FDA WARNING_LETTER - Ferrum City Liquid - April 05, 2022

The FDA issued a Warning Letter to Daniel Laughery and Ashley Milner of Ferrum City Liquid on November 24, 2021, following a review of their website, ferrumcityliquid.com. The FDA determined that their e-liquid products, specifically "Blooberry" and "Choculate," are tobacco products under the FD&C Act and are being manufactured and sold in the U.S. without required marketing authorization.

These e-liquid products are considered "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The company is a registered manufacturer with 69 products listed with the FDA. A Premarket Tobacco Product Application (PMTA), STN PM0001345, submitted on September 8, 2020, was denied on September 7, 2021, covering all 69 products. The FDA emphasizes that all new tobacco products marketed without premarket authorization are unlawful and subject to enforcement actions, including civil money penalties, seizure, and injunction.

Ferrum City Liquid must submit a written response within 15 working days detailing actions taken