The Food and Drug Administration (FDA) will remove broad “black box” warning labels from hormone replacement therapy (HRT) for menopause.
The action, announced Monday, follows a comprehensive review of scientific literature by an expert panel at the agency in July, officials said, as well as a public comment period. Manufacturers are now expected to update and reprint their product labeling to remove references to risks of cardiovascular disease, breast cancer and probable dementia.
“The label was designed to frighten women and to silence doctors,” Department of Health and Human Services Secretary Robert F. Kennedy Jr. said onstage during the announcement on Monday morning. “The consequences have been devastating.”
The FDA will not remove the boxed warning for endometrial cancer for systemic estrogen-only products. Its labeled recommendation will be to start HRT within 10 years of menopause onset or before 60 years of age for systemic HRT.
Use of hormone replacement therapy (HRT) plummeted quickly after a flawed, now infamous 2002 study. While the study found a small increased risk of breast cancer among participants using HRT, described as less than a tenth of 1% per year for an individual woman, critics say its results were widely misinterpreted and blown out of proportion. A 2024 study found that only 5% of American women use HRT for menopause.
About 80% of women experience menopause symptoms that can last years, yet research has found women who initiate HRT before the age of 60 have a reduction in all-cause mortality. HRT may also reduce the risk of cardiovascular disease by up to 50%; Alzheimer’s disease by 35%; bone fractures by up to 60%, according to figures an HHS press release cited.
Echoing RFK Jr., FDA Commissioner Marty Makary, M.D., blamed the study and “medical group-think” for creating “a fear machine that still lingers.” No clinical trial has ever shown that HRT increases the risk of breast cancer mortality, said Makary, who was previously a surgical oncologist at Johns Hopkins.
“How could the medical establishment get it so wrong for so long?” Makary questioned. “Women deserve the same rigorous science as do men.”
Additionally, the FDA announced it has approved two new drugs to expand treatment options for menopausal symptoms. The first is the approval of a generic version of Premarin, a widely used HRT product. The generic is expected to improve affordability and access. The other approval is for a non-hormonal treatment for moderate to severe vasomotor symptoms, like hot flashes, for women who can’t use HRT.
“The science is clear … estrogen is one of the most effective longevity interventions for women,” Advanced Research Projects Agency for Health Director Alicia Jackson, Ph.D., said during her speech on stage at Monday's announcement. “It is time for American healthcare to catch up to American science.”
In response to a reporter's question, Makary clarified that the reason the FDA used an expert panel to inform the policy change, as opposed to an advisory committee, was to encourage spontaneous debate among medical experts without traditional barriers. He called advisory committees "bureaucratic, long, often conflicted and very expensive," adding that the FDA is pursuing more expert panels in general. He cited recent FDA forums, including using SSRIs during pregnancy and cell and gene therapy, as two examples. FDA's review of HRT is expected to be published in JAMA, per Makary.
“For the first time in a generation, the FDA is standing with science, and standing with women,” RFK Jr. said. “That’s what it means to Make America Healthy Again.”