{"abstract":"The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry #284 entitled \"Using Relative Supersaturation to Support \"Urinary Tract Health\" Claims for Adult Maintenance Cat Food.\" FDA's Center for Veterinary Medicine (CVM) has evaluated the use of relative supersaturation (RSS) methodology to support urinary tract health claims for certain adult maintenance cat food. RSS is a measurement that estimates the potential for crystal formation and bladder stone growth, which is a common affliction in cats. This draft guidance provides recommendations for how pet food manufacturers can use RSS methodology to substantiate general structure or function claims that an adult maintenance cat food supports urinary tract health by promoting a healthy mineral content in the urinary tract.","action":"Notice of availability.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2023/11/30/2023-26306.html","cfr_references":[],"citation":"88 FR 83552","comment_url":null,"comments_close_on":"2024-02-28","correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on the draft guidance by February 28, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-D-4095"],"dockets":[{"supporting_documents":[{"title":"Reference 1 - American Association of Feed Control Officials. 2024 Official Publication of the Association of American Feed Control Officials. Champaign, IL 61820. https://www.aafco.org/publications (accessed October 3, 2024).","document_id":"FDA-2023-D-4095-0042"},{"title":"List of references for final GFI #284","document_id":"FDA-2023-D-4095-0041"},{"title":"Reference 29 van Hoek 2009 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0032"},{"title":"Reference 28 Tournier et al. 2008 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0031"},{"title":"Reference 27 Tournier and Biourge 2008 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0030"},{"title":"Reference 26 Torres-Henderson 2017 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0029"},{"title":"Reference 23 Stevenson et al. 2000 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0026"},{"title":"Reference 21 Stevenson et al. 2003 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0024"},{"title":"Reference 20 Smith et al. 1998 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0023"},{"title":"Reference 19 Sagols et al. 2015 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0022"}],"agency_name":"FDA","documents":[{"comment_count":4,"comment_start_date":"2023-11-30","updated_at":"2024-02-29T00:01:32.803-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-D-4095-0001","allow_late_comments":null,"id":"FDA-2023-D-4095-0001","comment_end_date":"2024-02-29","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":34,"id":"FDA-2023-D-4095","title":"Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food; Draft Guidance for Industry; Availability"}],"document_number":"2023-26306","effective_on":null,"end_page":83554,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/11/30/2023-26306.xml","html_url":"https://www.federalregister.gov/documents/2023/11/30/2023-26306/using-relative-supersaturation-to-support-urinary-tract-health-claims-for-adult-maintenance-cat-food","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-26306?publication_date=2023-11-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-11-30/2023-26306/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":422,"last_updated":"2026-08-24 16:15:16 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-11-30/pdf/2023-26306.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-26306.pdf?1701265591","publication_date":"2023-11-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/11/30/2023-26306.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Reference 1 - American Association of Feed Control Officials. 2024 Official Publication of the Association of American Feed Control Officials. Champaign, IL 61820. https://www.aafco.org/publications (accessed October 3, 2024).","document_id":"FDA-2023-D-4095-0042"},{"title":"List of references for final GFI #284","document_id":"FDA-2023-D-4095-0041"},{"title":"Reference 29 van Hoek 2009 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0032"},{"title":"Reference 28 Tournier et al. 2008 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0031"},{"title":"Reference 27 Tournier and Biourge 2008 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0030"},{"title":"Reference 26 Torres-Henderson 2017 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0029"},{"title":"Reference 23 Stevenson et al. 2000 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0026"},{"title":"Reference 21 Stevenson et al. 2003 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0024"},{"title":"Reference 20 Smith et al. 1998 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0023"},{"title":"Reference 19 Sagols et al. 2015 re Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food Guidance for Industry","document_id":"FDA-2023-D-4095-0022"}],"comments_count":4,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2023-D-4095","supporting_documents_count":34,"docket_id":"FDA-2023-D-4095","document_id":"FDA-2023-D-4095-0001","regulation_id_number":null,"title":"Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food; Draft Guidance for Industry; Availability","checked_regulationsdotgov_at":"2024-03-01T02:00:07Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":83552,"subtype":null,"title":"Using Relative Supersaturation To Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food; Draft Guidance for Industry; Availability","toc_doc":"Using Relative Supersaturation to Support Urinary Tract Health Claims for Adult Maintenance Cat Food","toc_subject":"Guidance:\n","topics":[],"type":"Notice","volume":88}