FDA to Remove “Black Box” Warnings from Hormone Replacement Therapy Products

The US Department of Health and Human Services (HHS) announced that the Food and Drug Administration (FDA) will begin removing broad “black box” warnings from hormone replacement therapy (HRT) products used for menopause, marking the most significant regulatory shift in women’s health labeling in more than two decades.1

According to the announcement, the FDA’s action follows a comprehensive review of the scientific literature, an expert advisory panel convened in July, and a public comment period.2 The updated labeling will remove warnings related to risks of cardiovascular disease, breast cancer, and probable dementia, which were added after findings from the 2002 Women’s Health Initiative (WHI) trial. The boxed warning for endometrial cancer on systemic estrogen-alone products will remain in place.1

Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, MD, MPH, presented the decision at an HHS press conference attended by more than 200 people, including Second Lady Usha Vance and Secretary of Labor Lori Chavez-DeRemer.1

Kennedy stated that the decision aims to “return to evidence-based medicine and give women control over their health again,” emphasizing that prior risk warnings stemmed from data involving women well past the average age of menopause and using formulations no longer in common use.1

FDA Commissioner Makary noted that “tens of millions of women have been denied the life-changing and long-term health benefits of hormone replacement therapy because of a medical dogma rooted in a distortion of risk.”1

The agency’s updated recommendations will state that systemic HRT should generally be initiated within 10 years of menopause onset or before 60 years of age. Randomized studies cited by the FDA show that early initiation of HRT may reduce all-cause mortality and fractures and lower risks of cardiovascular disease by up to 50%, Alzheimer’s disease by 35%, and bone fractures by 50% to 60%.1

In conjunction with the labeling revisions, the FDA also announced the approval of 2 new therapies for menopausal symptom management1:

• A generic version of conjugated estrogens (Premarin), the first such approval in over 30 years, expected to improve affordability and access.
• A nonhormonal therapy for moderate to severe vasomotor symptoms (eg, hot flashes), expanding treatment options for women who cannot or choose not to use HRT.

“Estrogen is a key hormone for women's health. Every single part of a woman's body depends on estrogen to operate at its best—including the brain, bones, heart, and muscles,” said Alicia Jackson, PhD, director of the Advanced Research Projects Agency for Health.1

References:

1. HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy. US Department of Health and Human Services. News release. November 10, 2025. Accessed November 10, 2025. https://www.hhs.gov/press-room/hhs-advances-womens-health-removes-misleading-fda-warnings-hormone-replacement-therapy.html
2. FDA. FDA expert panel on menopause and hormone replacement therapy for women. Panel Discussion. July 17, 2025. Accessed November 10, 2025. https://www.youtube.com/live/_2ZRlOivC5M