Medical Groups Urge FDA to Review Estrogen Use in Boys and Young Adult Males
March 20, 2026
By Nadia Smith
A coalition of healthcare professionals and advocacy groups is calling on the U.S. Food and Drug Administration (FDA) to strengthen safety warnings for estrogen use in adolescent and young adult males, as part of a broader push to reevaluate ‘”gender affirming” medical interventions.
The effort stems from a citizen petition filed earlier this year, which requests that the FDA require a “Black Box Warning”—the agency’s most serious safety alert—on estrogen products prescribed to boys and young males. The petition also urges federal regulators to conduct a comprehensive review of the intervention’s clinical outcomes, particularly its psychosocial effects.
The initiative began in December 2025, when a group of parents and healthcare professionals launched the website ROGDBoys to raise awareness about concerns related to gender-related medical interventions in youth. The groups concern stems from the growing number of transitioners and detransitioners who are speaking out against the harms they have experienced.
One such individual, cited on the ROGDBoys website explained, “I began a rapid transition at 14 years old and was extremely uninformed and deceived about the realities of puberty blockers and hormone replacement. I was unable to truly comprehend the sterilization I underwent and was completely uninformed about the negative effects of lifelong puberty suppression and hormone replacement. I was too young to understand the effect of never having biological children, something I deeply desire now less than 10 years later. I was completely unaware that I would never have sexual functionality, sexual feelings, and sex drive.”
The group subsequently developed the petition and invited medical organizations nationwide, such as the Catholic Medical Association, to support the effort.
CMA, which has been outspoken of the dangers of such interventions, joined others in encouraging its members to sign and submit public comments. Dr. Tim Millea, the Chair for the Health Care Policy Committee said CMA’s involvement was based on the issue’s relevance to healthcare policy and patient safety.
“The primary goal is to ensure that patients and families are fully informed of the potential risks,” he noted, emphasizing the importance of ethical and evidence-based care.
The FDA has since opened a public comment period, inviting input from clinicians, patients, and families—particularly those with direct experience related to gender transition treatments. Supporters of the petition are urging broader participation, arguing that public feedback could influence regulatory decisions.
Advocates backing the petition cite a range of potential health risks associated with prolonged estrogen use in males, including increased likelihood of blood clots, stroke, certain cancers, and other serious conditions. They argue that these risks warrant heightened scrutiny and clearer communication through stronger warning labels.
“We are concerned by the dramatic increase in the off-label use of estrogen in natal males for the purpose of altering secondary sex characteristics to affirm a gender identity inconsistent with their natal sex,” the Petition states. “The recent peer-reviewed umbrella review from the Department of Health and Human Services has once again demonstrated the lack of benefits from these hormonal interventions. What is perhaps less appreciated is the increasing evidence of harm.”
While the issue remains the subject of ongoing medical and political debate, supporters of the petition say increased regulatory oversight is necessary to protect young patients.
The FDA has not yet announced a timeline for reviewing the petition or issuing a decision. In the meantime, public comments remain open as part of the agency’s standard review process.
