FDA WARNING_LETTER - The Smoke Shop, Inc - July 18, 2025

The FDA issued a Warning Letter to The Smoke Shop, located at 129 East Beaufort Street, Suite A, Normal, IL, on July 17, 2025. The inspection revealed that the company sells e-liquid products, including Big Bottle Co. Blueberry Cake 3mg 4 oz., without the necessary FDA marketing authorization. These products are classified as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) due to their nicotine content, which now includes nicotine from any source following the 2022 legislative amendment.

The Smoke Shop"s e-liquid products are considered "new tobacco products" as they were not marketed in the U.S. before February 15, 2007, and lack the required premarket authorization. Consequently, these products are deemed adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act, respectively.

The FDA mandates that The Smoke Shop take immediate corrective actions to comply with the FD&C Act and its regulations. The company must submit a written response within 15 working days, detailing the steps taken to address the violations, including the cessation of unauthorized sales and a compliance maintenance plan. Failure to comply may result in enforcement actions such as civil penalties, product seizure, or injunctions. The company is advised to ensure all products and marketing materials meet FDA requirements to avoid further regulatory actions.