Home › 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
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register 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.
- Document type
- Rule
- Federal Register document number
- 2025-00830
- Published
- Jan 16, 2025
- Action
- Final amendment; order.
- Docket
- FDA-2023-N-0437
- Comments posted on Regulations.gov (at last check)
- 1
- CFR parts
- 21 CFR 74
- DATES section (from the document)
- 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.
- Topics (auto-tagged)
- Food & dietary supplements
Source: Federal Register API, document 2025-00830. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.