As the FDA Removes the Black Box Warning Label From HRT Therapy, Folks Ask What It Means

The U.S. Food and Drug Administration has removed the black box warning labels from menopause hormone replacement therapy (HRT) products, and the move has folks asking why. The FDA announced the change on Nov. 10, 2025.

According to ABC News, FDA Commissioner Marty Makary announced during a press conference that the label would be removed from all hormone therapy pills, creams, and other HRT treatments that are prescribed to ease perimenopause and menopause symptoms. So, what does the black box warning mean?

The FDA black box warning label is a warning to let women in perimenopause and menopause know that taking hormones could raise their risk for getting cancer, dementia, heart attacks, and strokes. FDA Commissioner Marty Makary claims that new scientific evidence refutes the warnings.

"The FDA today is announcing that we are going to stop the fear machine steering women away from this life-changing, even lifesaving treatment," he said.

"The FDA is taking action to remove the black box warnings from estrogen-related products," he continued. "This is based on a robust review of the latest scientific evidence."

According to NPR, HRT products will instead have an explanation of the potential risks placed inside the packaging on an insert. "The idea is to get better information in front of women," he added.

"This is, in my opinion, one of the greatest mistakes in modern medicine, the demonization of hormone replacement therapy."

According to the Mayo Clinic, hormone therapy is a medicine used to replace the estrogen women lose during menopause, or female hormones. The medicine is meant to ease women's symptoms as their period ends and they enter menopause, such as hot flashes and vaginal discomfort, and it is also used to prevent bone loss after menopause.

HRT can raise the risk of heart disease, strokes, blood clots, breast cancer, gallbladder disease, and endometrial cancer in women, but the FDA Commissioner claims that the 2002 study that found hormone therapy was associated with an increased cancer risk was overstated.

"Fifty million women since that study 23 years ago have been denied or never offered or talked out of the life-changing, lifesaving benefits of hormone replacement therapy," he claimed, adding that divorce is a symptom of menopause. "The symptoms occur in over 80 percent of women. They last, on average, eight years. And for many women, they are severe, even debilitating — mood swings, night sweats, weight gain, hot flashes, divorce."

The Health and Human Services Secretary. Robert F. Kennedy Jr. also spoke about the black box warning label being removed.

"After a thorough, evidence-based review of decades of scientific data, an expert panel and public testimony, the FDA is announcing today that it will remove the misleading black box warnings from all HRT products," he said, per Mother Jones. "For the first time in a generation, the FDA is standing with science and standing with women.”