Published June 17, 2026
On June 17, 2026, EPPC Scholars Mary Rice Hasson and Theresa Farnan of the Person and Identity Project and Rachel N. Morrison of the Administrative State Accountability Project submitted a public comment to the U.S. Food & Drug Administration (FDA) in response to a Citizen Petition involving the off-label use of estrogen in males for sex-rejecting purposes.
The Citizen Petition—signed by a coalition of medical professional organizations, medical researchers, public health experts, legal professionals, educators, and concerned family members of individuals who have undertaken sex-rejecting procedures—asked the FDA to convene a public hearing to gather information from scientific experts, open a comprehensive safety review, mandate boxed warnings on all relevant estrogen-containing products, and establish a formal system for adverse event reporting.
The scholars urged the FDA to grant the petition and take action to protect males from the significant harms and risks associated with the off-label use of estrogen in males.
As the scholars explained in their comment, the claim that existing “standards” and protocols safely guide off-label estrogen use by males is specious, research on off-label estrogen use in males is lacking, and its long-term effects are unknown.
The comment stated:
No evidence supports the claim that providing males with high-dose estrogen for sex-rejecting purposes is beneficial; indeed, the evidence to date suggests the opposite. Off-label use of high-dose estrogen in otherwise healthy males disables healthy development, impairs healthy organ and endocrine functions, and results in demonstrable physical harm …. There is no ethical, medical purpose for prescribing estrogen as a treatment for males who experience identity distress, reject their male sex, or self-identify as transgender.
The scholars pointed out that because “males who identify as transgender currently are subject to intense social media campaigns that encourage them to use estrogen for sex-rejecting purposes, with little to no understanding of immediate and long-term harms that may result,” black box warnings can help prevent “parents, siblings, and friends who express concern” from being “sidelined or silenced” by pro-gender ideology advocates and organizations.
The scholars concluded by urging the FDA to take the following actions: (a) conduct a serious investigation into the harms of using supraphysiological doses of estrogen for sex-rejecting purposes in males, (b) hold a public hearing into their use and effects, and (c) require a black box warning regarding such use.
Other organizations submitting comments on the citizen petition include:
Mary Rice Hasson, JD, is the Kate O’Beirne Senior Fellow at the Ethics and Public Policy Center in Washington, D.C., where she co-founded and directs the Person and Identity Project, an initiative that promotes the truth of the human person and counters gender ideology.
