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

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 74</CFR> <DEPDOC>[Docket No. FDA-2023-N-0437]</DEPDOC> <SUBJECT>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</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final amendment; order. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> 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 <E T="04">Federal Register</E> . 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. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. The <E T="03">https://www.regulations.gov</E> 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 delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic objections in the following way: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2023-N-0437 for “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.” Received objections, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of objections. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <E T="03">https://www.regulations.gov.</E> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your objections and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Shayla West-Barnette, Office of Pre-market Additive Safety, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1262; or Alexandra Beliveau, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Table of Contents</HD> <EXTRACT> <FP SOURCE="FP-2">I. Introduction</FP> <FP SOURCE="FP-2">II. Background</FP> <FP SOURCE="FP1-2">A. Statutory and Regulatory Background of Color Additive Regulation</FP> <FP SOURCE="FP1-2">B. Chemical Identity and Nomenclature of FD&C Red No. 3</FP> <FP SOURCE="FP1-2">C. History of FDA's Regulatory Actions for FD&C Red No. 3</FP> <FP SOURCE="FP-2">III. Summary and Context of Determination</FP> <FP SOURCE="FP-2">IV. Evaluation of Petition</FP> <FP SOURCE="FP-2">V. Comments on the Notice of Petition</FP> <FP SOURCE="FP-2">VI. Conclusion</FP> <FP SOURCE="FP-2">VII. Public Disclosure</FP> <FP SOURCE="FP-2">VIII. Analysis of Environmental Impacts</FP> <FP SOURCE="FP-2">IX. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">X. Objections</FP> <FP SOURCE="FP-2">XI. References</FP> </EXTRACT> <HD SOURCE="HD1">I. Introduction</HD> In the <E T="04">Federal Register</E> of February 17, 2023 (88 FR 10245), we announced that we filed a color additive petition (CAP 3C0323) jointly submitted by the Center for Science in the Public Interest, Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Chef Ann Foundation, Children's Advocacy Institute, Consumer Federation of America, Consumer Reports, Defend Our Health, Environmental Defense Fund, Environmental Working Group, Feingold Association of the United States, Food & Water Watch, Healthy Babies Bright Futures, Life Time Foundation, Momsrising, Prevention Institute, Public Citizen, Public Health Institute, Public Interest Research Group, Real Food for Kids, Lisa Y. Lefferts, Linda S. Birnbaum, and Philip J. Landrigan, c/o Mr. Jensen Jose, 1250 I Street NW, Ste 500, Washington, DC 20005 (the petitioners). The petition proposed that we repeal the color additive regulations for FD&C Red No. 3 in § 74.303 (21 CFR 74.303), which permits the use of FD&C Red No. 3 in foods (including dietary supplements), and § 74.1303 (21 CFR 74.1303), which permits the use of FD&C Red No. 3 in ingested drugs. The notice of petition gave interested parties until April 18, 2023, to submit comments on the filed color additive petition. In response to a written request submitted to the docket, we extended the comment period to May 18, 2023 (88 FR 19026, March 30, 2023). This order granting the request to revise the regulations to no longer provide for these uses of FD&C Red No. 3 responds to the petition. <HD SOURCE="HD1">II. Background</HD> <HD SOURCE="HD2">A. Statutory and Regulatory Background of Color Additive Regulation</HD> The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes us to regulate “color additives” (see section 721(b) of the FD&C Act (21 U.S.C. 379e(b))). The FD&C Act defines “color additive” as “a material which . . . is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and . . . [that] when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with [an]other substance) of imparting color thereto . . . The term “color” includes black, wh ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 45k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━