FDA Panel Urges Testosterone Descheduling and Easier TRT Access

FDA Expert Panel Urges Descheduling Testosterone: Major Push for Easier Access and Updated Labeling

On December 10, 2025, an FDA-convened expert panel discussed significant updates to testosterone therapy regulations, with strong support for FDA testosterone descheduling by removing its Schedule III controlled substance status, expanding indications, and revising labels to reflect modern evidence.

Bottom line up front: The panel of urologists, endocrinologists, clinicians, and men's health experts emphasized testosterone's role in broader male health. They advocated for FDA testosterone descheduling, broader approved uses (including age-related low T with symptoms), and updating warnings no longer supported by trials like TRAVERSE.

Key Outcomes from the FDA Testosterone Descheduling Discussion

Support for removing Schedule III controlled substance status – Panelists highlighted unnecessary barriers and stigma from the current classification
Expand indications to include age-related symptomatic low testosterone, aligning with professional society guidelines
Revise or remove warnings, including those related to prostate cancer and cardiovascular risk
Address stigma that pushes men toward unregulated sources

Read the full STAT News coverage of the panel →

Why FDA Testosterone Descheduling Is Being Considered

The 1990 classification targeted abuse potential, not therapeutic use at physiological doses
Controlled status creates prescribing hurdles, pharmacy challenges, and deters providers
Unlike estrogen therapy for women (recently updated and not controlled), testosterone faces unique restrictions

Modern Evidence Supports Broader, Safer Use in FDA Testosterone Descheduling Context

Key Concern	What the Latest Data Shows	Supporting Evidence
Cardiovascular risk	No increased events; possible benefits	TRAVERSE Trial (2023, 5,200+ men) – led to FDA removing CV black box warning in 2025
Prostate cancer risk	No increase; saturation model supported	Multiple modern studies and clinical cohorts
Abuse potential at therapeutic doses	Low risk compared to supraphysiological use	Panel discussion: descheduling appropriate for medical use
Overall benefits	Improved vitality, mood, muscle mass, metabolic health	Links between low T and obesity, diabetes, reduced lifespan

What Happens Next with FDA Testosterone Descheduling?

The FDA is not bound by the panel's recommendations, but Commissioner Martin Makary (often referred to as Marty Makary) signaled strong openness to changes. In introducing the panel, he noted that estrogen and testosterone therapy share similarities — including outdated beliefs about their safety — and important differences, indicating the "door is open" for revisions.

Following the recent updates to menopause hormone therapy, further regulatory changes could emerge in 2026.

Your Next Step

At IncreaseMyT, we follow evidence-based, physician-supervised protocols focused on safety and optimization—even under current rules. As the landscape evolves with potential FDA testosterone descheduling, we'll stay at the forefront of science-backed care.

Get Priced

Always consult your physician before beginning testosterone therapy.

Articles