(NEW YORK) — The Food and Drug Administration said Monday it will remove the “black box” warning from hormone replacement therapy (HRT) products for menopause.

The change comes after two studies in the early 2000s claimed that there were major risks associated with HRT, including breast cancer. This led to the FDA placing its highest warning label on the drugs, prompting a significant decline in usage.

The public health agency estimates millions of women have avoided HRT out of fear of cancer or heart risks, based on an outdated analysis of data.

“This is, in my opinion, one of the greatest mistakes in modern medicine — the demonization of hormone replacement therapy,” FDA Commissioner Dr. Marty Makary said on Monday.

An expert panel formed at the FDA in recent months reviewed the late

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