FDA WARNING_LETTER - Elevate Your Wellness LLC, dba Elevated - August 01, 2025

On September 9, 2025, the FDA issued a warning letter to Elevate Your Wellness LLC, doing business as Elevated, after a review of the company’s website in August 2025. The investigation revealed that the company is marketing compounded drug products, specifically semaglutide and tirzepatide, using false or misleading claims. The company’s marketing suggested that these compounded versions are essentially the same as FDA-approved branded medications, providing a ‘personalized’ and injection-free alternative. However, because compounded drugs are not FDA-approved, the agency determined that these claims incorrectly imply equivalence to approved products. Under the Federal Food, Drug, and Cosmetic Act (FDCA), these promotional tactics constitute misbranding. The FDA highlighted that such violations involve the illegal introduction of misbranded drugs into interstate commerce. To resolve these issues, the FDA requires Elevated to take immediate action to correct the violations, including ceasing the use of misleading promotional language. The company must investigate the root cause of the non-compliance and establish protocols to prevent future occurrences. Elevated is required to provide a written response to the FDA within 15 working days detailing their corrective actions. Failure to address these concerns may lead to legal action, such as product seizures or injunctions.