CVM GFI #284 Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food November 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-2023-D-4095
• Issued by: Center for Veterinary Medicine

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.  

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.     
 

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