Doc Ike Retail, LLC d/b/a Bama Vapor – FDA Warning Letter, Sep 13, 2022

The FDA issued a Warning Letter to Doc Ike Retail LLC d/b/a Bama Vapor on September 7, 2022, following a review of submissions and inspection records. The company manufactures and distributes e-liquid products, which are classified as tobacco products under the FD&C Act, including those containing nicotine from any source as per the Consolidated Appropriations Act, 2022.

The primary violation identified is the marketing of "DOC IKE E-Juice PINWHEEL 125ml 00mg" without the required premarket authorization. This product is deemed a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required notice or information.

The FDA states that manufacturing, selling, or distributing such adulterated or misbranded products is a prohibited act under section 301(k) and failure to provide required reports is a prohibited act under section 301(p). The company must submit a written response within 15 working days detailing actions taken to address violations, including discontinuation of violative sales and a plan for future compliance. Failure to comply may