On November 10, 2025, the U.S. Food and Drug Administration (FDA) made a landmark announcement: the agency is removing its longstanding "black box" safety warnings from all estrogen-based hormone replacement therapy (HRT) products prescribed to ease the symptoms of menopause and perimenopause. The move, unveiled at a press briefing at Health and Human Services (HHS) headquarters in Washington, D.C., marks a pivotal shift in the way millions of American women and their doctors will approach menopause management.
Health and Human Services Secretary Robert F. Kennedy Jr., standing alongside FDA Commissioner Dr. Marty Makary, addressed the assembled media with a sense of urgency and resolve. "For more than two decades, the American medical establishment turned its back on women. Millions of women were told to fear the very therapy that could have given them strength, peace and dignity through one of life’s most difficult transitions, menopause," Kennedy said, as reported by Nexstar Media Inc. "That ends today. The FDA is initiating the removal of a broad black box warnings on hormone replacement therapy products for menopause."
The black box warning, the strongest caution the FDA can require on a prescription drug label, was first added to HRT products in 2003. It warned of increased risks for cancers, dementia, heart attacks, and strokes, based on the results of the 2002 Women’s Health Initiative (WHI) study—a $1 billion research effort, the largest of its kind in U.S. history. That study, however, has since come under scrutiny for how its findings were interpreted and communicated.
"The Women’s Health Initiative study was the largest study ever done in U.S. history, a $1 billion study at the time, and you just heard how that study was misrepresented and created a fear machine that lingers to this day," Dr. Makary explained during the press conference, according to Fox News. "There’s no statistical significance in the increase in breast cancer. If we don’t have statistics, then we don’t have science." He emphasized that decades of subsequent research and clinical trials have failed to support the earlier fears linking HRT to higher breast cancer mortality.
Makary further underscored the real-world consequences of the black box label, stating, "The FDA today is announcing that we are going to stop the fear machine steering women away from this life-changing, even lifesaving treatment." He told NPR’s All Things Considered that women have "been denied or never offered hormone replacement therapy despite the profound short term and long term benefits." In his words, "Fifty million women since that study 23 years ago have been denied or never offered or talked out of the life changing lifesaving benefits of hormone replacement therapy – including my mom."
Urologist Kelly Casperson, who spoke at the HHS event, cited data indicating that 30% of women avoid HRT because of the black box label. She called the FDA’s step to remove the warning "revolutionary," stating, "The FDA's decision to remove the box warning is not just regulatory. It's revolutionary. It will correct decades of misleading guidance."
The FDA’s new policy will apply to both bioidentical and synthetic hormones, making the decision to use HRT a matter for women and their doctors to discuss based on individual needs and risks. Instead of stark black box warnings, the agency now wants a more nuanced explanation of potential risks to appear in packaging inserts. "The idea is to get better information in front of women," Makary said to NPR, allowing for more informed and individualized decision-making.
The announcement was welcomed by leading women’s health organizations. Dr. Steven Fleischman, president of the American College of Obstetricians & Gynecologists (ACOG), said in a statement, "The updated labels will better allow patients and clinicians to engage in a shared decision-making process, without an unnecessary barrier, when it comes to treatment of menopausal symptoms." He added that ACOG has long advised its members to talk to patients about their unique risks, and that the medical organization’s official guidance on estrogen therapy remains unchanged.
Monique Yohanan, senior fellow for health policy at the Independent Women nonprofit, praised the move. "Today’s decision restores balance to women’s health policy. For years, risk was overstated and benefit was understated. By aligning labeling with current evidence, FDA is giving physicians and women the clarity they deserve to make informed choices." Kathryn Schubert, president and CEO of the Society for Women’s Health Research, echoed these sentiments, saying her group "greatly appreciates that the administration is aligning policy with current science, which shows that local vaginal estrogen is safe and effective under appropriate clinical guidance, including for women with a history of breast cancer when non-hormonal options aren’t sufficient."
Even as the FDA moves to update its approach, some experts and organizations urge continued caution. The Menopause Society, while agreeing with the FDA’s decision, noted, "Systemic estrogen still comes with potential risks that should be reviewed in detail with women initiating therapy. As stated in The Menopause Society’s hormone therapy position statement, the risks are low for younger, healthy women initiating hormone therapy closer to the menopause transition. Risks are greater when initiated in older women and in those who are further from menopause onset."
The process leading to the FDA’s decision was itself a subject of debate. In July 2025, the agency convened an expert panel to discuss removing the warnings from at least low-dose vaginal estrogen, opening a public comment docket that received nearly 3,000 responses by the September 24 deadline. However, ACOG and others noted that the special panel deviated from the usual process, which typically involves a more rigorous advisory committee meeting. "While we appreciate the FDA Expert Panel's interest in reevaluating the label warnings on hormone therapy, a brief panel such as the two-hour July 17th Expert Panel should not be considered an adequate substitute for an advisory committee meeting," ACOG wrote in its formal comment, as reported by NPR. Makary responded that advisory committees are "bureaucratic, long, often conflicted and very expensive," and that his FDA is favoring more flexible expert panels instead.
Scientific support for the FDA’s decision comes from a range of studies, both old and new. Makary cited a 1991 UC San Diego review showing HRT may reduce fatal coronary events by about 50%, and a 1996 University of Southern California study finding a 35% lower risk of Alzheimer’s disease among estrogen users. More recently, a study published in Cancer three years ago demonstrated a decrease in coronary heart disease among women using hormone replacement therapy. The agency also pointed to an analysis of 30 studies published in 2004, which suggested that starting HRT earlier could save lives.
Doctors and advocates hope that the new labeling will reverse the dramatic decline in HRT use. As Monique Yohanan noted, "Today, fewer than 5 percent of post-menopausal U.S. women use menopausal hormone therapy, down from 25-30 percent two decades ago." The FDA’s move, many say, is a long-overdue correction that promises to empower women and their doctors to make choices based on the best available evidence—rather than outdated fears.
As the dust settles on this historic policy change, the future of menopause care in the United States appears poised for a new era—one in which women’s voices, experiences, and choices are finally taking center stage.
