FDA WARNING_LETTER - The HCG Institute - August 01, 2025

On September 9, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter to The HCG Institute following a website review conducted in August 2025. The agency found that the company’s marketing for compounded semaglutide products was false and misleading. Specifically, the website incorrectly characterized compounded semaglutide as a "generic" version of FDA-approved drugs like Ozempic and described it as "FDA-inspected medication." Because compounded drugs are not FDA-approved, the agency determined that these claims deceive consumers by implying the products meet the same safety and effectiveness standards as approved pharmaceuticals. Under the Federal Food, Drug, and Cosmetic Act (FDCA), these misrepresentations render the products misbranded and illegal to distribute in interstate commerce. The FDA has directed The HCG Institute to immediately cease these misleading marketing practices and conduct a thorough investigation into their operations to ensure full regulatory compliance. The company must provide a written response within fifteen working days detailing the specific corrective actions taken to address the violations and prevent their recurrence. Failure to resolve these issues promptly may result in legal consequences, including product seizures or legal injunctions.