What the FDA’s Expert Panel Is Saying About Testosterone Replacement Therapy?
For many years, testosterone replacement therapy—commonly called TRT—has been surrounded by questions, warnings, and sometimes conflicting information. Men frequently ask whether testosterone is safe, whether it increases the risk of heart attack or prostate cancer, and whether declining testosterone is simply something they must accept as part of getting older.
On December 10, 2025, the U.S. Food and Drug Administration brought together a panel of physicians and experts in urology, sexual medicine, male reproductive health, and testosterone therapy to discuss these very issues. The purpose of the FDA Expert Panel on Testosterone Replacement Therapy for Men was to examine the evolving scientific evidence, discuss potential risks and benefits, and consider whether some long-standing assumptions about testosterone need to be reconsidered.
It is important to understand that this meeting was an expert roundtable, not a declaration that TRT is appropriate for every man and not a blanket FDA endorsement of testosterone therapy. Individual experts presented their views and recommendations for consideration by the FDA.
1. The Conversation About Heart Risk Has Changed
One of the biggest concerns surrounding testosterone therapy has been the possibility that it could increase a man's risk of heart attack or stroke.
Much of that concern changed following the TRAVERSE trial, a large randomized study involving more than 5,200 men with low testosterone who either had cardiovascular disease or were at increased cardiovascular risk.
Researchers found that major cardiovascular events occurred in 7.0% of men receiving testosterone compared with 7.3% receiving placebo. In other words, testosterone did not produce a meaningful increase in the study's primary measure of heart attack, stroke, or cardiovascular death.
Based partly on these findings, the FDA announced in February 2025 that the boxed-warning language concerning increased cardiovascular risk should be removed from testosterone products.
That does not mean testosterone has no cardiovascular considerations. The TRAVERSE study found higher rates of certain events, including atrial fibrillation, pulmonary embolism, and acute kidney injury, among testosterone-treated participants, and the FDA has also required updated information concerning possible increases in blood pressure.
The simple message: Current evidence is considerably more reassuring regarding heart attack and stroke than many men may have heard in the past, but TRT still requires appropriate medical evaluation and monitoring.
2. Experts Challenged the Long-Standing Fear of Prostate Cancer
Another major topic was prostate cancer.
For decades, many men have been told that raising testosterone could cause prostate cancer. Panel members argued that this blanket assumption is not supported by the newer evidence and recommended that the FDA reconsider the language used in testosterone labeling.
An important part of that evidence comes from a prostate-safety analysis of more than 5,200 men in the TRAVERSE trial. Among carefully screened men with hypogonadism, researchers found that rates of high-grade prostate cancer, overall prostate cancer, urinary retention, and prostate procedures were low and were not significantly different between men receiving testosterone and those receiving placebo.
There is an important qualification: men considered at high risk for prostate cancer were excluded from that study, and prostate cancer can take many years to develop. Therefore, these results do not mean prostate monitoring is unnecessary.
In June 2026, following additional review, HHS and the FDA requested updated testosterone labeling regarding prostate cancer and benign prostate enlargement. The agencies noted that available clinical and epidemiologic data generally have not shown an increased prostate-cancer risk with TRT, while also acknowledging that uncertainties remain regarding long-term risk.
The simple message: Testosterone should no longer automatically be viewed as something that “causes prostate cancer,” but prostate risk assessment and appropriate PSA monitoring remain important parts of responsible treatment.
This may be one of the most important discussions to come from the panel.
Historically, FDA-approved testosterone products have primarily been indicated for men whose low testosterone resulted from a recognized medical problem involving the testes, pituitary gland, hypothalamus, genetic conditions, chemotherapy, or similar causes.
The panel discussed the much larger group of men who experience symptoms such as:
Decreased sexual desire
Reduced energy
Loss of muscle mass or strength
Changes in mood or motivation
Reduced physical performance
Erectile or sexual difficulties
while also having repeatedly documented low testosterone levels but no obvious structural or genetic explanation.
Panel members encouraged the FDA to reconsider the traditional distinction between these men and those with so-called “classic” hypogonadism.
That conversation has already influenced FDA policy.
In April 2026, the FDA invited manufacturers of approved testosterone products to explore applications for a potential new indication for men with low libido and idiopathic hypogonadism—meaning low testosterone without a clearly identifiable cause.
Then, in June 2026, the FDA requested removal of the previous labeling limitation stating that safety and effectiveness had not been established for men with age-related hypogonadism.
However, this distinction is important: removing that limitation does not automatically mean every FDA-approved testosterone product now has a broad new indication for any man with low testosterone. FDA's current consumer information continues to state that approved testosterone products are indicated for men with low testosterone associated with an underlying medical condition.
Several experts emphasized that testosterone should not be viewed only in terms of sexual function.
Low testosterone is frequently seen alongside obesity, insulin resistance, diabetes, metabolic disease, decreased bone density, reduced muscle mass, and cardiovascular disease. Panel members discussed whether testosterone measurement may provide useful information about a man's overall health.
However, an important distinction needs to be made.
An association does not necessarily mean low testosterone causes all of these conditions. Obesity, diabetes, sleep problems, medications, chronic illness, and other health conditions can themselves lower testosterone.
That is why a proper low-testosterone evaluation should look beyond a single lab number.
At EverStrong, our goal is not simply to ask, “What is your testosterone level?”
The better question is:
“Why is it low, what symptoms are you experiencing, and what does the rest of your health tell us?”
5. Testosterone Is Still a Controlled Substance
Some panel members also questioned whether testosterone should continue to be classified as a Schedule III controlled substance, arguing that this designation can create barriers and contribute to the stigma surrounding medically supervised testosterone therapy.
This was a recommendation for discussion—not a regulatory change.
As of 2026, testosterone remains a Schedule III controlled substance under federal law.
This is another example of why it is important to separate what experts discussed or recommended at the FDA panel from what has actually changed in law or FDA policy.
What Does All of This Mean for the Average Man?
Perhaps the biggest takeaway from the December 2025 FDA discussion is that the conversation surrounding testosterone is changing.
TRT should neither be portrayed as a dangerous therapy that men should automatically fear nor as a simple “anti-aging” treatment that every tired middle-aged man needs.
It is a medical therapy.
The decision to begin testosterone should be based on the whole patient—symptoms, properly obtained laboratory testing, medical history, fertility goals, cardiovascular health, prostate considerations, medications, sleep health, metabolic health, and other possible explanations for symptoms.
And once therapy begins, monitoring matters.
Depending upon the patient, that can include testosterone levels, hemoglobin and hematocrit, blood pressure, PSA and prostate assessment, estradiol when clinically appropriate, symptom response, and evaluation for treatment-related side effects.
Our Perspective at EverStrong
The FDA panel represents an encouraging movement toward evaluating testosterone therapy based on newer evidence rather than relying solely on assumptions that originated decades ago.
At the same time, responsible testosterone therapy is about much more than simply increasing a laboratory number.
At EverStrong Men’s Health, we believe men deserve a thorough evaluation, an understandable explanation of their results, a discussion of treatment alternatives, and ongoing monitoring when treatment is appropriate.
Sometimes TRT may be the right option.
Sometimes another treatment—or addressing weight, sleep apnea, medications, metabolic health, fertility concerns, or another underlying condition—may be more appropriate.
The goal should always be the same:
Identify the problem, understand the cause, discuss the evidence, and develop an individualized plan that improves health and quality of life as safely as possible. Schedule your free initial consultation today!
A Final Word
If you have symptoms of low testosterone, don't assume they are simply part of getting older—and don't assume testosterone is automatically the answer.
Start with a conversation and a proper evaluation.
Timothy J. Toguchi, APRNEverStrong Men’s Health
This article is provided for general educational purposes and is not intended to diagnose or treat a medical condition or replace individualized medical advice. Testosterone therapy has potential benefits and risks and should be prescribed and monitored by an appropriately licensed healthcare professional.
Sources
U.S. Food and Drug Administration. FDA Expert Panel on Testosterone Replacement Therapy for Men, December 10, 2025.
U.S. Food and Drug Administration. Testosterone Information. Updated 2026.
U.S. Food and Drug Administration. FDA Takes Step Forward on Testosterone Therapy for Men, April 16, 2026.
U.S. Department of Health and Human Services. HHS Announces Requested Updates to Testosterone Therapy Product Labels, June 18, 2026.
Lincoff AM, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. New England Journal of Medicine. 2023.
Bhasin S, et al. Prostate Safety Events During Testosterone Replacement Therapy in Men With Hypogonadism: A Randomized Clinical Trial. JAMA Network Open. 2023.
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