[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Notices]
[Pages 55480-55481]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22231]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0755]


Draft Compliance Policy Guide Sec. 690.150 on Labeling and 
Marketing of Nutritional Products Intended for Use To Diagnose, Cure, 
Mitigate, Treat, or Prevent Disease in Dogs and Cats; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft compliance policy guide (CPG) entitled 
``Compliance Policy Guide Sec. 690.150 Labeling and Marketing of 
Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, 
Treat, or Prevent Disease in Dogs and Cats.'' This draft CPG is 
intended to provide guidance to FDA staff and industry on how FDA 
intends to use its enforcement discretion with regard to the labeling 
and marketing of dog and cat food products that are labeled and/or 
marketed as intending to diagnose, cure, mitigate, treat, or prevent 
diseases and to provide nutrients in support of meeting the animal's 
total daily nutrient requirements.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft CPG before it begins work on the final version of the CPG, submit 
either electronic or written comments on the draft CPG by November 9, 
2012.

ADDRESSES: Submit written requests for single copies of the draft CPG 
to the Director, Division of Compliance Policy, Office of Enforcement, 
Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., rm. 
4044, Rockville, MD 20857. Send one self-addressed adhesive label to 
assist that office in processing your request, or fax your request to 
301-827-0482. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft CPG. Submit electronic comments to http://www.regulations.gov.
    Submit written comments on the draft CPG to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: William J. Burkholder, Center for 
Veterinary Medicine (HFV-228), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-453-6865, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft CPG entitled 
``Labeling and Marketing of Nutritional Products Intended for Use to 
Diagnose, Cure, Mitigate, Treat, or Prevent Disease in Dogs and Cats.'' 
The purpose of this CPG is to communicate FDA's strategy for enforcing 
the new animal drug provisions of the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) with respect to dog and cat food products that make 
labeling or marketing claims to diagnose, cure, mitigate, treat, or 
prevent disease. Since 1988, the Center for Veterinary Medicine (CVM) 
has observed an increase in the number of dog and cat food products 
making such claims that are sold with, or without, the direction of a 
licensed veterinarian. Because of this increase, and to help ensure 
animal safety, CVM is issuing this draft CPG to set out its current 
thinking with respect to factors it will consider before determining 
whether to take regulatory action against dog and cat food products 
intended for use in the diagnosis, cure, mitigation, treatment, or 
prevention of disease.
    FDA does not generally intend to recommend or initiate regulatory 
actions against dog and cat food products that are labeled and/or 
marketed as intended for use to diagnose, cure, mitigate, treat, or 
prevent diseases and to provide nutrients in support of meeting the 
animal's total daily nutrient requirements when all the following 
factors are present. Specifically: (1) Manufacturers make the products 
available to the public only through licensed veterinarians or through 
retail or Internet sales to individuals purchasing the product under 
the direction of a veterinarian; (2) manufacturers do not market such 
products as alternatives to approved new animal drugs; (3) the 
manufacturer is registered under section 415 of the FD&C Act (21 U.S.C. 
350(d)); (4) manufacturers comply with all food labeling requirements 
for such products (see 21 CFR part 501); (5) manufacturers do not 
include indications for a disease claim (e.g., obesity, renal failure) 
on the label of such products; (6) manufacturers limit distribution of 
material with any disease claims for such products only to veterinary 
professionals; (7) manufacturers secure electronic resources for the 
dissemination of labeling information and promotional materials such 
that they are available only to veterinary professionals; (8) 
manufacturers include only ingredients that are general regarded as 
safe (GRAS) ingredients, approved food additives, or feed ingredients 
defined in the 2012 Official Publication of the Association of American 
Feed Control Officials (AAFCO) for the intended uses in such products; 
\1\ and (9) the label and labeling for such products are not false and 
misleading in other respects.\2\
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    \1\ Although food containing these unapproved food additives is 
adulterated within the meaning of section 402(a)(2)(c)(i), FDA is 
unlikely to initiate enforcement action solely on this basis if the 
food additive in question is included in the 2012 edition of the 
Official Publication of AAFCO. As part of its efforts to work with 
State partners, FDA has reviewed safety information related to many 
of these listed products, and those listed in the 2012 Official 
Publication generally do not fall within our current enforcement 
priorities.
    \2\ A therapeutic claim that is not scientifically substantiated 
would be considered false or misleading, thus making the product 
misbranded.
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II. Significance of Guidance

    This level 1 draft CPG is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft CPG, when 
finalized, will represent the Agency's current thinking on this topic. 
It does not create or confer any rights for or on any person and does 
not operate to bind FDA or the public. An alternative approach may be 
used if such approach satisfies the

[[Page 55481]]

requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3 and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506 (c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, we are publishing a notice 
of the proposed collection of information set forth below.
    With respect to the following collection of information, we invite 
comments on: (1) Whether the proposed collection of information is 
necessary for the proper performance of our functions, including 
whether the information will have practical utility; (2) the accuracy 
of our estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.
    Title: Draft Compliance Policy Guide on Labeling and Marketing of 
Nutritional Products Intended for Use to Diagnose, Cure, Mitigate, 
Treat, or Prevent Disease in Dogs and Cats.
    Description: The purpose of this CPG is to communicate FDA's 
strategy with respect to dog and cat food products that are labeled 
and/or marketed as intending to diagnose, cure, mitigate, treat, or 
prevent diseases and to provide nutrients in support of meeting the 
animal's total daily nutrient requirements.
    Description of Respondents: Manufacturers of dog and cat foods that 
are labeled and/or marketed as intending to diagnose, cure, mitigate, 
treat, or prevent diseases and to provide nutrients in support of 
meeting the animal's total daily nutrient requirements.
    We estimate the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
            Activity                 Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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Sections 402 and 403 of the FD&C               5              75             375             .25              94
 Act............................
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\1\ There are no operating costs or maintenance costs associated with this collection of information.

    CVM estimates from its experience that approximately 5 
manufacturers will be affected by the draft CPG, times 75 products 
produced annually equals 375 total annual responses. The hours per 
response are based on approximately .25 hour per response for 
respondents to look up the ingredient names in the AFFCO Official 
Publication.
    This draft CPG also refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 571 (Food Additive Petitions 
and FAP Labeling) have been approved under OMB control number 0910-
0546. The collection of information in 21 CFR 570.35 (GRAS) has been 
approved under OMB control number 0910-0342. The requirement for food 
facility registration has been approved under OMB control number 0910-
0502.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this document. 
It is only necessary to send one set of comments. Received comments may 
be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

V. Electronic Access

    Copies of the CPG may be downloaded to a personal computer with 
access to the Internet. The Office of Regulatory Affairs home pages 
include this draft CPG and may be accessed at http://www.fda.gov/ICECI/ComplianceManuals/ under ``Compliance Policy Guides.''

    Dated: August 24, 2012.
Dara A. Corrigan,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 2012-22231 Filed 9-7-12; 8:45 am]
BILLING CODE 4160-01-P