In a significant shift regarding hormone replacement therapy (HRT) for menopause, the U.S. Food and Drug Administration (FDA) is moving to eliminate the broad “black box” warnings from HRT products. This decision follows over two decades of fear and misinformation surrounding the therapy.
Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary announced the change during a press conference. HRT has been utilized by women for many years to alleviate menopausal symptoms, but its usage significantly decreased in the early 2000s after the FDA imposed boxed warnings in light of a Women’s Health Initiative study that indicated a statistically non-significant increase in breast cancer risk. The average participant age in this study was 63, which is over a decade beyond the average onset of menopause, and the hormone formulation studied is no longer commonly used.
The FDA’s initiative to remove these warnings comes after a comprehensive review of the scientific literature conducted by an expert panel in July, coupled with a public comment period. The agency is collaborating with companies to revise product labels to eliminate references to risks related to cardiovascular disease, breast cancer, and probable dementia. However, the FDA intends to retain the boxed warning for endometrial cancer associated with systemic estrogen-only products.
Kennedy remarked, “For more than two decades, bad science and bureaucratic inertia have resulted in women and physicians having an incomplete view of HRT. We are returning to evidence-based medicine and giving women control over their health again.”
Makary added, “For too long, issues of women’s health have been under-recognized. Women and their physicians should make decisions based on data, not fear.”
As women experience menopause, the production of estrogen and progesterone by the ovaries declines. FDA-approved HRT options that include estrogens and progestins (or estrogens alone for postmenopausal women without a uterus) can help restore these declining hormones and mitigate symptoms such as hot flashes, night sweats, sleep disturbances, and bone loss.
(Source: USFDA)
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Published on November 17, 2025
