The U.S. Department of Health and Human Services (HHS) announced a label change for menopausal hormone therapies (MHT) or hormone replacement therapies (HRT) following an FDA request. The agency demanded the removal of broad “black box” warnings from HRT products for menopause, citing a desire to improve clarification of the benefit/risk considerations of using these medications.¹

Both Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, M.D., M.P.H. announced the agency’s intentions to change the label at a press conference held at HHS.¹

“Today, we are standing up for every woman who has symptoms of menopause and is looking to know her options and receive potentially life-changing treatment,” said Secretary Kennedy. “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.”

Why did the FDA request the label changes to MHT/HRT medicines?

FDA’s proposed label change comes on the heels of the agency’s assessment of related literature following the publication of two long-term, large-scaled studies under the Women’s Health Initiative, updated drug utilization review, and public input about MHTs.¹ According to a press release, the two Women’s Health Initiative studies, conducted in the early 1990’s, investigated the role of estrogen plus progestin in women with a uterus or estrogen alone in women without a uterus in preventing heart disease, cancer, and bone fractures in postmenopausal women 50 to 79 years.¹

In 2003, the findings of these study’s resulted in FDA approving class-wide labeling changes for estrogen plus progestogen and estrogen-alone products approved for the treatment of vasomotor symptoms, vulvovaginal atrophy, and postmenopausal osteoporosis.¹ The label changes included the addition of boxed warnings of increased risk of series adverse events such as cardiovascular disorders, invasive breast cancer, and probable demntia.¹

FDA’s decision to add boxed warnings was meet with questions regarding the necessity of these warnings, as some groups voiced concerns about the studies applicability to women who need MHT medications, along with other groups who raised concerns that certain women who would benefit from MHT are not prescribed it or are declined treatment with MHT, due to boxed warnings.¹

What is FDA’s requested label changes?

According to a press release, FDA based its decision on its assessment of available data, along with the agency’s recognition that menopause can significantly impact the quality of life for women.

Based on these factors, the FDA has requested the following changes, specifically in the label’s box warning, for all MHT product labels:

• Remove language related to cardiovascular diseases, breast cancer, and probable dementia
• Remove language related to endometrial cancer except in the systemic estrogen-alone drugs
• Remove the recommendation to use the lowest effective dose for the shortest amount of time
• Remove the probable dementia warning

In systemic products, FDA requested the following changes to the label as a whole:

• Add consideration of starting hormone therapy for moderate to severe VMS in women < 60 years old or < 10 years since menopause
• Add WHI data in women 50-59 years old
• Retain the Boxed Warning about endometrial cancer in the systemic estrogen-alone products
• Retain information about cardiovascular diseases and breast cancer warnings

The agency’s last label change request comes for local vaginal estrogen products, and asks HHS to condense safety information and prioritize information most relevant to the local vaginal formulation.¹

“Someday, science will help us slow or reverse all the damage of aging,” said Health and Human Services deputy secretary Jim O’Neill."A good safe way to address estrogen depletion already exists, and today Secretary Kennedy and Commissioner Makary are removing a barrier on this treatment. Many more women can reduce their risk of fracture, heart disease, and immune and cognitive decline while extending their vigor.”

Sources

1. FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies US Food and Drug Administration November 10, 2025 https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-labeling-changes-related-safety-information-clarify-benefitrisk-considerations
2. HHS Advances Women’s Health, Removes Misleading FDA Warnings on Hormone Replacement Therapy US Food and Drug Administration November 10, 2025 https://www.globenewswire.com/news-release/2025/11/10/3184853/0/en/HHS-Advances-Women-s-Health-Removes-Misleading-FDA-Warnings-on-Hormone-Replacement-Therapy.html