In a landmark decision that prioritizes scientific integrity over decades of bureaucratic fearmongering, the Trump Administration has taken a monumental step to liberate women’s healthcare. Health and Human Services Secretary Robert F. Kennedy Jr., alongside FDA Commissioner Dr. Marty Makary, announced the official removal of the misleading “black box” warnings from hormone replacement therapy (HRT) medications, finally ending a 20-year campaign of misinformation that caused immense and unnecessary suffering for millions of American women.
This historic move, announced with Second Lady Usha Vance and Labor Secretary Lori Chavez-DeRemer in attendance, directly confronts a legacy of failed public health policy. Secretary Kennedy did not mince words, stating that the administration’s decision “restores integrity to medicine and faith in public health.” He laid bare the devastating consequences of the 2003 FDA ruling, which was based on a flawed and widely misinterpreted 2002 study from the Women’s Health Initiative (WHI). That study, which focused on older women far beyond the typical age for starting menopause treatment, triggered a media frenzy and led to government-mandated warnings that terrified women and their doctors away from a life-changing therapy.
For more than two decades, women were unjustly warned that HRT could increase the risk of breast cancer and heart disease. Yet, as Secretary Kennedy powerfully articulated, the reanalyzed data told a different story. “The study was not statistically significant, but it triggered a media frenzy that led to the FDA applying unscientific black box warnings to all hormone replacement therapy products in 2003,” he explained. “The label was designed to frighten women and to silence doctors. It warned of diseases and dangers that the data simply did not support.” The result was a catastrophic public health outcome, with HRT usage plummeting from one in four women to fewer than one in twenty.
RFK Jr. has announced that the FDA will remove the black box warnings from hormone replacement therapy for women — ending decades of medical neglect.
“For more than two decades, the American medical establishment turned its back on women.”
“We’re challenging outdated thinking… pic.twitter.com/J60lbWxR4j
— MAHA Action (@MAHA_Action) November 10, 2025
The Trump Administration’s action, driven by a comprehensive scientific review and a recommitment to evidence-based medicine, unveils the profound benefits of HRT that were obscured by previous government overreach. Secretary Kennedy detailed how, when prescribed responsibly, hormone replacement therapy “has been found to reduce the risk of cardiovascular disease and mortality by as much as 50%, Alzheimer’s disease by 35%, bone fractures by 50–60%, as well as reducing cognitive decline and all-cause mortality. In other words, extending lives by as much as ten years.” This stands in stark contrast to the previous regime of fear that dominated women’s healthcare.
This correction of a two-decade-old error is a direct result of President Trump’s leadership and his administration’s unwavering commitment to dismantling the failed orthodoxies of the past. “But today, thanks to President Trump’s bold leadership and unwavering commitment to restoring trust in public health… the FDA is correcting that mistake,” Kennedy declared. The administration is not only removing the stigmatizing warnings but also expanding access and choice by approving a long-awaited generic version of Premarin and a new non-hormonal treatment, ensuring affordability and options for all women. This decisive action proves that under President Trump, the government is finally putting the health, dignity, and well-being of American women first.