← REGULATORY CHANGES
FEDERAL REGISTER · RULEJanuary 16, 2025FINAL — NOT YET EFFECTIVE

Color Additive Petition From Center for Science in the Public Interest, et al.; Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSFINAL — NOT YET EFFECTIVE
EFFECTIVEJan 15, 2027
COMMENTS CLOSE—
APPLIES TO · SPEQ TAGDrugDeviceFood
Document type
Rule
Agency
Health and Human Services Department
Published
January 16, 2025
Effective
January 15, 2027
Document number
2025-00830
CFR references
21 CFR 74
Docket
FDA-2023-N-0437
ABSTRACT

The Food and Drug Administration (FDA or we) is granting a color additive petition submitted by Center for Science in the Public Interest, et al., by repealing the color additive regulations that permit the use of FD&C Red No. 3 in foods (including dietary supplements) and in ingested drugs. The petitioners provided data demonstrating that this additive induces cancer in male rats. Therefore, FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No. 3 in the color additive regulations.

Abstract as published in the Federal Register.

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