A panel convened by the U.S. Food and Drug Administration (FDA) has recommended the removal of the black box warning from vaginal estrogen products used to treat symptoms of menopause, citing growing scientific evidence that the warning may be unnecessary and harmful.

The panel discussion, hosted by FDA Commissioner Martin Makary, brought together leading experts in women’s health to reassess the decades-old warning. Dr. Makary, a vocal supporter of hormone therapy for menopause, encouraged the panelists to present the latest clinical findings and advise on appropriate regulatory action.

“The warning is doing more harm than good,” several experts argued, referencing studies that show low-dose vaginal estrogen poses minimal systemic risk and is not linked to the same dangers as systemic hormone replacement therapies.

The current black box warning, one of the FDA’s most serious advisories, was implemented in the early 2000s in response to concerns about increased risks of breast cancer, stroke, and cardiovascular disease from systemic estrogen. However, medical professionals and researchers now say vaginal estrogen — typically administered in creams, tablets, or rings — does not carry the same risks and has been unfairly stigmatized.

Millions of women suffer from genitourinary symptoms of menopause, such as dryness, burning, and painful intercourse. Doctors argue that the warning has discouraged effective treatment, leaving many patients to suffer unnecessarily.

Removing the black box label could improve access and reduce stigma around treatment, giving women more confidence in safe, localized hormone therapies.

The FDA has not yet announced a final decision, but Commissioner Makary stated that the agency would review the panel’s recommendations carefully in the coming months.