Sec. 680.100 Tracers in Animal Feed (CPG 7126.01)
BACKGROUND:
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).*
POLICY:
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*
Issued: 2/6/74
Revised: 10/1/80, 6/1/86, 4/5/93