FDA Removes Black Box Warnings From Hormone Replacement Therapy Products

In November 2025, the U.S. Department of Health and Human Services announced it was removing black box warnings from menopausal hormone replacement therapy (HRT) products. This change comes “after more than two decades of fear and misinformation” surrounding HRT, the Food and Drug Administration — a division of the HHS — stated in a news release reversing its own censure.

In supporting this radical shift, the HHS cites numerous studies — some dating as far back as four decades — in a fact sheet outlining the decision, suggesting that “starting HRT within 10 years of the onset of menopause can have numerous benefits which for most women outweigh potential risks.”

Women have long used HRT to relieve menopausal symptoms. But demand fell in the early 2000s when the FDA applied the warnings following a Women’s Health Initiative study that associated HRT with an increased risk of a breast-cancer diagnosis — even though that increase was statistically insignificant, the FDA now says.

Benefits of HRT, the HHS states, include a reduced risk of bone fractures and all-cause mortality, a 50 percent reduction in heart-attack risk, a 64 percent reduction in cognitive decline, and a 35 percent lower risk of Alzheimer’s.

“There are essentially over 400 purposes for estrogen in our body.”

“There are essentially over 400 purposes for estrogen in our body,” says Karen Kaufman, MD, a board-certified obstetrician and gynecologist and medical director of MIORA in Colorado. “It’s joint health, it’s bone health, it’s brain health, it’s heart health, it’s vaginal health, it’s urinary health.”

The removal of the black-box warning, she adds, is groundbreaking and will revolutionize access to natural HRT. “It’s a significant moment in medical history for women and their health, including quality of life.”

Still, HRT is not right for everyone. Women with a history of breast cancer may want to avoid systemic HRT: Previous studies have found that the treatment increased the risk that breast cancer could recur. This was especially true for patients with a history of hormone receptor–positive disease.

Yet risk level varies based on a person’s circumstances, medical history, and HRT type. Those experiencing discomfort from menopausal symptoms should consult with their provider to make an informed decision on HRT use based on their situation and goals.