FDA WARNING_LETTER - freedom smoke usa international - September 20, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Freedom Smoke USA following a review of their website, freedomsmokeusa.com. The FDA determined that e-liquid products, specifically "Kiwi Pre-Mixed by Freedom Smoke USA" and "Watermelon Pre-Mixed by Freedom Smoke USA," are manufactured and offered for sale without the required marketing authorization. These products are classified as "tobacco products" under section 201(rr) of the FD&C Act, especially after the March 15, 2022, amendment extending jurisdiction to products containing nicotine from any source. The FDA found these e-liquids to be "new tobacco products" as they were not commercially marketed in the U.S. as of February 15, 2007, and lack the necessary premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these 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 notice under section 905(j). Freedom Smoke USA must submit a written response within 15 working days detailing corrective actions, including discontinuing violative sales and distribution, and outlining a plan for maintaining compliance with the FD&C Act. Failure to comply may lead to regulatory actions such as civil money penalties, seizure, and/or injunction.