Testosterone therapy is indeed regulated by the U.S. Food and Drug Administration (FDA), but the nature and extent of this regulation have evolved over time and depend on the specific testosterone products and their intended uses. Testosterone replacement therapy (TRT), also known as androgen replacement therapy, involves administering testosterone to men who have low levels of this hormone, often due to hypogonadism or other medical conditions. The FDA oversees the approval, labeling, safety warnings, and marketing of testosterone products to ensure they meet standards of safety and effectiveness.
The FDA has approved various forms of testosterone therapy, including injections, gels, patches, pellets, and oral formulations. These products must undergo clinical trials to demonstrate their safety and efficacy before receiving FDA approval. For example, testosterone gels have specific dosing guidelines approved by the FDA, which clinicians follow to adjust treatment based on testosterone blood levels. Newer oral testosterone products have also been developed and approved, expanding treatment options beyond traditional delivery methods.
Historically, the FDA has required testosterone products to carry warnings about potential risks, particularly concerning cardiovascular health. At one point, testosterone therapy carried FDA warnings about increased risks of heart attacks and strokes. However, recent large-scale clinical trials, such as the TRAVERSE trial completed in 2025, have shown that testosterone therapy, when prescribed appropriately to men with documented testosterone deficiency, does not increase cardiovascular risk compared to placebo. This has led to the FDA removing some of the previous cardiovascular warnings from testosterone products, marking a significant regulatory update.
Despite these positive safety findings, the FDA continues to emphasize careful patient selection and monitoring during testosterone therapy. Treatment is recommended only for men who have both symptoms consistent with testosterone deficiency and confirmed low testosterone levels measured on multiple occasions. Contraindications remain, including active prostate or breast cancer, elevated prostate-specific antigen (PSA) levels, and uncontrolled heart failure. The FDA also highlights the need for monitoring blood pressure during therapy, as testosterone can cause increases in blood pressure in some patients.
The FDA’s regulation extends to ensuring that testosterone products are not marketed or used for unapproved purposes, such as anti-aging or athletic performance enhancement, which remain controversial and are not FDA-approved indications. The agency monitors the safety profile of testosterone therapies continuously, updating labeling and warnings as new evidence emerges.
In summary, testosterone therapy is FDA regulated through a process that includes product approval based on clinical evidence, mandated safety warnings, and ongoing post-market surveillance. Recent advances and clinical trial data have influenced the FDA’s stance, leading to updated safety information and expanded treatment options, including new oral testosterone formulations. However, the FDA maintains strict guidelines to ensure testosterone therapy is used safely and appropriately in men with genuine medical need.