FDA WARNING_LETTER - Gram Peptides - March 31, 2026

The FDA issued a warning letter to Gram Peptides following a review of the company"s website conducted between January and March 2026. The agency identified that the firm is marketing unapproved new drugs, specifically Retatrutide (GLP-1-R peptide), Tirzepatide (GLP-2 peptide), and Bacteriostatic Water for Injection, for sale in the United States. Under the Federal Food, Drug, and Cosmetic Act, these products are classified as drugs because the company’s marketing materials suggest they are intended for the diagnosis, treatment, or prevention of disease and to influence bodily functions. Although the products are labeled "for research use only" and "not for human consumption," the FDA found that website claims regarding weight management, appetite suppression, and insulin sensitivity prove their intent for human use. The FDA expressed particular concern regarding the injectable nature of these products, which can lead to life-threatening conditions if they are not sterile or bypass the body’s natural defenses. Because these products lack approved applications, their distribution violates federal law. Gram Peptides has been ordered to respond within fifteen working days with a detailed plan for corrective actions and documentation showing how they will prevent future violations. Failure to address these concerns may result in regulatory enforcement, including product seizure or legal injunctions.