U.S. Department of Health and Human Services (HHS), through the Food and Drug Administration (FDA), included in the Spring 2025 Unified Agenda a proposed rulemaking initiative on the disclosure of fragrance allergens in cosmetic labeling. The proposal is intended to implement requirements established under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which mandates greater transparency regarding fragrance ingredients that may cause allergic reactions in consumers. Under the planned rule, FDA would identify specific substances as fragrance allergens and require their disclosure on cosmetic product labels. The initiative is designed to help consumers, particularly those with fragrance sensitivities or allergies, make more informed purchasing decisions and reduce the risk of adverse reactions associated with cosmetic use. The regulatory action is being developed under the authority of sections 609(b), 602(b)(3), and 701(a) of the Federal Food, Drug, and Cosmetic Act. MoCRA required the agency to issue a Notice of Proposed Rulemaking (NPRM) within 18 months of the law’s enactment, establishing a statutory deadline of 29 June 2024. According to the Spring 2025 Unified Agenda, publication of the NPRM is currently anticipated in May 2026.
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