Senior Policy Analyst

0910-AI90 202410 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Disclosure of Fragrance Allergens in Cosmetic Labeling

FDA is proposing to identify certain substances as fragrance allergens and to require the disclosure of fragrance allergens on the labels of cosmetic products.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined Undetermined Not Yet Determined Secs. 609(b), 602(b)(3), and 701(a) of the Federal Food, Drug, and Cosmetic Act Statutory NPRM 06/29/2024 Under section 609(b) of the Federal Food, Drug, and Cosmetic Act, added by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the Secretary of Health and Human Services shall issue a notice of proposed rulemaking to implement MoCRA's fragrance allergen labeling requirement not later than 18 months after MoCRA's enactment, which would be June 29, 2024. Yes

This proposed rule, if finalized, would identify substances as fragrance allergens and require the labeling of these individual fragrance allergens on finished cosmetic products.

Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of certain color additives. Currently, FDA’s regulations generally require the declaration of ingredients on the label on each package of a cosmetic unless the ingredient(s) is a fragrance or flavor, in which case it can be listed just as fragrance or flavor (see 21 CFR 701.3).

Sensitization reactions are amongst the common types of adverse reactions associated with the use of cosmetic products. Repeated contact with a sensitizing substance can lead to the development of allergic contact dermatitis (ACD), which can have a significant impact on the health and the quality of life in affected individuals. Disclosing fragrance allergens on the labels of cosmetic products provides information that will help consumers to avoid products containing fragrance ingredients to which they may be allergic.

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FDA is issuing this rule under section 609 of the FD&C Act. On December 29, 2022, the President signed the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) into law, which included MoCRA. Among other provisions, MoCRA added section 609(b) to the FDA&C Act. Section 609(b) requires each fragrance allergen included in a cosmetic product to be identified on the label of such cosmetic product. This statutory provision also directs the Secretary to determine which substances are fragrance allergens for purposes of this statutory requirement and directs the Secretary to issue a notice of proposed rulemaking to implement such requirement. MoCRA also amended the FD&C Act to include section 602(b)(3), which provides that a cosmetic is misbranded if it is in package form unless it bears a label containing the information required under section 609 of the FD&C Act. Further, under section 701(a) of the FD&C Act, the Agency is empowered to issue regulations for the efficient enforcement of the Act.

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Alternative 1: Shorten compliance date

FDA will consider an earlier compliance date for making the required labeling changes. Under this regulatory alternative, the costs of the rule are expected to be higher because earlier compliance date would give no time for producers to coordinate their label changes. However, the benefits could be realized much quickly

Alternative 2: Require alternative labeling

FDA will also consider an alternative labeling requirement, such as a more general allergen statement. We expect the costs of the labeling change under this alternative would be similar to the costs of the labeling change in our main analysis while we expect the benefits to be lower under this option.

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We estimate the costs of this rule will mainly come from compliance costs on affected entities to change their product labels to disclose the fragrance allergens. Additional costs will come from reading and understanding the rule.

The benefits of this rule will accrue to consumers and producers from increased information about their cosmetic products, allowing them to make more economically efficient consumption decisions and avoiding deadweight loss caused by production and use of fragrance allergens.

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None.

]]> NPRM 01/00/2025 Undetermined None Undetermined No No Elizabeth Anderson Senior Policy Analyst 0910 Food and Drug Administration FDA 240 402-4565 elizabeth.anderson@fda.hhs.gov Office of the Chief Scientist, 4300 University Station, River Road, College Park MD 20740