FDA WARNING_LETTER - Prime Sciences - March 31, 2026

On March 31, 2026, the FDA issued a warning letter to Prime Sciences following an evaluation of the company"s website conducted between January and March 2026. The FDA determined that Prime Sciences is illegally marketing several unapproved injectable drug products, including Cagrilintide, various GLP-1 analogs (identified as Retatrutide, Semaglutide, and Tirzepatide), Mazdutide, and bacteriostatic water kits. These products are being distributed in violation of the Federal Food, Drug, and Cosmetic Act because they have not undergone the required safety and effectiveness reviews. Although the company labeled these items for "research purposes only," the FDA found that the website"s promotional content specifically targeted human medical conditions, such as obesity and diabetes. The agency noted that injectable products are especially concerning because they bypass the body"s natural defenses, potentially leading to severe health risks if not manufactured and regulated properly. To resolve these issues, Prime Sciences must provide a written response within 15 working days detailing the specific steps taken to correct the violations and prevent them from happening again. Failure to comply with these requirements may lead to legal action, including product seizures or court-ordered injunctions against the company.