On December 10, 2025, the FDA convened a panel of leading urologists, endocrinologists, researchers, and clinicians to review the current evidence on testosterone replacement therapy (TRT) for men. The panelists were broadly aligned: in their view, the way testosterone therapy is currently regulated no longer reflects what the research supports.
The experts urged the FDA to consider expanding who qualifies for TRT, removing its classification as a controlled substance, and revisiting the contraindication linking testosterone to prostate cancer. None of these changes have been adopted, and the FDA has not committed to acting on the recommendations. But the panel reflects a shift in how this topic is being discussed at the federal level.
Broader Indications, Fewer Restrictions, and a Reclassification
The 13-member expert panel made several specific recommendations. They urged the FDA to broaden the approved indication for testosterone therapy to include age-related low testosterone, a condition the current labeling excludes. Right now, TRT is only FDA-approved for men whose low testosterone comes from a specific identifiable cause, such as a genetic condition, pituitary injury, or chemotherapy. Men whose levels decline gradually with age, even when they have clear symptoms, fall outside that narrow definition.
The panel also called for removing testosterone's designation as a Schedule III controlled substance. That classification, which puts testosterone in the same regulatory category as ketamine, requires DEA tracking for every prescription. Panelists argued this creates unnecessary barriers for both patients and providers, and contributes to a stigma around men's health that discourages screening and treatment.
A third recommendation was removing the contraindication for men with a history of prostate cancer. Multiple panelists cited the TRAVERSE trial and other recent data showing no increased prostate cancer risk associated with testosterone therapy. Mohit Khera, MD, a professor of urology at Baylor College of Medicine and an investigator on the TRAVERSE trial, told the panel that testosterone deficiency "negatively impacts health, reduces quality of life, and increases the risk for mortality."
The TRAVERSE Trial and Cardiovascular Safety
For years, the primary concern about testosterone therapy was cardiovascular risk. The TRAVERSE trial, a large randomized controlled study published in the New England Journal of Medicine in 2023, addressed that question head-on. The trial enrolled over 5,200 men ages 45 to 80 with hypogonadism and found no significant increase in major cardiovascular events among men receiving TRT compared to placebo.
That finding was consistent with earlier research. A Kaiser Permanente study published in JAMA Internal Medicine evaluated over 44,000 men diagnosed with androgen deficiency across Northern and Southern California. Men who received testosterone therapy had a 33 percent lower rate of cardiovascular events, including heart attacks and strokes, compared to men who did not receive treatment. The study's lead author, T. Craig Cheetham, PharmD, stated that the findings showed "no indication of an increased risk for cardiovascular events."
TRAVERSE was cited repeatedly during the December 2025 panel discussion. Earlier observational studies like the Kaiser Permanente analysis have also contributed to the broader conversation about whether cardiovascular concerns around TRT are supported by the data.
Low Testosterone Is More Common Than Most Men Realize
Testosterone levels in men decline gradually starting around age 30. The drop is slow enough that many men do not connect their symptoms to a hormonal cause. Fatigue, low mood, reduced sex drive, difficulty concentrating, loss of muscle mass, increased body fat, and poor sleep are all associated with low testosterone, but each of those symptoms can also be attributed to stress, aging, or other conditions.
According to data cited at the FDA panel, approximately 5.6 percent of American men aged 30 to 79 have low testosterone with accompanying symptoms. Yet many men with low levels are never screened, and the symptoms are frequently attributed to other causes.
The panel emphasized that routine testosterone screening, similar to cholesterol or blood sugar checks, could help identify men who might benefit from treatment before their symptoms worsen.
Not Everyone Agreed
The panel drew criticism from some quarters. Public Citizen, a consumer advocacy organization, submitted formal comments to the FDA raising concerns about potential conflicts of interest among panelists and questioning whether the panel adequately considered all of the available evidence. The organization noted that the TRAVERSE trial found higher rates of atrial fibrillation and nonfatal arrhythmias in the testosterone group, and called for further independent studies before any expansion of approved uses.
These are legitimate points. TRT, like any medical treatment, carries potential side effects and is not appropriate for every man. The discussion is evolving, and the FDA has not yet acted on the panel's recommendations.
The Panel Did Not Change Policy, but the Conversation Has Moved
The December 2025 panel does not change what is currently available. Testosterone therapy is still prescribed and monitored the same way it was before the panel met. What has changed is the tenor of the federal conversation around it. The FDA is actively reevaluating how testosterone is classified, who it is indicated for, and whether the current warnings still reflect the evidence.
For men who have been experiencing symptoms of low testosterone, this is a topic worth raising with a qualified provider. A blood test can measure testosterone levels, and if those levels are low, a provider who specializes in hormone health can walk through the options, the potential benefits, and the risks based on your individual health profile.
Sources:
FDA Panel Supports Expanding Population Indicated for Testosterone Therapy, Healio, December 10, 2025.
Experts Urge FDA to Revisit Labeling for Testosterone Replacement Therapy in Men, Urology Times, December 10, 2025.
What the FDA's Latest Expert Panel Reveals About Testosterone Therapy for Men, Couri Center, January 15, 2026.
Testosterone Replacement Therapy Reduces Cardiovascular Risk Among Men With Androgen Deficiency, Kaiser Permanente Department of Research & Evaluation, 2017.
Comments to the FDA on the Expert Panel on Testosterone Replacement Therapy for Men, Public Citizen, February 10, 2026.