FDA WARNING_LETTER - The Iron Crow LLC - May 18, 2021

On May 7, 2021, the FDA issued a Warning Letter to Robert and Melissa Smith of Iron Crow Distro, following a review of their website, http://ironcrowdistro.com. The FDA determined that the company manufactures and sells e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, and are subject to FDA jurisdiction.

The letter states that the e-liquid products "Chaos – Lemon Poundcake," "Murder – Chocolate Milkshake," "Drips Ink – Orangesicle," and "Drips Ink – Cherry Pop" are "new tobacco products" because they were not commercially marketed in the U.S. as of February 15, 2007. These products lack the required premarket marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act, making them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

Iron Crow Distro, a registered manufacturer with over 400 products listed with the FDA, is required to ensure compliance with the FD&C Act and FDA regulations. The FDA demands a written response within 15 working days detailing corrective actions, including discontinuing the sale and distribution of the violative products and a plan for future compliance. Failure