FDA Wants Your Thoughts on Men's Testosterone Therapy Treatments
Published Date: 12/11/2025
Notice
Summary
The FDA wants to hear from men, doctors, and anyone interested about testosterone replacement therapy. They’re gathering info to help decide if and how this treatment should be used or changed. If you want to share your thoughts, make sure to send them by February 9, 2026—this could shape future rules and affect costs or access to therapy.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 0 costs, 2 mixed.
Public comment window — deadline Feb 9, 2026
The FDA is asking the public to submit information about testosterone replacement therapy by February 9, 2026. You can send electronic comments at https://www.regulations.gov (Docket No. FDA-2025-N-6743) until 11:59 p.m. Eastern Time on that date; paper comments received by mail/hand delivery will also be considered timely if received on or before February 9, 2026.
Possible updates to TRT labeling and indications
FDA stated that any potential updates to testosterone labeling, including revisions to approved indications, would go through the Agency's standard scientific review process. Changes to labeling or approved uses could affect who is eligible for testosterone therapy and how it is prescribed, which may in turn affect access or cost for people receiving treatment.
Continued oversight of prescription and OTC products
FDA said it will continue robust oversight of both prescription testosterone therapies and over-the-counter supplements. That oversight aims to protect patient safety (for example, around cardiovascular risk, prostate health, fertility, and potential for abuse) and may affect the availability, marketing, or labeling of some products.
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