FDA WARNING_LETTER - Juicemafia Inc. d/b/a ECIG-Works - November 03, 2022

The FDA issued a Warning Letter to Juicemafia, Inc. d/b/a Ecig-Works, on November 3, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically "BLUEBERRY DREAM" e-liquid, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source.

The primary violation is the marketing of "BLUEBERRY DREAM" e-liquid as a "new tobacco product" without the required premarket authorization. These 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 due to the failure to provide required information under section 905(j).

The FDA considers the sale and distribution of these unauthorized products prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The company is required to submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.