Contains Nonbinding Recommendations 
 
Guidance for FDA Staff 
 
Compliance Policy Guide 
 
Sec. 690.150 Labeling and Marketing of Dog and Cat Food 
Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent 
Diseases 
 
Additional copies are available from: 
Food and Feed Policy Staff 
Office of Policy and Risk Management 
Office of Regulatory Affairs 
Food and Drug Administration 
12420 Parklawn Drive 
Rockville, MD 20857 
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm 
 
 
Submit comments on this guidance at any time.  Submit written comments to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 
1061, Rockville, MD 20852.  Submit electronic comments to http://www.regulations.gov.  All 
comments should be identified with the Docket No. FDA-2012-D-0755. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Regulatory Affairs 
and 
Center for Veterinary Medicine 
 
April 2016 
  Contains Nonbinding Recommendations 
Table of Contents 
 
I.  Introduction ........................................................................................................................... 3 
II.  Background ............................................................................................................................ 3 
III.  Discussion .......................................................................................................................... 5 
A.  Marketing Unapproved New Animal Drugs to Pet Owners .............................................. 5 
B.  Animal Food Ingredients ................................................................................................... 6 
IV.  Enforcement Policy ............................................................................................................ 6 
V.  Regulatory Action Guidance ................................................................................................. 8 
 
 
2  Contains Nonbinding Recommendations 
COMPLIANCE POLICY GUIDE 
 
Sec. 690.150 Labeling and Marketing of Dog and Cat Food 
Diets Intended to Diagnose, Cure, Mitigate, Treat, or Prevent 
Diseases 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on 
this topic.  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.  
To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the 
title page. 
 
I.  Introduction 
 
This document provides guidance to Food and Drug Administration (FDA) staff on how to 
address dog and cat food diets that are labeled and/or marketed as intended for use to diagnose, 
cure, mitigate, treat, or prevent diseases and are also labeled and/or marketed to provide all or 
most of the nutrients in support of meeting the animal's total daily nutrient requirements by 
serving as the pets sole diet.  Section IV below lists the factors FDA intends to consider in 
determining whether to exercise enforcement discretion with regard to animal drug approval 
requirements for dog and cat food diets that claim to treat or prevent disease.  This guidance 
does not apply to products intended for nutritional supplementation of foods for animals and/or 
products marketed as dietary supplements for animals. 
 
In general, FDA's guidance documents do not establish legally enforceable responsibilities.  
Instead, they describe the agency's current thinking on various topics and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited.  The use of 
the word should in agency guidances means that something is suggested or recommended, but 
not required. 
 
II.  Background 
 
For more than fifty years, dog and cat food manufacturers have marketed diets identified on their 
labels or in labeling or other communications disseminated by or on behalf of the manufacturers 
(manufacturer communications) as being intended to diagnose, cure, mitigate, treat, or prevent 
diseases (treat or prevent disease).  These products are intended to provide all or most of the 
nutrients in support of meeting the animals daily nutrient needs, serving as the animals sole 
source of nutrients or diet other than water.  By virtue of their intended use to treat or prevent 
disease, such products meet the statutory definition of a drug in section 201(g)(1)(B) of the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. 321(g)(1)(B)].  In addition, 
these products meet the definition of food in section 201(f) of the FD&C Act [21 U.S.C. 321(f)] 
because they are articles used for food for animals.  Consequently, under the FD&C Act, dog and 
cat food products that are intended to treat or prevent disease and to provide nutrients in support  
   
3  Contains Nonbinding Recommendations 
of the animal's daily nutrient needs can be regulated as drugs (section 201(g) of the FD&C Act 
[21 U.S.C. 321(g)]), foods (section 201(f) of the FD&C Act [21 U.S.C. 321(f)]), or both. 
 
Section 512(a)(1) [21 U.S.C. 360b(a)(1)] of the FD&C Act provides, in general, that new animal 
drugs are unsafe unless they have an approved New Animal Drug Application (NADA), an 
approved Abbreviated New Animal Drug Application (ANADA) under section 512 of the 
FD&C Act [21 U.S.C. 360(b)], a conditional approval under section 571 of the FD&C Act [21 
U.S.C. 360ccc], or an index listing under section 572 of the FD&C Act [21 U.S.C. 360ccc-1] 
(approved or index listed").1  Unsafe new animal drugs are adulterated within the meaning 
of section 501(a)(5) of the FD&C Act [21 U.S.C. 351(a)(5)], misbranded under section 502(f)(1) 
for lacking adequate directions for use [21 U.S.C. 352(f)(1)], and their introduction into 
interstate commerce is a prohibited act as specified in section 301(a) of the FD&C Act [21 
U.S.C. 331(a)]. 
 
The FD&C Act also places other requirements on the manufacture of drugs.  For example, it 
requires that all drug manufacturers register and list drugs with FDA (section 510 of the FD&C 
Act [21 U.S.C. 360]).  This requirement applies regardless of whether the drug at issue is 
approved or index listed.  Drugs that are manufactured in an unregistered facility, or are not drug 
listed, are misbranded within the meaning of section 502(o) of the FD&C Act [21 U.S.C. 
352(o)], and their introduction into interstate commerce is a prohibited act as specified in section 
301(a) of the FD&C Act [21 U.S.C. 331(a)]. 
 
In addition, section 501(a)(2)(B) of the FD&C Act [21 U.S.C. 351(a)(2)(B)] requires that any 
animal drug product be manufactured in accordance with current good manufacturing practices 
applicable to drugs.  Drugs that are not manufactured in accordance with current good 
manufacturing practices are adulterated within the meaning of section 501(a)(2)(B) of the 
FD&C Act [21 U.S.C. 351(a)(2)(B)], and their introduction into interstate commerce is a 
prohibited act as specified in section 301(a) of the FD&C Act [21 U.S.C. 331(a)]. 
 
At the time of this CPG issuance, most dog and cat food products that claim on their labels or 
in their labeling or other manufacturer communications to treat or prevent disease are not 
approved new animal drugs, and do not comply with drug registration and listing requirements, 
or with current good manufacturing practices applicable to drugs even though the products are 
drugs under the FD&C Act.  Nevertheless, in the past, FDA generally exercised enforcement 
discretion with regard to these requirements for dog and cat food diets that claim to treat or 
prevent disease when 1) those products provided all or most of the nutrients in support of the 
animals total required daily nutrient needs, 2) product labels and labeling and other 
manufacturer communications that were available to the general public (i.e., non-veterinary 
professionals) did not contain claims to treat or prevent disease, and 3) those products were 
distributed only through licensed veterinarians. 
 
   
                                                            
1Products intended for use in dogs or cats are not eligible to be index listed new animal drugs because dogs and cats 
are considered major species under the FD&C Act, and index listing is limited to products for minor species. 
4  Contains Nonbinding Recommendations 
FDA has observed an increase in the number of dog and cat food products that manufacturers 
offer for use in the treatment or prevention of disease and an increase in the number of such 
products that are being sold directly to consumers.  Because of this increase, and to help ensure 
animal safety, FDA is issuing this CPG to provide guidance to FDA staff with respect to factors 
to consider in determining whether to take regulatory action against dog and cat food products 
intended to be fed as the pets sole diet and intended for use in the treatment or prevention of 
disease. 
 
III. Discussion 
 
A.  Marketing Unapproved New Animal Drugs to Pet Owners 
 
Animal health may suffer when dog and cat food diets intended to treat or prevent disease, but 
which are not approved as new animal drugs, are fed to pets.  These products have not been 
evaluated by FDA for safety, efficacy, or nutritional adequacy.  Many of these products affect 
physiological processes to extents that may not be tolerated by all animals, may not achieve 
effective treatment, and/or may not provide adequate daily nutrition if fed as a sole diet. 
 
These concerns are heightened when these products are put into use by pet owners without the 
direction of a licensed veterinarian.  When these products are marketed directly to pet owners, 
there is a greater potential for product misuse and/or misunderstanding of the role of the product 
in the disease treatment.  These products are commonly labeled or marketed for use in dogs or 
cats with diseases or conditions that cannot be accurately diagnosed by pet owners.  In addition, 
the labeling or other materials may lack sufficient information, particularly for pet owners, on 
the effectiveness, possible side effects, and contraindications for use.  For example, owners of 
diabetic dogs and cats may misinterpret claims to control blood glucose to represent that the 
product is the sole treatment required for diabetic dogs and cats when, in fact, these animals may 
require insulin therapy or other treatments to adequately control blood glucose.  Also, some dog 
and cat food diets intended to treat obesity may not be formulated to meet daily requirements for 
nutrients other than calories, which pet owners may not understand without guidance from a 
veterinary professional. 
 
These concerns are reduced when such dog and cat food diets are marketed only through and 
used under the direction of a licensed veterinarian.  Veterinarians typically discuss an animals 
nutritional needs with the pet owner, make periodic assessments of the animals health, and 
provide direction to the pet owner for how to use the product.  Veterinarians can also help 
ensure that animals diagnosed as suffering from a disease or other health condition receive 
other appropriate treatments for their condition.  Because these products have not been 
evaluated for safety and efficacy, veterinary oversight is especially important to provide 
periodic assessment of how the animal is reacting to the diet and to discontinue the products 
use when warranted.  Accordingly, one of the factors FDA will consider in exercising 
enforcement discretion is whether the product is made available to the public exclusively 
through licensed veterinarians or through retail or internet sales to individuals purchasing the 
product under the direction of a veterinarian. 
 
   
5  Contains Nonbinding Recommendations 
FDA will consider whether the product is responsibly marketed in other respects as well.  For 
example, a therapeutic claim that is not scientifically substantiated would be considered false or 
misleading, thus making the product misbranded.  FDA does not intend to exercise enforcement 
discretion when such products present a known safety risk (e.g., when a product labeled for use 
in dogs or cats with a particular disease would be unsafe in such animals) or if the labeling of 
the product or other manufacturer communications regarding the product contain false or 
misleading claims (e.g., dog food labeled and promoted for the treatment of cancer with no 
basis for the claim).  See Compliance Policy Guide, Sec. 120.500: Health Fraud - Factors in 
Considering Regulatory Action.  FDA also does not intend to exercise enforcement discretion 
when a product is marketed as an alternative to approved new animal drugs. 
 
B.  Animal Food Ingredients 
 
Ingredients added to food must be either approved food additives or generally recognized as safe 
(GRAS) for their intended use in food.  Title 21, Code of Federal Regulations, section 570.30 [21 
C.F.R. 570.30] sets out the eligibility for classification of food ingredients to be GRAS.  A partial 
listing of substances that are GRAS for an intended use in animal food appears in 21 C.F.R. 582 
and 584; 21 C.F.R. 573 contains approved food additives permitted in animal food.  Section 409 
of the FD&C Act [21 U.S.C. 348] provides that food additives are unsafe unless they are the 
subject of a food additive regulation prescribing the conditions under which the food additive 
may be safely used [21 C.F.R. 573].  In addition, section 402(a)(2)(C) of the FD&C Act [21 
U.S.C. 342(a)(2)(C)] deems foods that contain an unapproved food additive to be adulterated. 
 
FDA does not generally intend to recommend or initiate regulatory actions against food 
products containing unapproved food additives if those unapproved food additives are included 
as a food ingredient definition in the 2015 Official Publication of the Association of American 
Feed Control Officials (AAFCO), unless there are data indicating that safety or suitability issues 
exist with an AAFCO defined ingredient.2 
 
IV. Enforcement Policy 
 
Under section 201(g)(1)(B) of the FD&C Act, dog and cat food products that are intended to 
treat or prevent disease are drugs, even if they also provide nutrients in support of the animals 
total required daily nutrient needs. 
 
Unless these products are approved as new animal drugs, these products are adulterated under 
section 501(a)(5) and misbranded under 502(f)(1) of the FD&C Act.  In addition, in the absence 
of compliance with current good manufacturing practice requirements, these products are 
adulterated under section 501(a)(2)(B) of the FD&C Act.  Unless these products are 
                                                            
2Although 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 2015 edition of the Official Publication of the Association of American Feed Control Officials.  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 2015 Official Publication generally do not fall within our current enforcement 
priorities. 
6  Contains Nonbinding Recommendations 
manufactured in and listed by a facility that is registered under section 510 of the FD&C Act, 
they are misbranded under section 502(o) of the FD&C Act.  However, FDA is less likely to 
initiate enforcement action against dog and cat food products intended to be fed as the pets sole 
diet that claim to treat or prevent disease when all of the following factors are present: 
 
1.  The product is made 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.  The product does not present a known safety risk when used as labeled (e.g., when a 
product labeled for use in dogs or cats with a particular disease would be unsafe in such 
animals). 
 
3.  The product label does not include representations that it can be used to treat or 
prevent disease (e.g., obesity, renal failure). 
 
4.  Distribution of labeling and other manufacturer communications that contain 
representations that the product is intended for treatment or prevention of disease is 
limited so that it is provided only to veterinary professionals. 
 
5.  Electronic resources for the dissemination of labeling information and other 
manufacturer communications related to the intended use of the product are secured 
so that they are available only to veterinary professionals. 
 
6.  The label and labeling of the product is not false or misleading in other respects (e.g., dog 
food labeled and promoted for the treatment of cancer with no basis for the claim). 
 
7.  The product is not marketed as an alternative to approved new animal drugs. 
 
8.  The manufacturer is registered under section 415 of the FD&C Act. 
 
9.  The product is manufactured in accordance with CGMPs applicable to animal food (see 
21 CFR part 507 subpart B)3 and other regulations applicable to animal food 
manufacturing. 
 
10. The products labeling complies with all food labeling requirements for such products 
(see 21 CFR part 501). 
 
11. The product contains only ingredients that are GRAS ingredients, approved food 
additives, or ingredients defined in the 2015 Official Publication of the Association 
of American Feed Control Officials. 
                                                            
3Compliance with 21 CFR part 507, subpart B, begins on September 19, 2016, for certain animal food facilities.  
Other facilities are required to comply on September 18, 2017, and September 17, 2018.  For more information on 
these compliance dates, see the preamble for  Current Good Manufacturing Practice, Hazard Analysis, and Risk-
Based Preventive Controls for Food for Animals (80 FR 56170 at 56328-30). 
7  Contains Nonbinding Recommendations 
V.  Regulatory Action Guidance 
 
Districts should consult with the CVM, Division of Compliance, Post-Market Compliance Team 
(HFV-232) prior to taking regulatory action against dog and cat food products intended to be 
fed as the pets sole diet and intended for use to treat or prevent disease. 
 
Districts should consider enforcement action against a product when one or more of the factors 
listed in Section IV of this CPG are not present. 
8