FDA WARNING_LETTER - Elevate Your Wellness LLC, dba Elevated - August 31, 2025

The FDA issued a warning letter to Elevated Health on September 9, 2025, following a review of their website in August 2025. The review identified that the company was marketing compounded drug products, including semaglutide and tirzepatide, with claims that were deemed false or misleading under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). These claims suggested that the compounded products were equivalent to FDA-approved drugs, which they are not, resulting in the products being classified as misbranded.

The regulatory framework cited includes sections 502(a), 502(bb), and 301(a) of the FDCA, which address misbranding and the unlawful introduction of such products into interstate commerce. The FDA has mandated that Elevated Health take immediate corrective actions, including ceasing the use of misleading language on their website. The company is required to submit a written response within 15 working days to the Office of Compounding Quality and Compliance, detailing the steps taken to rectify the violations and prevent future occurrences.

Failure to comply with these requirements may lead to legal actions, including product seizure and injunctions. Elevated Health is also advised that if they believe their products are not in violation, they must provide supporting information for FDA consideration. The letter emphasizes the company"s responsibility to ensure compliance with all federal laws and FDA regulations.