The US Food and Drug Administration (FDA) announced plans to remove the longstanding 'black box' safety warning from hormone treatments for menopause symptoms. This warning, introduced in 2003 after the Women’s Health Initiative study linked hormone therapy to increased risks of cardiovascular disease, stroke, breast cancer, and dementia, led to a dramatic decline in prescriptions, dropping from over 25% of postmenopausal women in the late 1990s to about 4% in 2020. The FDA’s move aims to update the labels to reflect current scientific understanding, particularly emphasizing that hormone therapy can be safe and beneficial for women under 60 or within 10 years of menopause, with risks being more nuanced than previously presented. The label changes will also remove the previous guidance to use the lowest effective dose for the shortest duration, allowing women to stay on therapy longer if appropriate. Experts such as Dr. JoAnn Manson and Dr. JoAnn Pinkerton welcomed the change, highlighting that the previous warnings were overly broad and did not account for individual risk factors or different formulations. The move is supported by a broader societal shift, with 19 states introducing legislation to improve menopause care, and a longstanding demand from the medical community for more accurate labeling. Advocates argue that the black box warning contributed to under-treatment of menopause symptoms, which can significantly impact women’s quality of life and contribute to chronic illnesses. The FDA’s decision follows a series of expert panels, petitions, and legislative efforts aimed at making hormone therapy more accessible and better understood, recognizing its potential to improve health outcomes and quality of life for millions of women.