FDA WARNING_LETTER - Ohm Centric Coils LLC - November 16, 2023

On November 16, 2023, the FDA issued a Warning Letter to Ohm Centric Coils LLC for manufacturing and distributing unapproved electronic nicotine delivery system (ENDS) products. The FDA determined that the company's "OHM Centric Staggered fuse coil set" is a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the required premarket authorization.

This product is deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) because no notice or information was provided as required by section 905(j). The introduction of adulterated or misbranded tobacco products into interstate commerce is a prohibited act under section 301(a), and failure to provide a required report is prohibited under section 301(p).

Ohm Centric Coils LLC must submit a written response within 15 working days detailing actions taken to address violations, including discontinuing sales and distribution, and a plan for maintaining compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.