Michael Nevradakis, Ph.D., The Defender, March 19, 2025
After a meeting Tuesday with leading U.S. infant formula makers, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced plans to make sure baby formula is safe, has the necessary ingredients and is free of contaminants.
The new initiative, “Operation Stork Speed,” to be administered jointly by HHS and the U.S. Food and Drug Administration (FDA), will require increased testing for heavy metals and other contaminants, initiate a nutrient review process and encourage manufacturers to improve product labeling.
HHS launched the initiative on the same day Consumer Reports published the results of an investigation that found significant levels of contaminants including lead and arsenic in many commercially available baby formulas.
According to HHS, Operation Stork Speed will include the “first comprehensive update and review of infant formula nutrients by the FDA since 1998.”
The initiative also encourages companies to develop new infant formula products.
In a statement, Kennedy said, “The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them.”
In a statement provided to The Defender, Emily G. Hilliard, HHS deputy press secretary, said the FDA has already launched “a targeted survey” of infant formula and is currently testing approximately 340 samples of a variety of infant formulas for contaminants including arsenic, cadmium, lead and mercury.
Diana Zuckerman, Ph.D., president of the National Center for Health Research, called Operation Stork Speed “an important step forward,” amid concerns about infant formula.
“The presence of lead, arsenic and hormone-disrupting chemicals such as PFAS ‘forever chemicals’ needs to be addressed, and the new Consumer Reports investigation of dozens of infant formulas shows that this is still an important problem,” Zuckerman said.
Teresa Murray, consumer watchdog director for the U.S. Public Interest Research Group, said baby formula safety concerns extend beyond just children’s health.
“We welcome any efforts to make infant formula and baby food safer for children and anyone else. It’s important to remember that it’s not just children who rely on these products. Infant formula is sometimes prescribed for adults with disabilities or certain medical conditions because of the high nutritional value,” Murray said.
“If the regulations were adequate, we wouldn’t be seeing all of these problems,” Murray added.
Kendall Mackintosh, a board-certified nutrition specialist and member of the “MAHA Moms” movement, called the initiative “an absolutely critical and long-overdue step.”
“For years, parents have been raising concerns about the toxicity of commercial baby formulas, from excessive sugar and seed oils to synthetic additives that do not belong in an infant’s diet,” Mackintosh said.
Consumer Reports finds some baby formulas contaminated with heavy metals
Consumer Reports tested 41 powdered infant formulas. The results, shared with the FDA, indicated that while most of the baby formulas tested did not contain high levels of contaminants, some contained “potentially harmful levels of arsenic and lead.”
The tests also found per- and polyfluoroalkyl substances, or PFAS, in almost all the products tested. One product contained bisphenol A (BPA) and acrylamide — both possible carcinogens.
“Our tests found that some infant formulas had concerning levels of arsenic and lead that could pose health risks for young children,” said James Rogers, director of product safety testing at Consumer Reports.
“The good news is that most of the samples we tested did not pose these risks, demonstrating that it’s possible to produce baby formula without these dangerous contaminants.”
Brian Ronholm, director of food policy at Consumer Reports, called on the FDA to dedicate sufficient resources to Operation Stork Speed. He said:
“It’s very encouraging to see the FDA issue this announcement after Consumer Reports shared our findings about contaminants in infant formula. … We look forward to seeing the details of how they intend to implement the plan, and we hope the FDA is provided adequate resources and staffing to actually follow through with these promises.”
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Other recent studies have indicated high levels of contaminants in baby formula.
A 2024 study by GMOScience and Moms Across America tested samples from 20 formulas made by well-known brands. All samples tested positive for aluminum and lead. Some formulas contained high arsenic, cadmium and mercury levels, while 35% of those sampled contained all the heavy metals tested.
A 2023 Imperial College London investigation found that nearly three-quarters of baby formula products that claimed at least one health benefit did not cite a supporting study.
A study published in the American Journal of Clinical Nutrition in 2022 found that nearly half of baby formula products available in the U.S. contained corn syrup. Babies who were fed those formulas had a higher risk of obesity compared to babies who were given lactose-based formulas.
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The HHS said the FDA will collaborate with the National Institutes of Health (NIH) and “other scientific bodies” to address “research gaps” regarding the short-term and long-term health impacts of baby formula.
Science journalist Nina Teicholz, Ph.D., founder of the Nutrition Coalition, said the “widespread use of soybean oil, corn syrup and even sucrose,” or table sugar, in baby formula, raises concerns about the health benefits of these products.
“None of these ingredients are natural or healthy for babies,” Teicholz said. “They put babies at a higher risk for obesity, diabetes and other chronic diseases.”
Jaydee Hanson, policy director at the Center for Food Safety, said baby formula manufacturers should “test regularly and thoroughly” for heavy metals and pathogens.
“We have tested formulas for the presence of nanochemicals. We found that nearly every infant formula company’s products contain nano-scale chemicals that the FDA has not been notified of,” Hanson said.
“Inspections at manufacturing facilities must be thorough and frequent, and evidence of any contamination that takes place there must be immediately investigated and eliminated,” Zuckerman said.
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To read the entire article, click here ‘Operation Stork Speed’: HHS, FDA Launch Plan for More Testing, Scrutiny of Infant Formula Ingredients • Children’s Health Defense