FDA ‘liberates’ hormone therapy for menopause

Published November 10, 2025 10:01am ET



Food and Drug Administration Commissioner Marty Makary announced on Monday that his agency is deregulating hormone replacement therapies for menopause patients by calling for manufacturers to remove black box warnings from their products.

Black box warnings are the highest level of caution that the FDA requires for certain potentially dangerous products. Makary, at a press conference Monday, cited several studies touting the benefits of hormone replacement therapy and demonstrating a lack of correlation between HRT and dangerous outcomes such as breast cancer.

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