This alert comes from another mailing list. I edited this slightly and added emphases.
Call to Action! Time sensitive. Deadline is September 24, 2025.
FDA is currently taking comments on a proposal to remove the warning label on low-dose estrogen when used as legitimate hormone replacement therapy (HRT) for women. A former FDA insider has recommended that this could be an opportunity to raise awareness with FDA staff that there are public concerns about estrogen being used by males.
Parents and activists are being invited to submit comments on the portal to simply suggest that as FDA reviews the appropriate use of estrogen by women, it should look at the problems arising from its off-label use as cross-sex hormone therapy in males.
The comment portal is here: https://www.regulations.gov/docket/FDA-2025-N-2589/document .
Parents, detransitioners, and clinicians are the best sources of comments to generate awareness with FDA, although everyone can and should comment.
Here is a guideline for comments:
1) Make it clear that you are NOT commenting on the use of estrogen by women as part of legitimate HRT. (If you support FDA’s proposal to remove the warning label in this case, feel free to say so.)
2) State that you are writing to bring to FDA’s attention the widespread, medically unsupported, off-label use of estrogen by males in “gender affirming care (“GAC.”)
3) You can provide as much clinical or research information as you want, or simply provide your or your child’s personal experience of estrogen used as cross-sex hormone therapy. Ask FDA to investigate potential dangers from this use, which is now being aggressively marketed by for-profit companies like Plume and Folx.
4) You can indicate where you or your child was prescribed or provided the cross-sex hormones and if you or he experienced, either by self-reporting, diagnosis, or observation, any adverse effects no matter how mild they may seem.
Again, FDA’s deadline for comments is September 24, 2025.
Please note that this is a DIFFERENT ACTION from the request for comments to FTC on “GAC” for minors. That deadline is September 26, 2025. Don’t forget to comment on this alert too! See this post for the details.