Proposal To Revoke 23 Standards of Identity for Foods

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Parts 136, 139, 146, 161, and 169</CFR> <DEPDOC>[Docket No. FDA-2025-N-1307]</DEPDOC> <RIN>RIN 0910-AJ12</RIN> <SUBJECT>Proposal To Revoke 23 Standards of Identity for Foods</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is proposing to revoke 23 standards of identity for food. FDA is taking this action because we tentatively conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This proposed action would reduce redundant regulatory requirements. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Submit either electronic or written comments on the proposed rule by September 15, 2025. FDA does not intend to extend the comment period. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments as follows. Please note that late, untimely filed comments 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 September 15, 2025. Comments 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 comments in the following way: • <E T="03">Federal eRulemaking Portal: https://www.regulations.gov.</E> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment 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 comments, that information will be posted on <E T="03">https://www.regulations.gov.</E> • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment 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 comments submitted to the Dockets Management Staff, FDA will post your comment, 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-2025-N-1307 for “Proposal to Revoke 23 Standards of Identity for Foods.” Received comments, 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 a comment with confidential information that you do not wish to be made publicly available, submit your comments 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 comments. 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 comments 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, the plain language summary of the proposed rule of not more than 100 words as required by the “Providing Accountability Through Transparency Act,” 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> Claudine Kavanaugh, Office of Nutrition and Food Labeling, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371; Meridith L. Kelsch, 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. Executive Summary</FP> <FP SOURCE="FP1-2">A. Purpose of the Proposed Rule</FP> <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Proposed Rule</FP> <FP SOURCE="FP1-2">C. Legal Authority</FP> <FP SOURCE="FP1-2">D. Costs and Benefits</FP> <FP SOURCE="FP-2">II. Background</FP> <FP SOURCE="FP-2">III. Description of the Proposed Rule</FP> <FP SOURCE="FP-2">IV. Proposed Effective Date</FP> <FP SOURCE="FP-2">V. Preliminary Economic Analysis of Impacts</FP> <FP SOURCE="FP1-2">A. Introduction</FP> <FP SOURCE="FP1-2">B. Overview of Benefits, Costs, and Transfers</FP> <FP SOURCE="FP-2">VI. Analysis of Environmental Impact</FP> <FP SOURCE="FP-2">VII. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">VIII. Federalism</FP> <FP SOURCE="FP-2">IX. Consultation and Coordination with Indian Tribal Governments</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose of the Proposed Rule</HD> This action proposes to remove 23 standards of identity for food that FDA tentatively concludes are no longer necessary to promote honesty and fair dealing in the interest of consumers. <HD SOURCE="HD2">B. Summary of the Major Provisions of the Proposed Rule</HD> This action proposes to remove the following food standard regulations: <HD SOURCE="HD3">Part 136—Bakery Products</HD> <EXTRACT> <FP SOURCE="FP-1">• 136.130 Milk bread, rolls, and buns</FP> </EXTRACT> <HD SOURCE="HD3">Part 139—Macaroni and Noodle Products</HD> <EXTRACT> <FP SOURCE="FP-1">• 139.117 Enriched macaroni products with fortified protein</FP> <FP SOURCE="FP-1">• 139.120 Milk macaroni products</FP> <FP SOURCE="FP-1">• 139.121 Nonfat milk macaroni products</FP> <FP SOURCE="FP-1">• 139.122 Enriched nonfat milk macaroni products</FP> <FP SOURCE="FP-1">• 139.140 Wheat and soy macaroni products</FP> <FP SOURCE="FP-1">• 139.160 Vegetable noodle products</FP> <FP SOURCE="FP-1">• 139.165 Enriched vegetable noodle products</FP> <FP SOURCE="FP-1">• 139.180 Wheat and soy noodle products</FP> </EXTRACT> <HD SOURCE="HD3">Part 146—Canned Fruit Juices </HD> <EXTRACT> <FP SOURCE="FP-1">• 146.121 Frozen concentrate for artificially sweetened lemonade</FP> <FP SOURCE="FP-1">• 146.126 Frozen concentrate for colored lemonade</FP> <FP SOURCE="FP-1">• 146.137 Frozen orange juice</FP> <FP SOURCE="FP-1">• 146.148 Reduced acid frozen concentrated orange juice</FP> <FP SOURCE="FP-1">• 146.150 Canned concentrated orange juice</FP> <FP SOURCE="FP-1">• 146.151 Orange juice for manufacturing</FP> <FP SOURCE="FP-1">• 146.152 Orange juice with preservative</FP> <FP SOURCE="FP-1">• 146.153 Concentrated orange juice for further manufacturing</FP> <FP SOURCE="FP-1">• 146.154 Concentrated orange juice with preservative</FP> </EXTRACT> <HD SOURCE="HD3">Part 161—Fish and Shellfish</HD> <EXTRACT> <FP SOURCE="FP-1">• 161.136 Olympia oysters</FP> <FP SOURCE="FP-1">• 161.176 Frozen raw lightly breaded shrimp</FP> </EXTRACT> <HD SOURCE="HD3">Part 169—Food Dressings and Flavorings </HD> <EXTRACT> <FP SOURCE="FP-1">• 169.180 Vanilla-vanillin extract</FP> <FP SOURCE="FP-1">• 169.181 Vanilla-vanillin flavoring</FP> <FP SOURCE="FP-1">• 169.182 Vanilla-vanillin powder</FP> </EXTRACT> In addition to the removal of these food standards, this action proposes to amend regulations that reference these food standards. <HD SOURCE="HD2">C. Legal Authority</HD> We are issuing this proposed rule based on our authority under section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 341), which directs the Secretary of Health and Human Services (Secretary) to issue regulations fixing and establishing for any food a reasonable definition and standard of identity, quality, or fill of container whenever in the judgment of the Secretary such action will promote honesty and fair dea ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 47k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━