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 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2022-D-1102]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice of availability.
 SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Labeling of Plant-Based Alternatives to Animal-Derived Foods.” This draft guidance, when finalized, will provide our recommendations on best practices for naming and labeling of certain plant-based foods that are marketed and sold as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 This draft guidance does not address the naming and labeling of plant-based milk alternatives; FDA is providing recommendations regarding these products in a separate guidance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.
 DATES: Submit either electronic or written comments on the draft guidance by May 7, 2025 to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance. Submit electronic or written comments on the proposed collection of information in the draft guidance by March 10, 2025.
 ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: *Federal eRulemaking Portal: https://www.regulations.gov.*
                     Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to 
                    *https://www.regulations.gov*
                     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 
                    ( print page 1140)
                    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 
                    *https://www.regulations.gov.*
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”). Written/Paper Submissions Submit written/paper submissions as follows: *Mail/Hand Delivery/Courier (for written/paper submissions):*
                     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.” *Instructions:*
                     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 
                    *https://www.regulations.gov*
                     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*https://www.regulations.gov.*
                     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: 
                    *https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.* *Docket:*
                     For access to the docket to read background documents or the electronic and written/paper comments received, go to 
                    *https://www.regulations.gov*
                     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 
                    **SUPPLEMENTARY INFORMATION**
                     section for electronic access to the guidance.
 FOR FURTHER INFORMATION CONTACT:  *With regard to the draft guidance:*
                         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. *With regard to the proposed collection of information:*
                         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, 
                        *PRAStaff@fda.hhs.gov.*


SUPPLEMENTARY INFORMATION:  I. Background 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 
                    **Federal Register**
                     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 
                    *https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​draft-guidance-industry-labeling-plant-based-milk-alternatives-and-voluntary-nutrient-statements.*) 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. II. Paperwork Reduction Act of 1995 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 
                    **Federal Register**
                     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 information set forth in this document.
                    ( print page 1141) With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology. Labeling of Plant-Based Alternatives to Animal-Derived Foods: Draft Guidance for Industry OMB Control Number 0910-0381—Revision The draft guidance, once finalized, will provide recommendations on best practices for naming and labeling of certain plant-based alternative foods. Industry's use of these recommendations for naming and labeling plant-based alternative foods will help ensure consumers understand the nature of individual plant-based alternative foods, including differences among these products, and have the information they need to make informed purchasing decisions. Standards of identity have not been established for plant-based alternative foods. As such, plant-based alternative foods are non-standardized foods and must be labeled with their common or usual name, or in the absence thereof, a statement of identity that accurately describes the food. See 21 CFR 101.3(b). Many plant-based alternative foods are novel foods and do not have common or usual names established by common usage. Currently, products appear to be identified in multiple ways, sometimes inconsistently across the category. Thus, the purpose of this guidance is 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. *Description of respondents:*
                     Respondents to this information collection are manufacturers, packers, and distributors of plant-based alternative foods that are marketed and sold in the United States. Respondents are from the private sector (for-profit businesses). We estimate the burden of this collection of information as follows: Table 1—Estimated Third-Party Disclosure Burden
Activity
Number of
                             respondents
Number of
                             disclosures  
                             per respondent
Total annual
                             disclosures
Average
                             burden per 
                             disclosure
Total hours
Total capital costs 1
                             2Labeling recommendations in “Labeling of Plant-Based Alternatives to Animal-Derived Foods”
160
5
800
1
800
$1,231,2001
                         One-time relabeling costs.2
                         There are no operating and maintenance costs associated with this collection of information.
 The estimates in table 1 are based on our experience with similar labeling programs. We estimate that each year 160 manufacturers will relabel their products following recommendations found in the draft guidance. We estimate that each manufacturer will relabel 5 products for 800 total annual disclosures (160 manufacturers × 5 labels). Each disclosure will take an estimated 1 hour to complete for an annual third-party disclosure burden of 800 hours (800 disclosures × 1 hour). We estimate that there will be an annual capital cost of $1,231,200 associated with relabeling. This is the cost of designing a revised label and incorporating it into the manufacturing process. We believe that this will be a one-time burden per respondent. III. Electronic Access Persons with access to the internet may obtain the guidance at either 
                    *https://www.fda.gov/​regulatory-information/​search-fda-guidance-documents, https://www.fda.gov/​FoodGuidances,*
                     or 
                    *https://www.regulations.gov.*
                     Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: December 27, 2024. Kimberlee Trzeciak, Deputy Commissioner for Policy, Legislation, and International Affairs.


[FR Doc. 2024-31535 Filed 1-6-25; 8:45 am] BILLING CODE 4164-01-P