November 10, 2025 — The Society for Women’s Health Research released the following statement after the November 10 U.S. Department of Health and Human Services press conference where Secretary Kennedy announced the removal of black box warnings from all estrogen-based hormone replacement therapy products.
U.S. Department of Health and Human Services (HHS) Secretary Kennedy announced the administration’s decision to remove the black box warning from all estrogen-based hormone therapy products, signaling a landmark moment in women’s health. Since the early 2000s, these black box warnings have deterred women experiencing genitourinary syndrome of menopause (GSM), which includes symptoms like vaginal dryness, burning, painful intercourse, and recurrent urinary tract infections (UTIs), from receiving local vaginal estrogen, a treatment option that has been proven to be safe and effective under appropriate clinical guidance. For that reason, women’s health stakeholders, medical societies, and the broader scientific community have been advocating for the removal of black box warnings from these products since 2003. Today’s announcement from HHS officials was a welcome development, indicating that these concerns were heard and that the administration is heeding the advice of scientists throughout the country.
The Society for Women’s Health Research (SWHR) appreciates that the administration, through the U.S. Food and Drug Administration (FDA), has taken important steps to reassess the evidence and align its policy with current scientific literature, and continue to encourage clinicians to engage in shared decision-making with their patients to treat the full spectrum of menopause symptoms with hormone therapy. While the use of vaginal estrogen for the treatment of GSM has a wealth of evidence in favor of its use and the backing of leading medical experts and professional societies, there are important considerations when it comes to the use of systemic hormone therapy. Labeling practices should reflect evidence-based risks and benefits and align with the latest guidelines from medical professional societies in women’s health, allowing women and their health care providers to make fully informed shared decisions. More research and data are necessary for understanding how the use of certain hormone therapies in women may impact their health long term.
SWHR appreciates this important first step to ensuring that women have access to appropriate and effective treatment for the menopausal symptoms, and we look forward to working with the FDA to implement these important changes. We encourage the FDA to clearly communicate what research shows about the safe and effective use of hormone therapies for women transitioning through menopause, while also supporting continued research on how systemic hormone therapies impact women’s health and outcomes.