FDA WARNING_LETTER - PekCura Labs - January 01, 2026

On March 31, 2026, the FDA issued a Warning Letter to PekCura Labs following a January 2026 review of the company’s website. The agency identified several injectable peptide products, including “GLP-1-S,” “GLP-2-T,” and “GLP-3-R,” along with “Bacteriostatic Water,” as unapproved new drugs being sold in the United States. Although the firm labeled these products for “research use only,” the FDA found that the company marketed them for medical purposes, such as weight loss, cardiovascular health, and managing diabetes. Under the Federal Food, Drug, and Cosmetic (FD&C) Act, these products qualify as drugs because they are intended to mitigate or treat diseases and affect the body"s structure or function. The FDA highlighted that injectable products are particularly concerning because they bypass natural biological defenses, potentially exposing users to serious infections or toxins. By distributing these products without federal approval, PekCura Labs violated sections 301 and 505 of the FD&C Act. The company is required to respond to the FDA within 15 working days, outlining the specific corrective measures taken to address these violations and ensure future compliance. Failure to resolve these issues may result in legal action, including product seizures or injunctions.