Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced on Monday that the Food and Drug Administration (FDA) has removed broad “black box” warnings from hormone replacement therapy (HRT) for menopause.
The move reverses FDA action to apply the warning more than two decades ago. It’s been praised by some medical professionals as “far overdue” and a reversal of the “greatest single failure of the modern medical system.”
“Women have used HRT products for decades to relieve menopausal symptoms,” an HHS press release sent to The Daily Wire said. “However, their use plummeted in the early 2000s when the FDA applied boxed warnings following a Women’s Health Initiative study that found a statistically non-significant increase in the risk of breast cancer diagnosis. The average age of women in the study was 63 years — over a decade past the average age of a woman experiencing menopause — and study participants were given a hormone formulation no longer in common use.”
“The FDA is initiating removal of the boxed warnings following a comprehensive review of the scientific literature, an expert panel in July, and a public comment period,” HHS said. “The agency is working with companies to update language in product labeling to remove references to risks of cardiovascular disease, breast cancer, and probable dementia. The FDA is not seeking to remove the boxed warning for endometrial cancer for systemic estrogen-alone products.”
FDA Commissioner Dr. Marty Makary said the FDA has moved away from harmful “groupthink” with this decision, and stressed that HRT has “profound long term health benefits” for women.
According to HHS, randomized studies show that women who start HRT within 10 years of the onset of menopause have a reduction in all-cause mortality and fractures. They also may reduce their risk of cardiovascular diseases by as much as 50%, Alzheimer’s disease by 35%, and bone fractures by 50 to 60%.
“Tragically, tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk,” Makary said. “For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear.”
NEW: HHS advances women’s health by removing misleading FDA warnings on hormone replacement therapy to help women through menopause.
FDA COMMISSIONER MAKARY: “By a large body of evidence, there are now recognized to be profound long-term health benefits that few people — even… pic.twitter.com/c4yrRiYXrG
— Fox News (@FoxNews) November 10, 2025
Secretary Kennedy said his department was “standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment.”
“We are returning to evidence-based medicine and giving women control over their health again,” RFK Jr. added.
In addition to the removal of “black box” warnings, the FDA is approving two new drugs to expand treatment options for menopausal symptoms.
Physician, podcast host, and author Dr. Peter Attia said in a pre-recorded interview released Monday that the warnings on HRT were “the greatest single failure of the modern medical system,” and noted the FDA’s plans to reverse the error.
“It’s very hard not to argue that this is the greatest single failure of the modern medical system,” says Dr. Peter Attia, referring to the hesitancy to prescribe hormone replacement therapy for perimenopausal and menopausal women. https://t.co/g7LbhIrY5f pic.twitter.com/NoFfGWlwR1
— 60 Minutes (@60Minutes) November 10, 2025
“FDA removes black box warning on HRT for women, FAR OVERDUE!” Dr. Nicole Saphier posted to X. “These absurd 2002-based fears scared millions from safe relief based on antiquated data and mislabeled products. The entire FDA should be EMBARRASSED it took 20+ years to fix this blunder. Ladies, talk to your doc.”
FDA removes black box warning on HRT for women, FAR OVERDUE!
These absurd 2002-based fears scared millions from safe relief based on antiquated data and mislabeled products.
The entire FDA should be EMBARRASSED it took 20+ years to fix this blunder.
Ladies, talk to your doc.
— Nicole Saphier, MD (@NBSaphierMD) November 10, 2025
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