- 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.
“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
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 appropriately prescribed and monitored. For patients, the proposed updates could expand access to treatment while also clarifying risks based on the most up-to-date evidence.
The announcement was supported by men’s health experts interviewed by Healthline, who agreed that TRT-associated cardiovascular, prostate cancer, and BPH risk have been overstated.
The proposed labeling revisions focus on three major areas: age-related hypogonadism, prostate cancer risk, and BPH.
The FDA is requesting the removal of a limitation stating that the safety and effectiveness of testosterone replacement therapy have not been established in males with age-related hypogonadism. The condition refers to the gradual decline in testosterone that can occur with aging, rather than due to an identifiable medical condition.
That
Since then, additional data have emerged, including the TRAVERSE trial, a large study involving more than 5,200 males. According to HHS, the trial found no meaningful increase in the risk of major adverse cardiovascular events, including heart attack and stroke, among males receiving testosterone replacement therapy.
Based on its review of the TRAVERSE findings and other available evidence, the FDA concluded that the limitation is no longer warranted.
Franck Mauvais-Jarvis, MD, PhD, a professor of medicine at Tulane University and director of the VA hormone therapy clinic at New Orleans Medical Center, called the decision “a very important victory.”
Other experts said the findings reinforce what many men’s health experts have known for years.
“Even before this trial had been conducted, it was well known in the men’s health community that testosterone replacement within physiologic ranges is safe and should not cause adverse cardiovascular events. This study reinforces this common knowledge,” said S. Adam Ramin, MD, board certified urologist, urologic oncologist, and medical director of Urology Cancer Specialists in Los Angeles, California.
However, he emphasized that safety depends heavily on maintaining testosterone levels within the normal physiologic range.
According to Ramin, clinicians should generally target testosterone levels between approximately 350 and 750 ng/dL. Super physiologic levels substantially above that range may increase red blood cell production and potentially raise the risk of blood clots, heart attack, or stroke.
Ramin added that testosterone replacement has also been shown to be effective: consistently raising testosterone levels and improving symptoms associated with low testosterone. He noted that treatment may help prevent muscle loss and osteoporosis in appropriately selected individuals.
“I am in agreement with the FDA removing this warning label. However, I would also suggest that healthcare providers strive to maintain their patients’ testosterone levels within the physiological range,” he said.
The FDA is also proposing substantial revisions to longstanding prostate cancer warnings.
Current labeling generally states that testosterone therapy should not be used in males with known or suspected prostate cancer and warns that treatment may increase the risk of developing prostate cancer.
Under the proposed changes, testosterone therapy would be contraindicated only in males with metastatic prostate cancer.
Mauvais-Jarvis said the claim that TRT causes prostate cancer is “a myth.”
“There is no evidence that TRT promotes prostate cancer,” he said.
According to HHS, available clinical trial and epidemiologic evidence have not generally shown an increased risk of prostate cancer among men receiving testosterone replacement therapy.
However, they acknowledge that some uncertainty exists because prostate cancer can take years to develop.
Ramin also concurred that current evidence does not support the idea that testosterone therapy causes prostate cancer.
“It is false to state that testosterone replacement may cause prostate cancer,” he said. “There is no scientific evidence for this kind of a statement.”
He noted that testosterone may accelerate growth of an already existing prostate cancer, but that differs from causing cancer to develop in the first place.
He agreed with the FDA’s emphasis on screening and monitoring, describing prostate cancer risk assessment as an important component of testosterone therapy. He also agreed that males with metastatic prostate cancer should not receive TRT.
According to Ramin, appropriate screening can help identify patients who may safely undergo treatment. He noted that some men with a history of treated prostate cancer who have remained disease-free for more than two years, as well as certain males with low-grade, dormant prostate cancers, may be considered for TRT in selected circumstances.
At the same time, he cautioned against overinterpreting the proposed labeling revisions.
“While I agree with the proposed changes, it is important to note that the proposed change does not specifically say TRT is safe in men with localized or non-metastatic prostate cancer. It merely says that it is not safe in men with metastatic prostate cancer,” he said.
The FDA is requesting updates to warnings related to benign prostatic hyperplasia, or enlarged prostate.
Current labeling warns that testosterone therapy may worsen symptoms of the condition.
However, according to the HHS announcement, available clinical trial data do not demonstrate worsening symptoms in men with mild to moderate BPH, although some evidence exists for men with more severe symptoms.
Under the proposed revisions, labeling would continue to recommend monitoring patients who have severe symptomatic disease.
Ramin said he supports the change.
“Testosterone replacement in a man with mild to moderate BPH should be safe as long as they are followed with proper supervision,” he said.
According to Ramin, monitoring should include periodic assessment of urinary symptoms, routine measurement of the International Prostate Symptom Score (IPSS), and periodic prostate ultrasounds to evaluate whether the prostate remains stable or continues to grow during treatment.
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