[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9788 Introduced in House (IH)]

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119th CONGRESS
  2d Session
                                H. R. 9788

    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.


_______________________________________________________________________


                    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.
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