FDA WARNING_LETTER - Juicemafia Inc. d/b/a ECIG-Works - October 26, 2022

On October 26, 2022, the FDA issued a Warning Letter to Juicemafia Inc. d/b/a Ecig-Works for manufacturing and distributing e-liquid products, specifically "Juice Mafia Strawberry Peach Freeze 6MG/ML e-liquid product," without required marketing authorization. The FDA determined these products are "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed in the U.S. as of February 15, 2007, and contain nicotine from any source.

The identified product is deemed adulterated under section 902(6)(A) of the FD&C Act because it lacks an FDA marketing authorization order under section 910(c)(1)(A)(i) and is not otherwise exempt. It is also misbranded under section 903(a)(6) for failure to provide required notice or information under section 905(j). These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Juicemafia Inc. must submit a written response within 15 working days detailing actions to address violations, including discontinuation dates for violative sales/distribution and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or