A Regulatory Turning Point

On November 11, 2025, the FDA announced a significant change to how hormone therapy (HRT) products used for menopause are labeled — removing warning language that had shaped how both doctors and patients thought about hormones for over two decades. This is a big deal. Let's break down what happened, why it matters, and what the science actually says.

What Is the Women's Health Initiative?

The Women's Health Initiative (WHI) was a large study started in 1995 to investigate the effects of hormone replacement on women's health. In 2002, the study was halted early when an initial analysis appeared to suggest that HRT significantly increased a woman's risk of certain health concerns. Despite the fact that a group of scientists actively involved in the study — at that very moment — pushed back and said the results were not statistically significant, the message of harm went out in a press statement. When the full study was published a few days later, many researchers read the data and agreed it did not support the claims made in that press release.

It was too late. The media ran with it. Almost overnight, doctors stopped prescribing HRT and women threw their prescriptions away. In the intervening 20-plus years, the WHI data has been re-evaluated repeatedly — and the study has been shown to have a flawed framework with analysts making incorrect interpretations of the data. The 2002 press statement, it turns out, was not the final word.

NAMS Guideline Changes

In 2017, the North American Menopause Society (NAMS) incorporated some of the re-evaluations of the WHI data and stated that "Hormone therapy (HT) remains the most effective treatment for vasomotor symptoms (VMS) and the genitourinary syndrome of menopause (GSM) and has been shown to prevent bone loss and fracture."

By 2022, NAMS updated its guidelines again and clearly stated that vaginal use of bioidentical estriol has a strong safety profile for women experiencing genitourinary changes during menopause — including vaginal dryness, vaginal discomfort, and related concerns. The science was shifting. The research community was catching up with what many practitioners and patients had been experiencing all along.

November 2025: What the FDA Said

Fast-forward to November 2025 — and the FDA has taken a meaningful step toward aligning its guidance with the weight of the accumulated evidence. The outdated warning language has been removed. Hormones are now recognized as important for women's health during and after the menopausal transition.

Here is a direct quote from the FDA paper: "Current evidence suggests that hormone therapy initiated within a decade of the onset of perimenopause has been associated with numerous long-term health benefits, including reduced vasomotor symptoms, without significantly affecting atherosclerotic cardiovascular disease among younger postmenopausal women aged 50 to 59 years. Hormone therapy has also been associated with a 25% to 50% reduction in fatal cardiovascular events (the leading cause of death in women), a 50% to 60% reduction in bone fractures, a 64% reduction in cognitive decline, and a 35% decreased risk of Alzheimer disease." (Source: FDA, November 2025)

Read that again. Right up there at the top of the list of things that matter for women's long-term health — hormone therapy. Not a fringe opinion. Not a naturopath's blog. The FDA's own paper.

This Is a Big Moment — And Here's Why It's Complicated

Women who have used hormones for years have been saying they help. Practitioners who have worked with bioidentical hormones for decades have been reporting that their patients are doing well. The evolving science has been pointing in this direction for years. The FDA's updated position is a meaningful public acknowledgment of that shift, and it deserves a genuine celebration.

At the same time, let's look at two important nuances from the announcement.

A Closer Look at the FDA Changes

First: the updated guidance still refers to pharmaceutical synthetic hormones — there is still no widespread, large-scale study specifically examining long-term bioidentical hormone use. This is primarily because no entity has been willing to fund that research. There are, however, thousands of practitioners who have been using bioidentical hormones with their patients for decades and consistently report strong outcomes.

Second: the FDA's message still places some limitations on timing — noting that starting hormone therapy early in the menopausal transition is associated with greater benefit, and that starting later carries more consideration. There are studies that offer a different perspective on this. The emerging view is that even when hormone therapy begins well after menopause, there are still meaningful benefits — the approach is simply to go slowly and allow the body to gradually adjust to having these important chemical messengers available again.

The Relationship Between Hormones and Your Health

When estrogen, progesterone, testosterone, and DHEA decline through age-related change — including the menopausal transition — many women notice shifts across a wide range of wellbeing. Heart health, bone density, cognitive sharpness, sleep, mood, and intimate comfort are all areas where hormones play a documented role. The scientific picture is increasingly clear: for many women, hormone therapy initiated at the right time is one of the most impactful things available for long-term health.

The relationship between hormones and women's health is an active, evolving area of science. If you are considering hormone therapy or have questions about what's right for you, a knowledgeable healthcare provider who is up to date on the current research is your best resource.

What Can I Do?

Share this information. Many practitioners have fewer than five hours of formal training on menopause, and many doctors who graduated after 2002 were taught to avoid prescribing HRT. Changing that takes all of us. Share this article with your friends, your sisters, your daughters, your doctors. The more women who know that the science has shifted — and what it's shifted to — the better.

References

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2. Iorga A, et al. Rescue of pressure overload-induced heart failure by estrogen therapy. J Am Heart Assoc. 2016;5(1):e002482.
3. Shwaery GT, Vita JA, Keany JF. Antioxidant protection of LDL by physiologic concentrations of 17Beta Estradiol. Circulation. 1997 Mar 18;95(6):1378-85.
4. Kaemmle LM, Stadler A, Janka H, von Wolff M, Stute P. The impact of micronized progesterone on cardiovascular events - a systematic review. Climacteric. 2022 Aug;25(4):327-336.
5. Wharton W, Gleason CE, et al. Potential role of estrogen in the pathobiology and prevention of disease. Am J Transl Res. 2009;1(2):131-147.
6. Engler-Chiurazzi EB, Brown CM, Povroznik JM, Simpkins JW. Estrogens as neuroprotectants: Estrogenic actions in the context of cognitive aging and brain injury. Prog Neurobiol. 2017 Oct;157:188-211.
7. Berent-Spillson A, et al. Distinct cognitive effects of estrogen and progesterone in menopausal women. Psychoneuroendocrinology. 2015 Sep;59:25-36.
8. Abdi F, et al. The Effects of Transdermal Estrogen Delivery on Bone Mineral Density in Postmenopausal Women: A Meta-analysis. Iranian Journal of Pharmaceutical Research. 2017;16(1):380-389.
9. Could transdermal estradiol + progesterone be a safer postmenopausal HRT? A review. https://pubmed.ncbi.nlm.nih.gov/18775609/

This article is for educational and general wellness purposes only. It is not medical advice and is not intended to diagnose, treat, cure, or prevent any disease. If you are noticing changes in your body or have questions about your health, please consult a knowledgeable healthcare provider.