MR FOG d/b/a MR FOG Officials – FDA Warning Letter, Sep 13, 2024

On September 12, 2024, the FDA's Center for Tobacco Products issued a Warning Letter to the entity operating https://mrfogofficials.com, identifying the sale and distribution of Electronic Nicotine Delivery System (ENDS) products in the U.S. These products are considered tobacco products under the FD&C Act, specifically section 201(rr), and are subject to FDA jurisdiction.

The key violation is the marketing of "new tobacco products" without the required premarket authorization. The identified products—MR FOG Max Air 3000 Puffs Strawberry Peach Pear, MR FOG Drop Blue Slushy, and MR FOG Max 1000 Puffs Hyper—were not commercially marketed in the U.S. as of February 15, 2007, and lack FDA marketing authorization orders or exemptions. This renders them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The letter mandates a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.