FDA WARNING_LETTER - Wholesale Peptide - May 01, 2026

Wholesale Peptide, based in Brooksville, Florida, received a formal warning letter from the FDA following a May 2026 review of its website. The agency identified significant violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), specifically involving the marketing of two products: "Prostamax" and "Gonadorelin." The FDA determined that these products are unapproved new drugs because they are marketed with claims that they can treat, cure, or prevent medical conditions such as chronic prostatitis, enlarged prostate (BPH), and hormone-dependent cancers. Although the company labeled these products for "research use only," the agency concluded that the marketing language clearly establishes their intended use as human drugs. Furthermore, the FDA emphasized that these injectable products pose a heightened safety risk to the public because they bypass the body’s natural defenses against toxins and microorganisms. Under the regulatory framework of the FD&C Act, new drugs cannot be legally sold without an approved application proving safety and effectiveness. Wholesale Peptide is required to provide a written response within 15 business days outlining the specific steps taken to correct these violations and prevent their recurrence. Failure to address these issues may result in legal actions, such as product seizures or court-ordered injunctions.