FDA Lifts Decades-Old "Black Box" Warnings on Menopausal Hormone Therapy, Heralding New Era for Women's Health

WASHINGTON D.C. – The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a landmark decision on November 10, 2025, to remove broad "black box" warnings from hormone replacement therapy (HRT) products for menopause. This move aims to re-establish evidence-based science in women's health, overturning over two decades of widespread fear and misinformation surrounding HRT, as reported by hhs.

Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, M.D., M.P.H., made the significant announcement at a press conference, emphasizing a return to data-driven medical decisions. Commissioner Makary described the previous warnings as contributing to an "American tragedy," denying millions of women life-changing benefits.

The FDA's action follows a comprehensive review of scientific literature, an expert panel convened in July, and a public comment period. This decision is expected to empower more women to access effective treatments, potentially reducing their risk of fractures, heart disease, immune and cognitive decline, and extending their overall vigor.

Specifically, the updated labeling will remove references to risks of cardiovascular disease, breast cancer, and probable dementia, which were previously highlighted. However, the boxed warning for endometrial cancer will remain for systemic estrogen-alone products, as noted by HHS.

This policy shift addresses the long-standing impact of the initial warnings, which caused a dramatic decline in HRT use among women. Experts believe the original 2002 Women's Health Initiative (WHI) study, which prompted the warnings, was based on flawed data.

The average age of women in the original WHI study was 63, significantly older than the typical age of menopause onset, and they received a hormone formulation no longer commonly used. This context led to an overstatement of risks, according to recent analyses and expert consensus.

FDA Commissioner Makary told CBS News that the change ends a "fear machine" that has deterred women and physicians from considering HRT. He asserted that HRT, when appropriately prescribed, offers substantial long-term health benefits for many women.

• Historical Context and the WHI Study: The "black box" warnings were initially placed on estrogen treatments in 2003, following the release of data from the Women's Health Initiative (WHI) study in 2002. This large clinical trial suggested an increased risk of breast cancer, stroke, and heart disease with hormone therapy, leading to a dramatic 70% plummet in HRT prescriptions within three years, as reported by UDS. However, subsequent re-evaluations revealed that the study's participants were, on average, 63 years old—well past the typical onset of menopause—and used hormone formulations now considered outdated.

• Evolution of Scientific Understanding: Over the past two decades, a more nuanced understanding of HRT has emerged, highlighting that the benefits often outweigh the risks for healthy women who initiate therapy within 10 years of menopause onset or before age 60. Recent studies, including a 2024 analysis of the original WHI data published in the Journal of the American Medical Association (JAMA), have clarified these findings. The Menopause Society (formerly NAMS) has consistently advocated for individualized treatment based on current evidence.

• Implications for Women's Health: The removal of these warnings is expected to significantly improve access to HRT for menopausal women, potentially enhancing their quality of life and long-term health outcomes. According to hhs Deputy Secretary Jim O'Neill, many more women can now reduce their risk of fracture, heart disease, immune and cognitive decline, and extend their vigor. This change empowers women and their healthcare providers to make informed decisions based on current scientific data rather than outdated fears.

• Expert Consensus and Advocacy: Medical societies, including The Menopause Society and the American College of Obstetricians and Gynecologists, have long urged the FDA to re-evaluate the warning labels, particularly for low-dose vaginal estrogen products. An FDA expert panel convened in July 2025, with experts like Dr. Rachel S. Rubin emphasizing that "science evolves and so must our warning labels." They highlighted that local vaginal estrogen is "categorically safe" as it does not travel systemically.

• Specific Benefits of HRT: When initiated appropriately, HRT can effectively alleviate severe menopausal symptoms such as hot flashes, night sweats, and sleep disturbances. Beyond symptom relief, studies indicate that HRT can reduce the risk of osteoporosis and fractures by 50-60%, cardiovascular diseases by up to 50%, and Alzheimer's disease by 35%, as stated by hhs. It also contributes to improved cognitive function, mood, and overall well-being.

• Regulatory and Future Developments: The FDA's decision to initiate removal of the warnings follows a rigorous process, including an expert panel meeting and a public comment period. In addition to this significant policy change, the FDA also approved two new drugs: a generic HRT product to improve affordability and access, and a non-hormonal treatment for vasomotor symptoms, expanding options for women. This signals a commitment to continuously review and update drug labeling based on the latest evidence.