FDA WARNING_LETTER - DNA Distributors, Inc. d/b/a Just Juice - August 23, 2022

The FDA issued a Warning Letter to Anthony Hepker and Daniel Mastrolonardo of Just Juice USA on August 11, 2022, following a review of their website, justjuiceusa.com. The FDA determined that e-liquid products offered for sale, including Apple, Cherry, and Grape flavors, are "new tobacco products" under section 201(rr) of the FD&C Act, as they contain nicotine and were not commercially marketed in the U.S. as of February 15, 2007.

These products are in violation because they lack the required premarket authorization order under section 910(c)(1)(A)(i) of the FD&C Act. Consequently, the products 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 information under section 905(j).

The FDA requires a written response within 15 working days detailing actions taken to address violations, including discontinuing the sale and 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, or injunction.