Medical experts are urging the FDA to remove remaining restrictions on testosterone replacement therapy while arguing that decades of safety concerns were overstated and are not supported by modern evidence.
During a landmark FDA expert panel on testosterone therapy leading physicians and researchers presented data showing that low testosterone represents a widespread but under-recognized health issue affecting millions of American men. The panel followed the FDA’s recent decision to remove cardiovascular warnings from testosterone product labels which signaled a major change in the agency’s position.
FDA Commissioner Marty Makary drew a comparison to earlier changes in hormone replacement therapy for women and stated that decades of institutional thinking had unnecessarily frightened patients away from care.
“22 years of dogma and a terrible mistake by the medical establishment”
Makary suggested testosterone therapy faces a similar stigma despite roughly 10 million men currently using the hormone under medical supervision.
The panel highlighted that testosterone deficiency affects about 5.6 percent of men between ages 30 and 79 who experience both low hormone levels and symptoms such as reduced vitality strength libido and mood stability. Research presented showed men with low testosterone face higher risks of cardiovascular disease diabetes obesity bone fractures and nearly double the mortality rate compared to men with normal levels.
Dr. Abraham Morgentaler of Harvard University directly challenged long-standing fears linking testosterone to prostate cancer and dismissed them as outdated.
“In 2025 the belief that testosterone is dangerous for the prostate is no more scientifically valid than belief in the tooth fairy”
He referenced the TRAVERSE trial which is the largest randomized testosterone study ever conducted and included more than 5,200 men. The trial was published in 2023 and found no increase in cardiovascular events or prostate cancer risk among men receiving testosterone therapy.
Dr. Marty Miner summarized the findings clearly.
“Low testosterone increases cardiovascular risk. Testosterone therapy does not.”
Experts also criticized current FDA labeling that restricts approved use to men with specific testicular or pituitary disorders. Dr. John Mulhall explained that this excludes most men with age-related testosterone deficiency even though the majority of clinical research involves those exact patients.
“Thousands of men who are worthy of treatment”
The panel further recommended removing testosterone from the DEA Schedule III controlled substance list where it has remained since 1990 due to concerns about athletic misuse. Dr. Landon Trost argued that the classification creates stigma and access barriers while failing to curb misuse and noted testosterone is the only naturally produced hormone regulated in this way.
Admiral Brian Christine the Assistant Secretary for Health announced the need for a national men’s health initiative. He noted that men die an average of seven years earlier than women from nine of the ten leading causes of death yet use healthcare services roughly 70 percent less often. He emphasized that testosterone screening should be part of routine preventive care alongside cholesterol and glucose testing.
The FDA signaled a willingness to work with manufacturers on label revisions based on the evidence presented which could expand access for millions of men whose long-term health may benefit from treatment.
