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Protecting Infants from Formula Shortages Act of 2022
12/29/2022, 5:18 PM
Summary of Bill HR 7989
The main provisions of the bill include measures to increase the production and distribution of infant formula, as well as to improve coordination between government agencies and private sector partners to ensure a steady supply of formula for families in need. The bill also includes provisions to increase funding for programs that provide formula to low-income families, as well as to improve data collection and reporting on formula shortages.
Overall, the Protecting Infants from Formula Shortages Act of 2022 aims to ensure that all families have access to the infant formula they need to properly nourish their babies. The bill has received bipartisan support in Congress and is expected to be passed into law in the near future.
Congressional Summary of HR 7989
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.
