FDA WARNING_LETTER - Juicemafia, Inc d/b/a Ecig-Works - September 22, 2022

The FDA issued a Warning Letter to Juicemafia, Inc. d/b/a Ecig-Works on September 22, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, specifically "Peanut Butter Cup" and "Berry Crunch," which are classified as tobacco products under the FD&C Act, including recent amendments expanding jurisdiction to products with nicotine from any source.

The primary violation is the marketing of "new tobacco products" without the required premarket authorization. These 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, they are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notices or information.

The FDA states that the failure to provide required reports is a prohibited act under section 301(p) of the FD&C Act. The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation dates for the sale/distribution of non-compliant products and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.