The U.S. Department of Health and Human Services (HHS) announced on November 10, 2025, that the Food and Drug Administration (FDA) will begin removing broad “black box” warnings from hormone replacement therapy (HRT) products used to treat menopausal symptoms. This decision comes after a comprehensive review of scientific evidence, an expert panel held in July, and a public comment period.
Secretary of Health and Human Services Robert F. Kennedy Jr. and FDA Commissioner Marty Makary made the announcement at a press conference attended by over 200 people, including Second Lady Usha Vance and Secretary of Labor Lori Chavez-DeRemer.
Use of HRT products had dropped sharply in the early 2000s after the FDA introduced boxed warnings based on findings from the Women’s Health Initiative study. The study found a statistically non-significant increase in breast cancer diagnoses among women taking HRT. However, experts noted that most participants were older than the typical age for menopause and were given hormone formulations no longer commonly used.
Following its review, the FDA will work with manufacturers to update product labeling by removing references to risks such as cardiovascular disease, breast cancer, and probable dementia for most HRT products. The boxed warning for endometrial cancer will remain for systemic estrogen-alone therapies.
“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” said Secretary Kennedy. “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.”
“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,” said FDA Commissioner Makary. “For too long, issues of women’s health have been underrecognized. Women and their physicians should make decisions based on data, not fear.”
As estrogen levels decline during menopause, HRT can help restore hormonal balance to relieve symptoms such as hot flashes, night sweats, sleep disturbances, and bone loss.
“Estrogen is a key hormone for women's health. Every single part of a woman's body depends on estrogen to operate at its best—including the brain, bones, heart, and muscles,” said Advanced Research Projects Agency for Health Director Alicia Jackson. “The removal of the black box warning, based on the best science and data, is an incredible step forward to empower millions of women to live longer, healthier lives.”
“Someday, science will help us slow or reverse all the damage of aging,” said Deputy Secretary Jim O’Neill. “A good safe way to address estrogen depletion already exists, and today Secretary Kennedy and Commissioner Makary are removing a barrier on this treatment. Many more women can reduce their risk of fracture, heart disease, and immune and cognitive decline while extending their vigor.”
Research shows that starting HRT within ten years after menopause onset or before age 60 may lower all-cause mortality rates as well as risks for fractures and cardiovascular diseases. There are also potential reductions in Alzheimer’s disease risk by up to 35% and bone fractures by 50-60%. The updated FDA recommendation encourages initiating systemic HRT within these timeframes.
Additionally, the FDA approved two new drugs aimed at expanding treatment options for menopausal symptoms: a generic version of Premarin (conjugated estrogens), which is expected to increase access due to improved affordability; and a non-hormonal therapy designed for moderate to severe vasomotor symptoms like hot flashes—providing alternatives for those who cannot or do not wish to use hormones.
Further details can be found in the agency’s fact sheet: FDA Initiates Removal of “Black Box” Warnings from Menopausal Hormone Replacement Therapy Products.
