FDA WARNING_LETTER - Sprout Health Partners LLC dba Sprout Health - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to Sprout Health Partners LLC, doing business as Sprout Health, following a review of the company’s website conducted in August 2025. The letter identifies significant violations regarding the marketing of compounded drug products, specifically semaglutide and tirzepatide. The primary issue is that Sprout Health’s website claimed these medications are FDA-approved. The FDA clarifies that while certain commercial versions of these drugs are approved, compounded versions are not. By suggesting their products are the same as FDA-approved drugs, the company engaged in false and misleading advertising. Under the regulatory framework of the Federal Food, Drug, and Cosmetic Act (FDCA), these products are classified as misbranded because their labeling and promotion are deceptive. The introduction of such misbranded drugs into interstate commerce is a prohibited act. The FDA requires Sprout Health to take immediate corrective action, including ceasing the use of the misleading claims. The company must investigate the cause of the violations and implement measures to prevent their recurrence. Sprout Health is directed to provide a written response within 15 working days detailing the specific steps taken to address the issues. Failure to comply may result in legal action, such as product seizures or injunctions.