I
119THCONGRESS
1
STSESSION H. R. 2203
To amend the Federal Food, Drug, and Cosmetic Act with respect to the
regulation of zootechnical animal food substances.
IN THE HOUSE OF REPRESENTATIVES
MARCH18, 2025
Mr. L
ANGWORTHY(for himself, Ms. SCHRIER, Mr. BAIRD, Ms. PINGREE, Mrs.
H
OUCHIN, Mr. COSTA, Mr. MOOLENAAR, Ms. TENNEY, Mr. RILEYof
New York, Mr. J
OHNSONof South Dakota, Mr. PFLUGER, Mr. LATTA,
Mr. J
OYCEof Pennsylvania, Mr. MESSMER, Mr. BENTZ, Mr.
O
BERNOLTE, Mr. MILLERof Ohio, Mr. NUNNof Iowa, Mr. FEENSTRA,
Mr. N
EWHOUSE, Mr. BALDERSON, Mrs. MILLER-MEEKS, Mr. FINSTAD,
Mr. V
ALADAO, Mr. EVANSof Colorado, and Mr. FONG) introduced the
following bill; which was referred to the Committee on Energy and Com-
merce
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-1
tives of the United States of America in Congress assembled, 2
SECTION 1. SHORT TITLE. 3
This Act may be cited as the ‘‘Innovative Feed En-4
hancement and Economic Development Act of 2025’’ or 5
the ‘‘Innovative FEED Act of 2025’’. 6
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SEC. 2. REGULATION OF ZOOTECHNICAL ANIMAL FOOD 1
SUBSTANCES. 2
(a) D
EFINITION.—Section 201 of the Federal Food, 3
Drug, and Cosmetic Act (21 U.S.C. 321) is amended by 4
adding at the end the following: 5
‘‘(tt)(1) The term ‘zootechnical animal food sub-6
stance’ means a substance that— 7
‘‘(A) is added to the food or drinking water of 8
animals; 9
‘‘(B) is intended to— 10
‘‘(i) affect the byproducts of the digestive 11
process of an animal; 12
‘‘(ii) reduce the presence of foodborne 13
pathogens of human health significance in an 14
animal intended to be used for food; or 15
‘‘(iii) affect the structure or function of the 16
body of the animal, other than by providing nu-17
tritive value, by altering the animal’s gastro-18
intestinal microbiome; and 19
‘‘(C) achieves its intended effect by acting solely 20
within the gastrointestinal tract of the animal. 21
‘‘(2) Such term does not include a substance that— 22
‘‘(A) is intended for use in the diagnosis, cure, 23
mitigation, treatment, or prevention of disease in an 24
animal; 25
‘‘(B) is a hormone; 26
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‘‘(C) is an active moiety in an animal drug, 1
which, prior to the filing of a petition under section 2
409 was approved under section 512, conditionally 3
approved under section 571, indexed under section 4
572, or for which substantial clinical investigations 5
have been instituted and for which the existence of 6
such investigations has been made public; 7
‘‘(D) is an ionophore; or 8
‘‘(E) is otherwise excluded from the definition 9
based on criteria established by the Secretary 10
through notice and comment rulemaking. 11
‘‘(3) A zootechnical animal food substance shall be 12
deemed to be a food additive within the meaning of para-13
graph (s) and its introduction into interstate commerce 14
shall be in accordance with a regulation issued under sec-15
tion 409. A zootechnical animal food substance shall not 16
be considered a drug under paragraph (g)(1)(C) solely be-17
cause the substance has an intended effect described in 18
subparagraph (1).’’. 19
(b) F
OODADDITIVES.—Section 409 of the Federal 20
Food, Drug, and Cosmetic Act (21 U.S.C. 348) is amend-21
ed— 22
(1) in subsection (b)— 23
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(A) by redesignating paragraphs (3) 1
through (5) as paragraphs (4) through (6), re-2
spectively; and 3
(B) by inserting after paragraph (2) the 4
following: 5
‘‘(3) In the case of a zootechnical animal food 6
substance, such petition shall, in addition to any ex-7
planatory or supporting data, contain— 8
‘‘(A) all relevant data bearing on the effect 9
the zootechnical animal food substance is in-10
tended to have and the quantity of such sub-11
stance required to produce the intended effect; 12
and 13
‘‘(B) full reports of investigations made 14
with respect to the intended use of such sub-15
stance, including full information as to the 16
methods and controls used in conducting such 17
investigations.’’; 18
(2) in subsection (c)— 19
(A) by amending subparagraph (A) of 20
paragraph (1) to read as follows: 21
‘‘(A)(i) by order establish a regulation (whether 22
or not in accord with that proposed by the peti-23
tioner) prescribing— 24
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‘‘(I) with respect to one or more proposed 1
uses of the food additive involved, the condi-2
tions under which such additive may be safely 3
used (including specifications as to the par-4
ticular food or classes of food in or on which 5
such additive may be used, the maximum quan-6
tity which may be used or permitted to remain 7
in or on such food, the manner in which such 8
additive may be added to or used in or on such 9
food, and any directions or other labeling or 10
packaging requirements for such additive as the 11
Secretary determines necessary to assure the 12
safety of such use); and 13
‘‘(II) in the case of a zootechnical animal 14
food substance, the conditions under which such 15
substance may be used to achieve the intended 16
effect; and 17
‘‘(ii) notify the petitioner of such order and the 18
reasons for such action; or’’; and 19
(B) in paragraph (3)— 20
(i) in subparagraph (A), by striking ‘‘; 21
or’’ and inserting a semicolon; 22
(ii) in subparagraph (B), by striking 23
the period and inserting ‘‘; or’’; and 24
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(iii) by adding at the end the fol-1
lowing: 2
‘‘(C) in the case of a zootechnical animal food 3
substance, fails to establish that the proposed use of 4
the substance, under the conditions of use to be 5
specified in the regulation, will achieve the intended 6
effect.’’; and 7
(3) by adding at the end the following: 8
‘‘(l) Z
OOTECHNICALANIMALFOODSUBSTANCES.— 9
The labeling of a zootechnical animal food substance— 10
‘‘(1) shall include the statement: ‘Not for use in 11
the diagnosis, cure, mitigation, treatment, or preven-12
tion of disease in animals.’; and 13
‘‘(2) may include statements regarding the in-14
tended effect of the substance on the structure or 15
function of the body of animals, as set forth in sec-16
tion 201(tt)(1).’’. 17
(c) M
ISBRANDEDFOOD.—Section 403 of the Federal 18
Food, Drug, and Cosmetic Act (21 U.S.C. 343) is amend-19
ed by adding at the end the following: 20
‘‘(z) If it is a zootechnical animal food substance and 21
the labeling of the food does not include the statement 22
required by section 409(l)(1).’’. 23
(d) R
ULE OFCONSTRUCTION.—Nothing in this sec-24
tion, or the amendments made by this section, shall be 25
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construed to authorize the Secretary of Health and 1
Human Services to require the use of any zootechnical 2
food substance or food additive (as those terms are defined 3
in section 201 of the Federal Food, Drug, and Cosmetic 4
Act, as amended by subsection (a)). 5
Æ
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