On June 18, 2026, the U.S. Department of Health and Human Services (HHS), in partnership with the U.S. Food and Drug Administration (FDA), announced that it is beginning the process of updating the prescribing information for testosterone replacement therapy products. The proposed changes would: 

• Remove the limitation of use, stating that the safety and effectiveness of testosterone replacement therapy in men with age-related hypogonadism have not been established. 

• Update information related to prostate cancer risk. 

• Revise warnings regarding benign prostatic hyperplasia, also known as enlarged prostate. 

The American Urological Association (AUA) is proud to have played an active role in this process over the past several years. AUA maintains that testosterone replacement therapy is a safe and effective treatment for a variety of conditions. On December 10, 2025, AUA members participated in a panel discussion on this issue at the FDA. Additionally, in February 2026, AUA submitted comments to the FDA that detailed substantial evidence of the indications, safety and efficacy of testosterone replacement therapy.  

The AUA applauds HHS and FDA for this evidence-based decision to update labeling for these products. We are thrilled about this advancement for men’s health. 

Furthermore, AUA’s advocacy on this subject complements AUA’s broader efforts to address men’s overall health needs. For example, AUA is the lead organization championing The State of Men’s Health Act, which would establish an Office of Men’s Health at HHS. To show your support for this legislation, you can send a message to your member of Congress here.  

For an illuminating discussion of this topic with Mark Edney, MD, Chair of AUA’s Public Policy Council, and Helen Bernie, MD, listen to the podcast.