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Protecting Infants from Formula Shortages Act of 2022

USA117th CongressHR-7989| House 
| Updated: 6/8/2022
Kim Schrier

Kim Schrier

Democratic Representative

Washington

Cosponsors (3)
Jahana Hayes (Democratic)Nanette Diaz Barragán (Democratic)Debbie Wasserman Schultz (Democratic)

Energy and Commerce 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

Latest Companion Bill Action

S 117-4256
Introduced in Senate
Jun 8, 2022
Introduced in House
Jun 8, 2022
Referred to the House Committee on Energy and Commerce.
  • May 18, 2022

    Latest Companion Bill Action

    S 117-4256
    Introduced in Senate


  • June 8, 2022
    Introduced in House


  • June 8, 2022
    Referred to the House Committee on Energy and Commerce.

Health

Related Bills

  • S 117-4256: 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 CongressHR-7989| House 
| Updated: 6/8/2022
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

Latest Companion Bill Action

S 117-4256
Introduced in Senate
Jun 8, 2022
Introduced in House
Jun 8, 2022
Referred to the House Committee on Energy and Commerce.
  • May 18, 2022

    Latest Companion Bill Action

    S 117-4256
    Introduced in Senate


  • June 8, 2022
    Introduced in House


  • June 8, 2022
    Referred to the House Committee on Energy and Commerce.
Kim Schrier

Kim Schrier

Democratic Representative

Washington

Cosponsors (3)
Jahana Hayes (Democratic)Nanette Diaz Barragán (Democratic)Debbie Wasserman Schultz (Democratic)

Energy and Commerce Committee

Health

Related Bills

  • S 117-4256: 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