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

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration 21 CFR Part 74 [Docket No. FDA-2023-N-0437] AGENCY: Food and Drug Administration, HHS. ACTION: Final amendment; order. SUMMARY: 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. 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 ( printed page 4629) section X for further information on the filing of objections. ADDRESSES: You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 18, 2025. Objections received by mail/hand del…