A coalition of anti-transgender advocacy organizations has filed a formal citizen petition with the U.S. Food and Drug Administration asking the agency to investigate and potentially restrict the use of estrogen in transgender women, according to newly surfaced documents reviewed by TransVitae.
The petition, submitted to the FDA on December 17, 2025, requests that regulators open a new public docket, hold a public hearing, and consider regulatory actions targeting the use of estrogen as part of gender-affirming hormone therapy.
The document also asks the FDA to require boxed warning labels on estrogen products when used for gender-affirming care and to create a patient registry system that would track individuals receiving such treatment.
News of the petition was first reported by The Needle, which uncovered the filing and highlighted its potential implications for transgender healthcare access.
The petition was submitted by a network of groups that have long opposed gender-affirming medical care, including organizations such as Partners for Ethical Care, the LGB Courage Coalition, Genspect, and the Women’s Liberation Front. These groups have previously advocated for restrictions on hormone therapy and other forms of transgender healthcare.
According to the filing, petitioners argue that estrogen used by transgender women represents an “off-label” application of the medication and claim federal regulators should reevaluate its safety and effectiveness in this context. The document calls on the FDA to examine potential risks associated with hormone therapy and suggests new oversight measures for physicians prescribing it.
Among the recommendations included in the petition are mandatory adverse event reporting related to gender-affirming hormone therapy and additional guidance for healthcare providers regarding mental health assessments before prescribing treatment.
Medical organizations and transgender advocates have repeatedly pushed back against similar claims in the past, noting that gender-affirming hormone therapy is endorsed by major professional bodies including the Endocrine Society, the American Medical Association, and the World Professional Association for Transgender Health.
These organizations argue that hormone therapy is a well-established component of care for many transgender adults experiencing gender dysphoria and is associated with improved quality of life and mental health outcomes when delivered under appropriate medical supervision.
The citizen petition process allows individuals and groups to formally request regulatory action from federal agencies. However, petitions do not automatically lead to policy changes. The FDA may review the submission, request additional information, or ultimately deny the request.
Advocates say the filing reflects a broader national strategy by anti-trans organizations to challenge transgender healthcare through regulatory channels after facing setbacks in courts and legislatures.
If the FDA were to pursue the actions requested in the petition, it could trigger new hearings and regulatory reviews affecting access to hormone therapy across the United States.
For now, the petition remains under FDA review, and no regulatory action has been announced.
