March 27, 2025

Reps. Sykes, Pallone, Krishnamoorthi Reintroduce the Improving Newborns’ Food and Nutrition Testing Safety (INFANTS) Act

Last Week, HHS, FDA took Action to Expand Options for Safe, Reliable, and Nutritious Infant Formula Based on Congresswoman’s Legislation

WASHINGTON, D.C. — Today, U.S. Representatives Emilia Sykes (OH-13), Frank Pallone, Jr. (NJ-06), and Raja Krishnamoorthi (IL-08) reintroduced the Improving Newborns’ Food and Nutrition Testing Safety (INFANTS) Act, legislation to protect the health and safety of infants and toddlers by requiring finished baby food products and infant formula to be tested for toxic heavy metals and other contaminants. Last week, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced that they would take action on key priorities of Rep. Sykes’ legislation to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply and baby food. However, more action is needed.  

“I was happy to see that HHS is taking steps in line with my legislation to protect baby formula and ensure that the food we are feeding infants and toddlers does not contain dangerous amounts of toxic heavy metals like lead or arsenic. Reps. Pallone, Krishnamoorthi and I have reintroduced the INFANTS Act to codify these efforts into law and require commonsense nutrition testing that will keep babies safe and healthy,” said Rep. Sykes. “The INFANTS Act will reinforce efforts from HHS and ensure that infants and toddlers have the safe, nutritious food they need to grow and develop.”

“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. 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’m grateful to Congresswoman Sykes for her leadership and look forward to working together to see this bill signed into law,” said Rep. Frank Pallone, Ranking Member of the House Energy and Commerce Committee. 

"As a proud dad of three, my number one priority is keeping our children safe. Since my investigation exposed the widespread danger of toxic heavy metals in baby foods in 2021, I have been sounding the alarm on the need to reduce the amount of lead, inorganic arsenic, mercury, and cadmium in these products," said Rep. Krishnamoorthi. "The INFANTS Act is the first step of many to ensure that HHS and FDA have the proper authority to test products and recall them when they pose a risk to our children. I look forward to collaborating with Representative Sykes and Ranking Member Pallone to pass this legislation and ensure families will not have to question whether their children’s food is safe."

Last week, the FDA announced a set of actions and initiatives focused on infant formula, such as beginning the nutrient review process required by Congress and increasing testing for heavy metals and other contaminants, as Representative Sykes’ legislation has prioritized. The agency is also encouraging companies to develop new infant formulas and clarify opportunities to help inform consumers about formula ingredients. These enhanced FDA commitments are focused on making sure a strong supply of the sole source of nutrition for formula-fed babies and children remains available for one of our nation’s most vulnerable populations.

Exposure to toxic heavy metals can cause permanent decreases in IQ, diminished future economic productivity, and increased risk of future criminal and antisocial behavior in children. Toxic heavy metals endanger infant neurological development and long-term brain function. As opposed to just testing the ingredients, heavy metal levels can be higher after food processing. Additionally, contaminants such as cronobacter and salmonella have been found in infant formula, which can cause serious infections.  

The INFANTS Act 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 those samples 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 spp. or Salmonella.

Find the full bill text for the INFANTS Act here.