United States 119th Congress Status: Passed Senate Bipartisan · 7 D · 3 R cosponsors

S 272 — Protect Infant Formula from Contamination Act

Last action — Held at the desk.

  1. ✓
    Introduced
  2. ✓
    In Committee
  3. 3
    Passed Senate
  4. 4
    Passed House
  5. 5
    To Executive
  6. 6
    Enacted

This bill has passed the Senate. Introduced January 28, 2025. It now moves to the second chamber.

Next likely step: consideration and a floor vote in the House.

Odds of enactment

Moderate chance

Based on the sponsor, cosponsors, and committee posture, this bill has a moderate chance of becoming law.

Upgrade to see the exact probability and what's driving it.

A statistical estimate from our own model of past outcomes — an insight, not a guarantee. Policymaking is volatile.

Prognosis

Advancing 54% · moderate confidence

  • Passed Senate

    Current position in the legislative process.

  • 10 sponsors

    1 primary, 9 co-sponsors signed on.

  • Bipartisan support

    Sponsored across 2 parties (7 D · 3 R) — cross-party backing.

Based on stage, sponsorship breadth, committee status, recorded votes, and cross-state momentum — a description of the observable signals, not a prediction.

Summary

Protect Infant Formula from Contamination ActThis 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.

Bill Text

What changed in the latest version

8 added · 125 removed

Plain-language change summary

The bill was amended to remove references to "toxic elements" from the text and does not include a short title or specific sections regarding notifications for testing of infant formula. This change simplifies the focus of the bill to exclusively address microorganisms in infant formula. As a result, there may be less emphasis on regulating toxic elements in relation to infant formula, potentially impacting how safety assessments are structured.

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Previous
Latest
272 Reported in Senate (RS)] <DOC> Calendar No.
272 Engrossed in Senate (ES)] <DOC> 119th CONGRESS 2d Session S.
306 119th CONGRESS 2d Session S.
272 _______________________________________________________________________ AN ACT To improve the safety of infant formula through testing of infant formula for microorganisms, and for other purposes.
272 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.
_______________________________________________________________________ IN THE SENATE OF THE UNITED STATES January 28, 2025 Mr.
Peters (for himself, Mr.
Hoeven, Ms.
Collins, Ms.
Smith, Mrs.
Shaheen, Ms.
Hassan, Mr.
Kaine, and Ms.
Baldwin) introduced the following bill;
which was read twice and referred to the Committee on Health, Education, Labor, and Pensions January 28, 2026 Reported by Mr.
Cassidy, with an amendment and an amendment to the title [Strike out all after the enacting clause and insert the part printed in italic] _______________________________________________________________________ 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, <DELETED>SECTION 1.
SHORT TITLE.</DELETED> <DELETED> This Act may be cited as the ``Protect Infant Formula from Contamination Act''.</DELETED> <DELETED>SEC.
2.
NOTIFICATIONS FOR TESTING OF INFANT FORMULA.</DELETED> <DELETED> Section 412(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350a(e)) is amended--</DELETED> <DELETED> (1) in paragraph (1), in the matter following subparagraph (B)--</DELETED> <DELETED> (A) by striking ``promptly'';</DELETED> <DELETED> (B) by inserting ``, within 1 business day of acquiring such knowledge'' after ``such knowledge'';
and</DELETED> <DELETED> (C) by striking ``the infant formula'' and inserting ``an infant formula'';</DELETED> <DELETED> (2) by redesignating paragraph (2) as paragraph (5);
and</DELETED> <DELETED> (3) by inserting after paragraph (1) the following:</DELETED> <DELETED> ``(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--</DELETED> <DELETED> ``(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;</DELETED> <DELETED> ``(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</DELETED> <DELETED> ``(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.</DELETED> <DELETED> ``(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.</DELETED> <DELETED> ``(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.''.</DELETED> <DELETED>SEC.
3.
REPORTING TO IMPROVE THE SAFETY AND SUPPLY OF INFANT FORMULA.</DELETED> <DELETED> Section 412 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
350a) is amended by adding at the end the following:</DELETED> <DELETED> ``(n) Reporting To Improve the Safety and Supply of Infant Formula.--</DELETED> <DELETED> ``(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.</DELETED> <DELETED> ``(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-- </DELETED> <DELETED> ``(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</DELETED> <DELETED> ``(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.</DELETED> <DELETED> ``(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.</DELETED> <DELETED> ``(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--</DELETED> <DELETED> ``(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</DELETED> <DELETED> ``(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.''.</DELETED> SECTION 1.
Amend the title so as to read:
Passed the Senate April 28, 2026.
``A bill to improve the safety of infant formula through testing of infant formula for microorganisms, and for other purposes.''.
Attest:
Calendar No.
Secretary.
306 119th CONGRESS 2d Session S.
119th CONGRESS 2d Session S.
272 _______________________________________________________________________ A BILL To improve the safety of infant formula through testing of infant formula for microorganisms and toxic elements, and for other purposes.
272 _______________________________________________________________________ AN ACT To improve the safety of infant formula through testing of infant formula for microorganisms, and for other purposes.
Show all 41 changed rows (1 more)
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_______________________________________________________________________ January 28, 2026 Reported with an amendment and an amendment to the title
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Action History

  1. Introduced in Senate

  2. Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

  3. Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

  4. 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.

  5. 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.

  6. Placed on Senate Legislative Calendar under General Orders. Calendar No. 306.

  7. Passed/agreed to in Senate: Passed Senate with an amendment and an amendment to the Title by Unanimous Consent.

  8. Passed Senate with an amendment and an amendment to the Title by Unanimous Consent. (consideration: CR S2074-2075; text: CR S2074)

  9. Message on Senate action sent to the House.

  10. Received in the House.

  11. Held at the desk.

Sponsors

Sponsorship breakdown

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1 sponsors · 9 co-sponsors · 537 not signed on

Sponsors (1)

Co-sponsors (9)

Not signed on (537)

537 members have not signed on to this bill.

Show all 537 →

"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

public-safety healthcare health-insurance
Cross-referencing the record. Reading this bill against every other bill in the corpus by meaning, not keywords. Only the first open is slow. It’s instant for you after this. Matching · Ranking · Engrossing

Frequently asked questions

What does S 272 do?
Protect Infant Formula from Contamination ActThis 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.
Who sponsors S 272?
S 272 is sponsored by Peters, Gary C. (Democratic), Hoeven, John (Republican), Collins, Susan M. (Republican), Smith, Tina (Democratic), Shaheen, Jeanne (Democratic), Hassan, Margaret Wood (Democratic), Kaine, Tim (Democratic), Baldwin, Tammy (Democratic), Murray, Patty (Democratic), and Fischer, Deb (Republican).
What is the current status of S 272?
This bill has passed the Senate. Introduced January 28, 2025. It now moves to the second chamber.
Where can I track S 272?
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