Data / Federal rules / 2025-00830
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
The Food and Drug Administration published this final rule in the Federal Register on January 16, 2025. It takes effect on January 15, 2027.
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What the agency says
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.
Key facts
- Document number
- 2025-00830
- Type
- Final rule
- Action
- Final amendment; order
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- January 16, 2025
- Takes effect
- January 15, 2027
- Dates
- This order is effective January 15, 2027, except for amendatory instruction 4, which is effective January 18, 2028. If any provisions are delayed or stayed by the filing of proper objections, FDA will publish such notification in the Federal Register. Submit either electronic or written objections and requests for a hearing on the order by February 18, 2025. See section X for further information on the filing of objections.
- Docket
- Docket No. FDA-2023-N-0437
- Code of Federal Regulations
- 21 CFR 74
- Topics
- Color additives; Cosmetics; Drugs
- Pages
- 7
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on color additives · Rules on cosmetics · Rules on drugs · Published in January 2025
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.