Sec. 653.100 Animal Grooming Aids 
 
Compliance Policy Guide 
 
Guidance for FDA Staff 
 
This version of the Compliance Policy Guide replaces the version made available March 1995.  
The document has been revised to current CPG formatting standards, update contact 
information, and clarify existing language. 
 
Additional copies are available from: 
Policy and Regulations Staff (HFV-6) 
Center for Veterinary Medicine 
Food and Drug Administration 
7500 Standish Place 
Rockville, MD 20855 
https://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/default.htm 
 
 
Submit either electronic or written comments on this compliance policy guide at any time.  
Submit electronic comments to https://www.regulations.gov.  Submit written comments to the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.  All comments should be identified with docket number FDA-2018-
N-3188. 
 
For further information regarding this document, contact AskCVM@fda.hhs.gov. 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Regulatory Affairs 
and 
Center for Veterinary Medicine 
 
March 2019 Contains Nonbinding Recommendations  
Sec. 653.100 Animal Grooming Aids 
 
Compliance Policy Guide 
 
Guidance for FDA Staff  
 
This compliance policy guide represents the current thinking of the Food and Drug Administration (FDA) 
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 the approach satisfies the requirements of the applicable statutes 
and regulations.  To discuss an alternative approach, contact the FDA office responsible for this 
compliance policy guide as listed on the title page. 
 
I.  Introduction 
 
The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff on 
products intended solely to cleanse or beautify animals, commonly referred to as grooming 
aids. 
 
In general, FDAs guidance documents, including this CPG, do not establish legally enforceable 
responsibilities.  Instead, they describe the Agencys 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 
 
The Center for Veterinary Medicine (CVM) often receives inquiries concerning the status of 
products intended for use in animals that are similar to cosmetics.  The term cosmetic, as defined 
in section 201(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), is limited to articles 
intended for use for humans for cleansing, beautifying, promoting attractiveness or altering the 
appearance.  Products intended solely to cleanse or beautify animals, commonly referred to as 
grooming aids, are not subject to the FD&C Act and are not regulated by FDA. 
 
However, if a product purporting to be a grooming aid is intended to cure, mitigate, treat, or, 
prevent disease in animals or to affect the structure or function of the body of animals, the 
product is a drug under section 201(g) of the FD&C Act.  Additionally, it is a new animal drug 
under section 201(v) of the FD&C Act if it is not generally recognized as safe and effective.  To 
be legally marketed in the United States, new animal drugs must be the subject of an approved 
new animal drug application, conditionally approved new animal drug application, or index 
listing under sections 512, 571, and 572 of the FD&C Act. 
 
   
2  Contains Nonbinding Recommendations  
III.  Policy 
 
Products intended solely to cleanse or beautify the animal, as evidenced by the products claims, 
formulation, and other information in the products labeling and promotional materials, should 
be considered grooming aids not regulated by FDA.  Products for animals that make direct or 
implied disease or structure/function claims or are otherwise represented as a drug on product 
labeling or other promotional materials, such as by label reference to the presence of an active 
ingredient, may be considered drugs. 
 
IV.  Regulatory Action Guidance 
 
To determine if a product will be considered a grooming aid or a drug, FDA staff should review 
product labeling and other promotional materials associated with the product.  If Districts have 
questions about whether a product is an unapproved new animal drug or a grooming aid, or 
suspect that a product purporting to be a grooming aid is an unapproved new animal drug, they 
should consult with CVM, Division of Compliance.  Unapproved new animal drugs are deemed 
unsafe under section 512(a) of the FD&C Act, and adulterated under section 501(a)(5) of the 
FD&C Act, and may be subject to FDA enforcement action. 
 
 
Issued: 10/1/80 
Revised: 3/95; 3/19 
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