I 

118TH CONGRESS 

1ST SESSION H. R. 6687 

To amend the Federal Food, Drug, and Cosmetic Act with respect to the 

regulation of zootechnical animal food substances. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 7, 2023 

Mr. PENCE (for himself, Mr. BAIRD, Ms. SCHRIER, Ms. CRAIG, Mr. 

LANGWORTHY, Mr. JOHNSON of South Dakota, Mr. VALADAO, Mr. CURTIS, Mr. FEENSTRA, Mrs. MILLER-MEEKS, Mr. BUCSHON, and Mr. 

JOYCE of Pennsylvania) introduced the following bill; which was referred 

to the Committee on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act with 

respect to the regulation of zootechnical animal food 

substances. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Innovative Feed En5 hancement and Economic Development Act of 2023’’ or 

6 the ‘‘Innovative FEED Act of 2023’’. 


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1 SEC. 2. REGULATION OF ZOOTECHNICAL ANIMAL FOOD 

2 SUBSTANCES. 

3 (a) RULE OF CONSTRUCTION.—Nothing in this sec4 tion, or the amendments made by this section, shall be 

5 construed to authorize the Secretary of Health and 

6 Human Services to require the use of any zootechnical 

7 food substance or food additive (as those terms are defined 

8 in section 201 of the Federal Food, Drug, and Cosmetic 

9 Act, as amended by subsection (b)). 

10 (b) DEFINITION.—Section 201 of the Federal Food, 

11 Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 

12 adding at the end the following: 

13 ‘‘(tt)(1) The term ‘zootechnical animal food sub14 stance’ means a substance that— 

15 ‘‘(A) is added to the food or drinking water of 

16 animals; 

17 ‘‘(B) is intended to— 

18 ‘‘(i) affect the byproducts of the digestive 

19 process of an animal; 

20 ‘‘(ii) reduce the presence of foodborne 

21 pathogens of human health significance in an 

22 animal intended to be used for food; or 

23 ‘‘(iii) affect the structure or function of the 

24 body of the animal, other than by providing nu25 tritive value, by altering the animal’s gastro26 intestinal microbiome; and 


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1 ‘‘(C) achieves its intended effect by acting solely 

2 within the gastrointestinal tract of the animal. 

3 ‘‘(2) Such term does not include a substance that— 

4 ‘‘(A) is intended for use in the diagnosis, cure, 

5 mitigation, treatment, or prevention of disease in an 

6 animal; 

7 ‘‘(B) is a hormone; 

8 ‘‘(C) is an active moiety in an animal drug, 

9 which, prior to the filing of a petition under section 

10 409 was approved under section 512, conditionally 

11 approved under section 571, or indexed under sec12 tion 572, or for which substantial clinical investiga13 tions have been instituted and for which the exist14 ence of such investigations has been made public; 

15 ‘‘(D) is an ionophore; or 

16 ‘‘(E) is otherwise excluded from the definition 

17 based on criteria established by the Secretary 

18 through notice and comment rulemaking. 

19 ‘‘(3) A zootechnical animal food substance shall be 

20 deemed to be a food additive within the meaning of para21 graph (s) and its introduction into interstate commerce 

22 shall be in accordance with a regulation issued under sec23 tion 409. A zootechnical animal food substance shall not 

24 be considered a drug under paragraph (g)(1)(C) solely beVerDate Sep 11 2014 22:32 Dec 27, 2023 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6687.IH H6687

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1 cause the substance has an intended effect described in 

2 subparagraph (1).’’. 

3 (c) FOOD ADDITIVES.—Section 409 of the Federal 

4 Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amend5 ed— 

6 (1) in subsection (b)— 

7 (A) by redesignating paragraphs (3) 

8 through (5) as paragraphs (4) through (6), re9 spectively; and 

10 (B) by inserting after paragraph (2) the 

11 following: 

12 ‘‘(3) In the case of a zootechnical animal food 

13 substance, such petition shall, in addition to any ex14 planatory or supporting data, contain— 

15 ‘‘(A) all relevant data bearing on the effect 

16 the zootechnical animal food substance is in17 tended to have and the quantity of such sub18 stance required to produce the intended effect; 

19 and 

20 ‘‘(B) full reports of investigations made 

21 with respect to the intended use of such sub22 stance, including full information as to the 

23 methods and controls used in conducting such 

24 investigations.’’; 

25 (2) in subsection (c)— 


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1 (A) by amending subparagraph (A) of 

2 paragraph (1) to read as follows: 

3 ‘‘(A)(i) by order establish a regulation (whether 

4 or not in accord with that proposed by the peti5 tioner) prescribing— 

6 ‘‘(I) with respect to one or more proposed 

7 uses of the food additive involved, the condi8 tions under which such additive may be safely 

9 used (including specifications as to the par10 ticular food or classes of food in or on which 

11 such additive may be used, the maximum quan12 tity which may be used or permitted to remain 

13 in or on such food, the manner in which such 

14 additive may be added to or used in or on such 

15 food, and any directions or other labeling or 

16 packaging requirements for such additive as the 

17 Secretary determines necessary to assure the 

18 safety of such use); and 

19 ‘‘(II) in the case of a zootechnical animal 

20 food substance, the conditions under which such 

21 substance may be used to achieve the intended 

22 effect; and 

23 ‘‘(ii) notify the petitioner of such order and the 

24 reasons for such action; or’’; and 

25 (B) in paragraph (3)— 


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1 (i) in subparagraph (A), by striking ‘‘; 

2 or’’ and inserting a semicolon; 

3 (ii) in subparagraph (B), by striking 

4 the period and inserting ‘‘; or’’; and 

5 (iii) by adding at the end the fol6 lowing: 

7 ‘‘(C) in the case of a zootechnical animal food 

8 substance, fails to establish that the proposed use of 

9 the substance, under the conditions of use to be 

10 specified in the regulation, will achieve the intended 

11 effect.’’; and 

12 (3) by adding at the end the following: 

13 ‘‘(l) ZOOTECHNICAL ANIMAL FOOD SUBSTANCES.— 

14 The labeling of a zootechnical animal food substance— 

15 ‘‘(1) shall include the statement: ‘Not for use in 

16 the diagnosis, cure, mitigation, treatment, or preven17 tion of disease in animals.’; and 

18 ‘‘(2) may include statements regarding the in19 tended effect of the substance on the structure or 

20 function of the body of animals, as set forth in sec21 tion 201(tt)(1).’’. 

22 (d) MISBRANDED FOOD.—Section 403 of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend24 ed by adding at the end the following: 


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1 ‘‘(z) If it is a zootechnical animal food substance and 

2 the labeling of the food does not include the statement 

3 required by section 409(l)(1).’’. 

Æ 


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