On July 17, 2025, the FDA brought together a panel of experts to discuss the benefits and risks of hormone therapy for women going through menopause. The conversation focused on important health concerns like the risks of breast and uterine cancer, as well as certain heart-related issues. The panel also explored the potential benefits of hormone therapy for bone strength, urinary and sexual health, heart health, and brain function.

A key part of the discussion was how these risks and benefits may vary based on factors like a woman’s age when she starts hormone therapy, how long she uses it, the type and dose of hormones used, and the form in which they’re taken (such as pills, patches, or creams). These topics were especially relevant in light of new data that’s emerged since the original Women’s Health Initiative (WHI) study.

Now, the FDA wants to hear from public. As a follow-up to the expert meeting, they’re opening a public comment period. Anyone—whether you’re a healthcare professional, researcher, patient, or member of the public—is invited to share insights, experiences, or scientific data related to menopause hormone therapy.

The agency is especially interested in input about:

• Breast and uterine cancer risks

• Cardiovascular health

• Genitourinary symptoms

• Bone health

• Dementia

• How these may be influenced by factors like age, timing of therapy, type of hormones, and how the therapy is given

Your comments could help shape future updates to the labeling and use of hormone therapy products.

Deadline to submit comments: September 24, 2025, by 11:59 p.m. ET
Where to submit: Regulations.gov, Docket Number: FDA-2025-N-2589

The FDA will review all comments received by the deadline, although individual responses will not be provided.