FDA WARNING_LETTER - Peak Performance Peptides - August 03, 2026

On August 24, 2026, the FDA issued a Warning Letter (Reference Number 735127) to Peak Performance Peptides following an agency review of the company’s website conducted in July 2026. The FDA identified several products, including Semaglutide, Retatrutide (GLP-3R), SS-31, PT-141, Tesamorelin, and bacteriostatic water, as unapproved new drugs being sold in violation of the Federal Food, Drug, and Cosmetic Act. Although the company labeled these products for "research use only," the FDA determined they were intended for human medicinal purposes, such as treating obesity, diabetes, and sexual dysfunction. The agency expressed significant concern regarding these injectable products, noting that they pose a high risk to public health because they bypass the body’s natural defenses and have not been evaluated for safety or efficacy. Peak Performance Peptides is required to take immediate action to correct these violations and prevent their recurrence. The firm must provide a written response within 15 business days detailing its plan for compliance. Failure to address these issues may result in legal action, including product seizures or court-ordered injunctions.