[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2203 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
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
March 18, 2025
Mr. Langworthy (for himself, Ms. Schrier, Mr. Baird, Ms. Pingree, Mrs.
Houchin, Mr. Costa, Mr. Moolenaar, Ms. Tenney, Mr. Riley of New York,
Mr. Johnson of South Dakota, Mr. Pfluger, Mr. Latta, Mr. Joyce of
Pennsylvania, Mr. Messmer, Mr. Bentz, Mr. Obernolte, Mr. Miller of
Ohio, Mr. Nunn of Iowa, Mr. Feenstra, Mr. Newhouse, Mr. Balderson, Mrs.
Miller-Meeks, Mr. Finstad, Mr. Valadao, Mr. Evans of Colorado, and Mr.
Fong) 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 Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Innovative Feed Enhancement and
Economic Development Act of 2025'' or the ``Innovative FEED Act of
2025''.
SEC. 2. REGULATION OF ZOOTECHNICAL ANIMAL FOOD SUBSTANCES.
(a) 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 substance' 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 nutritive
value, by altering the animal's gastrointestinal
microbiome; and
``(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,
indexed under section 572, or for which substantial clinical
investigations have been instituted and for which the existence
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 paragraph (s) and its introduction
into interstate commerce shall be in accordance with a regulation
issued under section 409. A zootechnical animal food substance shall
not be considered a drug under paragraph (g)(1)(C) solely because the
substance has an intended effect described in subparagraph (1).''.
(b) Food Additives.--Section 409 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 348) is amended--
(1) in subsection (b)--
(A) by redesignating paragraphs (3) through (5) as
paragraphs (4) through (6), respectively; 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 explanatory or
supporting data, contain--
``(A) all relevant data bearing on the effect the
zootechnical animal food substance is intended to have
and the quantity of such substance required to produce
the intended effect; and
``(B) full reports of investigations made with
respect to the intended use of such substance,
including full information as to the methods and
controls used in conducting such investigations.'';
(2) in subsection (c)--
(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 petitioner) prescribing--
``(I) with respect to one or more proposed uses of
the food additive involved, the conditions under which
such additive may be safely used (including
specifications as to the particular food or classes of
food in or on which such additive may be used, the
maximum quantity 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)--
(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 following:
``(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 prevention of
disease in animals.'; and
``(2) may include statements regarding the intended effect
of the substance on the structure or function of the body of
animals, as set forth in section 201(tt)(1).''.
(c) Misbranded Food.--Section 403 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343) is amended by adding at the end the
following:
``(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).''.
(d) Rule of Construction.--Nothing in this section, 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 (a)).
<all>