Duckworth Joins Casey, Colleagues to Introduce Bill to Empower FDA to Get Infant Formula Back on Shelves, Prevent Future Shortages
New bill would give FDA more authority to resolve formula shortage, ensure families can access life-sustaining products
[WASHINGTON, DC] – In the wake of the nationwide infant formula shortage, U.S. Senator Tammy Duckworth (D-IL) joined U.S. Senators Bob Casey (D-PA), Sherrod Brown (D-OH), Kirsten Gillibrand (D-NY) and Elizabeth Warren (D-MA) in introducing legislation to protect families and patients who rely on infant formula and other essential sources of nutrition (ESN). The Protect Infants from Formula Shortages Act would safeguard the availability of these products by requiring manufacturers to notify the Food and Drug Administration (FDA) of potential supply disruptions and give the FDA additional tools to proactively work with manufacturers to help prevent or mitigate potential shortages. Currently, the agency lacks visibility into disruptions that could cause shortages, limiting its ability to work with manufacturers to adequately prepare for and respond to supply chain disruptions.
“Our nation's infant formula shortage is alarming, and we must do all we can to ensure it doesn’t happen again,” said Duckworth. “Shortages like these can have serious consequences for a child’s growth and development—especially in the first year of their life—and it’s unacceptable. That’s one of the many reasons I’m proud to join my colleagues in helping Senator Casey introduce our commonsense legislation to prevent these kinds of shortages in the future and support working families across the nation.”
“Parents and families across the country are feeling desperate and scared. There is no greater fear than not being able to feed your child or of feeding your child contaminated formula. Congress has a responsibility to do everything we can to ensure formula is on shelves and parents can feed their kids,” said Casey. “I am introducing the Protect Infants from Formula Shortages Act to avoid another massive disruption in availability of life-saving and life-sustaining formula and other products. I will continue to push Abbott and the FDA to get the answers we need to make sure no family ever has to go through the fear and frustration parents are feeling now.”
“This infant formula supply shortage has placed an unacceptable burden on parents and caregivers and has put the health of too many babies and infants at risk. I am proud to introduce this legislation with Sen. Casey to ensure this never happens again and that families have access to the essential formula they need,” said Brown.
“It is imperative that we take all steps necessary to prevent another formula shortage from happening in the United States,” said Gillibrand. “75 percent of babies in the United States are fed formula at some point in their first six months of life. So this is not just a problem for some babies, it’s a problem for the vast majority of infants and their families. This urgently needed bill will help prevent Americans from facing such a shortage again.”
“The infant formula shortage has created a crisis for the babies, children, and families who rely on this essential product. I'm glad to join Senator Casey and my colleagues in introducing this legislation to prevent future shortages and help ensure American families never have to face a crisis like this again,” said Warren.
The Protect Infants from Formula Shortages Act:
- Ensures manufacturers of ESN provide timely notification of known circumstances that are likely to lead to meaningful disruption in their domestic supply;
- Allows the FDA to expand and accelerate notification requirements for certain foods during public health emergencies;
- Directs manufacturers of ESN to develop risk management plans for the supply of their product and
- Gives the FDA authority to request records in advance or in lieu of an in-person inspection, and requires that manufacturers of ESN comply with these requests.
This legislation is endorsed by the American Academy of Pediatrics, the National WIC Association, North American Society For Pediatric Gastroenterology, Hepatology & Nutrition, the National PKU Alliance and National PKU News.
A copy of the bill text can be found here.?
Since the nationwide infant formula shortage began, Duckworth has been working to address this issue and prevent it from happening again. Last week, Duckworth sent a letter to the Federal Trade Commission (FTC) requesting that the FTC conduct a Section 6(b) wide-ranging study of the infant formula industry to examine how that market’s composition, along with the behavior and business practices of market participants, affect competition, consumer prices, consumer choice, product safety, product quality, product transparency, supply chain efficiency, supply chain resilience and public health. Additionally, Duckworth joined her colleagues in urging the United States Department of Agriculture (USDA) to address extremely high levels of corporate concentration in the infant formula marketplace.
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