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Protecting Infants from Formula Shortages: New Rules for Manufacturers

The Act amends the Federal Food, Drug, and Cosmetic Act to prevent shortages of essential products like infant formula. It mandates manufacturers to notify the Secretary of production interruptions or discontinuances and requires the development of risk management plans to ensure supply continuity.
Key points
Manufacturers of essential sources of nutrition must notify the Secretary of a discontinuance or interruption in production likely to lead to a meaningful disruption in supply.
The Secretary is required to distribute information regarding reported interruptions to appropriate organizations and the Secretary of Agriculture.
Manufacturers are required to develop and maintain redundancy risk management plans for each manufacturing establishment.
If a manufacturer fails to provide required information after receiving a warning letter, the Secretary will make the letter and the manufacturer's response public on the website.
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Additional Information
Print number: 117_S_4256
Sponsor: Sen. Casey, Robert P., Jr. [D-PA]
Process start date: 2022-05-18
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OFFICIAL LEGAL TITLE

Protecting Infants from Formula Shortages Act of 2022

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 117_S_4256.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2022-05-18.

What are the main provisions?

Key points include:

  • Manufacturers of essential sources of nutrition must notify the Secretary of a discontinuance or interruption in production likely to lead to a meaningful disruption in supply.
  • The Secretary is required to distribute information regarding reported interruptions to appropriate organizations and the Secretary of Agriculture.
  • Manufacturers are required to develop and maintain redundancy risk management plans for each manufacturing establishment.
  • If a manufacturer fails to provide required information after receiving a warning letter, the Secretary will make the letter and the manufacturer's response public on the website.
What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Casey, Robert P., Jr. [D-PA].

What is the latest detailed status?

The latest detailed status is: Introduced in Senate

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2026-01-02.

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