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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3422 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 3422
To establish the Federal Food Administration within the Department of
Health and Human Services.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 10, 2025
Mr. Durbin (for himself and Mr. Blumenthal) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To establish the Federal Food Administration within the Department of
Health and Human Services.
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 ``Federal Food Administration Act of
2025''.
SEC. 2. ESTABLISHMENT OF FEDERAL FOOD ADMINISTRATION.
(a) Establishment.--As soon as practicable, but not later than 1
year after the date of enactment of this Act, the Secretary of Health
and Human Services shall establish within the Department of Health and
Human Services an agency to be known as the ``Federal Food
Administration''.
(b) Mission.--The Federal Food Administration shall--
(1) promote the public health by promptly and efficiently
reviewing food and nutrition research and taking appropriate
action on the marketing of regulated products in a timely
manner;
(2) with respect to such products, protect the public
health by ensuring that foods are safe, wholesome, sanitary,
and properly labeled;
(3) participate through appropriate processes with
representatives of other countries to protect public health and
promote fair trade practices in food; and
(4) as determined to be appropriate by the Secretary, carry
out paragraphs (1) through (3) in consultation with experts in
science, medicine, and public health, and in cooperation with
consumers, users, manufacturers, importers, packers,
distributors, and retailers of regulated products.
(c) Interagency Collaboration.--The Secretary shall implement
programs and policies that will foster collaboration between the
Federal Food Administration, the Department of Agriculture, the Centers
for Disease Control and Prevention, the National Institutes of Health,
and other science-based Federal agencies, to enhance the scientific and
technical expertise available to the Secretary in the conduct of the
duties of the Secretary with respect to the development, investigation,
evaluation, and postmarket monitoring of food.
(d) Commissioner of Foods.--
(1) In general.--The Federal Food Administration shall be
headed by the Commissioner of Foods, who shall be appointed by
the President, by and with the advice and consent of the
Senate.
(2) General powers.--The Secretary, acting through the
Commissioner of Foods, shall be responsible for--
(A) providing overall direction to the Federal Food
Administration and establishing and implementing
general policies respecting the management and
operation of programs and activities of the Federal
Food Administration;
(B) coordinating and overseeing the operation of
all administrative entities within the Federal Food
Administration;
(C) research relating to foods in carrying out the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.);
(D) conducting educational and public information
programs relating to the responsibilities of the
Federal Food Administration; and
(E) performing such other functions as the
Secretary may prescribe.
(e) Technical and Scientific Review Groups.--The Secretary, acting
through the Commissioner of Foods, may, without regard to the
provisions of title 5, United States Code, governing appointments in
the competitive service and without regard to the provisions of chapter
51 and subchapter III of chapter 53 of such title relating to
classification and General Schedule pay rates, establish such technical
and scientific review groups as are needed to carry out the functions
of the Federal Food Administration, including functions under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) relating
to food, and appoint and pay the members of such groups, except that
officers and employees of the United States shall not receive
additional compensation for service as members of such groups.
SEC. 3. INSPECTION OF FOOD FACILITIES.
(a) Establishment of Inspection Program.--
(1) In general.--The Commissioner of Foods shall establish
an inspection program, which shall include inspections of food
facilities in accordance with subsection (b), subject to the
facility category determined in accordance with the guidance
issued under paragraph (2).
(2) Facility categories.--As soon as practicable, but not
later than 1 year after the date of enactment of this Act, the
Commissioner of Foods shall issue formal guidance defining the
criteria by which food facilities will be divided into ``high-
risk,'' ``intermediate risk,'' and ``low-risk'' facilities.
(b) Inspections of Food Facilities.--
(1) Frequency of inspections.--
(A) High-risk facilities.--The Commissioner of
Foods shall inspect high-risk facilities not less
frequently than annually.
(B) Intermediate-risk facilities.--The Commissioner
of Foods shall inspect intermediate-risk facilities not
less frequently than once every 2 years.
(C) Low-risk facilities.--The Commissioner of Foods
shall inspect low-risk facilities, which shall include
warehouses or similar facilities that engage in
packaging or distribution, and pose very minimal public
health risk, not less frequently than once every 3
years.
(2) Infant formula manufacturing facilities.--The
Commissioner of Foods shall inspect the facilities of each
manufacturer of infant formula not less frequently than every 6
months.
(c) Federal and State Cooperation.--The Commissioner of Foods shall
contract with State officials to carry out not less than half of the
inspections required under this section.
(d) Compliance Checks.--Not later than 30 days after issuing to a
facility a form that is equivalent to FDA Form 483, pursuant to an
inspection conducted under section 704 of Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374), the Commissioner of Foods shall conduct a
follow-up compliance check of the facility.
SEC. 4. TRANSFER OF AUTHORITY, FUNCTIONS AND AGENCIES.
(a) Transfer of Authority.--The Federal Food Administration shall
assume responsibility for carrying out the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.), as related to food, and shall
assume and maintain all regulatory, administrative, and enforcement
authorities with respect to food held by the Food and Drug
Administration on the date of enactment of this Act.
(b) Transfer of Functions.--For each Federal agency, office, and
center specified in subsection (c), there are transferred to the
Federal Food Administration all functions that the head of the Federal
agency exercised on the day before the date of enactment of this Act
(including all related functions of any officer or employee of the
Federal agency) that relate to the regulation of food or the
administration or enforcement of food law, as determined by the
President.
(c) Transferred Agencies.--The Federal agencies referred to in
subsection (b) are--
(1) the resources and facilities of the Human Foods Program
of the Food and Drug Administration for purposes of
administering the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) with respect to food;
(2) the resources and facilities of the Office of
Inspections and Investigations of the Food and Drug
Administration for purposes of administering the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) with respect to
food;
(3) the resources and facilities of the Center for
Veterinary Medicine of the Food and Drug Administration for
purposes of administering the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.) with respect to food; and
(4) such other offices, services, or agencies as the
President designates by executive order to carry out this Act.
(d) Conforming Amendment.--Subchapter A of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended
by adding at the end the following:
``SEC. 716. REGULATION OF FOOD.
``Notwithstanding any other provision of this Act, beginning as
soon as practicable but not later than the date that is 1 year after
the date of enactment of the Federal Food Administration Act of 2025--
``(1) any authority under this Act that relates to food
shall be under the authority of the Federal Food
Administration, and shall be carried out by the Commissioner of
Foods described in section 2(d) of the Federal Food
Administration Act of 2025; and
``(2) any reference in this Act to authorities related to
food held by the Commissioner of Food and Drugs, including any
reference in this Act to such authorities held by the
Secretary, acting through the Commissioner of Food and Drugs,
shall be deemed to be a reference to authorities held by the
Commissioner of Foods, or by the Secretary, acting through the
Commissioner of Foods, as appropriate.''.
SEC. 5. FUNDING.
(a) Transfer of Funds.--The appropriations, allocations, and other
funds that relate to the authorities, functions and agencies
transferred under section 4 shall be transferred to the Federal Food
Administration.
(b) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, such sums as may be necessary
for fiscal year 2026 and each fiscal year thereafter.
SEC. 6. DEFINITIONS.
In this Act:
(1) Commissioner of foods.--The term ``Commissioner of
Foods'' means the Commissioner described in section 2(d).
(2) Facility.--The term ``facility'' means any factory,
warehouse, or establishment that is subject to the requirements
of section 415 or 419 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 350d; 350h).
(3) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S8626)
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