FDA Lifts MHT Black Box Warning
In a landmark decision on November 10, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced the removal of broad "black box" warnings from hormone replacement therapy (HRT) products for menopause, aiming to re-establish evidence-based science in women's health. This significant policy shift, overturning over two decades of fear and misinformation stemming from a flawed 2002 study, is expected to empower more women to access effective treatments and potentially reduce risks of various health issues, though the boxed warning for endometrial cancer will remain for systemic estrogen-alone products.
