CVM GFI #284 Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food

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Claims for Adult Maintenance Cat Food</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/regulatory-information/search-fda-guidance-documents" title="Search for FDA Guidance Documents"> Search for FDA Guidance Documents </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-11" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <p class="content-type-label text-center">GUIDANCE DOCUMENT</p> <h1 class="text-center content-title">CVM GFI #284 Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food <span class="article-subtitle text-center"></span> <span class="font-family-sans">October 2024</span> </h1> <div class="lcds-toolbar text-center"> <a class="btn btn-primary" href="/media/173985/download">Download the Final Guidance Document</a> <a class="btn btn-primary" href="https://www.federalregister.gov/public-inspection/2024-23706/guidance-using-relative-supersaturation-to-support-urinary-tract-health-claims-for-adult-maintenance">Read the Federal Register Notice</a> </div> <div class="lcds-statusbar text-center"> <span class="label label-default">Final</span> </div> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fcvm-gfi-284-using-relative-supersaturation-support-urinary-tract-health-claims-adult-maintenance-cat" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a 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href="mailto:?subject=CVM%20GFI%20%23284%20Using%20Relative%20Supersaturation%20to%20Support%20%E2%80%9CUrinary%20Tract%20Health%E2%80%9D%20Claims%20for%20Adult%20Maintenance%20Cat%20Food&body=https://www.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fcvm-gfi-284-using-relative-supersaturation-support-urinary-tract-health-claims-adult-maintenance-cat" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <div class="inset-column"> <dl class="lcds-description-list--grid"> <dt class="cell-1_1">Docket Number:</dt> <dd class="cell-2_1"><a href="https://www.regulations.gov/docket/FDA-2023-D-4095">FDA-2023-D-4095</a></dd> <dt class="cell-1_2">Issued by:</dt> <dd class="cell-2_2"><a href="/regulatory-information/search-fda-guidance-documents/cvm-gfi-284-using-relative-supersaturation-support-urinary-tract-health-claims-adult-maintenance-cat"></a> <div class="field field--name-field-issuing-office-taxonomy field--type-entity-reference field--label-above"> <div class="field--label">Guidance Issuing Office</div> <div class="field--items"> <div class="field--item">Center for Veterinary Medicine</div> </div> </div> </dd> </dl> </div> <p>The Center for Veterinary Medicine has evaluated the use of relative supersaturation (RSS) methodology to support urinary tract health (UTH) labeling for certain adult maintenance cat food.  RSS is a measurement that estimates the potential for crystal formation and bladder stone (urolith) growth, which is a common affliction in cats.  This guidance provides recommendations for how pet food manufacturers can use RSS methodology to substantiate labeling that an adult maintenance cat food supports urinary tract health by promoting a healthy mineral content in the urinary tract.  </p> <p>The recommendations we provide in this guidance include:  (1) the wording of UTH adult maintenance cat food UTH labeling based on RSS methodology; (2) the RSS criteria to substantiate UTH labeling; and (3) the study data CVM requests from pet food manufacturers that demonstrate the utility and target animal safety of the cat food.     <br>  </p> <div class="inset-column"> <hr> <h2>Submit Comments</h2> <div class="row"> <div class="col-xs-12 col-sm-4"> <a class="btn btn-primary" <a href="https://www.regulations.gov/docket/FDA-2023-D-4095/document">Submit Comments Online</a> </div> <div class="col-xs-12 col-sm-8"> <p class="lcds-explainer-txt">You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))</p> <p class="lcds-explainer-txt">If unable to submit comments online, please mail written comments to:</p> <p class="lcds-explainer-txt"> Dockets Management<br/> Food and Drug Administration<br/> 5630 Fishers Lane, Rm 1061<br/> Rockville, MD 20852</p> <p class="lcds-explainer-txt"> All written comments should be identified with this document's docket number: <a href="https://www.regulations.gov/docket/FDA-2023-D-4095">FDA-2023-D-4095</a>. </p> </div> </div> </div> <h2>Questions?</h2> <div class="field field--name-field-contact-point field--type-entity-reference field--label-above"> <div class="field--label">Contact Point</div> <div class="field--items"> <div class="field--item"> <div class="inset-column"> <div class="row"> <div class="col-xs-12 col-md-6"> <dl> <dd>CVM</dd> <dd>Center for Veterinary Medicine<br /> Food and Drug Administration<br /> 7500 Standish Place<br /> Rockville, MD 20855<br /> </dd> <dd></dd> </dl> </div> <div class="col-xs-12 col-md-6"> <dl> <dd><span class="fa fa-envelope" aria-hidden="true"></span> <a 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CVM GFI #284 Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food | FDA