FDA WARNING_LETTER - Midwest Goods Inc., d/b/a Midwest Distribution and Midwest Distribution Illinois - January 15, 2025

On January 8, 2025, the FDA's Center for Tobacco Products issued a Warning Letter to Midwest Goods Inc., d/b/a Midwest Distribution and Midwest Distribution Illinois, following a review of inspection records. The letter states that the company sells and/or distributes e-liquid products, which are classified as tobacco products under section 201(rr) of the FD&C Act, and are subject to FDA jurisdiction and compliance requirements.

The primary violation identified is the marketing of a "new tobacco product," MR FOG BUBBLE GANG BLUE RASPBERRY 100mL 12mg/mL, without the required premarket authorization order. This product is considered "new" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks the necessary FDA marketing authorization 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.

The FDA requires Midwest Goods Inc. to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing the sale and distribution of the violative product and outlining a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction. The letter emphasizes the company's