They Removed the Black Box Warning on MHT. Now What?
Materia Femina
You’ve likely seen the headlines. The FDA has removed the black box warning from hormone replacement therapy, or more accurately, Menopausal Hormone Therapy (MHT) ~ both terms are used, though MHT is more precise.
You might be wondering what this means, especially if perimenopause has been on your mind lately (and let’s be honest, it’s been everywhere lately). The conversation around this life phase has intensified in recent years (good!), and it’s also an area of focus for my practice, so when I saw this news, my response was layered. Good to see, yes. But also not black and white. Let’s dive in.
The Announcement
After twenty years of the FDA’s most severe warning making Menopausal Hormone Therapy sound deadly, the black box is gone. How we talk about menopause just changed.
This is science and policy evolving together in a way that gives patients more options, and I’m glad to see this kind of revisiting happen. The conversation has been too fearful for too long, driven by headlines from a flawed study that sent an entire generation of women into suffering silence. Many clinicians have been calling for years to ease the severity of this warning, particularly because patients would see it and become terrified of a therapy that might genuinely help them. Women didn’t have proper access to therapies that would have supported them through a difficult transition.
But before we celebrate too quickly, we need to talk about what this decision actually means and what it might cost us.
The press conference itself was studded with problematic claims. Robert F. Kennedy Jr., U.S. Secretary of Health and Human Services, stated that menopause hormone therapy (MHT) could “extend women’s lives by as much as 10 years.” Dr. Marty Makary, Commissioner of the U.S. Food and Drug Administration, claimed that “with the exception of vaccines or antibiotics, there’s no medication that can improve the health of women on a population level more than hormone replacement therapy.” Deputy Secretary Jim O’Neill spoke about someday reversing “all the damage of aging,” framing estrogen depletion as damage that needs pharmaceutical correction.
These are overstatements not exactly supported by the current evidence, and they set up MHT as an a panacea for aging rather than one therapeutic option among many for managing menopausal symptoms. It’s a tool, not a cure-all.
The process itself raises concerns. Rather than convening an advisory committee to scrutinize the research through the FDA’s standard scientific review process, Makary chose to hold an expert panel in July with physicians who were already pro-MHT. Diana Zuckerman of the National Center for Health Research noted that Makary undermined the FDA’s credibility by announcing this change without having scientists scrutinize the research at a proper FDA scientific meeting. Makary defended this choice by saying advisory committees are “bureaucratic, long, often conflicted and very expensive,” opting instead for what he called more spontaneous expert panels.
This matters because it sets a precedent for how regulatory decisions get made. When we bypass established scientific review processes in favor of faster, less rigorous approaches, we risk making decisions based on incomplete analysis.
The Science Behind the Decision
The removal of the black box warning on topical vaginal estrogen is warranted and backed by solid evidence. Local estrogen therapy for vaginal atrophy carries minimal systemic absorption and has consistently shown safety across studies. That change makes sense. (And honestly, it’s overdue.)
The extension of this removal to systemic MHT is where things get complicated. Systemic MHT still carries risks, as any medication does. The opportunity to fund much needed studies became short circuited by this action. Instead of generating new research to fill the gaps in our knowledge, the FDA essentially closed the conversation by removing warnings based on reanalysis of old data rather than demanding new, well designed trials.
I also reject the oversimplified portrayal of menopause as a disease that shortens women’s lives as a whole. There is more nuance to that claim than the pro-MHT narrative often acknowledges. Life expectancy for women remains greater than men’s, which should make us pause before framing menopause as a pathological state requiring pharmaceutical intervention to prevent early death.
I’m relieved to see discussion and critical reexamination of the Women’s Health Initiative study, which was indeed flawed in design and interpretation but the FDA’s process here might set a dangerous precedent for both scientific rigor and public health communication. Regulatory decisions should open doors for research, not close them prematurely.
The WHI Shadow
In 2002, the Women’s Health Initiative study detonated. Headlines screamed that hormone replacement therapy caused breast cancer! heart attacks! strokes! Women stopped their prescriptions overnight. Doctors stopped prescribing. An entire generation of perimenopausal women was left to white knuckle through hot flashes, bone loss, brain fog, and vaginal atrophy because the fear had been planted too deep.
The WHI wasn’t completely wrong, exactly. It was misinterpreted, misapplied, and weaponized by headlines that didn’t understand nuance. The study used one type of synthetic hormone (conjugated equine estrogens plus medroxyprogesterone acetate) in women whose average age was 63, which is about a decade past menopause. These weren’t women starting MHT during perimenopause when symptoms hit hardest or within the “window of opportunity.” These were older women, many with existing cardiovascular risk, given hormones they’d never taken before.
The results showed a slight increase in certain risks that, when you actually parse the numbers, amounted to a few additional cases per 10,000 women years. Context and timing matter but the media ran with “hormones are dangerous!” and an entire therapeutic option became taboo.
Dr. Avrum Bluming and Carol Tavris spent years untangling this mess in Estrogen Matters. They showed how the fear became doctrine while women suffered unnecessarily and how the WHI’s findings were never meant to apply to younger perimenopausal women starting MHT at symptom onset. The reanalysis has been clear for years: bioidentical estradiol with micronized progesterone, started during the menopausal transition in healthy women, carries minimal risk and substantial benefit.
And yet the black box stayed. Until now.
The Research Gap We Still Haven’t Filled
What troubles me beyond this regulatory shift is that women remain dramatically under-researched in medicine, and this area alone is dismal. We still don’t have large scale, well designed trials on modern bioidentical hormone formulations in diverse populations of perimenopausal women. We don’t have enough data on transdermal estradiol versus oral routes. We don’t have sufficient long term safety data on micronized progesterone. We don’t know enough about how race, genetics, metabolic health, and lifestyle factors modify MHT outcomes.
Removing the black box warning might make doctors more comfortable prescribing MHT, which could help many women but it also removes pressure on pharmaceutical companies and research institutions to generate the evidence we desperately need. The conversation shifts from “we need better research” to “the debate is settled,” and that’s scientifically premature.
An even larger issue? Most women don’t know their bodies well enough to make informed decisions about MHT in the first place. They don’t understand their circadian biology, their nervous system patterns, how stress affects their hormone synthesis, or what foundational support their bodies need before adding hormones into the mix. Traditional Chinese Medicine, Ayurveda, and other ancient healing systems offer frameworks for this foundational work not as replacements for MHT, but as the missing piece that makes any intervention work better, together.
These systems have been helping women understand their cyclical nature and build resilience for millennia. But because this kind of integrative approach isn’t profitable to Big Pharma, it doesn’t get the research funding or the clinical attention it deserves. So women devoid of these systems/understandings are left with a binary choice: suffer through symptoms or take hormones. When what they we actually need is both the foundational work that builds hormonal resilience and the option of MHT when it’s genuinely needed.
Where the Real Problem Begins
What the MHT discourse often misses is this: most women are arriving at perimenopause already depleted.
The symptoms that drive women to seek MHT aren’t solely about declining ovarian hormones. Due to the lack of supportive systems, women’s bodies have so often been running on fumes for decades. And no amount of estrogen will fix that if we don’t address the depletion underneath.
Let me be specific about what I see clinically. Women come to me in their mid thirties and forties, sometimes earlier, with cycles that have lost all rhythm, sleep that doesn’t restore, weight that won’t budge, anxiety that spikes without warning, and a lead-heavy exhaustion that no amount of rest seems to touch (like the women with the bag of bones). Their labs often come back “normal” (which is medical gaslighting at its finest), because normal ranges don’t account for optimal function or individual variation.
What I see is highly dysregulated cortisol that has been burning through their reserves since their twenties. The expectation that women should produce, nurture, optimize, and never slow down. The dismal care, especially in motherhood, which is a hormonal drain that nobody talks about honestly.
Pregnancy and breastfeeding are profoundly depleting to a woman’s body if she isn’t nurtured. In East Asian Medicine, we understand this as drawing down Kidney jing/essence and blood. If a woman doesn’t have time to replenish between pregnancies, if she’s back at work six weeks postpartum, if she’s functioning on broken sleep for years while caring for small children, and if she has no community support and is doing everything alone, her body never recovers. The yin resources that should carry her through perimenopause gracefully are already gone. It’s why/how we see so many women go straight from delivery into late stage perimenopause.
Chronic stress suppresses progesterone production. This is basic endocrinology. When your body perceives threat (whether it’s an actual tiger or just the relentless pace of modern life), it prioritizes cortisol synthesis over sex hormone production. Progesterone, which is calming and nourishing, gets shunted into making more cortisol instead. You end up with estrogen dominance relative to progesterone, even as both hormones are declining overall. This manifests as irregular cycles, heavy bleeding, mood swings, insomnia, anxiety, and weight gain around the middle.
The lack of village is hormonal. When women are isolated, when they’re doing the work of three people with no reciprocal support, when they have no elders modeling how to move through life transitions with grace, their nervous systems stay in sympathetic overdrive. Fight-flight-freeze-fawn becomes the baseline. When she cannot make adequate progesterone, she cannot sleep deeply, she cannot digest properly, and she cannot regulate inflammation when her nervous system never feels safe enough to rest.
This is what I mean by yin deficiency in ancient terms. Yin is the cooling (contra-hot flashes), nourishing, restorative aspect of the body’s energy. Yin offers the juice: sleep that restores, tissue that’s well hydrated, hormones that buffer stress, and the capacity to rest and replenish. When yin is depleted, you get night sweats, insomnia, dry skin, brittle hair, anxiety, bone loss, and the sense that your body is burning itself up from the inside. I know many of us ladies have felt this.
By the time perimenopause arrives and ovarian hormones start their erratic decline, there’s nothing left in the tank. The symptoms are brutal not just because estrogen and progesterone are dropping, but because the body has no reserves to cushion the transition.
Women in the Western world were left to endure this without the informed option of MHT, layered on top of modern stressors: misogyny, lack of proper maternity leave, absence of community support, and limited access to timeless therapies and frameworks of understanding the body that work. That picture makes it clear why the Western pharmaceutical option being unavailable was even worse. Women needed options, plural, and they had almost none.
The Lifestyle Medicine Piece
Your hormonal health is inseparable from how you live. And no, I’m not talking about wellness culture fluff and smoothie aesthetics ~ the whole aspirational void. We’re talking mechanism.
Estrogen and progesterone don’t operate in isolation. They’re part of a neuroendocrine orchestra that includes cortisol, melatonin, thyroid hormones, insulin, and growth hormone--all of which follow circadian patterns tied to light exposure. When you’re regularly exposed to bright artificial light at night, your melatonin production tanks. This isn’t the way to unwind as much as we might think it is. Melatonin suppression disrupts ovarian function. Poor sleep quality reduces progesterone synthesis. Chronic circadian misalignment (whether from late nights, early mornings, shift work, or constant screen exposure) accelerates ovarian aging.
Women who maintain strong circadian rhythms tend to move through perimenopause with fewer symptoms. Early morning light exposure. Darkness at night. Consistent sleep wake times. Eating patterns that align with insulin cadence. Seasonal variations in activity level that honor the body’s need to rest in winter and emerge in spring. These are foundational lifestyle tweakes to hormonal health.
The women who arrive at perimenopause in crisis are often the ones who’ve been overriding these rhythms for decades. Working late under artificial light. Eating erratically. Exercising at high intensity (often under the very blue light at night) without adequate recovery. Drinking caffeine to push through fatigue instead of addressing why they’re so tired… all that borrowed energy. Taking sleep aids instead of fixing what’s disrupting their sleep in the first place.
You can layer MHT onto that depleted system, and it might help with acute symptoms but if you don’t address the underlying patterns, the depletion just continues in a different form. The hot flashes might ease, but the insomnia persists. The brain fog might lift temporarily, but the anxiety remains. The weight still won’t budge because the metabolic dysfunction runs deeper than just hormone deficiency.
Worth noting: these interventions aren’t profitable to Big Pharma, which means they don’t get the research funding or marketing campaigns that pharmaceutical solutions receive. It’s up to women to learn and support themselves with this knowledge until it becomes standard medical practice (which may take generations). That’s what this space is for.
When Hormones Help (And When They Don’t)
I’m not anti-MHT. I’ve seen women transformed by bioidentical hormones. Sleep returning, brain fog lifting, joints that no longer ache, libido restored, bone density stabilizing, and anxiety calming. For some women, particularly those with early menopause or surgical menopause or debilitating symptoms that aren’t responding to other interventions, MHT is essential medicine and the standard of care.
But MHT is one therapeutic option among many, and it comes with trade offs that need honest discussion.
Before reaching for hormones, I want to know how depleted you were before perimenopause even started. What’s your sleep like (and I don’t mean “fine,” I mean actually what time do you go to bed, do you wake, and is it restorative). What’s your light exposure pattern through the day? How much stress are you carrying and what are you doing to metabolize it? Are you eating in a way that supports hormone synthesis with adequate protein, healthy fats, micronutrient density? Do you have community, purpose, rest built into your life?
If the answers reveal profound depletion, we start there. Kidney yin tonics. Adaptogens that support the hypothalamic pituitary adrenal axis. Circadian rhythm restoration. Nervous system regulation. Seasonal living that honors the body’s need to slow down and turn inward during certain phases.
For some women, these interventions are enough. Symptoms ease, energy returns, and the body finds how to regulate itself again. For others, these practices create the foundation that makes MHT work better with fewer side effects and better outcomes. And for some, MHT is the right choice from the start, particularly when symptoms are severe, quality of life is compromised, or bone health is at risk.
What I resist is the narrative that menopause is a disease requiring pharmaceutical correction. Menopause is a transition. It’s supposed to happen. The question is whether your body has the resources to make that transition gracefully, or whether decades of depletion have left you without a buffer.
The Doors This Opens and Closes
The FDA’s decision opens space for more nuanced conversations about MHT, and that matters. Women shouldn’t have to suffer through debilitating symptoms when safe, effective treatments exist. Doctors should be able to prescribe modern bioidentical formulations without twenty year old fear blocking the conversation.
But here’s what this decision doesn’t do: it doesn’t address why so many women arrive at perimenopause depleted in the first place. It doesn’t fund the integrative research we need. It doesn’t change the cultural systems that burn women out long before their ovaries slow down. It doesn’t create workplaces/systems that support mothers, healthcare that studies women thoroughly, or communities that hold women through life transitions.
The removal of the black box warning gives women more options for symptom management, and I’m grateful for that. So many are grateful for the advancements here but let’s not pretend it solves the deeper problem of how we’ve been treating women’s bodies and women’s health for generations. Access to MHT matters and so does everything that comes before a woman ever needs it.
What Women Actually Need: More.
More research and honesty about what menopause is and isn’t. More acknowledgment that symptoms are real and deserve treatment whether that treatment is hormonal, herbal, lifestyle based, or all of the above. More understanding that depletion often starts decades before menopause, and if we don’t address that, no amount of MHT will make women truly well.
And perhaps most importantly, more recognition that ancient medicine systems have been helping women through this transition for thousands of years. The fact that we’re only now beginning to integrate that wisdom with modern research should humble us about pharmaceutical solutions being framed as the primary answer. We need all tools available to women, working together, not hierarchies that privilege profit over healing.
If you’re in perimenopause or approaching it, here’s what I want you to know: Your symptoms are information, not failure. Before you decide whether MHT is right for you, learn your patterns. Understand your circadian rhythms. Assess your depletion. Know your body well enough to make an informed choice, not a desperate one.
That’s what Materia Femina is for. To give you the frameworks for reading your body’s language so you can work with your cycles, your seasons, and your nervous system. Whether you choose MHT or not, you deserve to understand what your body is asking for.
Stay. The medicine is just beginning.
I want to hear from you:
Where are you in this conversation? Are you considering MHT? Have you tried foundational approaches first? What questions do you still have about reading your body’s patterns?
Leave a comment below. Let’s talk about what you’re experiencing. And if this resonated, hit the ❤️ button and share it with someone who needs to read it. That would mean so much.
With care,
New to this space? This essay lives in the Materia Femina series in DR. SEBAA. Visit the About page to learn more.
Welcome. What you'll find in this space lives in different tones because I do. Some weeks I'll pop in with commentary on current events (like this one). Some days I'll pull you into a patient's story like you're in the room watching medicine happen. Other weeks we'll massage theory into a poultice, something you can hold. Sometimes I'll give you the protocol straight. Sometimes the writing arrives raw and honest ~ I call it: 3am honesty with daytime clarity. And sometimes it's just me, Aïcha, talking like we're texting at dawn, so casual you might forget this is medicine at all.
That's when it works best.
All of it comes from the same place: twenty-something years of watching bodies speak a language most people were never taught to hear. The rhythm shifts with the seasons, with what you need, and with what wants to be said.
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