Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

<NOTICE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <DEPDOC>[Docket No. FDA-2022-D-1102]</DEPDOC> <SUBJECT>Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Notice of availability. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Labeling of Plant-Based Alternatives to Animal-Derived Foods.” This draft guidance, when finalized, will provide our recommendations on best practices for naming and labeling of certain plant-based foods that are marketed and sold as alternatives for animal-derived foods (plant-based alternative foods), especially in the absence of a common or usual name for the product. This draft guidance does not address the naming and labeling of plant-based milk alternatives; FDA is providing recommendations regarding these products in a separate guidance document. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Submit either electronic or written comments on the draft guidance by May 7, 2025 to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the draft guidance by March 10, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> You may submit comments on any guidance at any time as follows: <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-2022-D-1102 for “Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request.” Received comments 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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to Office of Nutrition and Food Labeling (HFS-800), Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the <E T="02">SUPPLEMENTARY INFORMATION</E> section for electronic access to the guidance. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">With regard to the draft guidance:</E> Andrea Krause, Office of Nutrition and Food Labeling (HFS-820), Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371; or Lauren Kleinman, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2378. <E T="03">With regard to the proposed collection of information:</E> Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733, <E T="03">PRAStaff@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Background</HD> We are announcing the availability of a draft guidance for industry entitled “Labeling of Plant-Based Alternatives to Animal-Derived Foods.” This draft guidance is intended to provide our recommendations on best practices for naming and labeling of certain plant-based foods that are marketed and sold as alternatives for animal-derived foods (plant-based alternative foods), especially in the absence of a common or usual name for the product. Consumer demand for plant-based alternative foods has increased and FDA is committed to helping ensure consumers understand the foods they buy, to help them make informed dietary choices. The scope of this draft guidance includes plant-based alternatives to eggs, seafood, poultry, meat, and dairy (excluding plant-based milk alternatives) that fall under FDA jurisdiction. (In the <E T="04">Federal Register</E> of February 23, 2023 (88 FR 11449), we announced the availability of a draft guidance entitled “Labeling of Plant-based Milk Alternatives and Voluntary Nutrient Statements: Draft Guidance for Industry.” When finalized, the guidance will provide FDA's view on the naming of plant-based food products that are marketed and sold as alternatives to milk (plant-based milk alternatives) and our recommendations on the use of voluntary nutrient statements. The draft guidance entitled “Labeling of Plant-based Milk Alternatives and Voluntary Nutrient Statements: Draft Guidance for Industry” is available online at <E T="03">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-labeling-plant-based-milk-alternatives-and-voluntary-nutrient-statements.</E> ) We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. <HD SOURCE="HD1">II. Paperwork Reduction Act of 1995</HD> Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the <E T="04">Federal Register</E> concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of informatio ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 14k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━