On June 18, 2026, the FDA announced it is requesting updates to the labels of testosterone replacement therapy (TRT) products — including removing the long-standing statement that TRT's safety and effectiveness "have not been established" for men with age-related low testosterone. For many men who've been told "your levels are just normal for your age," it's a meaningful shift. Here's what changed, what the science behind it says, how to know if low testosterone is behind your symptoms, and how Alpine Health & Wellness in Kalispell, MT approaches testosterone therapy for men.
The FDA requested class-wide updates to testosterone product labeling. The key proposed changes:
These are label updates requested of manufacturers, so the exact wording on each product may roll out over time. What hasn't changed: testosterone is still a prescription, controlled medication that requires a diagnosis, lab monitoring, and medical supervision.
The biggest driver was the TRAVERSE trial, a large randomized study of more than 5,200 men aged 45–80 with low testosterone and existing heart disease or elevated cardiovascular risk. Published in the New England Journal of Medicine in 2023, it found that testosterone therapy did not significantly increase major cardiovascular events like heart attack or stroke compared to placebo.
To be complete and honest: TRAVERSE did find somewhat higher rates of atrial fibrillation, pulmonary embolism, and acute kidney injury in the testosterone group. That's why careful screening and ongoing monitoring still matter — the new label makes TRT more accessible, not risk-free.
Testosterone naturally declines about 1% per year after age 30–40, but some men drop much lower than others. Common symptoms include:
These symptoms overlap with thyroid issues, sleep apnea, depression, vitamin D deficiency, and metabolic problems — which is exactly why a symptom checklist alone isn't enough.
A proper diagnosis requires both symptoms and lab confirmation. Guidelines from the American Urological Association use a total testosterone below about 300 ng/dL, confirmed on two separate early-morning blood draws, as a common threshold. A thorough workup also looks at:
At Alpine, our functional wellness labs look at the whole picture, so we treat the cause — not just the number.
Lifestyle factors matter too. Sleep, strength training, body fat, alcohol, and stress all influence testosterone. For some men, addressing those — or using supportive peptide therapy — is part of the plan.
The FDA's 2026 labeling request reflects evidence — mainly from the TRAVERSE trial — that TRT does not significantly raise the risk of heart attack or stroke in appropriately selected men with low testosterone, including older men. It still carries risks such as elevated red blood cell counts, and requires lab monitoring.
Most labs list a reference range of roughly 300–1,000 ng/dL for total testosterone in adult men. Levels below about 300 ng/dL on repeated morning tests, together with symptoms, are commonly used to diagnose low testosterone.
Many men notice improvements in energy, mood, and libido within 3–6 weeks. Changes in muscle, body fat, and strength usually take 3–6 months, especially when paired with resistance training.
Current evidence has not shown that TRT causes prostate cancer in men without it, which is part of why the FDA requested updated prostate cancer language. However, testosterone can stimulate existing prostate cancer, so PSA screening before and during treatment remains standard.
Neither is universally better. Pellets offer steady levels and convenience with fewer appointments; injections allow quicker dose adjustments. Your lab results, lifestyle, and preferences determine the best fit.
Yes — at much lower doses. Learn more in Testosterone Therapy for Women, and see what the FDA's recent change to menopause hormone therapy means in The FDA Just Removed Hormone Therapy's Black Box Warning.
At Alpine Health & Wellness, Elizabeth, our Nurse Practitioner, takes the time to understand your symptoms, run comprehensive labs, and build a hormone optimization plan that fits your goals — whether that's more energy for work, keeping up on the mountain, or feeling like yourself again. Follow-up labs every 3–6 months keep your treatment safe and dialed in.
Call Alpine Health & Wellness in Kalispell, MT at 406-361-7421 or book an appointment online.
This article is for educational purposes only and is not medical advice. Testosterone therapy requires a diagnosis, a prescription, and ongoing medical monitoring. FDA labeling information reflects announcements as of September 2026 and may continue to be updated. Talk with a qualified healthcare provider about whether testosterone therapy is appropriate for you.
