Tell The FDA Why Testosterone Should Not Be a Schedule III Controlled Substance

Why is testosterone—a naturally occurring hormone essential to male health—regulated alongside ketamine, codeine, and barbiturates?

For the millions of men diagnosed with hypogonadism—a medical condition characterized by abnormally low testosterone levels—this question is more than academic. The classification of testosterone as a Schedule III controlled substance under the Controlled Substances Act creates significant barriers to accessing a treatment that can transform their quality of life, reduce disease risk, and potentially extend their lifespan.

In December 2025, an FDA expert panel made headlines by unanimously recommending that testosterone's controlled substance status be reconsidered. The panel—composed of leading urologists, endocrinologists, and federal health officials—argued that testosterone's current classification is outdated, unsupported by modern evidence, and actively harmful to public health. This article examines the compelling case for why testosterone should not remain a Schedule III controlled substance and what the reclassification could mean for men's health.

The Origin of Testosterone's Controlled Status: A Response to Athletic Doping

Testosterone was not always a controlled substance. Its classification as Schedule III came through the Anabolic Steroids Control Act of 1990, legislation passed in direct response to the high-profile doping scandals of the 1980s. The law was designed to combat the illicit use of anabolic steroids by athletes seeking competitive advantages—not to regulate the legitimate medical treatment of hormone deficiencies.

Notably, both the American Medical Association (AMA) and the Drug Enforcement Administration (DEA) originally opposed the classification of anabolic steroids as controlled substances. They argued that testosterone lacked the characteristics that typically define drugs requiring such stringent regulation—specifically, the potential for abuse, dependence, and psychoactive effects that drive recreational misuse.

As Dr. Landon Trost, director of the Male Fertility and Peyronie's Clinic at Brigham Young University, explained at the December 2025 FDA panel: "There is no evidence to suggest dependency at any physiologic levels with testosterone, in contrast to things like narcotics." The law was passed despite these objections, and 35 years later, we continue to regulate testosterone replacement therapy as if it were analogous to opioids or stimulants.

Why Schedule III Classification Is Inappropriate for Testosterone

No Euphoria or Psychotropic Effects
Unlike other Schedule III substances—such as ketamine, buprenorphine, or codeine-containing products—testosterone replacement therapy does not produce immediate euphoria or psychotropic effects that typically drive recreational abuse. When used at physiologic doses to treat documented hypogonadism, testosterone simply restores normal hormone levels, much like thyroid medication restores thyroid function or insulin manages diabetes.

No Evidence of Physical Dependence at Therapeutic Doses
The criteria for Schedule III classification include "moderate to low potential for physical and psychological dependence." However, when testosterone is prescribed appropriately for men with documented low testosterone, it is replacing a hormone their bodies are not producing adequately—not introducing a foreign substance that creates dependence. The distinction between treating a deficiency and creating addiction is fundamental.

The Law Has Failed to Achieve Its Intended Purpose
Research from the University of Michigan demonstrated that while illicit steroid use initially declined following the 1990 legislation, usage rebounded and eventually surpassed pre-1990 levels within a decade. The controlled substance classification has done little to curtail illicit use while creating substantial barriers for men seeking legitimate medical care. As Dr. Trost noted, the law "did have an effect on the 60-year-old man who was trying to do this legitimately"—but that was never its intended target.

The Real-World Impact: How Schedule III Classification Harms Patients

Prescription Limitations Create Unnecessary Burdens
Schedule III controlled substances cannot be filled or refilled more than five times or more than six months after the prescription date—whichever comes first. For men on lifelong testosterone therapy, this means:
• Frequent office visits solely to obtain new prescriptions
• Increased healthcare costs for both patients and the system
• Administrative burden on physicians who must generate new prescriptions every six months
• Potential gaps in treatment when scheduling conflicts arise

Physician Reluctance to Prescribe
The stigma associated with controlled substances extends to testosterone. Many primary care physicians are hesitant to prescribe testosterone because of the regulatory oversight, documentation requirements, and potential scrutiny from the DEA. This reluctance leaves patients without access to treatment from their regular healthcare providers.
As one ExcelMale forum member shared: "A lot of managed healthcare doctors want nothing to do with steroids. It's stigmatized and is associated with cheating athletes, toxic masculinity, and bodybuilding, and is demonized in western medicine."


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The Scientific Evidence: Testosterone Therapy Is Safe and Effective

The TRAVERSE Trial: Resolving Decades of Cardiovascular Concerns
The landmark TRAVERSE trial (Testosterone Replacement Therapy for Assessment of Long-term Vascular Events and Efficacy Response in Hypogonadal Men), published in the New England Journal of Medicine in 2023, provides the strongest evidence to date on testosterone's cardiovascular safety.
This multicenter, randomized, double-blind, placebo-controlled trial enrolled 5,246 men aged 45 to 80 years with hypogonadism and either preexisting cardiovascular disease or high cardiovascular risk. The key findings were compelling:
• Testosterone therapy was noninferior to placebo for major adverse cardiovascular events (MACE)
• MACE occurred in 7.0% of testosterone-treated patients vs. 7.3% on placebo—no increased risk
• A 22.5% reduction in new-onset diabetes was observed in the testosterone group
• No increase in prostate cancer or prostate-related events
In February 2025, based on TRAVERSE trial data, the FDA recommended removing the black-box warning related to cardiovascular risk from all testosterone products—a significant acknowledgment that previous safety concerns were overstated.

Prostate Cancer: Debunking the Myth
For decades, physicians operated under the assumption—based on early 20th-century research by Huggins—that testosterone "fuels" prostate cancer. Modern evidence has thoroughly debunked this myth:
• A 2008 analysis of 18 prospective studies involving nearly 4,000 men with prostate cancer found no relationship between baseline testosterone levels and cancer risk
• A 2023 JAMA Network Open study confirmed that TRT does not increase prostate cancer risk in appropriately selected patients
• Studies following prostate cancer patients on TRT after definitive treatment show no increased risk of recurrence or progression
As Dr. Franck Mauvais-Jarvis of Tulane University stated: "The bottom line is no, testosterone does not increase the risk of prostate cancer."



The Health Consequences of Untreated Hypogonadism
While debate continues about testosterone's controlled status, the medical consequences of untreated hypogonadism are well-documented. Low testosterone is associated with:

• Increased all-cause mortality—men with testosterone deficiency have significantly higher mortality rates
• Metabolic syndrome and increased risk of type 2 diabetes
• Decreased bone mineral density and increased fracture risk (osteoporosis)
• Depression, cognitive decline, and reduced quality of life
• Sexual dysfunction, including erectile dysfunction and decreased libido
• Loss of muscle mass and increased body fat
• Increased cardiovascular risk factors

According to the Journal of Clinical Endocrinology and Metabolism, approximately 5.6% of men aged 30 to 79 have low testosterone with associated symptoms. Dr. Adrian Dobs of Johns Hopkins summarized the panel's position: "Testosterone deficiency is an important medical condition that adversely affects a man's health, quality of life, and risk of mortality."

What Would Reclassification or Descheduling Mean?

Experts and lawmakers have proposed several alternatives to testosterone's current Schedule III status:

Option 1: Rescheduling to Schedule V
Moving testosterone to Schedule V—the category for drugs with the lowest abuse potential—would remove federal refill limitations while maintaining prescription requirements and DEA registration for tracking purposes. This approach balances access with oversight.

Option 2: Complete Descheduling
Removing testosterone from the Controlled Substances Act entirely would treat it like other hormone therapies. Notably, estrogen—the primary female hormone used in hormone replacement therapy—is not a controlled substance. There is no pharmacological justification for treating testosterone differently.

Either option would:

• Allow longer prescription durations and easier refills
• Reduce stigma and encourage primary care physicians to treat hypogonadism
• Improve telemedicine access, particularly for patients in rural areas
• Reduce administrative burden on healthcare providers


Schedule III vs. Proposed Alternatives: A Comparison

The Path Forward: FDA Panel Recommendations

The December 2025 FDA expert panel's recommendations represent a potential turning point for testosterone policy. The panel called for:

1. Removing testosterone's Schedule III controlled substance designation
2. Expanding FDA-approved indications to include age-related hypogonadism
3. Removing outdated prostate cancer contraindications from labeling
4. Implementing routine testosterone screening as part of men's health assessments

FDA Commissioner Martin Makary signaled that the agency is receptive to these changes, drawing parallels to the recent removal of black-box warnings from women's hormone replacement therapy based on updated evidence.

Conclusion: Evidence Should Drive Policy

Testosterone's classification as a Schedule III controlled substance was a product of its time—a response to athletic doping scandals that failed to account for the millions of men who would need this hormone as a legitimate medical treatment. Thirty-five years of evidence have demonstrated that testosterone replacement therapy, when properly prescribed and monitored, is safe and effective for treating hypogonadism.

The current regulatory framework:

• Has not achieved its goal of reducing illicit steroid use
• Creates barriers that discourage appropriate medical treatment
• Stigmatizes testosterone therapy and those who need it
• Paradoxically drives patients toward less regulated care settings
• Is inconsistent with the treatment of estrogen, which is not controlled

It is time for policy to catch up with science. As Dr. Mohit Khera of Baylor College of Medicine stated at the FDA panel: "Testosterone therapy is safe, effective, and preventive. Large randomized controlled trials and observational studies have demonstrated the safety and multiple clinical benefits of testosterone therapy."

Men with documented hypogonadism deserve access to treatment without unnecessary bureaucratic barriers. Reclassifying or descheduling testosterone would be a meaningful step toward evidence-based men's health policy.

Related ExcelMale Forum Discussions

Explore these community discussions for additional insights:
• US Federal and State Regulations on Testosterone and HCG — Comprehensive guide to testosterone's controlled substance status and state-by-state variations
• THE DEA And ACCESS TO TRT TELEMEDICINE — Discussion on proposed DEA rules that would further restrict telemedicine prescribing of testosterone
• Is it possible to get a prescription for test these days? — Community members share experiences navigating the healthcare system for TRT prescriptions
• CVS Caremark denies TRT prescription — Real-world examples of insurance barriers and how forum members have worked around them
• Testosterone Replacement Therapy (TRT) Facts Every Man Should Know — Essential information about TRT including that it does not cause prostate cancer or heart attacks

Key References
1. Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular Safety of Testosterone-Replacement Therapy. N Engl J Med. 2023;389(2):107-117. https://pubmed.ncbi.nlm.nih.gov/37326322/
2. Anabolic Steroids Control Act of 1990. Pub. L. 101–647, 104 Stat. 4851. https://www.congress.gov/bill/101st-congress/house-bill/4658
3. DEA Drug Scheduling Information. U.S. Drug Enforcement Administration. https://www.dea.gov/drug-information/drug-scheduling
4. FDA Expert Panel on Testosterone Replacement Therapy for Men. December 10, 2025. U.S. Food & Drug Administration. https://www.urologytimes.com/view/experts-urge-fda-to-revisit-labeling-for-testosterone-replacement-therapy-in-men
5. Endogenous Hormones and Prostate Cancer Collaborative Group. Endogenous sex hormones and prostate cancer: a collaborative analysis of 18 prospective studies. J Natl Cancer Inst. 2008;100(3):170-183. https://pmc.ncbi.nlm.nih.gov/articles/PMC4709428/
6. Bhasin S, Brito JP, Cunningham GR, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744. https://academic.oup.com/jcem/article/103/5/1715/4939465
7. Rasmussen JJ, Selmer C, Østergren PB, et al. Former Abusers of Anabolic Androgenic Steroids Exhibit Decreased Testosterone Levels and Hypogonadal Symptoms Years after Cessation: A Case-Control Study. PLoS One. 2016;11(8):e0161208. https://pmc.ncbi.nlm.nih.gov/articles/PMC4988681/
8. Senator Markey Letter on Testosterone Rescheduling. September 2022. U.S. Senate. https://www.markey.senate.gov/news/press-releases/senator-markey-calls-on-biden-admin-to-lift-barriers-to-testosterone-expand-access-to-gender-affirming-hormone-therapy

Medical Disclaimer
This article is for informational purposes only and does not constitute medical advice. Testosterone replacement therapy should only be initiated under the guidance of a qualified healthcare provider after appropriate diagnostic testing. Individual responses to TRT vary, and potential risks and benefits should be discussed with your physician. Always consult a healthcare professional before making decisions about hormone therapy.

About ExcelMale
ExcelMale.com is the leading men's health forum with over 24,000 members and 20+ years of community expertise in testosterone replacement therapy and hormone optimization. Founded by Nelson Vergel, author of "Testosterone: A Man's Guide" and "Beyond Testosterone," ExcelMale provides evidence-based information and peer support for men navigating hormone health. Visit us at
https://www.excelmale.com to join our community.






More details on current T schedule : US Federal and State Regulations on Testosterone and HCG - Excel Male Health Forum

Submitted by Nelson Vergel
Founder, ExcelMale.com | Author, Testosterone: A Man's Guide and Beyond Testosterone


To the Food and Drug Administration:

I have spent over 30 years as a patient advocate and educator in men's hormone health. I founded ExcelMale.com and built online communities serving 64,000+ men on TRT. I authored two books on testosterone optimization. I strongly urge the FDA to support removing testosterone from Schedule III.

Testosterone Saved My Life

In 1985, I was diagnosed with HIV when it was a death sentence. By the early 1990s, I was stricken by AIDS-related wasting syndrome—skeletal, weak, watching my body consume itself. After much research and trying to convince doctors to prescribe me testosterone, I was able to reverse my muscle wasting and save my life. That is not hyperbole. It is clinical truth. HIV physicians started prescribing it to save their patients and the NIH performed a few studies proving the safety of testosterone in men and women challenged by HIV.

That experience transformed my life's work. I know how transformative TRT can be for men with hypogonadism. I also know the stigma and barriers that prevent men from accessing treatment. Forty years later, those barriers persist—not because of science, but because of outdated policy.

The Classification Is Scientifically Indefensible


Testosterone was scheduled in 1990 to combat athletic doping—not to restrict treatment for hypogonadal men. Both the AMA and DEA opposed this classification. They were right.

The TRAVERSE trial (5,246 men, NEJM 2023) definitively proved TRT does not increase cardiovascular events. The FDA acknowledged this by removing the black-box cardiovascular warning in February 2025. The prostate cancer myth has been repeatedly debunked in peer-reviewed literature. The saturation model demonstrates that prostate tissue reaches maximal androgen stimulation at low testosterone levels—additional testosterone does not increase risk.

Every major safety concern used to justify scheduling has collapsed under scientific scrutiny. The evidence is clear. The policy is not.

The Policy Harms Patients

In three decades of advocacy, I have heard from thousands of men harmed by this classification:

Physicians refuse to prescribe testosterone to avoid DEA scrutiny and controlled-substance documentation burdens. Men with clear laboratory diagnoses of hypogonadism cannot find willing prescribers.

Six-month prescription limits force unnecessary clinic visits, creating barriers for working men, rural patients, and those with limited mobility or finances. These visits serve no clinical purpose for stable patients.

Insurance companies exploit the Schedule III designation to impose prior authorizations, step therapy requirements, and coverage denials. The scheduling provides justification for restrictions that are about cost control, not safety.

Men unable to navigate these barriers turn to unregulated black-market sources—or go untreated entirely.

Untreated hypogonadism is not benign. It increases all-cause mortality, accelerates diabetes and metabolic syndrome, causes osteoporosis and fractures, and worsens depression and cognitive decline. This policy does not protect public health. It actively undermines it by driving patients away from supervised medical care.

The Policy Is Inconsistent and Inequitable

Estrogen is not a controlled substance. Women on hormone replacement therapy face none of these barriers—no DEA monitoring, no prescription limits, no scheduling stigma.

This disparity has no pharmacological or clinical justification. Both testosterone and estrogen are sex hormones used for replacement therapy in patients with documented deficiencies. Both require monitoring. Both have been studied extensively for safety.

The differential treatment reflects cultural bias and historical accident, not science. Men with hypogonadism deserve the same regulatory treatment as women receiving hormone therapy.

The Path Forward

The December 2025 FDA advisory panel reviewed the evidence and recommended removing testosterone from Schedule III. The panel recognized what the data clearly shows: this classification was never intended for patients with hypogonadism, and it has caused 35 years of unnecessary harm.


The FDA's own actions support this conclusion. You removed the cardiovascular black-box warning because the evidence did not support it. The same evidence-based reasoning demands removing the scheduling classification.

Recommendation

I support the advisory panel's recommendation to remove testosterone from Schedule III. This would not leave testosterone unregulated—it would remain a prescription medication requiring physician oversight. It would simply remove the additional regulatory layer that burdens prescribers, barriers patients, contradicts current evidence, and serves no legitimate public health purpose.

Let physicians and patients make treatment decisions based on science and clinical judgment—not on a 35-year-old law that was never meant for them.


Respectfully,


Nelson Vergel
Founder, ExcelMale.com
Houston, Texas