Testosterone therapy use grows as FDA revisits prescribing rules and safety warnings
Interest in testosterone therapy has grown sharply in the United States, driven by social media, online clinics, and public figures including podcaster Joe Rogan and Health Secretary Robert F. Kennedy Jr. who have discussed their own use. The FDA is considering revising its criteria to allow men with low testosterone—regardless of the underlying cause—to qualify for treatment if they have low libido as a symptom, and has already moved to remove cardiovascular-risk warning language from product labels based on the 2023 TRAVERSE trial. Medical experts are divided on whether expanded access represents an overdue update to treatment guidelines or an insufficiently supported regulatory shift.
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Testosterone therapy, once largely associated with doping scandals in professional sports, has moved into mainstream conversation in recent years. Social media platforms are filled with content around "low T" fears and "t-maxxing" tutorials, while a growing industry of direct-to-consumer online clinics makes prescriptions relatively easy to obtain. The Trump administration has signaled it wants to broaden who qualifies for the treatment, adding a policy dimension to what has long been primarily a clinical debate.
Under current FDA criteria, testosterone therapy is approved only for men whose low levels can be traced to an identifiable medical condition—such as a genetic disorder or a pituitary condition. The administration has indicated it wants to revise that standard so that men with low testosterone, whatever the cause, can qualify if they also have low libido as a symptom. The FDA has also moved to remove language from drug labels stating that safety and effectiveness for "age-related hypogonadism" had not been established, citing the 2023 TRAVERSE trial published in the New England Journal of Medicine, which did not find an increased risk of heart attack, stroke, or other major cardiovascular events compared to placebo.
Dr. Steven Nissen, the cardiologist at the Cleveland Clinic who led the TRAVERSE study, noted that the trial used the drug in a specific way—administering it as a gel to middle-aged and older men and ensuring blood levels did not exceed normal ranges. "What we know is what we studied," he told NPR. "Did our study answer all questions about the safety of testosterone? No, it did not." Dr. Steven Woloshin, a professor at Dartmouth's Geisel School of Medicine who has testified against a testosterone manufacturer in court, said removing the warning label was premature, citing the study's limited follow-up period and the fact that testosterone blood levels in the trial were not raised as high as they often are in clinical practice.