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<dc:title>119 S3422 IS: Federal Food Administration Act of 2025</dc:title>
<dc:publisher>U.S. Senate</dc:publisher>
<dc:date>2025-12-10</dc:date>
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<dc:language>EN</dc:language>
<dc:rights>Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.</dc:rights>
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<distribution-code display="yes">II</distribution-code><congress>119th CONGRESS</congress><session>1st Session</session><legis-num>S. 3422</legis-num><current-chamber>IN THE SENATE OF THE UNITED STATES</current-chamber><action><action-date date="20251210">December 10, 2025</action-date><action-desc><sponsor name-id="S253">Mr. Durbin</sponsor> (for himself and <cosponsor name-id="S341">Mr. Blumenthal</cosponsor>) introduced the following bill; which was read twice and referred to the <committee-name committee-id="SSHR00">Committee on Health, Education, Labor, and Pensions</committee-name></action-desc></action><legis-type>A BILL</legis-type><official-title>To establish the Federal Food Administration within the Department of Health and Human Services.</official-title></form><legis-body><section id="S1" section-type="section-one"><enum>1.</enum><header>Short title</header><text display-inline="no-display-inline">This Act may be cited as the <quote><short-title>Federal Food Administration Act of 2025</short-title></quote>.</text></section><section id="id728dca9a9b644790ac382afdef5026fd"><enum>2.</enum><header>Establishment of Federal Food Administration</header><subsection id="ida62283055d9342fe922087faf2f1b58f"><enum>(a)</enum><header>Establishment</header><text>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 <quote>Federal Food Administration</quote>.</text></subsection><subsection id="id33b40a891e3b4b168d022f97273008b5"><enum>(b)</enum><header>Mission</header><text>The Federal Food Administration shall—</text><paragraph id="id583b1a8a088f468fbc6562b7ce7c879f"><enum>(1)</enum><text>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;</text></paragraph><paragraph id="id477e50f5361f4c3fb0de8c87241161e8"><enum>(2)</enum><text>with respect to such products, protect the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled;</text></paragraph><paragraph id="id85c3160ead4f42e5988c66605c79341a"><enum>(3)</enum><text>participate through appropriate processes with representatives of other countries to protect public health and promote fair trade practices in food; and</text></paragraph><paragraph id="id1172723e63e14e10bbbc7643166ba0d1"><enum>(4)</enum><text>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.</text></paragraph></subsection><subsection id="id3ff2f8f6ff74406b957435991144292f"><enum>(c)</enum><header>Interagency collaboration</header><text>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.</text></subsection><subsection id="id4a99ee20acab4bfd86603b52d01bef66"><enum>(d)</enum><header>Commissioner of Foods</header><paragraph id="idf722bd1389394bc6bed247a2af6e267b"><enum>(1)</enum><header>In general</header><text>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.</text></paragraph><paragraph id="id98daf37cf9da4f01bf92ecd7476b562b"><enum>(2)</enum><header>General powers</header><text>The Secretary, acting through the Commissioner of Foods, shall be responsible for—</text><subparagraph id="idc168fd25aad34b41a26457499abba5f3"><enum>(A)</enum><text>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;</text></subparagraph><subparagraph id="id5dff4ef954954020bcdda216069d1d1d"><enum>(B)</enum><text>coordinating and overseeing the operation of all administrative entities within the Federal Food Administration;</text></subparagraph><subparagraph id="idf6e834f258294edabb5757210bea0bc9"><enum>(C)</enum><text>research relating to foods in carrying out the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>);</text></subparagraph><subparagraph id="id7be5e701e9184451be2d9b62a0637d05"><enum>(D)</enum><text>conducting educational and public information programs relating to the responsibilities of the Federal Food Administration; and</text></subparagraph><subparagraph id="id6a09d184b63a4cc19c89ecfe06655ff5"><enum>(E)</enum><text>performing such other functions as the Secretary may prescribe.</text></subparagraph></paragraph></subsection><subsection id="id95216438c7734f96b901fef934354d1f"><enum>(e)</enum><header>Technical and scientific review groups</header><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>) 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.</text></subsection></section><section id="iddd28b7fa40444e038ba189a4f834e276"><enum>3.</enum><header>Inspection of food facilities</header><subsection commented="no" display-inline="no-display-inline" id="id1df333ca9f244e9580bfdee734e5c7e7"><enum>(a)</enum><header display-inline="yes-display-inline">Establishment of inspection program</header><paragraph id="id589fb3e2b7d641cca7ea5c3304a3837a"><enum>(1)</enum><header>In general</header><text>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).</text></paragraph><paragraph id="id1be34aa1155d4b5988a7379caebe53e8"><enum>(2)</enum><header>Facility categories</header><text>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 <quote>high-risk,</quote><quote>intermediate risk,</quote> and <quote>low-risk</quote> facilities.</text></paragraph></subsection><subsection id="id3a84963a45bd44898148fc3ac218ee56"><enum>(b)</enum><header>Inspections of food facilities</header><paragraph id="id981ee431a512463d9b5c8f50ec31c4d2"><enum>(1)</enum><header>Frequency of inspections</header><subparagraph id="idde7d9dbf8a7346ca9192b1b80bc9a424"><enum>(A)</enum><header>High-risk facilities</header><text>The Commissioner of Foods shall inspect high-risk facilities not less frequently than annually.</text></subparagraph><subparagraph id="id1497bb7bd490413b8709c520d480a54b"><enum>(B)</enum><header>Intermediate-risk facilities</header><text>The Commissioner of Foods shall inspect intermediate-risk facilities not less frequently than once every 2 years.</text></subparagraph><subparagraph id="idd849a743ee0d452c90976943972b3929"><enum>(C)</enum><header>Low-risk facilities</header><text>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.</text></subparagraph></paragraph><paragraph id="idd2ff9ef44f964c549c093ada7d2c4160"><enum>(2)</enum><header>Infant formula manufacturing facilities</header><text>The Commissioner of Foods shall inspect the facilities of each manufacturer of infant formula not less frequently than every 6 months.</text></paragraph></subsection><subsection id="idc149b86c44b9451e962b120266af32b2"><enum>(c)</enum><header>Federal and State cooperation</header><text>The Commissioner of Foods shall contract with State officials to carry out not less than half of the inspections required under this section.</text></subsection><subsection id="idbbcd8ba3435f4f80b25b4572ee065234"><enum>(d)</enum><header>Compliance checks</header><text display-inline="yes-display-inline">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 (<external-xref legal-doc="usc" parsable-cite="usc/21/374">21 U.S.C. 374</external-xref>), the Commissioner of Foods shall conduct a follow-up compliance check of the facility.</text></subsection></section><section commented="no" display-inline="no-display-inline" section-type="subsequent-section" id="id1594de82d2404b7c87112ed1079413f6"><enum>4.</enum><header display-inline="yes-display-inline">Transfer of authority, functions and agencies</header><subsection id="id7035ed69b1c54545bae241d848bd9bf2"><enum>(a)</enum><header>Transfer of authority</header><text>The Federal Food Administration shall assume responsibility for carrying out the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>), 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.</text></subsection><subsection id="id488a4144f97b4e03898e922699aba850"><enum>(b)</enum><header>Transfer of functions</header><text>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.</text></subsection><subsection id="ida17ec73a7373445790051dbb79cdab03"><enum>(c)</enum><header>Transferred agencies</header><text>The Federal agencies referred to in subsection (b) are—</text><paragraph id="idd916b750487c496da9ee2f96781a8707"><enum>(1)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>) with respect to food;</text></paragraph><paragraph id="id9987be8da8094dc89ca4555f49916d0a"><enum>(2)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>) with respect to food;</text></paragraph><paragraph id="idad3649afd0de425eabbc2caafbfe6111"><enum>(3)</enum><text>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 (<external-xref legal-doc="usc" parsable-cite="usc/21/301">21 U.S.C. 301 et seq.</external-xref>) with respect to food; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd59de4e63d0a4861b889f0b7bfcbe04f"><enum>(4)</enum><text display-inline="yes-display-inline">such other offices, services, or agencies as the President designates by executive order to carry out this Act.</text></paragraph></subsection><subsection id="id98f8279b63ec4c75a7bc68bcae2e2791"><enum>(d)</enum><header>Conforming amendment</header><text>Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic Act (<external-xref legal-doc="usc" parsable-cite="usc/21/371">21 U.S.C. 371 et seq.</external-xref>) is amended by adding at the end the following:</text><quoted-block style="OLC" display-inline="no-display-inline" id="id90efd61eb6c24c26878c76c7982a9dbc"><section id="id41cf309b6d2848ac9e0ef78af418217c"><enum>716.</enum><header>Regulation of food</header><text display-inline="no-display-inline">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 <short-title>Federal Food Administration Act of 2025</short-title>—</text><paragraph commented="no" display-inline="no-display-inline" id="id3f83c02591844504bcba5a2e12b19938"><enum>(1)</enum><text display-inline="yes-display-inline">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 <short-title>Federal Food Administration Act of 2025</short-title>; and</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id63a69ca8fc2a4936a93b85b8bf6b069c"><enum>(2)</enum><text display-inline="yes-display-inline">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.</text></paragraph></section><after-quoted-block>.</after-quoted-block></quoted-block></subsection></section><section id="ide3ca128e96bf4c018dfe3c2bcffbb706"><enum>5.</enum><header>Funding</header><subsection id="idf8e4d53defb94f8992f850ce7a630c3e"><enum>(a)</enum><header>Transfer of funds</header><text>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.</text></subsection><subsection id="id9713b2750c0b4d809fa3d24737a809bb"><enum>(b)</enum><header>Authorization of appropriations</header><text>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.</text></subsection></section><section id="id57268ffdf1c14b59b35f99a7878bed1f"><enum>6.</enum><header>Definitions</header><text display-inline="no-display-inline">In this Act:</text><paragraph id="idafd137b808f94e658501d548fe442814" commented="no"><enum>(1)</enum><header>Commissioner of Foods</header><text>The term <term>Commissioner of Foods</term> means the Commissioner described in section 2(d).</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="idd0fd58545d90451ebbfc69920685fc99"><enum>(2)</enum><header display-inline="yes-display-inline">Facility</header><text>The term <term>facility</term> 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 (<external-xref legal-doc="usc" parsable-cite="usc/21/350d">21 U.S.C. 350d</external-xref>; 350h).</text></paragraph><paragraph commented="no" display-inline="no-display-inline" id="id0d0848c6be2a4c089a0fa2a8efef5ca9"><enum>(3)</enum><header>Secretary</header><text>The term <term>Secretary</term> means the Secretary of Health and Human Services.</text></paragraph></section></legis-body></bill>

