RICHMOND, VA; December 18, 2025 – This week, Do No Harm proudly signed onto a citizen petition sent to the Food and Drug Administration (FDA) requesting it address the risks and scientific uncertainty of widespread off-label prescription of estrogen to males in gender medicine.
Filed Wednesday evening, the citizen petition reflects growing concern among clinicians, researchers, affected individuals, and public health stakeholders about increased off-label estrogen use and regulatory gaps concerning its harmful and irreversible effects.
“The evidence makes clear that off-label use of cross-sex hormones for males is extremely high risk. The FDA has a duty to protect Americans from harm and safeguard their health by ensuring patients and their doctors have the most accurate, science-based information about these medications,” said Kurt Miceli, MD, Medical Director for Do No Harm. “By implementing the recommended changes, the FDA would be taking significant steps to protect Americans from a harmful ideology that has promoted the use of estrogen in male patients with incomplete information and little consideration for the associated risks. This administration has taken extraordinary steps to end the gender medicine scandal, and we urge them to continue their track record of common-sense patient protections by adopting these recommendations.”
The petition urges the FDA to take two immediate actions: open a dedicated docket to evaluate the safety and potential effectiveness of off-label estrogen use, and convene a Part 15 public hearing to gather expert and patient testimonies on its risks and benefits.
The coalition of petition signers urges the FDA to also consider the following recommendations to protect public health and spread awareness to patients:
The petition goes on to share substantial evidence confirming the serious and growing risks associated with the use of estrogen in males. This includes a 10-fold increase in the risk of stroke after six years, an annual incidence of testicular cancer that is more than 26 times higher than the general population, and an 80% increased risk in the standardized mortality ratio.
The petition was signed by fifteen organizations representing a politically diverse group of advocacy and clinical organizations, as well as more than 220 individuals, including over 60 health care professionals, five men who are former patients of gender medicine, and numerous concerned citizens. Co-signing the petition is a continuation of Do No Harm’s work to support clinicians and patients who deserve adequate warning of these irreversible harms.
Do No Harm, established in April 2022, has rapidly gained recognition and made significant strides in its mission to safeguard healthcare from ideological threats. It has over 50,000 members, including doctors, nurses, physicians, and concerned citizens across all 50 states and 14 countries.
