CPG Sec. 680.100 Tracers in Animal Feed
There have been inquiries about the use of reduced iron coated with color, as a "tracer" in animal feed, without declaring its presence on the label. The purpose of the "tracer" in this instance is to provide a quick method to help assure that the drug component containing the tracer is present in the Type A medicated article, and that when formulated into a finished feed, it has been uniformly mixed.
Regulations in 21 CFR 501.100(a)(3)(ii)(c) exempt from label declaration a harmless substance added to an animal food for a technical or functional effect in its processing, where it is present at insignificant levels and has no technical or functional effect in the finished animal food. A harmless inactive ingredient of a Type A medicated article is not required to be declared on the label under the drug provisions of the Federal, Food, Drug and Cosmetic Act.
Section 512 of the Act requires preclearance of all ingredients in a new animal drug Type A medicated article by means of an approved new animal drug application or supplement. *Inclusion of tracers in Type A medicated articles does not fall under 21 CFR 514.8(a)(5) (changes which may be placed in effect without the approval of a supplemental NADA). Similarly, it does not fall under 21 CFR 514.8(d)(3) (changes that should be placed into effect at the earliest possible time because they give increased assurance of identity, strength, quality and purity).*
A harmless substance, such as reduced iron colored with a permitted FDC color, present at insignificant levels in a medicated or non-medicated animal feed as a tracer to help assure the presence of and thorough mixing of a component, is exempt under 21 CFR 501.100(a)(3)(ii)(c) from the requirement that its presence be declared on the label of the finished feed. Such a tracer is not considered to have a technical or functional effect on the finished feed.
A harmless tracer used in a Type A medicated article to help assure the presence of and thorough mixing of a drug component is considered to be an acceptable inactive ingredient which does not have to be declared on the label of the *type A article or any product made from it.*
A tracer may be used in a new animal drug Type A medicated article only if its use is approved in a new animal drug application or supplement, *prior to implementation.*
*Material between asterisks is new or revised*
Revised: 10/1/80, 6/1/86, 4/5/93
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.