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To amend the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services to establish maximum permissible levels for contaminants in infant formulas, and for other purposes.
Summary
- Directs the Secretary of Health and Human Services to establish maximum permissible levels for contaminants in infant formula by regulation.
- Defines contaminants broadly to include heavy metals, per- and polyfluoroalkyl substances (PFAS), phthalates, microplastics, synthetic pesticides, and biological toxins.
- Requires infant formula manufacturers to test for compliance with maximum permissible contaminant levels and maintain testing records for at least 2 years after shelf life expiration.
- Requires the Secretary to consider cumulative health impacts on infant neurodevelopment, prevalence of contaminants in soil and water, and bioaccumulative properties when establishing contaminant levels.
- Requires the Secretary to issue implementing regulations within 180 days of enactment, with compliance required within 180 days after regulations are issued.
- Requires annual reports to Congress identifying manufacturers in violation and reporting specific contaminant concentrations detected in routine surveillance testing.
AI-generated plain-language summary of the bill text — neutral, and may be imperfect. See the full text below for the exact wording.
Sponsor (1)
1 cosponsor
Money behind the sponsor
Top reported contributors to Brian J. Mast’s campaign committee (2024 cycle) — who funds the bill’s sponsor, not a claim about this bill. Data from FEC.
- NULL $236,075
- EDW C LEVY CO $13,200
- NOBLE PROPERTIES $7,600
- EXPEDITED TRAVEL $7,100
- BLUE OWL CAPITAL $6,600
Organizations whose employees gave the most — itemized individual contributions grouped by the donor’s reported employer (FEC Schedule A). Full finance for Brian J. Mast → · Outside spending →
Actions (2)
- Jul 20, 2026 Referred to the House Committee on Energy and Commerce. · house
- Jul 20, 2026 Introduced in House
Text versions (1)
Bills are re-published as they move (Introduced → Reported → Engrossed → Enrolled …). Each stage below is a separate text; pick two to see what changed. Data from Congress.gov.
Full text
IN THE HOUSE OF REPRESENTATIVES
July 20, 2026
Mr. Mast (for himself and Mr. Carter of Georgia) 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 to direct the Secretary of Health and Human Services to establish maximum permissible levels for contaminants in infant formulas, and for other purposes.
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 “Formula Oversight, Regulation, and Manufacturing Uniformity for Life-sustaining Assurance Act of 2026” or the “FORMULA Act of 2026”.
SEC. 2. REQUIREMENTS FOR INFANT FORMULAS.
(a) Criteria for Determining if an Infant Formula Is Adulterated.— Section 412(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a(a)) is amended—
(1) in paragraph (2), by striking “or” at the end;
(2) in paragraph (3), by striking the period at the end and inserting “, or”; and
(3) by adding at the end the following:
“(4) such infant formula does not comply with the maximum permissible levels for contaminants in infant formula established by the Secretary under subsection (n).”.
(b) Maximum Permissible Levels for Contaminants in Infant Formula.—Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350a) is amended by adding at the end the following:
“(n) Maximum Permissible Levels for Contaminants in Infant Formula.—
“(1) Establishment.—The Secretary shall by regulation establish maximum permissible levels for contaminants in infant formula.
“(2) Maximum contaminant levels.—In prescribing regulations under paragraph (1), the Secretary shall ensure that the level of any contaminant in infant formula is as close to the maximum contaminant level goal as is feasible with the use of the best available technology, treatment techniques, and other means which the Secretary finds are available, taking cost into consideration.
“(3) Factors to consider.—In establishing the maximum permissible level for a contaminant under paragraph (1), the Secretary shall consider—
“(A) the cumulative health impacts of low-level exposure of the contaminant on infant neurodevelopment;
“(B) the prevalence of the contaminant in agricultural soil and manufacturing source-water; and
“(C) the bioaccumulative nature of the contaminant in the human body.
“(4) Testing and records.—In prescribing regulations under paragraph (1), the Secretary shall require a manufacturer of infant formula—
“(A) to conduct testing to ensure compliance with the maximum permissible contaminant levels established by the Secretary under paragraph (1);
“(B) to maintain records relating to such testing for not fewer than 2 years after the expiration of the shelf life of such infant formula; and
“(C) to make such records available to the Secretary upon request.
“(5) Contaminant defined.—In this subsection, the term ‘contaminant’ means any physical, chemical, biological, or radiological substance or matter that is man-made or introduced into the environment via human activity, including heavy metals, per- and polyfluoroalkyl substances, phthalates, microplastics, synthetic pesticides, and biological toxins, including cyanotoxins associated with harmful algal blooms.
“(6) Annual report to congress.—As part of the annual report required under subsection (l), the Secretary shall include—
“(A) a list of any manufacturers found to be in violation of the maximum permissible contaminant levels established by the Secretary under paragraph (1);
“(B) the specific concentrations of contaminants, including microplastics and cyanotoxins, detected in infant formula during routine surveillance testing; and
“(C) an assessment of the progress made toward achieving the lowest feasible levels for contaminants in infant formula in the domestic supply chain.”.
(c) Regulations.—Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services shall issue regulations to implement section 412(n) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (b) of this section). Such regulations shall apply to infant formula manufactured on or after the date that is 180 days after the date of issuance of the regulations. <all>
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