On Monday, Robert F. Kennedy, Jr., Secretary of Health and Human Services, made a significant and potentially divisive announcement: the Food and Drug Administration (FDA) will be removing the “black box warning” from hormone replacement therapy (HRT) medications intended for women experiencing low hormone levels during menopause or post-menopause.

According to Walgreens, black box warnings represent the most stringent cautions that the FDA can place on prescription drugs. These warnings signal a significant risk associated with the medication, and are literally encased in a black box on the label, which is how they got their name.

In the early 2000s, HRT received a black box warning following a Women’s Health Initiative study. The FDA noted that this study found a statistically non-significant rise in breast cancer risk. As a result, the use of HRT by menopausal women sharply declined, leaving many to endure symptoms like hot flashes and night sweats due to decreased estrogen levels.

“That ends today,” declared Kennedy during a press briefing he held with FDA Commissioner Marty Makary. “The era of neglecting women’s health is behind us,” Kennedy asserted. “We are challenging outdated perceptions and are committed to practicing evidence-based medicine.”

The FDA’s revised stance follows discoveries of flaws in the initial Women’s Health Initiative study that led to reduced HRT prescriptions. Notably, the average age of participants in that study was 63, much older than when most women experience menopause. Furthermore, the hormone formulation used by the participants is no longer widely prescribed.

.@SecKennedy: “For more than two decades the American medical establishment turned its back on women.”

“That ends today.” pic.twitter.com/Y3O49mycfv

— HHS Rapid Response (@HHSResponse) November 10, 2025

The change in FDA’s approach comes after flaws were found in the Women’s Health Initiative study that lead to the curtailing of HRT prescriptions. The average age of women who participated in that study was 63, which is well past when most women go through the hormonal changes that lead to menopause. Additionally, the women in the study were taking a hormone formulation that is no longer commonly prescribed. 

In doing its own review of data, the FDA found that women who started hormone replacement therapy within ten years of menopause – and typically before the age of 60 – reaped a multitude of benefits beyond relief of symptoms like hot flashes and night sweats. Studies have shown, according to the FDA, that the additional 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.”

In short, the government now argues that the benefits of HRT far outweigh the risks.

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“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 added, “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.”

Also in attendance for Monday’s announcement was Second Lady of the United States Usha Vance and Secretary of Labor Lori Chavez-DeRemer.

Editor’s Note: After more than 40 days of screwing Americans, a few Dems have finally caved. The Schumer Shutdown was never about principle—just inflicting pain for political points.

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