Drugs and Pet Food Additive

Section 200 Section 200.170  Drugs and Pet Food Additive a)         An artificial color may be used in a pet food only if it has been shown to be harmless to pets.  The permanent or provisional listing of an artificial color in the United States Food and Drug Regulations, as adopted in Section 10 of the Act, as safe for use, together with the conditions, limitations, and tolerances, if any, incorporated therein, shall be deemed to be satisfactory evidence that the color is, when used pursuant to such regulations, harmless to pets. b)         Prior to approval of a registration application or approval of a label for pet food which contains additives (including drugs, other special purpose additives, or non-nutritive additives), the distributor shall submit evidence to prove the safety and efficacy of the pet food, when used according to directions furnished on the label.  Satisfactory evidence of the safety and efficacy of a pet food may be: 1)         when the pet food contains such additives, the use of which conforms to the requirements of the applicable regulations in the 21 CFR, or which are "prior sanctioned" or "generally recognized as safe" for such use, or 2)         when the pet food itself is a drug as defined in Section 3(g) of the Act and is generally recognized as safe and effective or is marketed subject to an application approved by the Food and Drug Administration under 21 U.S.C. 360(b).