Opposing Gender Discrimination at the FDA
July 2, 2026
Woodhull Freedom Foundation Response to a Proposed Rule by the Food and Drug Administration, Department of Health and Human Services: Modification of Certain Terminology in Title 21
Woodhull Freedom Foundation is a national organization dedicated to defending and protecting sexual freedom as a fundamental human right. Woodhull protects individuals’ rights across the United States to enjoy sexual dignity, privacy, and consensual sexual expression without societal or governmental interference, coercion, or stigmatization. In carrying out this work, we defend the rights, health, and safety of Transgender, Nonbinary, and Gender Expansive individuals. It is in this capacity that we submit this comment to oppose the Federal Drug Administration’s (FDA) proposed rule change published in the Federal Register on May 6, 2026, to enforce the White House’s Executive Order 14168 “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.”
If the proposed rule goes into effect, the FDA will amend Title 21 of the Code of Federal Regulations (CFR) to “remove the term ‘gender’ wherever it appears, to either replace it with the term ‘sex,’ or delete reference to gender, as applicable, and make other editorial changes to the relevant sections for readability.” The FDA states it is, “taking this action to comply with E.O. 14168” and goes on to justify the EO’s enforcement by expressing, “We do not expect any loss of public health benefits as a result of this rule.” We are deeply disturbed by the methods proposed to implement Executive Order 14168 and the justification from the FDA.
Far from having no impact on public health benefits, the enforcement of Executive Order 14168 within the FDA represents a grave threat to protecting and advancing gender equality. Executive Order 14168 attempts to make it the United States policy to recognize only two sexes, male and female. This proposed rule reinforces this effort by removing any reference to gender in Title 21 and erroneously claiming that gender and sex are interchangeable terms. The recognition of only two sexes is not only scientifically inaccurate but extremely harmful to the mental and physical well-being of gender diverse individuals. We include here a brief excerpt from our Fact Checked by Woodhull series, which addresses the reality of sex and gender:
“Sex and gender are complex and exist on a spectrum, yet society often creates narrow, rigid categories that fail to reflect this diversity. These restrictive categories can cause harm by excluding and shaming anyone who exists outside of these lines, especially transgender and intersex people. Being forced into categories that do not align with identity can cause discrimination and violence in families, healthcare, and social systems. This can have serious long-term emotional and physical consequences for individuals who are outside of these lines. For example, transgender youth reported significantly increased rates of depression, suicidality, and victimization compared to their cisgender peers. These are often accompanied by struggling with belonging in school, family issues, and internalized self-stigma.”
It is imperative that the FDA and all federal government policies accurately represent the complexities of sex and gender. We include in this comment PDFs of Woodhull publications, which provide accurate language that should be used in public policy related to gender and sex:
This proposed rule from the FDA threatens human rights and civil protections for millions of people throughout the United States and furthers the cruel attacks against transgender, non-binary, and gender expansive individuals. We also raise alarm at the fact that this is all part of a nationwide assault on trans people that is so dire that the Lemkin Institute for Genocide Prevention and Human Security has warned that policies targeting transgender people in the United States are indicative of the early stages of genocide.
We call on the FDA to recognize the proposed rule’s inherent harms to equality, civil and human rights, and reject its implementation.