The FDA’s Next Move on HRT May Be the Most Important Longevity Policy Decision in Decades

A woman in her early fifties sits in her doctor’s office, exhausted. She hasn’t slept through the night in months. Her bones ache. Sex has become painful. She feels like she’s vanishing inside her own life. She’s read about menopause hormone therapy and asks if it might help. The doctor points to the FDA’s black box warning on estrogen and advises against it. She walks out with nothing.

That scene has played out for millions of women over the last two decades.

This week, FDA Commissioner Marty Makary, M.D., revealed that the agency is in “serious discussions” about removing or revising the black box warning on menopause hormone replacement therapy (HRT). “I think you’ll hear something very soon,” he told Sanjay Gupta on a podcast. ¹

This regulatory change is long overdue. And for the 3.3 million women who enter perimenopause or menopause each year, such a change could be a game-changer. It could also mark a turning point in how U.S. health policy treats midlife, shifting to an understanding of it as the foundation of women’s longevity.^{2 3}

Why the FDA Added a Warning to HRT

For more than two decades, the warning—which was added in 2002 after early findings from the Women’s Health Initiative (WHI) suggested that HRT increased risks for breast cancer, heart disease, and stroke—has discouraged physicians from prescribing HRT and scared women away from safe and effective treatments. Today, fewer than five percent of women who are eligible for HRT use it. ⁴

What the Research Now Shows About Hormone Therapy Risks

The WHI findings were later revealed to be more nuanced. The risks varied by age, by whether a woman began therapy at menopause or years later, and by the type of hormone used. Those details never made it onto the label.

Instead, it treated all forms of HRT as equally dangerous, even low-dose vaginal estrogen, which acts locally with negligible absorption into the bloodstream. Large-scale studies, including a 2024 analysis published in JAMA Oncology, confirm that there’s no evidence of a connection between it and adverse events such as stroke, breast cancer recurrence, breast cancer development, or overall mortality.⁵ 

Meanwhile, systemic therapy has been reevaluated. Two meta-analyses reinforced the “timing hypothesis,” finding that women who initiated HRT within 10 years of the onset of menopause had a 32% lower risk of coronary heart disease events and a 39% lower risk of all-cause mortality than those who started it later. ^{6 7} Decades of research support HRT’s role in preserving bone density and lowering fracture risk, which are crucial for long-term independence and healthspan.⁸

The Overlooked Benefits of Estrogen for Long-Term Health

Menopause is a hinge in a woman’s health trajectory. As estrogen declines, the risk for cardiovascular disease—the leading cause of death in women—rises sharply. Bones weaken, diabetes risk climbs, and muscle mass, a significant predictor of longevity, declines.

HRT is one of the few interventions that provides immediate symptom relief while also protecting long-term health. Although it is not prescribed as a primary intervention for cardiovascular disease, research suggests certain estrogen-based hormone therapies have positive impacts on the risk of heart disease.⁹

At Hone, we see how immediate relief translates into better long-term health. Ninety-two percent of our patients report improvements in energy, libido, and strength within six months of treatment. Eighty-five percent see mood improvements, measured by the PHQ-9 depression index, in the same period. These gains lay the foundation for healthier decades ahead: More energy leads to more movement. Better mood sustains healthy habits. Improved strength protects against metabolic dysfunction and bone decline.

If the FDA removes the black box warning from HRT, it will be an important correction. But the larger opportunity is to recognize hormone therapy for what it truly is: A treatment that, when prescribed thoughtfully and at the right time, improves quality of life and extends healthspan.

This decision could finally align policy with science, restoring trust between women, their physicians, and the healthcare system. Most importantly, it could give millions of women the chance not only to feel better today, but to live stronger, healthier decades ahead. 

About the author

Saad Alam is the CEO and co-founder of Hone, a modern health optimization platform that helps men and women take charge of their hormones, metabolism, and longevity through advanced biomarker testing and personalized, clinician-guided care.