Dr. Carlos J. Jurado, hormone wellness specialist, breaks down the FDA’s Nov 10, 2025 update on menopausal hormone therapy, what it means for BHRT, and why women deserve science-driven care.

The FDA hormone therapy announcement released on November 10, 2025 marks one of the most significant updates in women’s health in over two decades.

On November 10, 2025, the FDA issued a landmark directive requesting updates to the labeling of menopausal hormone therapies (often referred to as HRT—Hormone Replacement Therapy).
As a physician specializing in hormone optimization and a strong advocate for Bioidentical Hormone Replacement Therapy (BHRT), I believe this moment is pivotal for women who suffer from the debilitating effects of hormone depletion. At my practice, MD Touch Aesthetics & Wellness, we have seen how personalized hormone care dramatically improves vitality, mood, weight regulation, sleep, libido, and quality of life.

What the FDA Hormone Therapy Announcement Actually Says

The FDA’s statement outlines several key changes:

• The agency is requesting removal of certain broad “black box” (boxed) warnings related to cardiovascular disease, breast cancer, and probable dementia for many menopausal hormone therapy products.
• The FDA clarified that their review was prompted by evolving data, largely because the landmark Women’s Health Initiative (WHI) trials enrolled women with a mean age of 63 years—older than most women experiencing menopausal symptoms—and used hormone formulations no longer in broad use.
• Specifically for systemic (whole-body) hormone therapies, the updated labeling will include guidance to consider initiation within 10 years of menopause onset or before age 60.
• Local vaginal hormone products (for genitourinary syndrome of menopause) will have safety information that more appropriately aligns with their lower systemic risk.
• The aim is to replace fear-driven caution with data-driven, individualized decision-making between a patient and her physician.

Why This Matters for Women Suffering from Hormone Depletion

Hormone depletion is not simply a “natural phase” to be endured—it affects every system: brain, bone, heart, metabolism, mood, skin, sexual health. Many women experience:

• Persistent hot flashes, night sweats, and interrupted sleep
• Low energy, brain fog, and mood swings
• Weight gain or stubborn fat, loss of muscle tone
• Reduced libido and vaginal/urinary changes
• Accelerated bone loss or early signs of osteoporosis

At MD Touch, we’ve seen how BHRT restores hormone balance, enabling women to reclaim their vitality, strengthen their metabolism, support their skin and body composition, and feel like themselves again.

With the FDA’s shift in labeling and risk communication, the accessibility and confidence in hormone therapy is poised to improve. Patients who once felt boxed out by fear-based warnings may now have a clearer path—with proper evaluation, monitoring, and individualized protocols.

My Stance as a BHRT Expert about FDA Hormone Therapy Announcement

As a physician who has prioritized safe, bioidentical hormone protocols for years, I welcome the FDA’s announcement with optimism. Here is how I frame it for my patients and professional practice:

1. Individualized care is essential. No two women have the same hormone profile, medical history, or goals. BHRT allows tailored dosing, delivery modes (patch, gel, pellet, subcutaneous), and monitoring strategies that meet each woman where she is.
2. Timing matters. Starting hormone optimization closer to menopause onset—as the FDA now affirms—is associated with better outcomes and lower risk profiles. In our clinic, we emphasize early evaluation for any woman experiencing significant symptoms.
3. Bioidentical hormone formulations + lifestyle optimization = synergy. Hormone therapy is most effective when coupled with nutrition, movement, sleep hygiene, stress resilience, and metabolic support. BHRT is a tool—not a standalone fix.
4. Safety and monitoring are non-negotiable. While risks vary widely depending on formulation, route, and patient factors, our approach is science-based: baseline labs, ongoing follow-up, and adjustments as needed.
5. Empowerment through education. This FDA shift is an opportunity to demystify hormone therapy, remove stigma, and engage every woman in informed decision-making about her hormonal health.

What This Means for MD Touch Aesthetics & Wellness

At MD Touch, we are integrating this new regulatory shift into our protocols and patient education. Key implications:

• We’ll update our hormone therapy consultations to reflect the FDA Hormone Therapy Announcement
• We’ll prioritize early symptom recognition in perimenopausal and early-menopausal women (ages ~45–55) who may previously have been dismissed or undertreated.
• We’ll continue to monitor bioidentical hormones (estradiol, progesterone, testosterone, DHEA) within a comprehensive wellness framework—accounting for body composition, metabolism, skin health (liposculpting, body treatments), and optimized longevity (NAD+, BHRT, wellness optimization).
• We’ll provide content (blogs, FAQs, social posts) to help our community understand the benefits and considerations of hormone therapy—without fear-based messaging, and with full transparency.
• We’ll keep strong referral relationships with OB/GYN, endocrinology, cardiology, and bone-health specialists to ensure multidisciplinary oversight for patients with risk factors.

Why the FDA Hormone Therapy Announcement Supports BHRT Advancements How to Take Action

If you’re experiencing menopausal or perimenopausal symptoms that interfere with your quality of life, schedule a hormone-health evaluation with a physician experienced in BHRT (yes—we offer this at MD Touch).

Ask your provider about bioidentical hormone protocols, delivery methods, monitoring plans, and individualized risk-benefit assessment.

Discuss timing: Are you within 10 years of menopause onset, under age 60 (or close enough) for potential optimal benefit?

Inquire about lifestyle factors: Are we supporting your hormone optimization with sleep, nutrition, movement, stress management, and body composition?

Monitor results: We’ll track how you feel, changes in metabolism, skin, mood, sexual health, bone markers, and overall vitality.

Stay informed: Regulatory changes matter. Understand what the FDA’s updated guidance means for your choices.

The November 10, 2025 update from the FDA Hormone Therapy Announcement marks a turning point in women’s hormonal health. For too long, fear-shaped warnings have limited access to effective therapies for hormone depletion. As a clinician and BHRT advocate, I see this announcement as a validation of evidence and an invitation to elevate care.

Women deserve to live vibrant, balanced, energized lives. Hormonal health is fundamental to that mission. With proper evaluation, individualized protocols, proactive lifestyle support, and informed consent, BHRT stands as one of the most powerful tools in our wellness toolkit.

At MD Touch Aesthetics & Wellness, we’re committed to guiding you through this new era—energized by science, centered on you, and devoted to excellence.

References & further reading about FDA Hormone Therapy Announcement:

• FDA: “FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies”, Nov 10 2025. U.S. Food and Drug Administration+1
• HHS Fact Sheet: “FDA Initiates Removal of ‘Black Box’ Warnings from Menopausal Hormone Replacement Therapy Products”, Nov 10 2025. HHS
• Contemporary OB/GYN: “FDA initiates removal of boxed warnings, requests updated labeling for menopausal hormone therapy”, Nov 10 2025. Contemporary OB/GYN

1. What is the FDA hormone therapy announcement?

The FDA hormone therapy announcement refers to the agency’s updated guidance removing outdated boxed warnings and clarifying individualized treatment risks for menopausal hormone therapy.

2. Does the FDA hormone therapy announcement make BHRT safer?

The update aligns scientific consensus with current formulations and timing, supporting the safety of BHRT when properly monitored.

3. Who benefits most from these new FDA guidelines?

Women within 10 years of menopause onset, or under age 60, benefit most based on current safety data.

4. Does the FDA still warn about hormone therapy risks?

Yes—risks exist, but they are now communicated more accurately, separating systemic and local therapies.

5. How does this announcement affect hormone treatment options?

Women now have clearer, evidence-based pathways to personalized BHRT with less fear-driven messaging.