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.