S. 4256 · 117th Congress
Protecting Infants from Formula Shortages Act of 2022
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Never voted on. It didn't reach a floor vote before the 117th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
CaseySponsor7 cosponsors · 7 D
4 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill imposes requirements on manufacturers of infant formula and medical foods for individuals with inborn errors of metabolism.
What it does: CRS summary · Introduced in Senate · May 18, 2022
Protecting Infants from Formula Shortages Act of 2022
This bill imposes requirements on manufacturers of infant formula and medical foods for individuals with inborn errors of metabolism.
A manufacturer of such a food must notify the Food and Drug Administration (FDA) of any circumstance that is likely to lead to a meaningful disruption of the U.S. supply of the food, including a discontinuance or interruption of manufacturing. The manufacturer must submit the notification at least six months prior to the cause of the disruption or, if that is not possible, as soon as practicable. The FDA must provide the Department of Agriculture and appropriate organizations information about the cause of the disruption.
The FDA must inform a person (an individual or entity) of their failure to comply with these notification requirements. If the failure continues for a certain time period, the person shall be subject to fines, imprisonment, or both.
During a public health emergency, the FDA may impose additional conditions for such notifications and designate additional categories of food that are subject to the notification requirements.
The bill also requires each manufacturer of such a food to develop and maintain a redundancy risk management plan that identifies and evaluates risks for each manufacturing establishment for the food.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Protecting Infants from Formula Shortages Act of 2022
Latest action (May 18, 2022): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: May 18, 2022
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.