Notice2023-26306
Using Relative Supersaturation To Support “Urinary Tract Health” Claims for Adult Maintenance Cat Food; Draft Guidance for Industry; Availability
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Published
November 30, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry #284 entitled "Using Relative Supersaturation to Support "Urinary Tract Health" Claims for Adult Maintenance Cat Food."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 This draft guidance provides recommendations for how pet food manufacturers can use RSS methodology to substantiate general structure or function claims that an adult maintenance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.
Full Text
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<title>Federal Register, Volume 88 Issue 229 (Thursday, November 30, 2023)</title>
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[Federal Register Volume 88, Number 229 (Thursday, November 30, 2023)]
[Notices]
[Pages 83552-83554]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-26306]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-4095]
Using Relative Supersaturation To Support ``Urinary Tract
Health'' Claims for Adult Maintenance Cat Food; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: 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announcing the availability of a draft guidance for industry #284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.
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.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you
[[Page 83553]]
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:
<bullet> 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.
<bullet> 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-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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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.'' The Agency will
review this copy, including the claimed confidential information, in
its 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
FOR FURTHER INFORMATION CONTACT: Karen Donnelly, Center for Veterinary
Medicine (HFV-227), Food and Drug Administration, 12225 Wilkins Avenue,
Rockville, MD 20852, 240-402-9802, <a href="/cdn-cgi/l/email-protection#8de6ecffe8e3a3e9e2e3e3e8e1e1f4bfcdebe9eca3e5e5fea3eae2fb"><span class="__cf_email__" data-cfemail="86ede7f4e3e8a8e2e9e8e8e3eaeaffb4c6e0e2e7a8eeeef5a8e1e9f0">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
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.
II. Paperwork Reduction Act of 1995
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.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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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
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