FDA WARNING_LETTER - JP & SN Enterprises Inc. d/b/a eCigs International - December 22, 2022

On December 22, 2022, the FDA issued a Warning Letter to JP & SN Enterprises Inc. d/b/a eCigs International for manufacturing and distributing e-liquid products without required marketing authorization. The FDA determined that their "ZEN JUICE Absalom" e-liquid product is a "new tobacco product" under section 910(a) of the FD&C Act because it was not commercially marketed in the U.S. as of February 15, 2007.

The company failed to obtain a marketing authorization order under section 910(c)(1)(A)(i) or demonstrate an exemption. This renders the product adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as required notice or information was not provided per section 905(j). The failure to provide such a report is a prohibited act under section 301(p).

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