The Trump administration has signaled it wants to revise FDA criteria so men with low testosterone and low libido can qualify for treatment regardless of the cause. The Food and Drug Administration also wants to remove language from testosterone drug labels stating that safety and effectiveness for age-related hypogonadism had not been established.

Under current Food and Drug Administration criteria, testosterone therapy is approved only for men whose low levels are traced to an identifiable medical condition. This regulatory framework distinguishes between pathological causes and natural declines associated with aging.

Testosterone is involved in metabolism, bone health, muscle mass, red blood cell production, and brain function. Symptoms of testosterone deficiency, also known as hypogonadism, include depressed mood, fatigue, reduced libido, weight gain, and trouble concentrating. Low testosterone can be caused by genetic disorders, pituitary gland disorders, aging, obesity, diabetes, sleep apnea, drug use, and other medical conditions.

Dr. Martin Miner co-directs the Men's Health Center at the Miriam Hospital in Providence, R.I. and serves as president of the Androgen Society. He has consulted for several companies that manufacture testosterone. Miner supports expanding access and treating symptoms regardless of cause, comparing the approach to management of other chronic conditions.

"You wouldn't treat a person with high blood pressure because it's due to one cause and it's not due to another," Miner said. You treat it because a person has symptoms. The same is true for low testosterone. Miner and other figures in the field are calling on the administration to place testosterone in a less restrictive category of controlled substances. Testosterone is currently listed alongside drugs like ketamine in the controlled substances categories.

Dr. Helen Bernie is the director of Sexual and Reproductive Medicine at Indiana University. She emphasized that the therapy serves a specific physiological purpose rather than acting as a performance enhancer. "The goal of testosterone therapy isn't peak performance," Bernie said.

It's not some drug to promise the fountain of youth. It is restoring normal physiology in men who have a true deficiency. When levels are low and men are symptomatic, it is not just a testosterone issue, but a men's health issue, she added.

Dr. Jamin Brahmbhatt is a urologist at Orlando Health in Florida. He showed risks associated with unregulated clinics and online prescriptions that bypass standard medical oversight. "Testosterone has gotten a bad wrap because … you can walk into these clinics, go online, and get a prescription, they don't do all the testing, they don't do the follow up," Brahmbhatt said.

"Not every guy needs to be on it." Brahmbhatt shared his own experience with suspected low testosterone levels, noting that lifestyle factors were the primary drivers. "Turns out it was more so my sleep and stress and everything else," he said.

Public figures have contributed to the visibility of testosterone therapy. Podcaster Joe Rogan has publicly discussed his use of testosterone therapy. U.S. Health Secretary Robert F. Kennedy Jr. has publicly discussed his use of testosterone therapy. The U.S. military plans to start screening service members for low testosterone.

During the early 2000s, testosterone was one of the fastest-growing prescription drugs in the United States. The FDA placed warnings on testosterone products and requested drug companies conduct a major safety study after data suggested increased risk of heart attack and stroke. The TRAVERSE trial was published in 2023 in the New England Journal of Medicine.

Dr. Steven Nissen is a cardiologist at the Cleveland Clinic who led the TRAVERSE study. The study administered testosterone gel to middle and older-aged men and ensured their levels did not exceed the normal range.

The TRAVERSE trial did not find an increased risk of heart attack, stroke, and other major cardiovascular events when testosterone was compared to placebo. However, the trial raised concerns about a higher risk of fractures associated with testosterone use. Nissen noted that while the study addressed cardiovascular safety, it did not resolve all uncertainties.

"What we know is what we studied," Nissen said. "But did our study answer all questions about the safety of testosterone? No, it did not." Research titled Where is transatlantic intelligence-sharing headed under the Trump administration? Was published in 2026.

Dr. Steven Woloshin is a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice at Geisel School of Medicine. He has testified in court against a drug company that manufactures testosterone. Woloshin urged caution regarding the proposed regulatory changes.

"I think it is too soon," Woloshin said regarding expanded access to testosterone. "I think we really need to have a better handle on the long-term benefits and harms."

The potential revision of FDA criteria represents a significant shift in how testosterone therapy is regulated and prescribed. Moving away from the requirement of an identifiable medical condition could expand access to millions of men experiencing age-related declines in hormone levels. The removal of label warnings regarding age-related hypogonadism would further legitimize this use case in clinical practice.

Medical experts remain divided on the implications of such changes. Proponents argue that symptom-based treatment aligns with standard care for other conditions, while critics emphasize the need for more comprehensive long-term safety data. The TRAVERSE trial provided reassurance on cardiovascular risks but identified fracture risks that require further investigation. The debate also extends to the classification of testosterone as a controlled substance, with some clinicians advocating for less restrictive categorization to improve patient access.

Why It Matters

Revising FDA criteria to treat symptoms regardless of cause would shift testosterone therapy from managing specific pathologies to addressing natural aging, potentially expanding access beyond current restrictions. This change matters because low testosterone affects metabolism, bone health, and brain function, with symptoms including fatigue and depressed mood. However, experts note that not every man needs treatment, as lifestyle factors like sleep and stress can drive similar symptoms. The move also seeks to reclassify testosterone from restrictive controlled substance categories, altering how the drug is regulated and prescribed.