On Nov. 10, 2025, the Food and Drug Administration (FDA) is reversing a 2003 decision that put a stringent warning on hormone therapy products for menopausal women, saying that the treatments offer heart, brain, and bone health benefits. 

Commissioner Marty Makary wrote in a Wall Street Journal op-ed that the FDA is removing black box warning labels from all-combined estrogen-progestogen, estrogen-only, other estrogen-containing, and progestogen-only products used for hormone therapy. The agency said it’s asking companies to remove the warnings from their products, specifically mentions of cardiovascular, dementia, and breast cancer risk.

The impetus for the black box warning was a 2002 landmark study called the Women’s Health Initiative that suggested that hormone therapy came with an increased risk of heart disease and breast cancer. The study specifically focused on combination therapy among older, postmenopausal women, but the results were interpreted broadly, ultimately driving down rates of uptake for the therapies. 

Since then, a growing body of research has shown that hormone therapy can actually be beneficial to menopausal women’s heart health, reducing insulin resistance and improving other cardiovascular biomarkers. These therapies can be used to alleviate menopausal symptoms including hot flashes, sleeping troubles, vaginal dryness, and painful sex. 

Some clinicians, while agreeing that it makes sense to remove the black box warning, noted that the FDA has not followed the typical process to make the decision. The panel was a short and relatively informal conversation, not a traditional scientific advisory committee to review new safety data.

The American College of Obstetricians and Gynecologists has long shown support for reevaluating the label on local estrogen products, but in a comment submitted to the FDA in September, the organization “strongly encouraged” the agency to host a formal advisory committee meeting. The group also recommended an entirely separate process take place regarding systemic therapies. In a statement Monday, ACOG commended the FDA for its action.

While the black box labels are coming off, the therapies will continue to include adverse event information, taking a more tailored approach to each therapy. Systemic hormone therapy labels will include updated information on the best timing for the therapy. Experts widely agree that it is best to initiate hormone therapy under age 60. Safety data will reflect the specific, known risks with each treatment type, as estrogen alone can have different effects than estrogen and progestogen combined. The FDA will keep one boxed warning, for the risk of endometrial cancer when systemic estrogen is taken by a woman with “unopposed estrogen” who has a uterus. (That risk, when there isn’t enough progesterone in the body to balance out the estrogen, can be mitigated by including progestogen in a therapy regimen, officials wrote in JAMA.)