FDA WARNING_LETTER - 10 Days Inc - September 13, 2022

The FDA Center for Tobacco Products issued a Warning Letter to Mohammed Shubyre Humkar after reviewing podjuice55.com, determining that e-liquid products offered for sale, such as Cotton Carnival and Pink Burst Tobacco-Free Nicotine Vape Juice, are tobacco products subject to FDA jurisdiction. This includes products containing nicotine from any source, following recent legislative amendments. The FDA found that these products are "new tobacco products" because they were not commercially marketed in the U.S. before February 15, 2007. The firm is in violation for manufacturing and distributing these products without the required premarket authorization order under section 910(a) 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 lack of required information under section 905(j). The FDA demands a written response within 15 working days detailing corrective actions, including discontinuing violative sales and a plan for maintaining compliance. Failure to comply may lead to regulatory actions like civil money penalties, seizure, injunction, and detention of imported products.