ACPeds Supports Citizen Petition Requesting the FDA to Consider Regulatory Action and Public Hearing on the Harmful Use of Estrogen in Young Males with Sexual Identity Disorder

For Immediate Release:
December 18, 2025

For More Information Contact:
connect@acpeds.org

ACPeds Supports Citizen Petition Requesting the FDA to Consider Regulatory Action and Public Hearing on the Harmful Use of Estrogen in Young Males with Sexual Identity Disorder

Atlanta, GA – Today, the American College of Pediatricians (ACPeds) announced its support for a citizen petition submitted to the U.S. Food and Drug Administration (FDA) calling for regulatory review, public hearings, and potential safety warnings regarding the off-label use of estrogen in young males for the treatment of sexual identity disorder.

ACPeds recognizes the growing body of medical evidence demonstrating that the off-label administration of estrogen to male adolescents and young adults is associated with serious and potentially irreversible harms. These risks raise profound concerns about patient safety, informed consent, and the ethical practice of pediatric medicine—particularly when such interventions lack FDA approval for this indication and are increasingly used in children. ACPeds has been sounding the alarm on the risks of cross-sex hormones and other sex-rejecting interventions for years. See our Factsheets on Cross-Sex Hormones and Puberty Blockers.

The citizen petition highlights multiple well-documented medical risks associated with estrogen exposure in males, including:

• A fivefold increase in venous thromboembolism (VTE)
• A tenfold increase in stroke risk
• A 22- to 40-fold increase in male breast cancer risk
• A 26-fold increase in testicular cancer risk
• An 80 percent increase in standardized all-cause mortality
• Evidence of decreased brain volume and adverse neurological changes
• Increased suicidality, including higher rates of suicide planning, attempts, and hospitalization

Executive Director Dr. Jill Simons has issued the following statement:

“By supporting this petition, ACPeds urges the FDA to exercise its regulatory authority to ensure transparency, accountability, and the protection of ethical pediatric care. This is a call to return medicine to its foundational principles—open scientific analysis and ethical, evidence-based practice—to ensure that the care provided to children in the United States remains not only among the best in the world, but also scientifically sound and morally responsible.”

ACPeds Past President and Pediatric Endocrinologist Dr. Quentin Van Meter added:

“This is an important issue because the medical community has known for a long time that pathological disease states which result in high levels of endogenous estrogens in males have been associated with lethal consequences. With the advent of high dose estrogens as an intervention to change the appearance of a male body to the likeness of a female body, there is clear harm to such patients. Such malpractice should be recognized and penalized at a federal regulatory level.”

To arrange an interview with Dr. Jill Simons or Dr. Quentin Van Meter please contact connect@acpeds.org.

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About the American College of Pediatricians

The American College of Pediatricians is a national organization of pediatricians and other healthcare professionals dedicated to the health and well-being of children.

For more information, please visit our website.