Trump Proposes to Remove ‘Gender’ References in FDA Regulations

The Food and Drug Administration proposed Tuesday changing its regulations to remove references to gender in order to align with President Donald Trump’s executive orders.

The rule (RIN 0910-AJ26), if finalized as written, would remove all references to “gender” in FDA regulations or replace them with the word “sex.”

One of Trump’s first actions during his second term in office was issuing an executive order directing federal agencies to use the word “sex” in lieu of “gender.”

Tuesday’s proposal builds on a series of actions by the administration to signal that there are only two biological genders, and roll back expansions of gender-related policies implemented by the Biden administration. The administration has pushed policies to roll back gender-affirming care, require states to affirm the administration’s views on gender, and mandated that US passports can only be marked as male or female.

The FDA’s proposed rule states that the changes would affect language related to Institutional Review Boards, infant formula, human and animal drugs, medical devices, device labeling, drug importation, and premarket tobacco product applications.