FDA Delays MoCRA Fragrance Allergen Rule to May 2026

FDA Delays Proposed Rule on Fragrance Allergen Labelling

The US Food and Drug Administration (FDA) has delayed the publication of its proposed rule on fragrance allergen labelling. Under the Modernization of Cosmetics Regulation Act (MoCRA), the FDA is required to issue regulations that establish a list of fragrance allergens that must be disclosed on a product's label.

The original statutory deadline has been subject to several extensions, with the most recent timeline indicating that the proposed rule is not expected until May 2026. Once the proposed rule is issued, the FDA must consider public comments and then publish a final rule within 180 days after the comment period closes.

This delay changes the time horizon for brands to implement new US fragrance allergen disclosure requirements. The final rule will affect both cosmetic products and certain dual-status OTC drug-cosmetic products, such as sunscreens and acne treatments, requiring updates to formulations and packaging to align with the new standards once they are finalised.

You may access the FDA's overview on MoCRA here.