For decades, menopause care has felt like one long game of telephone: incomplete, inconsistent, and too often based on outdated or misunderstood science. But this July, the FDA took a major step. For the first time in over 20 years, they convened an independent advisory panel to revisit the safety and role of hormone therapy in menopause. The conversation that followed was thoughtful, long overdue, and potentially transformative for millions of women navigating perimenopause, menopause, and life beyond.
Here’s what went down, and why it matters.
But first: What is the boxed warning, and why has it shaped menopause care?
Let’s start with the context. In 2002, the Women’s Health Initiative (WHI) — a massive, federally funded study — found that women taking combined hormone therapy (estrogen plus progestin) had an increased risk of breast cancer, stroke, and blood clots. The headlines were sensational, and the response was swift: the FDA issued a “boxed warning” (also known as a black box warning, the most serious type) on all hormone therapy products.
Cue: panic, confusion, and a mass exodus from menopausal hormone therapy. Over the next two decades, many women were left to suffer through disruptive, even debilitating symptoms like hot flashes, night sweats, mood swings, and bone loss, often without any guidance or support. The narrative became: Hormones are dangerous. Full stop.
But the truth? It’s more complicated, and we’re finally starting to admit that.
So, what’s happening now?
On July 17–18, 2025, the FDA’s Bone, Reproductive, and Urologic Drugs Advisory Committee met for two days to review updated research and hear from experts on the benefits and risks of hormone therapy for menopause. At the center of the debate: whether the boxed warning is still appropriate, especially for estrogen-only therapy, and whether it may be doing more harm than good by scaring patients and providers away from potentially beneficial treatment.
Let’s break down some of the key issues on the table.
Estrogen and bone health: A missed opportunity?
Estrogen isn’t just about managing hot flashes. It plays a vital role in maintaining bone density. After menopause, estrogen levels plummet, and women become significantly more vulnerable to osteoporosis and fractures. Hormone therapy is FDA-approved for preventing osteoporosis, but that message often gets lost in the noise of the boxed warning.
Several experts argued that denying or discouraging estrogen therapy, especially for women in early menopause or those at high risk of fractures, could actually increase long-term harm. In other words, by avoiding hormones, we may be trading short-term perceived safety for long-term health consequences in certain populations.
The breast cancer question: Is the risk overblown?
This is the big one. The WHI study did find a small increase in breast cancer risk with combined hormone therapy, but only after about five years of use, and mainly in older women who started therapy long after menopause began. The increased risk was about 8 additional cases of breast cancer per 10,000 women per year. Estrogen-only therapy (used in women who’ve had a hysterectomy) didn’t carry the same risk; in fact, it appeared to lower it in some groups.
What’s becoming clear is that timing matters. Starting hormone therapy close to the onset of menopause (what researchers call the “window of opportunity”) may carry fewer risks and more benefits, particularly for heart and cognitive health. The “one-size-fits-all” approach doesn’t hold up anymore.
It’s also important to note that much of the current push to remove the FDA’s black box warning is focused on low-dose vaginal estrogen products. These are so safe that even breast cancer survivors can use them, according to major clinical guidance. That’s how dramatically our understanding around hormone therapy has evolved.
Where does testosterone fit in?
While estrogen and progesterone have dominated the conversation, some experts also pushed for broader recognition of testosterone in menopause care, particularly for women experiencing low libido, fatigue, and mood changes.
Australia and several European countries already offer testosterone products designed for women. In the U.S., women must rely on off-label use of male formulations, despite a growing body of evidence supporting their benefit for hypoactive sexual desire disorder (HSDD) in postmenopausal women.
The panel didn’t issue any final rulings on testosterone, but its inclusion signals a growing acknowledgment that menopause is about more than just estrogen — and that women's sexual health deserves attention, too.
What the FDA menopause panel got right, and what’s still missing
This wasn’t your average government meeting. It was packed with respected experts like Drs. Rachel Rubin, Heather Hirsch, JoAnn Manson, Barbara Levy, Mary Jane Minkin, Jim Simon, and others who brought thoughtful, evidence-based insights [You can watch the full panel here].
They approached menopause as a full-body, whole-life experience, not just a hormone problem. They discussed cognitive decline, bone health, sexual function, and quality of life. And they openly challenged the science behind the boxed warning on low-dose vaginal estrogen, which many now agree is not supported by current evidence.
But important gaps remain. The panel didn’t meaningfully address the role of progesterone, particularly for women with a uterus, and how differences between progesterone and synthetic progestins may affect breast cancer risk. That nuance matters.
They acknowledged the unmet need for testosterone therapies tailored to women but stopped short of regulatory action. And they didn’t dig into the systemic issues that make evidence-based care so hard to access: lack of provider training, poor insurance reimbursement, outdated clinical guidelines, and the near-total absence of public education on menopause.
What happens next?
Here’s the thing: this panel doesn’t have the authority to change the boxed warning, but their recommendations carry weight. If the FDA chooses to revise or remove the warning, it could open the door to better access, better care, and a long-overdue shift in the national menopause conversation.
It also raises bigger questions. If the boxed warning on vaginal estrogen is updated, will the FDA revisit similar gaps across other women’s health products? Will insurers follow suit and finally cover the treatments women need? And what role will media, advocates, and patients play in turning this regulatory shift into real-world change?
The bottom line
We’re living longer than ever. A woman who hits menopause at 50 could live another 30 to 40 years. That’s not a blip; it’s a full third of her life! Yet, menopause has been treated as an afterthought in medical education, research, and policy.
This FDA panel is a sign of progress. It shows what’s possible when experts, regulators, and advocates come together with openness and science. It’s a reminder that hormones aren’t one-size-fits-all, and that individualized, evidence-based care should be the norm, not the exception.
Menopause isn’t a disease. It’s a milestone. And women deserve to move through it with dignity, knowledge, and access to care that actually works for them.
Here’s hoping this moment isn’t a one-time conversation, but the start of a new era in women’s health.
Kristyn Hodgdon is a passionate women's health advocate and the Co-Founder and Chief Creative Officer of Rescripted, where she helps break down complicated medical info into content that's easy to understand — and actually helpful. As an IVF mom who’s experienced pregnancy loss and lives with PCOS, Kristyn blends her professional know-how with real-life experience to support others navigating similar journeys. Her work has been featured on Good Morning America, ScaryMommy, and more, and she’s the host of the podcast From First Period To Last Period. A Fordham University grad, Kristyn also volunteers with the Fly Again Foundation, which supports breast cancer patients. You can find her on Instagram or connect with her on Linkedin.