Modification of Certain Terminology in Title 21; Reopening of the Comment Period
Key claim: The FDA is reopening the comment period on a proposed rule that would remove or replace the term “gender” with “sex” throughout Title 21 of the CFR to comply with Executive Order 14168.
Abstract
(Proposed Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the proposed rule that appeared in the Federal Register of May 6, 2026, to modify certain terminology in Title 21 of the Code of Federal Regulations (CFR) to comply with Executive Order (E.O.) 14168, “Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government,” issued on January 20, 2025. Specifically, this proposed rule, if finalized, will remove the term “gender” wherever it appears and either replace it with the term “sex,” or delete reference to gender, as applicable, along with other editorial changes to improve readability. The Agency is taking this action to allow interested persons additional time to submit comments.
Why this matters
The FDA’s terminology rewrite is one of the first substantive regulatory implementations of EO 14168’s sex/gender definitions in a health-related Code of Federal Regulations title, extending the executive order’s reach into drug, device, and food regulation. Reopening the comment period offers affected groups—including patients, clinicians, and LGBTQ advocacy organizations—an additional window to weigh in on how definitional changes may affect clinical trial participation, labeling, and data collection.