FDA WARNING_LETTER - Big Chief Vapor Products LLC - May 20, 2021

The FDA issued a Warning Letter to Big Chief Vapor Products, LLC, owned by Heather Hutton, following a review of submissions and inspection records. The FDA determined that the company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act.

The primary violation identified is the manufacturing, sale, and/or distribution of "Big Chief Vapor Products Zulu Pride Nic 6 e-liquid product" without the required premarket marketing authorization. This product is considered a "new tobacco product" because it was not commercially marketed in the United States as of February 15, 2007, and lacks an FDA marketing authorization order or exemption.

Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, as the required notice or information under section 905(j) was not provided. These actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act.

Big Chief Vapor Products, LLC, a registered manufacturer with over 4,400 listed products, is responsible for ensuring compliance. Failure to address these violations may result in regulatory actions, including civil money penalties, seizure, and/or injunction. The FDA requires a written response within 15 working days detailing corrective actions, including discontinuation dates for violative sales