How to make sense of the FDA announcement about estrogen therapy for menopause
- Kate

- Nov 13, 2025
- 2 min read

Dr. Jen Gunter is my go-to source for menopause information -- I'm currently reading The Menopause Manifesto, and subscribe to her Substack, The Vajenda. She's a brilliant guest on the We Can Do Hard Things podcast "Menopause: What We Deserve to Know with Dr. Jen Gunter" here.
Here's Dr. Gunter's very helpful reaction to the breaking news on estrogen therapy: full post and video response here; and her recap follows. Be sure to check out her whole post, because it is full of more excellent information and resources. I watched the FDA announcement about removing the black box warning on estrogen…and it turns out it was not just on vaginal estrogen, but on all estrogen. In addition, both RFK Jr, and Dr. Makary spewed misinformation about menopause and menopause hormone therapy. I covered it all in the live. I also suggested resources and answered some questions. I hope you listen/watch.
To recap:
I agree with removing the black box warning on vaginal estrogen, but I do not agree with the way it was done. This did not follow the appropriate process. There was an opportunity to do it right and to fund some needed studies, but Makary and RFK Jr don’t actually care about women, so we didn’t get that. Click here for a deep dive into my opinion on the black box warning and the information that we need. And here is a deeper dive into vaginal estrogens.
I do not agree with removing the black box warning from systemic estrogen. Again, we could have had an appropriate process where we reviewed the data and decided if changes were needed, but that did not happen. The label needs updating, but not like this.
When HHS and the FDA act on whims instead of science, that means they can act on any whim. They alluded to the amazing (that is sarcasm from me) panel on SSRIs in pregnancy, so yes, I am very worried we’re going to see more proclamations. You should be worried about SSRIs in pregnancy, mifepristone and birth control.
RFK Jr and Makary both claimed they were using evidence-based medicine, and then proceeded to ignore that evidence in favor of data that was cherry picked from ancient studies, most of which are observational, and some things that sounded completely made up. They made false claims about MHT reducing the risk of cardiovascular disease by 50% and Alzheimer’s disease by 35%. WE DO NOT HAVE THAT DATA.
Dr. Gunter's entire post here.




