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.
US Federal Register - FDA Rules · August 03, 2026
Modification of Certain Terminology in Title 21; Reopening of the Comment Period
FDA reopens comment period on proposed rule to replace 'gender' with 'sex' throughout Title 21 CFR to comply with Executive Order 14168.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.