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Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry #284 entitled “Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food.”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 This draft guidance provides recommendations for how pet food manufacturers can use RSS methodology to substantiate general structure or function claims that an adult maintenance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.
Submit either electronic or written comments on the draft guidance by February 28, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2023-D-4095 for “Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food.” 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.
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 the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.
Karen Donnelly, Center for Veterinary Medicine (HFV-227), Food and Drug Administration, 12225 Wilkins Avenue, Rockville, MD 20852, 240-402-9802, karen.donnelly2@fda.hhs.gov.
FDA 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.” RSS methodology is a measurement that estimates the potential for crystal formation and bladder stone (urolith) growth, which is a common affliction in cats. One of the primary conditions for urolith formation in any species is oversaturation of the urine with dissolved substances (solutes) that have the potential to precipitate out of solution and form crystals. These crystals can eventually grow into uroliths. The two most common types of uroliths in cats are magnesium ammonium phosphate (struvite) and calcium oxalate (CaOx).
Based on concerns about uroliths, pet food manufacturers use various formulation strategies to make adult maintenance cat food, with general structure or function claims, that support urinary tract health (UTH cat food). Historically, manufacturers of UTH cat food restricted the magnesium content and/or formulated their cat food to produce slightly acidic urine (pH of 5.9 to 6.4). The slight acidity and low magnesium content create a urinary environment that is unfavorable for struvite crystallization and urolith growth but may be favorable for CaOx urolith growth in predisposed cats. Formulating cat food based on RSS methodology is a more recent dietary strategy that some pet food manufacturers use to create UTH cat food. RSS provides a numerical measurement of the degree of saturation of a specific urolith-forming substance, and thus a quantitative method to evaluate the risk of urolith formation. The principles of RSS apply to all urolith types, so UTH cat food based on RSS methodology has the potential to help protect cats from both struvite and CaOx uroliths.
In response to requests from pet food manufacturers, CVM has evaluated the use of RSS methodology to support urinary tract health claims for certain adult maintenance cat food. This draft guidance provides recommendations for how a cat food manufacturer 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. This draft guidance also includes information we recommend the manufacturer submits to us to ensure the urinary tract health claim is substantiated.
This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Using Relative Supersaturation to Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food.” 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.
FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: November 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-26306 Filed 11-29-23; 8:45 am]
BILLING CODE 4164-01-P
4 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.