FDA rolls back warning labels on HRT products for menopause, citing misinformation

The Food & 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,” Health and Human Services Secretary Robert F. Kennedy Jr. said on stage 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 Kennedy, FDA Commissioner Marty Makary 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.”

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Source: Fierce Healthcare, 10 November 2025