HHS to Update Testosterone Therapy Labels for Prostate Cancer, Hypogonadism
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HHS announced it would request updates to the warning labels for testosterone replacement therapy products. Malorny/Getty Images The Department of Health and Human Services (HHS) has proposed key changes to the labeling of testosterone replacement therapy (TRT) products. The proposed changes could expand access to TRT for men with idiopathic and age-related hypogonadism. According to HHS Secretary Robert F. Kennedy, Jr., the changes reflect the most current scientific evidence on the risks and benefits of TRT. The Department of Health and Human Services (HHS) announced plans on June 18 to update label information for testosterone replacement therapy (TRT) products, marking a significant shift in policy. The proposed changes would remove longstanding restrictions on TRT related to age-related hypogonadism, revise warnings about prostate cancer risk, and update safety information concerning benign prostatic hyperplasia (BPH), commonly known as an enlarged prostate. “During Men’s Health Month, we are putting science back at the center of men’s healthcare,” HHS Secretary Robert F. Kennedy Jr. said in the announcement. “By updating testosterone therapy labels to reflect current evidence, we are giving patients and physicians clearer information, supporting informed medical decisions, and improving care for millions of American men.” The announcement follows a December 2025 meeting of FDA experts, during which the panel signaled broad support for expanding access to TRT. In April, the FDA made an announcement encouraging manufacturers of approved TRT products to explore a potential new indication for low libido in males with idiopathic hypogonadism, or low testosterone without a known underlying cause. Currently, FDA-approved TRT products may only be prescribed for forms of hypogonadism with specific genetic or structural causes. Federal officials say the changes reflect a growing body of evidence supporting the safety and effectiveness of testosterone therapy when approp