Formula Shortage Reporting Act of 2022
Bill: H.R.8038 | Sponsor: Rep. Johnson, Dusty (R-SD)
Policy area: Health

Summary:
Formula Shortage Reporting Act of 2022
This bill requires manufacturers of infant formula to notify the Food and Drug Administration (FDA) at least 72 hours in advance of a manufacturing interruption or product discontinuance that is expected to meaningfully disrupt the product's supply. The FDA must post such information on its website and notify health care providers.

To authorize the Food and Drug Administration to require manufacturers 
of infant formula to warn about a discontinuance or interruption in the 
         production of infant formula, 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 Shortage Reporting Act of 
2022''.

SEC. 2. REQUIREMENT TO WARN ABOUT DISCONTINUANCE OR INTERRUPTION IN THE 
              PRODUCTION OF INFANT FORMULA.

    (a) In General.--Section 412 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 350a) is amended by adding at the end the 
following:
    ``(j)(1) A manufacturer of infant formula shall notify the 
Secretary, in accordance with paragraph (2), of a permanent 
discontinuance in the manufacture of the infant formula or an 
interruption of the manufacture of the infant formula that is likely to 
lead to a meaningful disruption in the supply of that infant formula in 
the United States, or a permanent discontinuance in the manufacture of 
an infant formula component or an interruption in the manufacture of an 
infant formula component that is likely to lead to a meaningful 
disruption in the supply of the infant formula component, and the 
reasons for such discontinuance or interruption. Notification under 
this subsection shall include disclosure of--
            ``(A) reasons for the discontinuance or interruption;
            ``(B) if an infant formula component is a reason for, or a 
        risk factor in, such discontinuance or interruption, the source 
        of the infant formula component and any alternative sources for 
        the infant formula component known by the manufacturer;
            ``(C) whether any associated device used for preparation or 
        administration included in the infant formula is a reason for, 
        or a risk factor in, such discontinuance or interruption;
            ``(D) in the case of an interruption, the expected duration 
        of the interruption; and
            ``(E) such other information as the Secretary may require.
    ``(2) A notice required under paragraph (1) shall be submitted to 
the Secretary--
            ``(A) at least 72 hours prior to the date of the 
        discontinuance or interruption; or
            ``(B) if compliance with subparagraph (A) is not possible, 
        as soon as practicable.
    ``(3) If a manufacturer of infant formula determines that 
compliance with paragraph (2)(A) is not possible, the manufacturer 
shall submit such determination in writing to the Secretary and the 
justification for such determination.
    ``(4) To the maximum extent practicable, the Secretary shall 
distribute to health care providers who treat pregnant women and 
children under the age of 2, and make publicly available on the website 
of the Food and Drug Administration, information on the discontinuance 
or interruption of the manufacture of the infant formula described in 
paragraph (1).
    ``(5) Nothing in this subsection shall be construed as authorizing 
the Secretary to disclose any information that is a trade secret or 
confidential information subject to section 552(b)(4) of title 5, 
United States Code, or section 1905 of title 18, United States Code.
    ``(6) The Secretary shall find a manufacturer of infant formula to 
be in violation of this section if--
            ``(A) the Secretary determines that--
                    ``(i) the manufacturer has failed to submit the 
                notice required by paragraph (2) and the determination 
                and justification required by paragraph (3); or
                    ``(ii) the determination and justification 
                submitted by the manufacturer are insufficient;
            ``(B) the Secretary issues a letter to such manufacturer--
                    ``(i) informing such manufacturer of such failure 
                or insufficiency; and
                    ``(ii) giving such manufacturer a period of not 
                more than 30 calendar days to correct such failure or 
                insufficiency; and
            ``(C) the Secretary determines such manufacturer has failed 
        to correct such failure or insufficiency by the end of such 
        period.
    ``(7) For purposes of this subsection--
            ``(A) the term `infant formula component' means a raw or 
        in-process material, ingredient, container, or closure used in 
        the manufacturing or processing of infant formula;
            ``(B) the term `infant formula shortage' or `shortage', 
        with respect to an infant formula, means a period of time when 
        the demand or projected demand for the infant formula within 
        the United States exceeds the supply of the infant formula; and
            ``(C) the term `meaningful disruption'--
                    ``(i) means a change in production that is 
                reasonably likely to lead to a reduction in the supply 
                of an infant formula by a manufacturer that is more 
                than negligible and affects the ability of the 
                manufacturer to fill orders or meet expected demand for 
                its product; and
                    ``(ii) does not include interruptions in 
                manufacturing due to matters such as routine 
                maintenance or insignificant changes in manufacturing 
                so long as the manufacturer expects to resume 
                operations in a short period of time.''.
    (b) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(fff) The failure by a manufacturer of infant formula, with 
respect to a notice of discontinuance or interruption, to make a 
correction as required by section 412(j)(6)(C).''.
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