After more than two decades, the U.S. Food and Drug Administration (FDA) is initiating the removal of broad “black box” warnings from hormone replacement (HRT) products for menopause. The decision to update the FDA’s position follows a comprehensive review of the scientific literature, an acknowledgement of the expert panel’s findings in July, and a public comment period.
Now, the agency is collaborating with companies to update product labeling to remove references to the risks of cardiovascular disease, breast cancer, and probable dementia, acknowledging that HRT’s risks are not uniform—they vary based on patient factors, delivery method, and formulation.
Hormone Therapy: A History
The first FDA-approved “estrogen replacement” product was created in 1934, but it wasn’t until the publication of the controversial book Feminine Forever by Dr. Robert Wilson in 1966 that HRT became widely popular. Links between estrogen replacement and cancer were first confirmed in 1975, and again in 1989, leading to the addition of progesterone to estrogen to protect the uterus. This adjustment resulted in a tremendous increase in the popularity of HRT until 2002, when preliminary studies by the Women’s Health Initiative (WHI) discovered an increase in chronic diseases in HRT patients. Starting in January 2003, the FDA began instituting class-wide labeling changes for estrogen-alone and combined estrogen-progestogen products approved for menopausal symptoms and osteoporosis, eventually adding black box warnings describing risks of cardiovascular disease, thromboembolism, breast cancer, and probable dementia.
These warnings had a profound influence on public perception of HRT, leading women to stop taking the medication and clinicians to stop prescribing it. But gradually, with further studies, more closely examined evidence, and the development of satisfactory guidelines for treatment, the pendulum has swung back to a favorable view of HRT.
Present Shift
The FDA warnings on HRT led to a sudden drop off of treatment options for symptomatic postmenopausal women. Consequent separate studies showed that this lack of treatment for such women may have translated into increased endometrial cancer risks, increased cardiovascular disease, increased myocardial infarctions and strokes, and increased bone fractures.
The decision to limit HRT use was, in most cases, the wrong conclusion — especially once it became common knowledge that the WHI trial had been inadequately designed, evaluated, and reported. The epidemiological data were not strong enough to document a clear harm to women’s health, and subsequent studies and analyses have consolidated the view that HRT is highly beneficial when given to symptomatic women under certain circumstances, namely, within 10 years since the onset of menopause or to symptomatic women who are under 60 years of age.
Looking to the Future
The FDA’s decision to remove its black box warning is excellent news for women experiencing menopausal symptoms, as it allows clinicians to consider hormone therapy as part of age management and chronic disease prevention without hesitation. As personalized medicine becomes the norm, and access to HRT once again becomes a safe and accepted practice, patients and practitioners can once again consider hormone optimization with a renewed confidence in its safety and efficacy.
Clinicians interested in the implications of the FDA’s reversal and its impact on the future of HRT should consider attending A4M’s BHRT Symposium in Las Vegas, February 26-28, 2026. The course will examine the future of hormone health and its impact on longevity, focusing on how to combat aging by addressing the root causes of chronic disease as hormones decline and environmental exposures increase. Attendees will also learn how to improve patients’ quality of life by restoring hormone levels to optimal levels, receive science-based guidance on minimizing side effects and complications, and explore real-world strategies and case studies for integrating hormone health into diverse practices.
The FDA’s removal of HRT “black box” warnings signals a new chapter in the history of treating menopause symptoms, and that’s incredible news for patients and the clinicians who treat them. The future of HRT is, once again, full of promise.