FDA WARNING_LETTER - Juice Man LLC - June 20, 2023

The FDA issued a Warning Letter to Giorgio Fadda regarding e-liquid products manufactured and sold via juicemanusa.com. The FDA determined that products like ZoNk! Orange Mango and ZoNk! Watermelon Strawberry are "new tobacco products" under section 201(rr) of the FD&C Act, as amended by the Consolidated Appropriations Act, 2022, which expanded the definition to include nicotine from any source.

These products are considered new tobacco products because they were not commercially marketed in the U.S. as of February 15, 2007. The FDA found that these e-liquid products lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act and are not otherwise exempt. 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 notice or information under section 905(j).

The letter requires a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and distribution of these products, and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.