Revocation of Food Standards for 11 Products Not Currently Sold

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Parts 145 and 155</CFR> <DEPDOC>[Docket No. FDA-2025-N-1184]</DEPDOC> <RIN>RIN 0910-AJ06</RIN> <SUBJECT>Revocation of Food Standards for 11 Products Not Currently Sold</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Direct final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) revokes 11 food standards for foods that are no longer sold in the United States. FDA is taking this action as these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. This action will remove obsolete rules to reduce unnecessary regulatory requirements. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective September 22, 2025, unless significant adverse comment is received by August 18, 2025. If FDA receives significant adverse comments, it will publish a timely withdrawal in the <E T="04">Federal Register</E> informing the public that this rule or a portion thereof will not take effect. </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 August 18, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic comments in the following way: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">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-1184 for “Revocation of Food Standards for 11 Products Not Currently Sold.” 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 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; Meadow Platt, 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 Direct Final Rule</FP> <FP SOURCE="FP1-2">B. Summary of the Major Provisions of the Direct Final 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 Direct Final Rule</FP> <FP SOURCE="FP-2">IV. 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">V. Analysis of Environmental Impact</FP> <FP SOURCE="FP-2">VI. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">VII. Federalism</FP> <FP SOURCE="FP-2">VIII. Consultation and Coordination With Indian Tribal Governments</FP> </EXTRACT> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose of the Direct Final Rule</HD> This action removes regulations that FDA believes are obsolete and no longer necessary to promote honesty and fair dealing in the interest of consumers. We are also publishing elsewhere in this issue of the <E T="04">Federal Register</E> a companion proposed rule proposing to take the actions described in this direct final rule. The companion proposed rule provides a procedural framework within which the rule may be finalized if the direct final rule is withdrawn because of any significant adverse comments. The comment period for the direct final rule runs concurrently with the companion proposed rule. Any comments received in response to the companion proposed rule will be considered as comments regarding the direct final rule. <HD SOURCE="HD2">B. Summary of the Major Provisions of the Direct Final Rule</HD> This direct final rule revokes: <HD SOURCE="HD3">Part 145—Canned Fruits</HD> <FP SOURCE="FP-1">• 145.116: Artificially sweetened canned apricots</FP> <FP SOURCE="FP-1">• 145.126: Artificially sweetened canned cherries</FP> <FP SOURCE="FP-1">• 145.131: Artificially sweetened canned figs</FP> <FP SOURCE="FP-1">• 145.134: Canned preserved figs</FP> <FP SOURCE="FP-1">• 145.136: Artificially sweetened canned fruit cocktail</FP> <FP SOURCE="FP-1">• 145.140: Canned seedless grapes</FP> <FP SOURCE="FP-1">• 145.171: Artificially sweetened canned peaches</FP> <FP SOURCE="FP-1">• 145.176: Artificially sweetened canned pears</FP> <FP SOURCE="FP-1">• 145.181: Artificially sweetened canned pineapple</FP> The revocation of the standards for artificially sweetened canned fruit applies only to canned fruit made with saccharin and/or sodium saccharin since these are the only products covered under these standards. The revocation does not apply to any other reduced sugar canned fruit products. <HD SOURCE="HD3">Part 155—Canned Vegetables</HD> <FP SOURCE="FP-1">• 155.131: Canned field corn</FP> <FP SOURCE="FP-1"> • 155.172: Canned dry peas </FP> <HD SOURCE="HD2">C. Legal Authority</HD> We are issuing this direct final rule to revoke the standards for the listed products based on our authority under section 401 of the Federal Food, Drug, and Cosmetic Act (the 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 Secretary's judgment, such action will promote honesty and fair dealing in the interest of consumers. This direct final rule is also issued upon the Secretary's authority under section 701(a) of the FD&C Act (21 U.S.C. 371) for the efficient enforcement of the FD&C Act. <HD SOURCE="HD2">D. Costs and Benefits</HD> Our analysis of the current market indicates that there ar ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 24k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━