The U.S. Food and Drug Administration is removing the stark “black box” warnings from hormone therapy products used to treat menopause symptoms — a dramatic reversal of a two-decade-old policy that officials now say may have unnecessarily frightened women away from beneficial treatment.
The FDA announced Monday that the agency is requesting drug manufacturers remove the most severe warning labels from hormone replacement therapy (HRT) products, particularly for women under 60 or within 10 years of menopause onset. The decision marks a significant shift in how the medical establishment views hormone therapy after years of debate about its risks and benefits.
“Today, the U.S. Food and Drug Administration is requesting that drug manufacturers remove black box warnings from these products,” FDA Commissioner Dr. Marty Makary stated. “These are the strongest drug warning the agency can require, and they have inappropriately scared women off from this life-changing, and sometimes life-saving, treatment.”
Rethinking decades of warnings
The black box warnings were first implemented following a 2002 Women’s Health Initiative study that linked hormone therapy to increased risks of breast cancer, heart disease, stroke, and blood clots. But that research has since been criticized for its methodology and applicability to younger women.
The study primarily involved women with an average age of 63 — more than a decade past typical menopause onset — and utilized hormone formulations that are no longer commonly prescribed. After the warnings were issued, HRT prescriptions plummeted across all age groups.
A more recent analysis published in September 2025 found that women in their 50s taking estrogen-based medications faced no increased risk of heart problems, though women in their 70s did show elevated risk. For women in their 60s, the data remained unclear, leading researchers to advise caution.
“With few exceptions, there may be no other medication in the modern era that can improve the health outcomes of women at a population level more than hormone replacement therapy,” Makary told reporters.
What’s changing?
Under the revised labeling, broad warnings about cardiovascular disease, breast cancer, and probable dementia will be removed. However, warnings related to endometrial cancer risk will remain for systemic estrogen-alone products. The original warning language will still be accessible to healthcare providers, but will appear lower in the prescribing information.
The FDA will also create distinct labeling for newer hormone therapy formulations such as vaginal creams, rings, and tablets that deliver lower hormone doses than systemic treatments. These localized treatments have different risk-benefit profiles.
Additionally, the agency is approving two new medications for menopause symptoms: a generic version of the conjugated-estrogen treatment Premarin and a non-hormonal treatment for vasomotor symptoms.
Not without controversy
Is this a victory for women’s health or a premature decision? The FDA’s process has drawn criticism from some researchers who argue that the agency bypassed its usual transparent review procedures.
Rather than convening a formal public advisory committee, the FDA relied on an expert panel largely composed of physicians who support hormone therapy’s benefits. Around 80 researchers had urged the FDA to hold an official advisory meeting.
Diana Zuckerman of the nonprofit National Center for Health Research accused Commissioner Makary of undermining the FDA’s credibility by announcing the change “rather than having scientists scrutinize the research at an FDA scientific meeting.”
Many doctors and pharmaceutical companies, however, have long advocated for revising or removing the warning label, arguing it has discouraged beneficial prescriptions and unnecessarily frightened women who could benefit.
The FDA’s new labeled recommendation will advise initiating hormone therapy within 10 years of menopause onset or before age 60, aligning with what many menopause specialists have been recommending for years.
For millions of women enduring hot flashes, sleep disruption, and other debilitating menopause symptoms, the FDA’s decision represents a dramatic shift in how their treatment options are presented — a change that arrives after more than twenty years of what officials now acknowledge was misplaced fear.
