The FDA's Testosterone Reset in 2026: What New Label Changes and Hearings Mean If You're Considering TRT

In February 2025, the FDA issued class-wide labeling changes for all testosterone products. The headline change: the agency removed the language in the boxed warning about an increased risk of adverse cardiovascular outcomes. That warning had shadowed TRT since 2015 and was a major reason many men — and many primary care doctors — hesitated to consider treatment.

The change was driven by the TRAVERSE trial, a large cardiovascular safety study of more than 5,000 men with hypogonadism. The FDA concluded that TRAVERSE showed no increase in the risk of adverse cardiovascular outcomes in men using testosterone for hypogonadism, and that finding is now written into the label itself.

The update wasn't all reassurance, though. Based on post-market ambulatory blood pressure studies, the FDA added new warnings that testosterone products can raise blood pressure. That applies across formulations — injections, gels, and patches alike — and it's one reason blood pressure monitoring should be part of any TRT plan.

Last December, the FDA convened a public expert panel on testosterone replacement therapy for men, bringing together physicians, researchers, and health officials to review the state of the evidence — from cardiovascular safety after TRAVERSE to long-standing questions about prostate health and access barriers. Regulatory attorneys who track the agency noted that the meeting drew enormous public interest, including a wave of comments from women asking why no testosterone product exists for them at all.

For men, the signal from the past year is a clear shift in tone: regulators are treating low testosterone as a legitimate medical condition that deserves evidence-based treatment, rather than a category to be discouraged by default.

On September 17, 2026, the FDA's Office of Women's Health held a public workshop on testosterone use in menopausal women. The backdrop, as ABC News reported, is a surge in demand: hormone therapy prescriptions among women aged 50 to 65 rose 72% between 2021 and 2025, and earlier in 2026 the FDA removed the decades-old boxed warning from menopause hormone therapy products.

Yet there is still no FDA-approved testosterone product for women. Women who use testosterone today get smaller, off-label doses of products approved for men, or compounded formulations. The strongest current evidence in women supports testosterone for hypoactive sexual desire disorder — not for broader uses like energy or mood, where data remains thin. The workshop was widely read as a call to action for drug companies to run the dose-finding and long-term safety studies a women's approval would require. For now, women considering testosterone should treat it as an explicitly off-label decision to make carefully with a clinician.

The label update did not turn testosterone into a general-purpose energy or longevity drug. Testosterone products remain approved only for men with low testosterone caused by an associated medical condition (hypogonadism), and the FDA kept the "limitation of use" language noting that the benefit of treating age-related low testosterone on its own hasn't been established.

That's why proper diagnosis matters. Legitimate TRT starts with lab work — typically two early-morning testosterone levels — plus a review of symptoms such as low libido, erectile difficulties, fatigue, and loss of muscle mass. Screening should also cover the things that make TRT a bad fit: untreated prostate or breast cancer, plans for near-term fertility (TRT suppresses sperm production), severe untreated sleep apnea, and very high red blood cell counts. Once treatment starts, good care includes periodic monitoring of testosterone levels, hematocrit, blood pressure, and prostate health. Common side effects can include acne, fluid retention, and the blood pressure and red-blood-cell effects now flagged on the label.

Low testosterone also travels with other men's health issues — erectile dysfunction in particular. If ED is part of the picture, treating both sides often works better than either alone; you can read about prescription options like sildenafil and tadalafil on our sexual health page.

If the past year of FDA news has you wondering whether your fatigue, low drive, or stalled workouts might be hormonal, the right first step is testing, not guessing. JoeyMed's licensed providers can order the labs, review your results and history, and — if you qualify — build a treatment plan with ongoing monitoring, delivered through a fully online visit. Treatment decisions are always made with a licensed provider based on your labs and medical history, and TRT isn't the right answer for everyone.

Explore our wellness and hormone health services to take an assessment, or browse men's sexual health treatments if ED or low libido is your main concern. The FDA is finally giving testosterone a fair, evidence-based look — your own decision deserves the same.