deeming rule. The FDA found that the aforementioned e-liquid product is a "new tobacco product" that was not commercially marketed as of February 15, 2007, and lacks the required FDA marketing authorization order. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the failure to provide required notice or information under section 905(j). The letter also cites prohibited acts under sections 301(k) for holding adulterated/misbranded products for sale and 301(p) for failing to provide a required report. Cool Vapes, a registered manufacturer with over 19,400 listed products, is responsible for ensuring all products comply with the FD&C Act. The firm 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.