FDA WARNING_LETTER - Central Iowa Electronic Cigarettes Inc - May 18, 2021

On May 7, 2021, the FDA Center for Tobacco Products issued a Warning Letter to Corey Halfhill regarding e-liquid products manufactured and sold via iowaecigs.com. The FDA determined that e-liquid products, including "CIV Unicorn Tears," "CIV Red Hot Cinnamon," and "CIV Tropical Explosion," are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA jurisdiction.

The key violation identified is the marketing of "new tobacco products" without required premarket authorization. These e-liquid products were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order or exemption. Consequently, they 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 letter emphasizes the firm's responsibility as a registered manufacturer with over 3,400 listed products to ensure compliance with the FD&C Act and FDA regulations. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The firm must submit a written response within 15 working days detailing corrective actions, including discontinuation of violative sales and a plan for ongoing compliance.