Protect Infant Formula from Contamination Act
This bill imposes certain new requirements on infant formula manufacturers and the Food and Drug Administration (FDA) following the discovery of contaminated, adulterated, or misbranded infant formula.
Specifically, the bill requires infant formula manufacturers to report to the FDA within one business day of learning that formula that was processed by the manufacturer but that is no longer within the manufacturer’s control may not provide required nutrients or may be otherwise adulterated or misbranded.
Further, if any testing of finished infant formula reveals the presence of specified microorganisms (e.g., salmonella), the manufacturer must notify the FDA within one business day. (Under current law, manufacturers are only required to report contamination to the FDA if the affected formula has left the manufacturer’s control.) The manufacturer must also promptly provide the test results to the FDA and consult with the FDA on proper isolation and disposal of the affected product. The FDA must respond to such a notification and begin discussing proper investigative and corrective action with the manufacturer within one business day.
Within 90 days of a report of adulterated, misbranded, or contaminated infant formula, the FDA must determine whether the manufacturer that reported the problem has performed, or is performing, appropriate investigative and corrective action.
Finally, the FDA is required to periodically report on the infant formula supply chain and efforts to improve the safety and supply of infant formula, and must consult with other federal agencies and infant formula stakeholders on these issues.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 272 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 272
To improve the safety of infant formula through testing of infant
formula for microorganisms and toxic elements, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
January 28, 2025
Mr. Peters (for himself and Mr. Hoeven) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To improve the safety of infant formula through testing of infant
formula for microorganisms and toxic elements, 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 ``Protect Infant Formula from
Contamination Act''.
SEC. 2. NOTIFICATIONS FOR TESTING OF INFANT FORMULA.
Section 412(e) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 350a(e)) is amended--
(1) in paragraph (1), in the matter following subparagraph
(B)--
(A) by striking ``promptly'';
(B) by inserting ``, within 1 business day of
acquiring such knowledge'' after ``such knowledge'';
and
(C) by striking ``the infant formula'' and
inserting ``an infant formula'';
(2) by redesignating paragraph (2) as paragraph (5); and
(3) by inserting after paragraph (1) the following:
``(2) If the result of any testing of a sample from any production
aggregate of finished infant formula product is confirmed as a positive
analytical result for any microorganism for which finished product
testing is required under section 106.55(e) of title 21, Code of
Federal Regulations (or any successor regulation), the manufacturer
shall--
``(A) within 1 business day of acquiring a confirmed
positive analytical result, notify the Secretary of such
result, regardless of whether such product has left an
establishment subject to the control of the manufacturer;
``(B) promptly consult with the Secretary for proper
isolation of the affected product, and, as the Secretary may
require, cease distribution and properly dispose of the
affected product; and
``(C) promptly provide to the Secretary results and
isolates from a positive sample of such product or the whole
genetic sequence from any confirmed positive analytical result.
``(3) Not later than 1 business day after receipt by the Secretary
of a notification under paragraph (2)(A), the Secretary shall respond
to the manufacturer of the infant formula to begin discussions
regarding investigation and corrective action, and, as appropriate,
share the findings of the Secretary with the manufacturer.
``(4) Not later than 90 days after receipt of a notification under
paragraph (1) or (2), the Secretary shall confirm, including through
the collection of documentation, that the manufacturer submitting the
notification performed, or is performing, an appropriate investigation
and corrective action, if applicable. The Secretary shall consider, as
part of the review of the root cause investigation, the analytical
method used to conduct laboratory testing and, as appropriate, the
potential for cross contamination of the sample by handling and
testing. The manufacturer shall make such documentation available to
the Secretary electronically and for inspection under section 704.''.
SEC. 3. REPORTING TO IMPROVE THE SAFETY AND SUPPLY OF 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) Reporting To Improve the Safety and Supply of Infant
Formula.--
``(1) Progress report.--Not later than 180 days after the
date of enactment of the Protect Infant Formula from
Contamination Act, the Secretary shall issue a progress report
on implementation of the recommendations to improve the safety
and supply of infant formula contained in the report titled,
`Long-Term National Strategy to Increase the Resiliency of the
U.S. Infant Formula Market', issued by the Food and Drug
Administration in January 2025. Such progress report shall
include additional authorities or resources that the Secretary
may require for purposes of improving the safety and supply of
infant formula.
``(2) Quarterly reports on supply chain.--Not later than
270 days after the date of enactment of the Protect Infant
Formula from Contamination Act, and not less frequently than
quarterly for the 5-year period thereafter, the Secretary shall
submit a report on the most current, critical supply chain data
for infant formula, including in-stock rates, to--
``(A) the Committee on Health, Education, Labor,
and Pensions; the Committee on Agriculture, Nutrition,
and Forestry; and the Subcommittee on Agriculture,
Rural Development, Food and Drug Administration, and
Related Agencies of the Committee on Appropriations of
the Senate; and
``(B) the Committee on Energy and Commerce; the
Committee on Agriculture; and the Subcommittee on
Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies of the Committee
on Appropriations of the House of Representatives.
``(3) Consultation.--The Secretary shall engage with the
Department of Agriculture and other relevant agencies of the
Federal Government regarding ongoing efforts to address
immediate formula needs and build long-term resiliency into the
infant formula market.
``(4) Reports on adequacy of supply.--Not later than 1
year, 3 years, and 5 years after the date of enactment of the
Protect Infant Formula from Contamination Act, the Secretary
shall--
``(A) engage with public stakeholders, infant
formula manufacturers, and other stakeholders, as
determined by the Secretary, to determine evidence-
based practices that can be implemented to maximize
infant formula supply and infant safety, which may
include the value of high frequency testing for
purposes of identifying contamination events and
bracketing potentially contaminated product, the impact
of corrective action on contamination events, and
evidence-based recommendations for enhancing infant
formula supply and safety; and
``(B) submit a report to the committees described
in subparagraphs (A) and (B) of paragraph (2) that
identifies the modifications to manufacturer practices
and actions described in subparagraph (A), if any, that
could be implemented to improve infant formula supply
and safety.''.
<all>
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute and an amendment to the title. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Cassidy with an amendment in the nature of a substitute and an amendment to the title. Without written report.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 306.
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