FDA WARNING_LETTER - Mane & Steel, LLC. dba Mane & Steel - August 01, 2025

On September 9, 2025, the FDA issued a warning letter to Mane & Steel, LLC. (dba Mane & Steel) after conducting a review of the company’s website in August 2025. The investigation revealed that the company was marketing compounded drug products, specifically semaglutide, using false and misleading claims. Promoted with statements such as "Clinically Proven Weight Loss" and "Clinically proven GLP-1 therapy," the FDA determined these claims incorrectly suggest that the compounded products have the same safety and efficacy status as FDA-approved medications. Under the Federal Food, Drug, and Cosmetic Act (FDCA), compounded drugs are not FDA-approved, and any advertising that implies otherwise constitutes misbranding. The FDA identified these marketing practices as violations of sections 502(a) and 502(bb) of the FDCA, making it illegal to distribute these products across state lines. To resolve these issues, Mane & Steel must take immediate corrective action, including removing the deceptive language from their promotional materials. The company is required to provide a written response within 15 working days detailing their corrective steps and plans to prevent future violations. Failure to address these concerns may result in legal action, including product seizures or injunctions.