Health and Human Services Secretary Robert F. Kennedy Jr. announced that the Food and Drug Administration will remove the “black box warning” from hormone replacement therapy products used to treat menopausal women.

The decision marks a historic shift in federal policy that could impact millions of women across the country who rely on HRT for relief from menopause-related symptoms.

Kennedy made the announcement during a press conference with FDA Commissioner Marty Makary, saying it was time to end decades of hesitation surrounding women’s care.

“That ends today,” Kennedy said. “The era of ignoring women’s health is over. We’re challenging outdated thinking and recommitting to evidence-based medicine.”

Black box warnings are the strongest alerts the FDA places on prescription drugs, reserved for medications linked to potential serious risks. Hormone replacement therapy was given this warning in the early 2000s after a federal study raised concerns about a possible link to breast cancer.

That study, known as the Women’s Health Initiative, led to a dramatic drop in the number of women using HRT, leaving many struggling with severe menopause symptoms like hot flashes, insomnia, and mood swings.

For years, those findings stood largely unchallenged. But new reviews have found major flaws in the original research.

The FDA said that the Women’s Health Initiative study included women who were much older than the typical age of menopause. The average participant was 63, well beyond the age when hormone therapy is usually started. In addition, the hormone formula used at the time is no longer prescribed today.

After a fresh review of modern medical data, the FDA concluded that hormone therapy provides significant benefits for women who begin treatment within ten years of menopause, typically before the age of 60.

According to the agency, those benefits “include a reduced risk of all-cause mortality and fractures. HRT has also been associated with 50% reduction in heart attack risk, 64% reduction in cognitive decline, and 35% lower risk of Alzheimer’s.”

That data led the agency to determine that the benefits far outweigh the potential risks for many patients.

“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,” Kennedy said. “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.”

FDA Commissioner Makary supported the move, saying outdated fears had denied millions of women the chance for better long-term health.

“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.

The announcement signals a major policy win for the Trump administration, which has pushed federal health agencies to prioritize patient choice and medical innovation over bureaucracy.

Second Lady Usha Vance and Labor Secretary Lori Chavez-DeRemer also attended the event, signaling the administration’s support for the shift.

Kennedy’s decision could change how doctors across America approach women’s health. By removing the black box warning, physicians may now be more willing to discuss hormone therapy with their patients, opening the door for treatment that was once considered too risky.

After years of federal hesitation and mixed messaging, Kennedy’s words summed up the moment: “The era of ignoring women’s health is over.”