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. CUR-
TIS, 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. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Innovative Feed En-
hancement and Economic Development Act of 2023’’ or 
the ‘‘Innovative FEED Act of 2023’’. 
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SEC. 2. REGULATION OF ZOOTECHNICAL ANIMAL FOOD 
SUBSTANCES. 
(a) RULE OF CONSTRUCTION.—Nothing in this sec-
tion, or the amendments made by this section, shall be 
construed to authorize the Secretary of Health and 
Human Services to require the use of any zootechnical 
food substance or food additive (as those terms are defined 
in section 201 of the Federal Food, Drug, and Cosmetic 
Act, as amended by subsection (b)). 
(b) DEFINITION.—Section 201 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 
adding at the end the following: 
‘‘(tt)(1) The term ‘zootechnical animal food sub-
stance’ means a substance that— 
‘‘(A) is added to the food or drinking water of 
animals; 
‘‘(B) is intended to— 
‘‘(i) affect the byproducts of the digestive 
process of an animal; 
‘‘(ii) reduce the presence of foodborne 
pathogens of human health significance in an 
animal intended to be used for food; or 
‘‘(iii) affect the structure or function of the 
body of the animal, other than by providing nu-
tritive value, by altering the animal’s gastro-
intestinal microbiome; and 
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‘‘(C) achieves its intended effect by acting solely 
within the gastrointestinal tract of the animal. 
‘‘(2) Such term does not include a substance that— 
‘‘(A) is intended for use in the diagnosis, cure, 
mitigation, treatment, or prevention of disease in an 
animal; 
‘‘(B) is a hormone; 
‘‘(C) is an active moiety in an animal drug, 
which, prior to the filing of a petition under section 
409 was approved under section 512, conditionally 
approved under section 571, or indexed under sec-
tion 572, or for which substantial clinical investiga-
tions have been instituted and for which the exist-
ence of such investigations has been made public; 
‘‘(D) is an ionophore; or 
‘‘(E) is otherwise excluded from the definition 
based on criteria established by the Secretary 
through notice and comment rulemaking. 
‘‘(3) A zootechnical animal food substance shall be 
deemed to be a food additive within the meaning of para-
graph (s) and its introduction into interstate commerce 
shall be in accordance with a regulation issued under sec-
tion 409. A zootechnical animal food substance shall not 
be considered a drug under paragraph (g)(1)(C) solely be-
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cause the substance has an intended effect described in 
subparagraph (1).’’. 
(c) FOOD ADDITIVES.—Section 409 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amend-
ed— 
(1) in subsection (b)— 
(A) 
by 
redesignating 
paragraphs 
(3) 
through (5) as paragraphs (4) through (6), re-
spectively; and 
(B) by inserting after paragraph (2) the 
following: 
‘‘(3) In the case of a zootechnical animal food 
substance, such petition shall, in addition to any ex-
planatory or supporting data, contain— 
‘‘(A) all relevant data bearing on the effect 
the zootechnical animal food substance is in-
tended to have and the quantity of such sub-
stance required to produce the intended effect; 
and 
‘‘(B) full reports of investigations made 
with respect to the intended use of such sub-
stance, including full information as to the 
methods and controls used in conducting such 
investigations.’’; 
(2) in subsection (c)— 
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(A) by amending subparagraph (A) of 
paragraph (1) to read as follows: 
‘‘(A)(i) by order establish a regulation (whether 
or not in accord with that proposed by the peti-
tioner) prescribing— 
‘‘(I) with respect to one or more proposed 
uses of the food additive involved, the condi-
tions under which such additive may be safely 
used (including specifications as to the par-
ticular food or classes of food in or on which 
such additive may be used, the maximum quan-
tity which may be used or permitted to remain 
in or on such food, the manner in which such 
additive may be added to or used in or on such 
food, and any directions or other labeling or 
packaging requirements for such additive as the 
Secretary determines necessary to assure the 
safety of such use); and 
‘‘(II) in the case of a zootechnical animal 
food substance, the conditions under which such 
substance may be used to achieve the intended 
effect; and 
‘‘(ii) notify the petitioner of such order and the 
reasons for such action; or’’; and 
(B) in paragraph (3)— 
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(i) in subparagraph (A), by striking ‘‘; 
or’’ and inserting a semicolon; 
(ii) in subparagraph (B), by striking 
the period and inserting ‘‘; or’’; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(C) in the case of a zootechnical animal food 
substance, fails to establish that the proposed use of 
the substance, under the conditions of use to be 
specified in the regulation, will achieve the intended 
effect.’’; and 
(3) by adding at the end the following: 
‘‘(l) ZOOTECHNICAL ANIMAL FOOD SUBSTANCES.— 
The labeling of a zootechnical animal food substance— 
‘‘(1) shall include the statement: ‘Not for use in 
the diagnosis, cure, mitigation, treatment, or preven-
tion of disease in animals.’; and 
‘‘(2) may include statements regarding the in-
tended effect of the substance on the structure or 
function of the body of animals, as set forth in sec-
tion 201(tt)(1).’’. 
(d) MISBRANDED FOOD.—Section 403 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend-
ed by adding at the end the following: 
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‘‘(z) If it is a zootechnical animal food substance and 
the labeling of the food does not include the statement 
required by section 409(l)(1).’’. 
Æ 
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