Secretary of Health and Human Services Robert F. Kennedy, Jr., made a huge – and possibly controversial – announcement Monday: the Food and Drug Administration (FDA) will be removing the “black box warning” from hormone replacement therapy (HRT) products used to treat low hormone levels in menopausal and post-menopausal women.
Black box warnings are, according to Walgreens, “the strictest warning put in the labeling of prescription drugs or drug products by the Food and Drug Administration (FDA) when there is reasonable evidence of an association of a serious hazard with the drug. It is basically a warning with a black box around it, hence the name.”
HRT first got a black box warning in the early 2000s following a Women’s Health Initiative study that, according to the FDA, “found a statistically non-significant increase in the risk of breast cancer diagnosis.” Due to that finding, use of HRT amongst menopausal women plummeted, leaving untold numbers of ladies suffering with things like hot flashes and night sweats due to low levels of the hormone estrogen.
“That ends today,” said Kennedy said of untreated menopause symptoms at a Monday press conference he conducted alongside FDA Commissioner Marty Makary. “The era of ignoring women’s health is over,” Secretary Kennedy continued. “We’re challenging outdated thinking and recommitting to evidence-based medicine.”
.@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.
RELATED: Trump Administration Announcing Deal on Lowering Cost, Access on Fertility Treatments, IVF
HHS Secretary Robert F. Kennedy Jr. Testifies to Senate Finance Committee: ‘Change Has Its Enemies’
“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.
Help us report the truth about the Schumer Shutdown. Use promo code POTUS47 to get 74% off your VIP membership.
