FDA WARNING_LETTER - Mane & Steel, LLC. dba Mane & Steel - August 31, 2025

The FDA issued a warning letter to Mane & Steel on September 9, 2025, following a review of their website in August 2025. The review identified misleading claims about compounded drug products, specifically semaglutide, which are not FDA-approved. The website falsely advertised these products as "clinically proven" for weight loss and other health benefits, implying equivalence to FDA-approved medications. These claims violate sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA), resulting in the products being misbranded and illegally introduced into interstate commerce, contravening section 301(a) of the FDCA.

The FDA requires Mane & Steel to take immediate corrective actions, including ceasing the use of misleading language. The company must respond within 15 working days, detailing steps taken to rectify the violations and prevent recurrence. Failure to comply may lead to legal actions such as product seizure or injunctions. Mane & Steel is also advised to provide a rationale if they believe their products do not violate the FDCA, along with supporting documentation. The letter serves as a formal notice, urging the company to ensure compliance with federal regulations to avoid further enforcement actions.