901:5-7-21 Drugs and food additives for pet food and specialty pet food.

(A) An artificial color may be used in a pet food or specialty pet food only if it has been shown to be harmless to pets or specialty pets. The permanent or provisional listing of an artificial color in the United States food and drug regulations 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 or specialty pets.

(B) Evidence may be required to prove the safety and efficacy or utility of a pet food or specialty pet food, which contains additives or drugs, when used according to directions furnished on the label. Satisfactory evidence of the safety and efficacy of a pet food or specialty pet food may be established:

(1) When the pet food or specialty pet food contains such additives, the use of which conforms to the requirements of the applicable regulation in the Title 21 of the Code of Federal Regulations or which are "prior sanctioned" or "informal review sanctioned" or "Generally Recognized as Safe" for such use; or

(2) When the pet food or specialty pet food itself is a drug or contains a drug as defined in division (F) of section 923.41 of the Revised Code and is "Generally Recognized as Safe and effective" for the labeled use or is marketed subject to an application approved by the food and drug administration under Title 21, U.S.C. 360(b).

(C) When a drug is included in a pet food or specialty pet food:

(1) The word "medicated" shall appear directly following and below the product name in type size, no smaller than one-half the type size of the product name.

(2) Purpose statement is required.

(3) The purpose of the medication (claim statement) is required.

(4) An active ingredient statement listing the active drug ingredients by their established name and the amounts in percentage by weight or in milligrams per pound.

Replaces: 901:5-7-21

Effective: 09/21/2014
R.C. 119.032 review dates: 09/21/2019
Promulgated Under: 119.03
Statutory Authority: 923.50
Rule Amplifies: 923.43
Prior Effective Dates: 5/1/1995