FDA WARNING_LETTER - IndulgeRx Brands, Inc - April 30, 2025

The FDA issued a warning letter to FightBack Foods, located in Woods Cross, Utah, following an inspection of their website in April 2025. The FDA identified that FightBack Foods is marketing products—Bravezil Butter, Inspiration Butter, and Wellnut Butter—as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act. These products are claimed to cure, mitigate, treat, or prevent diseases, which classifies them as "new drugs" under section 201(p) of the Act. As such, they require FDA approval before being introduced into interstate commerce, which FightBack Foods has not obtained.

The FDA highlighted that these products are misbranded under section 502(f)(1) of the Act because they lack adequate directions for safe use by laypersons, as they are intended for diseases that require supervision by a licensed practitioner. This misbranding and unauthorized marketing violate sections 301(a), 301(d), and 505(a) of the Act.

The FDA has requested that FightBack Foods respond within 15 working days with a detailed plan to address these violations, including corrective actions and documentation. Failure to comply may result in legal actions such as seizure or injunction. The company is advised to ensure compliance with all federal laws and FDA regulations. Responses should be directed to the FDA electronically, with specific reference to CMS 703668.