[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8038 Introduced in House (IH)]
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117th CONGRESS
2d Session
H. R. 8038
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.
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IN THE HOUSE OF REPRESENTATIVES
June 13, 2022
Mr. Johnson of South Dakota (for himself, Ms. Spanberger, Mrs. Bice of
Oklahoma, and Ms. Schrier) introduced the following bill; which was
referred to the Committee on Energy and Commerce
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A BILL
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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