The FDA is seeking comments on backbox warning for women's hormone therapy
The FDA is currently seeking public comments regarding the black box warning on women’s hormone therapy products for menopause. Here’s what you need to know:
Background: Since the early 2000s, all estrogen-containing menopause hormone therapies in the U.S. have carried a black box warning about increased risks of breast cancer, cardiovascular events, stroke, and dementia—based on findings from the Women’s Health Initiative (WHI). However, a growing body of experts, including original WHI researchers, now argue these risks were overstated, particularly for younger women and those using low-dose or non-oral formulations. They assert the warning discourages many who could benefit, especially from local (vaginal) estrogen therapy, which is not thought to increase these systemic risks in the same way[1][2][3][4][5].
Recent Action: On July 17, 2025, the FDA convened a panel of menopause and women’s health experts to review whether these warnings are still appropriate. The panel discussed updated data highlighting differences in risk based on age, therapy type, formulation, and timing of initiation. Panelists generally favored revising or removing the black box warning, especially for low-dose, vaginal estrogen used for localized symptoms.
Public Comment Period: Following the meeting, the FDA formally opened a public comment period inviting submissions from clinicians, researchers, patients, and the general public. The agency is particularly interested in updated evidence on the risks and benefits of hormone therapy—including differences due to age, formulation, timing, and route of administration—and wants to hear about patient experiences and perspectives.
· SHORT SUMMARY PODCAST: Click here
How to Submit a Comment
· Deadline: 11:59 p.m. Eastern Time (ET), September 24, 2025.
· Where: Submit comments through Regulations.gov under docket number FDA-2025-N-2589. Click here: Comment Now
· What to Include: You may provide evidence, opinions, or experiences regarding the risks and benefits of menopause hormone therapy (especially as relates to cancer, cardiovascular disease, bone health, cognition, or genitourinary symptoms), and whether the black box warning is justified for all types of treatments.
For professionals submitting evidence, references to published studies or experiences with different formulations/routes (oral/systemic vs. vaginal/local) are encouraged. The FDA will consider all comments received by the deadline in deciding whether to revise the warning label but will not respond individually.
This is a significant opportunity for those in the clinical and research community—as well as patients and advocates—to influence FDA labeling and access to hormone therapies for menopause.
References:
1. https://www.npr.org/sections/shots-...-5477644/menopause-hormone-therapy-fda-health
2. https://www.cnn.com/2025/07/24/health/menopause-hormone-treatment-wellness
3. https://www.axios.com/2025/07/18/fda-menopause-hormone-therapy
4. https://www.urologytimes.com/view/e...lack-box-warning-on-low-dose-vaginal-estrogen
5. https://www.contemporaryobgyn.net/v...d-warnings-on-hormone-therapies-for-menopause
6. https://www.fda.gov/patients/fda-ex...nd-hormone-replacement-therapy-women-07172025
7. https://www.npr.org/transcripts/nx-s1-5477644
8. https://www.regulations.gov/document/FDA-2025-N-2589-0001
9. https://content.govdelivery.com/accounts/USFDA/bulletins/3eb6f75
The FDA is currently seeking public comments regarding the black box warning on women’s hormone therapy products for menopause. Here’s what you need to know:
Background: Since the early 2000s, all estrogen-containing menopause hormone therapies in the U.S. have carried a black box warning about increased risks of breast cancer, cardiovascular events, stroke, and dementia—based on findings from the Women’s Health Initiative (WHI). However, a growing body of experts, including original WHI researchers, now argue these risks were overstated, particularly for younger women and those using low-dose or non-oral formulations. They assert the warning discourages many who could benefit, especially from local (vaginal) estrogen therapy, which is not thought to increase these systemic risks in the same way[1][2][3][4][5].
Recent Action: On July 17, 2025, the FDA convened a panel of menopause and women’s health experts to review whether these warnings are still appropriate. The panel discussed updated data highlighting differences in risk based on age, therapy type, formulation, and timing of initiation. Panelists generally favored revising or removing the black box warning, especially for low-dose, vaginal estrogen used for localized symptoms.
Public Comment Period: Following the meeting, the FDA formally opened a public comment period inviting submissions from clinicians, researchers, patients, and the general public. The agency is particularly interested in updated evidence on the risks and benefits of hormone therapy—including differences due to age, formulation, timing, and route of administration—and wants to hear about patient experiences and perspectives.
· SHORT SUMMARY PODCAST: Click here
How to Submit a Comment
· Deadline: 11:59 p.m. Eastern Time (ET), September 24, 2025.
· Where: Submit comments through Regulations.gov under docket number FDA-2025-N-2589. Click here: Comment Now
· What to Include: You may provide evidence, opinions, or experiences regarding the risks and benefits of menopause hormone therapy (especially as relates to cancer, cardiovascular disease, bone health, cognition, or genitourinary symptoms), and whether the black box warning is justified for all types of treatments.
For professionals submitting evidence, references to published studies or experiences with different formulations/routes (oral/systemic vs. vaginal/local) are encouraged. The FDA will consider all comments received by the deadline in deciding whether to revise the warning label but will not respond individually.
This is a significant opportunity for those in the clinical and research community—as well as patients and advocates—to influence FDA labeling and access to hormone therapies for menopause.
References:
1. https://www.npr.org/sections/shots-...-5477644/menopause-hormone-therapy-fda-health
2. https://www.cnn.com/2025/07/24/health/menopause-hormone-treatment-wellness
3. https://www.axios.com/2025/07/18/fda-menopause-hormone-therapy
4. https://www.urologytimes.com/view/e...lack-box-warning-on-low-dose-vaginal-estrogen
5. https://www.contemporaryobgyn.net/v...d-warnings-on-hormone-therapies-for-menopause
6. https://www.fda.gov/patients/fda-ex...nd-hormone-replacement-therapy-women-07172025
7. https://www.npr.org/transcripts/nx-s1-5477644
8. https://www.regulations.gov/document/FDA-2025-N-2589-0001
9. https://content.govdelivery.com/accounts/USFDA/bulletins/3eb6f75
