The FDA Is Rethinking Testosterone. That Quiet Decision Could Change Men’s Health

A December 2025 FDA panel signals a rare shift in how low testosterone, aging, and treatment access are viewed in the U.S.

FDA testosterone therapy

In December 2025, the U.S. Food and Drug Administration did something it rarely does. It publicly reopened a conversation many regulators had quietly sidelined for years: testosterone decline in men, and whether current medical rules still reflect modern science.

🔬The agency convened a dedicated expert panel on testosterone replacement therapy, explicitly invited public comment, and allowed senior leadership to speak openly about uncertainty, stigma, and access. For millions of men experiencing unexplained fatigue, low mood, or declining vitality, this was not background noise. It was a signal.

Key Takeaways

  • The FDA is formally reassessing testosterone therapy, not endorsing it but no longer ignoring it
  • Average testosterone levels in U.S. men have declined over time, according to FDA leadership
  • Only about one-third of men with low testosterone report clear symptoms, complicating diagnosis
  • Lifestyle, sleep, stress, and environment strongly influence testosterone levels
  • Natural strategies remain foundational, regardless of future medical policy changes

Why the FDA’s December 2025 Testosterone Panel Matters

🏛️On December 10, 2025, the FDA held a public expert panel under docket FDA-2025-N-6743, focused entirely on testosterone replacement therapy for men.

This was not a routine drug safety review. Panels structured this way typically indicate that clinical guidance, regulatory framing, or access rules may be reconsidered. The FDA also explicitly encouraged public comment, an uncommon step that signals early-stage policy exploration rather than a finalized position.

Notably, testosterone was discussed neither as a lifestyle enhancement nor as a dangerous fringe therapy. Instead, it was framed as a potential quality-of-life and public health issue that deserves clearer scientific and regulatory thinking.

What FDA Commissioner Martin Makary Said Publicly

Following the panel, FDA Commissioner Dr. Martin Makary addressed the issue in interviews with NPR’s Morning Edition and KUOW.

Makary acknowledged that testosterone levels in American men have declined across generations, a conclusion supported by multiple epidemiological studies. He emphasized that the science remains incomplete, noting that only about one-third of men with low testosterone experience clear symptoms.

Those symptoms commonly include reduced mood, lower energy, and diminished vitality, but they are not universal. Makary framed the FDA’s motivation as exploratory rather than promotional, focusing on reconsidering access, reducing stigma, and updating outdated assumptions without overstating certainty.

This measured tone marked a clear shift from past regulatory silence.

Testosterone Decline: What the Science Already Shows

Testosterone is a steroid hormone produced primarily in the testicles in men and the ovaries in women, with smaller contributions from the adrenal glands. Levels typically peak around age 19 and decline by approximately 1 to 2 percent per year after age 30.

🧬For many men, this decline is subtle. For others, it correlates with meaningful health changes. Low testosterone has been associated with:

  • Reduced sexual function
  • Loss of muscle mass and strength
  • Lower bone density
  • Mood disturbances and fatigue
  • Increased risk of chronic disease and premature mortality

What feels increasingly relevant is the possibility that modern lifestyle and environmental exposures may be accelerating this decline, beyond what aging alone would predict.

Exercise and Testosterone: More Is Not Always Better

Physical activity has a direct hormonal effect. Resistance training reliably produces short-term increases in testosterone, whilehigh-intensity interval training can trigger favorable endocrine responses.

However, the relationship has limits. 🚨 Chronic overtraining elevates cortisol, which suppresses testosterone production, particularly when combined with inadequate calories or poor sleep.

🏋️‍♂️ The takeaway is not maximal effort, but physiological balance.

Diet Patterns That Support Hormonal Health

Testosterone synthesis depends on adequate energy intake and balanced macronutrients. Research consistently shows that very low-fat diets are associated with lower testosterone levels, while balanced intake of protein, fats, and carbohydrates supports hormonal stability.

🥗 Mediterranean-style dietary patterns appear particularly protective. By improving insulin sensitivity and metabolic health, they indirectly support testosterone levels over time. This is not about rapid hormone boosts. It is about removing metabolic constraints that suppress production.

Foods Linked to Healthier Testosterone Levels

Several foods repeatedly show supportive associations

  • Onions and garlic support hormones involved in testosterone production and improve sperm quality
  • Fatty fish such as salmon and mackerel provide vitamin D
  • Oysters are among the richest dietary sources of zinc
  • Spinach, almonds, and cashews supply magnesium
  • Pomegranate may lower cortisol and improve mood and blood pressure
  • Avocados provide monounsaturated fats linked to healthier lipid and testosterone profiles
🥑🧄🐟 No single food is decisive. Patterns and consistency matter most.

Micronutrients and Supplements: Helpful, With Limits

Vitamin D deficiency affects up to one billion people worldwide, and low levels are consistently associated with low testosterone. Some randomized trials show supplementation raises testosterone and improves erectile function, while others show modest or no effect. Evidence remains mixed.

Zinc supplementation increases testosterone primarily in men who are deficient and supports fertility and sexual function. Excess intake does not confer added benefit.

🌞 Herbal supplements such as ashwagandha, ginger, and saw palmetto may offer modest support for some men, but evidence quality varies. Medical supervision is recommended.

Sleep, Stress, and the Cortisol–Testosterone Balance

Testosterone production peaks during REM sleep, making sleep duration and quality critical. Studies show that sleeping less than five hours per night can reduce testosterone by approximately 15 percent within days.

Chronic psychological stress compounds this effect. ⚖️ Cortisol and testosterone operate in opposition. Elevated cortisol suppresses testosterone, promotes visceral fat accumulation, and increases cardiometabolic risk.

Seven to eight hours of consistent, high-quality sleep remains one of the most reliable hormonal interventions available.

Alcohol, Plastics, and Hormonal Disruption

Testosterone levels begin to drop within 30 minutes of alcohol consumption, and chronic heavy drinking is linked to testicular atrophy, increased estrogen, hair loss, and gynecomastia.

Environmental chemicals matter as well. Bisphenol A (BPA), commonly found in plastics and food packaging, acts as an endocrine disruptor. Studies show that months of frequent exposure are associated with significant testosterone reductions.

🍺Simple choices help reduce exposure. Use glass containers. Avoid heating food in plastic. Limit what can be controlled.

Where Testosterone Therapy Stands Now

As of December 2025, the FDA is in a reassessment phase. No new prescribing rules or access changes have been finalized. What has changed is openness.

Testosterone is now being discussed as a legitimate medical and quality-of-life issue, rather than something to dismiss or quietly tolerate. Lifestyle and behavioral strategies remain foundational, regardless of whether medical therapy is considered.

🧭 What seems clear is that testosterone has returned to the public health agenda. And that shift alone carries consequences.

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Jérémie Robert is a multilingual writer and longevity enthusiast passionate about biohacking and health optimization. As editor-in-chief of BiohackingNews.org, he focuses on research shaping the future of health and longevity, translating complex studies into practical insights anyone can use to make evidence-based choices for a longer and better life.

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