The U.S. Food and Drug Administration (FDA) announced it will eliminate broad “black box” warnings from hormone replacement therapy (HRT) products used for menopause. The decision follows a detailed review of scientific research by an expert panel in July and a subsequent public comment period, according to agency officials.
Manufacturers will now be required to revise product labels to remove references linking HRT to cardiovascular disease, breast cancer, and probable dementia. However, the FDA stated that the boxed warning for endometrial cancer will remain on systemic estrogen-only products. Updated labeling will also recommend initiating systemic HRT within ten years of menopause onset or before the age of 60.
Health and Human Services Secretary Robert F. Kennedy Jr. addressed the change during a Monday announcement, saying, “The label was designed to frighten women and to silence doctors. The consequences have been devastating.”
The FDA’s decision revisits two decades of controversy surrounding HRT. The use of hormone therapy dropped sharply after a 2002 study that reported a slight increase in breast cancer risk among women using the therapy. The risk was described as less than one-tenth of 1% per year for an individual woman, but the findings were widely interpreted as evidence against HRT. A 2024 study found that only 5% of American women currently use hormone therapy for menopause.
According to figures cited by the Department of Health and Human Services, about 80% of women experience menopausal symptoms that can persist for years. Research has shown that women who begin HRT before age 60 may have lower overall mortality. The data also suggest potential reductions in cardiovascular disease risk by up to 50%, Alzheimer’s disease by 35%, and bone fractures by up to 60%.
FDA Commissioner Marty Makary attributed the long-standing caution around HRT to the 2002 study and what he described as “medical groupthink” that fueled unnecessary fear. He noted that no clinical trial has demonstrated an increased risk of breast cancer mortality from HRT. Makary said the medical community’s handling of HRT reflected a broader issue, asking, “How could the medical establishment get it so wrong for so long?” He added that women deserve scientific standards equal to those applied to men.
The FDA also announced two new approvals to expand treatment options for menopausal symptoms. The first approval allows a generic version of Premarin, one of the most commonly used hormone therapies, expected to improve affordability and access. The second approval is for a non-hormonal therapy aimed at treating moderate to severe vasomotor symptoms, including hot flashes, for women unable to use hormone-based treatments.
Alicia Jackson, Ph.D., Director of the Advanced Research Projects Agency for Health emphasized the significance of the change, stating that estrogen remains one of the most effective longevity interventions for women and that healthcare should align with modern science.
Makary later clarified that the FDA relied on an expert panel instead of a formal advisory committee to promote open scientific debate without procedural barriers. He explained that traditional committees tend to be bureaucratic, lengthy, and costly. He added that the FDA plans to use more expert panels in the future, citing recent forums on SSRIs in pregnancy and cell and gene therapy.
The FDA’s comprehensive review of HRT is expected to be published in the Journal of the American Medical Association (JAMA).
This is a landmark shift in how menopausal hormone therapy is regulated and communicated in the United States. For decades, many women either avoided HRT or were never offered it because of the broad warnings and fear of adverse outcomes.
With modern data pointing to a more balanced benefit-risk profile — especially when therapy is started earlier in menopause — many clinicians believe more women may benefit, particularly those struggling with symptoms like hot flashes, night sweats, sleep disruption and bone health decline.
