FDA WARNING_LETTER - OKC Vapes, LLC - October 22, 2024

The FDA's Center for Tobacco Products reviewed okcvapes.com and determined that e-liquid products, specifically OKC Vapes Salts Mermaid Potion and Peppermint, are manufactured and offered for sale without the required premarket authorization. These products are considered "new tobacco products" under section 201(rr) of the FD&C Act, as they were not commercially marketed before February 15, 2007, and lack a marketing authorization order under section 910(c)(1)(A)(i). Consequently, these products 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 premarket notification. The FDA mandates that all tobacco products comply with the FD&C Act and its regulations. The firm must submit a written response within 15 working days detailing actions taken to address these violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction.