FDA WARNING_LETTER - Big Chief Vapor Products LLC

The FDA Center for Tobacco Products issued a Warning Letter to Big Chief Vapors, specifically Mr. Campo and Ms. Hutton, after reviewing their website, http://www.bigchiefvapors.com. The review determined that e-liquid products, including Big Chief Vapor Products Pina Colada e-liquid, are offered for sale or distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of Big Chief Vapor Products Pina Colada e-liquid to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act. This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquid, to minors.

Big Chief Vapors is required to immediately correct this violation and any similar issues to ensure compliance with the FD&C Act and FDA's implementing regulations across all sales channels. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates of violative sales and a plan for maintaining compliance, must be submitted within 15 working days.