Low testosterone is increasingly recognized as a marker of overall health — yet access to treatment remains clouded by stigma and outdated regulatory language. In a recent FDA Expert Panel discussion, experts across medicine and research revisited the science behind TRT, questioned long-held fears, and examined whether current regulations reflect modern evidence. From cardiovascular safety to prostate health and patient access, the discussion highlighted a growing gap between modern science and existing policy.
Here’s a breakdown of what the panel covered, and why it matters for men seeking evidence-based care.
Current FDA regulations for testosterone replacement therapy are shaped by both scientific evidence and decades-old safety concerns. Today, FDA-approved testosterone products are indicated only for men with clinically confirmed hypogonadism caused by specific medical conditions, such as testicular dysfunction or pituitary disorders, where the body cannot produce adequate testosterone on its own. Use of TRT for age-related testosterone decline alone has not been established as safe and effective under current labeling, requiring physicians to follow strict diagnostic criteria before initiating treatment.
However, emerging evidence — including large, well-designed trials like the TRAVERSE trial — have shown no significant increase in cardiovascular risk among men with hypogonadism, prompting the FDA to update testosterone labeling by removing outdated risk language and placing greater emphasis on accurate, evidence-based safety data.
Across the panel, experts agreed that current testosterone regulations no longer reflect modern science or the realities of men’s health today. While safety remains essential, panelists emphasized that overly restrictive frameworks have contributed to under-diagnosis, under-treatment, and persistent stigma surrounding testosterone therapy — leaving millions of men struggling with symptoms that meaningfully impact quality of life.
Dr. Landon Trost focused on how testosterone’s current regulatory classification contributes to barriers in care. Testosterone is listed as a Schedule III controlled substance, a designation that carries unintended consequences. According to Dr. Trost, scheduling can reduce legitimate prescribing, limit pharmacy availability, and reinforce stigma that discourages patients from seeking treatment in the first place.
These regulatory barriers, panelists argued, don’t reflect modern scientific understanding of testosterone as an essential hormone. Instead, they can delay diagnosis, restrict access to care, and contribute to untreated symptoms that significantly impact quality of life.
Several panelists pointed to testosterone deficiency as part of a broader, systemic men’s health issue. They stressed that under-diagnosis and limited access to care contribute to preventable declines in quality of life and long-term health outcomes.
Panelists noted that improving education, screening guidelines, and access to care could have a meaningful impact on men’s long-term health — particularly as life expectancy gaps between men and women widen. At the same time, they pointed out that some of the most common fears around testosterone are rooted in outdated science.
The conversation also extended beyond the U.S., highlighting the global influence of FDA policy. Experts noted that regulatory decisions in the U.S. often shape international standards for hormone care.
Taken together, these perspectives reinforce a shared call for evidence-based modernization—one that dismantles outdated fears, improves access to care, and sets a new standard for testosterone and hormone health worldwide.
The conversation around testosterone is shifting. What once was clouded by fear and misinformation is now being reframed through rigorous data, clinical experience, and the real-world impact on men’s lives. This FDA panel underscored the need to align regulation with modern evidence, ensuring that safe, effective testosterone therapy isn’t unnecessarily out of reach for the men who need it. As research advances and advocacy grows, the opportunity is clear: move beyond outdated narratives and build a future of hormone care rooted in science, access, and quality of life.
This article is for informational purposes only and does not constitute medical advice. The information contained herein is not a substitute for and should never be relied upon for professional medical advice. Always talk to your doctor about the risks and benefits of any treatment.