Sec. 651.100 Ethylenediamine 
Dihydroiodide (EDDI) 
 
Compliance Policy Guide 
 
Guidance for FDA Staff 
 
This version of the Compliance Policy Guide replaces the version made available May 2000.  
The document has been revised to current CPG formatting standards and update contact 
information.   
 
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/regulatory-information/search-fda-guidance-documents/cpg-sec-651100-
ethylenediamine-dihydroiodide-eddi 
 
 
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-2013-
S-0610. 
 
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 
 
June 2019 Contains Nonbinding Recommendations 
Sec. 651.100 Ethylenediamine Dihydroiodide (EDDI) 
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
This guidance document represents the Agency's current thinking on animal products containing 
ethylenediamine dihydroiodide (EDDI) or feeds containing unapproved new drugs under the 
provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).   
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
EDDI has been incorporated into animal feed and drug products for many years for both 
nutritional and therapeutic purposes.  It has been formulated in salt/mineral mixtures and in 
liquids and powders for adding to feed or drinking water.  EDDI has been used as a supplemental 
source of iodine and is considered generally recognized as safe (GRAS) for nutritional purposes 
when used at levels consistent with good feeding practices (21 CFR 582.80).  EDDI products 
also have been marketed with claims for the treatment and prevention of certain diseases in 
several animal species, but primarily for "foot rot," soft tissue "lumpy jaw" and "wooden tongue" 
in cattle.  However, all such EDDI products (including feeds) bearing therapeutic claims are 
considered adulterated under sections 501(a)(5) or 501(a)(6) of the FD&C Act. 
III. Policy
All animal products containing EDDI that bear claims for treatment or prevention of any animal 
disease (other than the prevention of iodine deficiency) are considered unapproved new animal 
drugs or feeds bearing or containing unapproved new animal drugs.  They are adulterated under 
section 501(a)(5) of the FD&C Act if they are an unapproved new animal drug or adulterated 
under section 501(a)(6) of the FD&C Act if they are a feed bearing or containing an unapproved 
new animal drug. 
2  Contains Nonbinding Recommendations 
Cattle products that do not bear claims for treatment or prevention of animal disease and are 
formulated to provide 50 mg or more/hd/day of EDDI will be evaluated on a case-by-case basis 
and may be considered adulterated food under section 402(a)(2)(C)(i) of the FD&C Act if they 
raise safety concerns. 
IV.  Regulatory Action Guidance
The Center for Veterinary Medicine should be contacted for consultation before considering any 
possible regulatory action on animal products containing EDDI. 
Issued: 3/1/1986 
Revised: 5/1/2000; 6/2019 
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