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The Food and Drug Administration is issuing a rule to modify certain terminology in Title 21 of the Code of Federal Regulations to comply with Executive Order 14168, Defending Women From Gender Ideology Extremism and Restoring Biological Truth to the Federal Government, issued on January 20, 2025. Specifically, this 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.

Statement of Need:

The terms gender and sex appear in various contexts in FDA regulations, including in requirements related to Institutional Review Board (IRB) membership (see 21 CFR 56.107), records and reporting requirements for product applications and approvals (see, e.g., 21 CFR 312.42, 314.50, 314.80, 600.80, 803.32), and device classification regulations (see, e.g., 21 CFR 862.1840, 866.3215, 866.5950). Section 2(a) of EO 14168 defines sex as referring to "an individual’s immutable biological classification as either male or female. ‘Sex’ is not a synonym for and does not include the concept of ‘gender identity.’ Section 3(c) of EO 14168 requires, among other things, that [w]hen administering or enforcing sex-based distinctions, every agency and all Federal employees acting in an official capacity on behalf of their agency shall use the term sex and not gender in all applicable Federal policies and documents. Accordingly, FDA is modifying regulations to remove the term gender wherever it appears, to either replace it with the term sex, or delete reference to gender as applicable

Summary of the Legal Basis:

FDA proposes to issue this rule under the following authorities: The Federal Food, Drug, and Cosmetic Act (FD&C Act) (at 21 U.S.C. 321 et seq.) and specifically, sections 321-397; the Public Health Service (PHS) Act at 42 U.S.C. 201, 216, 241, 242(a), 262, 263a, 263b, 264; and 15 U.S.C. 1451-1461; 5 U.S.C. 551-558, 701-706; 21 U.S.C. 141-149, 467f, 679, 821, 1034; 28 U.S.C. 2112; and section 111 of Pub. L. 117-103 (Consolidated Appropriations Act, 2022), 136 Stat. 49 at 789. FDA also has general authority to issue regulations for the efficient enforcement of the FD&C Act and the PHS Act under section 701 of the FD&C Act (21 U.S.C. 371) and section 351(j) of the PHS Act.

Alternatives:

Alternative option: leave current regulations unchanged and update terminology when each regulation is amended for programmatic or other reasons. The drawback of this approach is that the sex/gender terminology in Title 21 would remain inconsistent until every provision is revised individually. In addition, taking this approach would not be in compliance with the directives of EO 14168.

Anticipated Costs and Benefits:

This proposed rule reflects editorial changes that affect FDA and does not impact industry practices. Consequently, we do not anticipate any measurable change in industry resulting from this proposed rule. We also expect the economic impact on the FDA to be minimal. This proposed rule will produce no quantifiable savings, costs, or transfers. We do not expect any loss of public health benefits as a result of this rule.

Risks:

TBD