Pallone Announces Introduction of Infant Formula Bill to Protect Infants and Toddlers

Congressman Frank Pallone (third from left) introduces new legislation that would keep toxic heavy metals out of infant and toddler food.

Congressman Frank Pallone, Jr. (NJ-06) today announced the introduction of the Improving Newborns’ Food and Nutrition Testing Safety (INFANTS) Act to protect the health and safety of infants and toddlers. The bill would require finished baby food products to be tested for toxic heavy metals and other contaminants, helping to establish precautionary measures to prevent infant formula shortages in the future. In 2022, the Food and Drug Administration (FDA) closed a facility due to contaminated products and poor factory conditions, leading to a nationwide formula shortage. Currently, FDA is investigating contamination in children’s applesauce products.

Pallone introduced the bill because there is currently no federal mandate for FDA to require manufacturers to test finished baby food products for contaminants like heavy metals, including lead, cadmium, and mercury. Pallone is the Ranking Member of the Energy and Commerce Committee, which has jurisdiction over FDA and baby food products.

“Parents should not have to worry about whether the food they buy for their children is contaminated with bacteria, lead, or another toxic heavy metal. In just the last few months, we have read frightening reports about contaminated applesauce leading to potential lead poisoning in dozens of children. This followed tragic stories last year about infants becoming sick and even dying after drinking infant formula contaminated with Cronobacter bacteria,” Pallone said. “The INFANTS Act would establish a testing regime to ensure toddler and infant food products are free of dangerous contaminants and clarify FDA’s authority to recall adulterated products. I look forward to working to get this bill signed into law.”

Exposure to toxic heavy metals can endanger infant neurological development, cause permanent decreases in IQ, and impair long-term brain function. By requiring final products to be tested for contaminants, FDA can ensure the products vulnerable young children are consuming are safe. Additionally, federal law does not require powdered infant formula manufacturers to have a regular environmental monitoring for powdered infant formula’s exposure to Cronobacter and salmonella. Tragically, the two bacteria have caused illness and death after being found in infant formula, which in one instance led to a nationwide infant formula crisis in 2022.

“Nutrition is a cornerstone for healthy childhood development, especially during the foundational stages of infancy and toddlerhood. This bill addresses a fundamental issue of ensuring the safety and accessibility of essential nutrition for our newborns and youngest children,” said Hannah Korn-Heilner, Outreach Coordinator, Advocates for Children of New Jersey. “Every parent deserves the right to make informed choices for their child’s health without stress or worry about scarcity. Access to essential nutrition for our newborns should not be a difficult task for any family. This bill aims to prevent another formula and food shortage for our youngest children, easing the burden on families and providing parents with viable options to secure the health and growth of our youngest community members.”

“As a Community Action Agency and a Federally Qualified Health Center, the Jewish Renaissance Foundation has been dedicated to addressing barriers to quality health care, along with ensuring that products released to the children and families we serve are safe and effective,” said Jaime Rivello, CEO, Jewish Renaissance Foundation. “The families we provide services to have been affected in some way by the formula shortage and the issues surrounding the products as well. We appreciate Congressman Pallone and his efforts to ensure that products released to the public remain safe to use.”

“Without routine testing and sampling, consumers will have little confidence in the safety of baby food and infant formula,” said Scott Faber, senior vice president for government affairs for the Environmental Working Group (EWG), a national environmental health group. “Toxic metals and pathogens have no place in the food we serve to our families, especially our babies and toddlers. EWG applauds Representative Pallone for making the safety of our babies and toddlers a top priority.”

“Our children are our most precious resource. As a parent of four young boys, I thank Congressman Pallone for his efforts to put infants at the forefront and prioritize safety,” said Jenny Alvarez, Program Manager at the Family Success Center. “The continuous testing of baby formula and food not only ensures food safety, but also provides peace of mind for me and the families we serve.”

The INFANTS Act of 2023 would:

·         Require the owner, operator, or agent in charge of a food facility that manufactures or processes food in final product form, including infant and toddler food, to:

·         Collect representative samples of each food manufactured or processed and test them at least once per quarter for contaminants, including toxic elements like lead, cadmium, mercury, and arsenic;

·         Prepare a written sampling plan for sampling and testing and ensure it is carried out; and

·         Maintain records of sampling and testing and allow those records to be inspected and copied by FDA.

·         Specify that foods manufactured or processed by facilities that fail to follow sampling and testing requirements are adulterated under the Federal Food, Drug, and Cosmetic Act;

·         Require records to be provided to FDA, at FDA’s request, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner;

·         Clarify FDA’s mandatory recall authority over infant or toddler foods that bear or contain a contaminant that renders the product adulterated;

·         Clarify that manufacturers of infant formula must notify FDA within 24 hours if they acquire knowledge that the infant formula they manufacture does not contain adequate nutrients or is otherwise adulterated or misbranded; and

·         Require manufacturers of powdered infant formula to establish and implement an environmental monitoring program to verify the effectiveness of sanitation and hygiene controls where food has the potential to be exposed to Cronobacter or salmonella.