FDA WARNING_LETTER - Juicemafia, Inc. d/b/a Ecig-Works - November 10, 2022

On November 10, 2022, the FDA issued a Warning Letter to Juicemafia, Inc. d/b/a Ecig-Works, following a review of submissions and inspection records. The FDA determined that Juicemafia manufactures and distributes e-liquid products, specifically "Very Cherry e-liquid products," which are considered tobacco products under section 201(rr) of the FD&C Act due to containing nicotine.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization. The "Very Cherry e-liquid products" were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notices or information were not provided under section 905(j).

The FDA cited prohibited acts under section 301(k) for holding adulterated or misbranded products for sale after interstate shipment, and under section 301(p) for failing to provide required reports. Juicemafia is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution of non-compliant products, and a plan for