FDA WARNING_LETTER - Juicemafia, Inc. d/b/a Ecig-Works - October 13, 2022

The FDA issued a Warning Letter to Juicemafia, Inc. d/b/a Ecig-Works on October 13, 2022, for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that the company's "banana nut bread e-liquid products" are "new tobacco products" under section 201(rr) of the FD&C Act because they contain nicotine and were not commercially marketed in the U.S. as of February 15, 2007.

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 lack of an FDA marketing authorization order or exemption. The failure to provide a required report under section 905(j) is also a prohibited act under section 301(p). The FDA has not received an application for these products.

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