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Protecting Infants from Formula Shortages Act of 2022

USA117th CongressS-4256| Senate 
| Updated: 5/18/2022
Robert P. Casey

Robert P. Casey

Democratic Senator

Pennsylvania

Cosponsors (7)
Tammy Duckworth (Democratic)Kirsten E. Gillibrand (Democratic)Elizabeth Warren (Democratic)Amy Klobuchar (Democratic)John W. Hickenlooper (Democratic)Tina Smith (Democratic)Sherrod Brown (Democratic)

Health, Education, Labor, and Pensions Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
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.
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Timeline
May 18, 2022
Introduced in Senate
May 18, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jun 8, 2022

Latest Companion Bill Action

HR 117-7989
Introduced in House
  • May 18, 2022
    Introduced in Senate


  • May 18, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • June 8, 2022

    Latest Companion Bill Action

    HR 117-7989
    Introduced in House

Health

Related Bills

  • HR 117-7989: Protecting Infants from Formula Shortages Act of 2022
Administrative law and regulatory proceduresBusiness recordsChild healthDepartment of Health and Human ServicesEmergency medical services and trauma careFood industry and servicesFood supply, safety, and labelingGovernment information and archivesGovernment studies and investigationsIndustrial facilitiesInfectious and parasitic diseasesManufacturingNutrition and diet

Protecting Infants from Formula Shortages Act of 2022

USA117th CongressS-4256| Senate 
| Updated: 5/18/2022
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.
View Full Text

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
May 18, 2022
Introduced in Senate
May 18, 2022
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Jun 8, 2022

Latest Companion Bill Action

HR 117-7989
Introduced in House
  • May 18, 2022
    Introduced in Senate


  • May 18, 2022
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • June 8, 2022

    Latest Companion Bill Action

    HR 117-7989
    Introduced in House
Robert P. Casey

Robert P. Casey

Democratic Senator

Pennsylvania

Cosponsors (7)
Tammy Duckworth (Democratic)Kirsten E. Gillibrand (Democratic)Elizabeth Warren (Democratic)Amy Klobuchar (Democratic)John W. Hickenlooper (Democratic)Tina Smith (Democratic)Sherrod Brown (Democratic)

Health, Education, Labor, and Pensions Committee

Health

Related Bills

  • HR 117-7989: Protecting Infants from Formula Shortages Act of 2022
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresBusiness recordsChild healthDepartment of Health and Human ServicesEmergency medical services and trauma careFood industry and servicesFood supply, safety, and labelingGovernment information and archivesGovernment studies and investigationsIndustrial facilitiesInfectious and parasitic diseasesManufacturingNutrition and diet