FDA Commissioner Dr. Marty Makary announcing the removal of HRT black box warnings on November 10, 2025

  • Nov 24, 2025

FDA Removes HRT Black Box Warnings: What This Means for Your Hormones, Your Skin, and Your Future

    On November 10, 2025, the FDA reversed 23 years of HRT warnings. Learn what this means for your hormones, your skin, and your health—plus why the science was distorted.

    Did you see what happened on November 10, 2025?

    For 23 years, you've been told hormone replacement therapy is dangerous. You've suffered through hot flashes, sleepless nights, brain fog, and watched your skin change practically overnight—all while the medical establishment told you there was no safe option. Some of you avoided HRT entirely because of scary warnings on the label. Others who wanted it couldn't get their doctors to prescribe it.

    That era is officially over.

    The FDA just announced they're removing the "black box" warnings from hormone replacement therapy products—the most severe safety warnings the FDA can place on a medication. And the reason why matters deeply, especially for your skin.

    In this post, you'll learn exactly what the FDA announced, what the science actually says about HRT and breast cancer, the hormone-skin connection that almost no one is talking about, and what steps you can take next—whether you choose HRT or not.

    📺 Watch the full announcement HERE


    The World Is Watching—And Agreeing

    This isn't just American news.

    The Canadian Menopause Society issued a statement on November 12, 2025, welcoming the FDA's decision: "For too long, an outdated warning increased anxiety and discouraged women and clinicians from discussing hormone therapy. The FDA's action reflects research and clinical evidence that, for properly selected women, modern menopausal hormone therapy offers significant benefits with low absolute risks." Health Canada will now review their labeling to reflect updated evidence.

    The European Menopause and Andropause Society (EMAS) released their official statement on November 17, 2025, stating: "This decision reflects the now well-established scientific consensus that the original interpretation of the Women's Health Initiative (WHI) was overly broad and, in several key aspects, misleading. For more than 20 years, these warnings have fuelled unwarranted fear, contributing to a substantial underuse of MHT among women who could have benefited from treatment."

    EMAS called this decision "more than a regulatory correction—it is an acknowledgement of a structural gap in women's health."​

    The Menopause Society also issued a statement agreeing with the FDA's decision, particularly for low-dose vaginal estrogen therapies.​

    In the UK, Dr. Nighat Arif noted that while the FDA decision is U.S.-specific, it "aligns with current UK medical understanding" and will help update product leaflets that still inaccurately list breast cancer and blood clots as risks for low-dose vaginal estrogen.​

    The science is catching up. The world is paying attention. And you deserve to know.


    What Did the FDA Actually Announce?

    On November 10, 2025, the U.S. Food and Drug Administration announced it is initiating the removal of broad "black box" warnings from HRT products for menopause. This is the most significant reversal in women's health policy in over two decades.

    FDA Commissioner Dr. Marty Makary made the announcement at a press conference attended by over 200 people, including the Second Lady of the United States, Usha Vance. His words were direct: "Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk."

    The FDA is removing references to risks of cardiovascular disease, breast cancer, and probable dementia from product labeling. They're also updating recommendations to start HRT within 10 years of menopause onset or before age 60 for systemic therapy.

    Secretary Robert F. Kennedy Jr. stated at the press conference: "For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again."

    ✨ Highlights✨ I broke down exactly what Dr. Makary said—and what it means for YOU—in this video: CLICK HERE


    Why Were These Warnings Added in the First Place?

    In 2002, the Women's Health Initiative (WHI) study—a $1 billion research project and the largest of its kind in U.S. history—released headline-grabbing results suggesting HRT increased breast cancer risk.

    Here's what went wrong: The headlines were released to the media before the scientific data was even published publicly. By the time researchers could examine the actual numbers, the damage was done.

    The study had critical flaws that weren't communicated to the public:

    • Average participant age was 63—over a decade past the average age of menopause

    • Hormone formulations used are no longer commonly prescribed

    • The breast cancer finding showed no statistical significance

    Dr. Makary called this "one of the greatest mistakes in modern medicine" and acknowledged something deeply personal: "50 million women have been denied treatment... including my mom."

    The fear machine had been set in motion. In 1999, approximately 27% of post-menopausal women used HRT. After the warnings, that number plummeted, and millions of women suffered unnecessarily.


    What Does the Science Actually Say About HRT?

    When HRT is started within 10 years of menopause onset or before age 60, the benefits are substantial and well-documented.

    According to the FDA's comprehensive scientific review and expert panel findings:

    • Cardiovascular disease risk reduction: Up to 50%

    • Alzheimer's disease risk reduction: 35%

    • Bone fracture risk reduction: 50-60%

    • Extended lifespan: Up to 10 years of healthy life added

    Heart disease is the #1 killer of women, taking eight times more lives than breast cancer. Women become two to three times more likely to develop Alzheimer's disease after menopause than men. These statistics matter deeply when evaluating treatment options.


    What About Breast Cancer?

    This is the question that caused 23 years of fear. Here's what the data actually shows:

    The WHI study found a slight increase in breast cancer diagnosis (not mortality) in women taking combined estrogen-progestin therapy. However, critical context was missing from those headlines:

    • The increase was not statistically significant

    • No clinical trial has ever shown HRT increases breast cancer mortality

    • Women taking estrogen alone had a 24% REDUCTION in breast cancer

    Let that sink in. Not an increase. A 24% reduction.

    Dr. Alicia Jackson, Director of the Advanced Research Projects Agency for Health (ARPA-H), stated at the press conference: "Estrogen is one of the most effective longevity interventions for women. And yet, we have told women and their doctors the exact opposite."


    Why Timing Matters

    The concept of the "window of opportunity" is critical. Starting HRT within 10 years of menopause provides protective benefits. Starting after age 60 or more than 10 years post-menopause carries a different risk profile.

    This nuance—that timing matters enormously—was completely lost in the 2003 fear machine. The new FDA labeling will emphasize this timing recommendation.


    What Does This Mean for Your SKIN?

    Here's what almost no one is talking about in all the coverage of this announcement: the hormone-skin connection.

    Most conversations about HRT focus on hot flashes, heart disease, and bone health. But estrogen affects every single organ in your body—including your largest one: your skin.

    When estrogen drops approximately 60% in perimenopause, a cascade of changes begins in your skin:

    • Ceramide production drops approximately 25%—these are the essential lipids that hold your skin barrier together

    • Collagen synthesis slows approximately 30% within the first five years of menopause

    • Your skin barrier weakens, leading to increased water loss and sensitivity

    • Sebum production decreases significantly, contributing to dryness

    This is why your skin can feel both dry AND sensitive at the same time. It's not your imagination. Your barrier is compromised.


    Why Your Products "Stopped Working"

    You didn't fail your skincare routine. Your hormones changed, and your skin biology changed with them.

    Products formulated for women in their 30s operate on assumptions that no longer apply to your skin. They assume adequate ceramide production. They assume a functioning barrier. They assume sufficient natural oil production.

    When those assumptions are wrong, even the most expensive products can feel ineffective.

    Research published in Scientific Reports in 2022 confirmed this connection directly: post-menopausal women showed lower levels of ceramides with shorter average length compared to pre-menopausal women. However, women taking HRT showed ceramide profiles similar to pre-menopausal women. The study demonstrated that serum estradiol levels directly correlated with ceramide abundance and length.


    HRT and Skin: What the Research Shows

    Multiple studies document HRT's positive effects on skin:

    • Improved skin hydration, elasticity, and thickness in women receiving estrogen therapy

    • Increased collagen content—one randomized controlled trial showed oral estrogen increased dermal thickness by 30% over 12 months

    • Improved skin surface texture and reduced pore enlargement

    • Better barrier function with hormone balance

    A review published in Climacteric journal confirmed: "Improvements in skin surface texture, hydration, collagen content of the dermis and viscoelasticity have been shown in women receiving HRT/estrogen."

    This doesn't mean you need HRT for better skin. But it does mean understanding how your hormones affect your skin is the first step to building a routine that actually works—regardless of your HRT decision.


    What Should You Do Now?

    Let's be clear: this blog post is not medical advice. The decision to use HRT is deeply personal and should be made with your healthcare provider based on your individual health history, risk factors, and symptoms.

    But you can be informed when you have that conversation.

    Step 1: Educate Yourself on the New Science

    Watch the full FDA press conference. Read the official FDA press release. Understand what actually changed and why.

    The more you understand the science, the better questions you can ask your doctor. Knowledge is empowering.

    Step 2: Understand YOUR Hormone-Skin Connection

    Whether you choose HRT or not, your skincare routine needs to adapt to your changing biology.

    Understanding how estrogen decline affects your ceramides, collagen, and barrier function gives you the foundation to make smarter product choices and build routines that work with your new biology—not against it.

    This is exactly what I teach. Start with the FREE 7-Day Menopause Skin Reset Plan—it's the exact foundation I use with my 12-Week Cohort clients, and it will help you understand how YOUR hormones are affecting YOUR skin.

    Step 3: Have an Informed Conversation with Your Doctor

    If you're considering HRT, here are questions to discuss:

    • Timing: Am I within 10 years of menopause onset or under age 60?

    • Delivery methods: What are my options (pills, patches, topical)?

    • Individual risk factors: What does my personal health history suggest?

    • Type of HRT: Estrogen-only vs. combined therapy based on my situation

    If your doctor dismisses your concerns, you have the right to seek a second opinion. Dr. Kelly Casperson, a urologist and hormone therapy expert who spoke at the FDA announcement, noted that many women go from "doctor to doctor to doctor" before finding help. That shouldn't happen, but it does—and advocating for yourself matters.

    Step 4: Adapt Your Skincare Routine (With or Without HRT)

    Regardless of your HRT decision, your skin needs hormone-aware care:

    • Focus on barrier repair: Ceramides, niacinamide, and cholesterol help rebuild what estrogen decline takes away

    • Prioritize hydration layering: Your skin can't hold moisture like it used to—you need strategic layering techniques

    • Use strategic actives carefully: Retinoids and vitamin C are still valuable, but your tolerance has changed

    • Protect and seal: Occlusive moisturizers help prevent trans-epidermal water loss

    That's exactly what I teach in Glow Wizard Academy. You don't need to guess anymore.


    What the Doctors at the FDA Press Conference Said

    These quotes come directly from medical leaders speaking at the November 10, 2025 press conference:

    Dr. Marty Makary, FDA Commissioner:

    "After 23 years of dogma, the FDA is announcing that we are going to stop the fear machine... This is, in my opinion, one of the greatest mistakes in modern medicine—the demonization of hormone replacement therapy."

    Dr. Alicia Jackson, Director of ARPA-H:

    "Estrogen is a key hormone for women's health. Every single part of a woman's body depends on estrogen to operate at its best—including the brain, bones, heart, and muscles... The removal of the black box warning is an incredible step forward to empower millions of women to live longer, healthier lives."

    Dr. Kelly Casperson, MD (Urologist):

    "80% of women will experience symptoms. Only 5% receive treatment. He gets treated. She gets dismissed."

    Dr. Rachel Rubin, MD (Urologist and Sexual Medicine Specialist):

    "Until today, the warning label falsely says that vaginal estrogen causes cancer, stroke, blood clots. Not a single scientific study shows this."

    These aren't fringe voices. These are the FDA Commissioner, the Director of ARPA-H, and leading physicians who have treated thousands of patients. The medical establishment is finally acknowledging what many women have known for years: we deserve better.


    Your Hormones Changed. Your Skin Changed. Now You Understand Why.

    For 23 years, women have been told to fear the very therapy that could have transformed their lives. That era is over.

    Whether you choose HRT or not, you now have access to the science that was hidden behind black box warnings and medical groupthink. And you understand something most women don't: the connection between your hormones and your skin.

    As a Hormonal Skincare Coach, I don't prescribe hormones—I teach the biology. Because when you understand HOW your hormones affect your skin, you can customize ANY routine, with ANY products, for YOUR biology. No more wasting money on products designed for someone else. No more wondering why nothing seems to work anymore.

    The transformation starts with understanding.

    Want to understand how YOUR hormones are affecting YOUR skin? Grab our FREE 7-Day Menopause Skin Reset Plan. It's the exact foundation I teach in my 12-Week Cohort—and it's yours for free.

    DOWNLOAD THE FREE 7-DAY RESET PLAN

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