‘Operation Stork Speed’: HHS, FDA Launch Plan for More Testing, Scrutiny of Infant Formula Ingredients

“Operation Stork Speed,” launched Tuesday by HHS and the FDA, will require increased testing for heavy metals and other contaminants in infant formula. The initiative also includes a nutrient review process and encourages manufacturers to improve product labeling and develop new products.

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.”

Sayer Ji, chairman and co-founder of the Global Wellness Forum and co-founder of Stand for Health Freedom, said the Consumer Reports tests “are a wake-up call.”

“This confirms what many health advocates have been saying for years: the food system, including baby formula, requires far more rigorous safety testing and accountability,” Ji said.

In her statement, Hilliard said the FDA’s ongoing survey of infant formula has already tested 221 samples. The results “do not indicate that the contaminants are present in infant formula at levels that would trigger a public health concern.”

According to Hilliard’s statement, the FDA Total Diet Study (TDS), which monitors levels of nutrients and contaminants in foods consumed by people in the U.S., including infant formula, found “the majority of the limited set of TDS samples of infant formula contained low or no detectable levels of lead, total arsenic and cadmium.”

“There were no detectable levels of PFAS in infant formula from the limited TDS data where infant formula was analyzed for PFAS. In two previous FDA surveys of individual food products for acrylamide, there were no detectable levels of acrylamide found in infant formula,” Hilliard said.

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.

In 2022, an outbreak of Cronobacter infections was linked to infant formula, leading Abbott Nutrition to recall its products, including the popular brand Similac. The FDA subsequently ordered the temporary closure of Abbott’s Michigan facility.

These actions sparked a nationwide baby formula shortage, lawsuits against Abbott and a congressional investigation. Last year, Abbott was ordered to pay $495 million in a lawsuit concerning an Illinois girl who developed a dangerous bowel disease after consuming contaminated baby formula.

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.

Current FDA baby formula standards ‘outdated and favor large corporations’

In her statement, Hilliard said, “Infant formula manufacturers are required under the Federal Food, Drug, and Cosmetic Act and its implementing regulations to ensure that their products are not adulterated with contaminants.”

But some food safety advocates said they hope that Operation Stork Speed will include a revamp of existing regulations governing the safety of baby food products.

“The FDA’s current standards are outdated and favor large corporations, rather than prioritizing the actual nutritional needs of infants,” Mackintosh said. She pointed to current regulations that allow seed oils and industrial additives, do not set limits on sugar and carbohydrate content and do not require transparency on ingredient sourcing.

Mackintosh also cited the presence of synthetic additives and preservatives, glyphosate and excess omega-6 fatty acids in baby formula as areas of concern.

A 2018 study by Moms Across America also found high levels of glyphosate in baby formula samples.

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.

Hanson called on the FDA to remove formulas containing nanochemicals from the market, particularly nano-hydroxyapatite, which he said is “tantamount to feeding babies asbestos.”

He also said the FDA should “respond promptly to any notification of adulterated formula or formulas on the market that have not been approved.”

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Source: https://naturalblaze.com/2025/03/operation-stork-speed-hhs-fda-launch-plan-for-more-testing-scrutiny-of-infant-formula-ingredients.html