FDA WARNING_LETTER - JuiceFly LLC - May 01, 2024

The FDA issued a Warning Letter to Melo Melih Pamuk and Ahmet Pamuk of Juicefly.com on April 30, 2024, following a review of their website, which revealed the sale of an electronic nicotine delivery system (ENDS) product, Funky Republic Ti7000, Peach Pie, in the United States.

The FDA determined this product is a "new tobacco product" under section 910(a) of the FD&C Act (21 U.S.C. § 387j(a)) because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as no notice or information was provided per section 905(j).

The letter emphasizes that all new tobacco products require premarket authorization to be legally marketed. The company must submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.