US FDA watchdog collapsing? Baby formula safety under fire

Experts are warning that the US FDA is failing to protect infant formula safety, citing inaction on toxic contaminants, nano ingredients, and regulatory conflicts of interest. We speak to the Center for Food Safety and the Alliance for Natural Health (ANH) to unpack concerns and solutions as the FDA undergoes staff cuts.

Jaydee Hanson, policy director at the Center for Food Safety, tells Nutrition Insight that the nonprofit is “very concerned that the FDA is not doing its job of protecting the safety of infant formula.”

“An FDA advisory committee was to make a report on how formula companies can ensure that microbes and heavy metals like lead, cadmium, and arsenic are not in formula. That committee has been shut down.”

“The new FDA administrator for food safety, Kyle Diamantas, used to work for Abbott Laboratories, fighting against parents of infants made ill from pathogens in Abbott’s formula,” he adds.

Environmental Health News reported that Diamantas represented Abbott in lawsuits against parents claiming the company’s formula risked a deadly bowel disease in premature infants. His FDA division now oversees the safety of 80% of the US food supply, including infant formula. 

Congresswoman Rosa DeLauro critiques: “The FDA’s job is to protect our babies, not the corporations that poisoned them. Appointing an Abbott lawyer to oversee food safety, which includes infant formula, is letting the fox guard the henhouse.”

Infant safety updates required

In 2022, the FDA’s internal review of infant formula shortage management exposed an outdated system. 

Hanson warns the FDA is failing to protect infant health, citing inaction on toxic metals and unapproved nano ingredients in baby formula.Russia’s invasion of Ukraine compounded the 2022 US infant formula shortage, alongside the supply chain crisis, Abbott Nutrition’s product recalls, and post-pandemic effects.

Abbott Nutrition is the largest formula producer in the US. It previously shut down its manufacturing plant in Sturgis, Michigan, after an FDA investigation found Cronobacter sakazakii and Salmonella in subsamples of the company’s products. These bacteria caused illness in four infants and two fatal cases.

From a natural health perspective, Robert Verkerk, Ph.D., ANH’s executive and scientific director, tells us that formula safety standards rely too heavily on post-market enforcement rather than ingredient review.

“However, there are even greater concerns that the standards have focused insufficiently on the nutritional requirements of growing infants and that these standards are outdated in relation to the available nutritional science.”

Last month, the US Department of Health and Human Services (HHS) said it would improve infant formula under Operation Stork Speed. “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,” said HHS Secretary Robert F. Kennedy Jr. at the time

The announcement revealed the FDA is taking measures to ensure infant formula’s safety and nutritional adequacy, including nutrient reviews, heavy metal testing, and expanding importation policies.

Science-approved nano-chemicals in infant formula

Hanson also worries about the FDA not responding to the Center for Food Safety’s nano-chemical petition. 

Critics point to a troubling conflict of interest, as the FDA’s new food safety administrator previously defended Abbott — the company behind a major formula recall linked to infant illness.“We are concerned that the FDA has taken no action to respond to our legal petition asking it to order companies whose formulas include unapproved nano chemicals.”

“We used an electron microscope to examine formulas from six companies and found that most contained nano chemicals. We are especially concerned that the FDA has not ordered companies to remove nano-hydroxyapatite, as the law requires FDA approval for any change in ingredients in the formula,” says Hanson.

According to ANH’s Verkerk, it is crucial that any comparisons between the nano-hydroxyapatite added to baby formulas and the hydroxyapatite that is naturally formed in human milk and embedded in casein micelles work similarly. 

“Inorganic hydroxyapatite in nano form likely behaves differently in the body; hence, it is very important that detailed studies are performed to compare the biological activity, fate, and function of nano-hydroxyapatite vis-à-vis natural hydroxyapatite.” 

“This same rigor should be applied to any new-to-nature analog of any nutrient naturally occurring in human breast milk. Given the new HHS radical transparency agenda, such data should be placed in the public domain and be available for independent scientific scrutiny,” he suggests.

Verkerk notes children’s health protection via the food supply — avoiding harmful substances and environmental toxins — comes at the cost of lesser attention on beneficial ingredients. “That is not to say that this focus isn’t important.” 

“However, there should be at least as much focus on ensuring that infant nutrition for those unable to be nourished by breast milk is optimized, and it is this area that has not been sufficiently prioritized.”

Amid sweeping staff cuts, advocates fear the FDA’s shrinking oversight could leave babies more vulnerable to unsafe and poorly regulated formula.“Areas that have been shown to be of critical importance in infant nutritional science include the relationship of human milk oligosaccharides and the development of the gut microbiome, pre- and postbiotics, lactoferrin, nucleotides, different carbohydrate/lipid profiles, and the nutritional role and effects of natural nano-scale nutrients,” he highlights.

Is FDA transparency and accountability sufficient?

Concerns about the FDA’s accountability and transparency regarding the safety of infant formula have existed for a long time, according to Verkerk, because of the agency’s slow response to quality control problems, like the ones that followed Abbott’s Michigan plant whistleblower complaints. 

“There is ample historical evidence that oversight and inspections have been inadequate, allegedly owing to a lack of resources. However, it is also likely that revolving doors have gotten in the way, having been exposed by campaigns by the International Baby Food Action Network.”

“These kinds of problems could get worse if recent staff cuts impact oversight and enforcement by the FDA,” Verkerk continues. “However, given HHS Secretary Kennedy’s long-standing interest in children’s health and the push for transparency and elimination of conflicts of interest, we are hopeful that under Dr. Marty Makary’s leadership of the FDA, this will be one of many key areas to be prioritized.” 

ANH would like to see the FDA’s updated guidelines place a lot more focus on creating standards for baby formulas that more closely resemble human breast milk, he adds. “We are hopeful that these cuts are linked primarily to reducing conflicts of interest and inefficiencies rather than compromising key functions of the agency itself.”

ANH would like to see the FDA’s updated guidelines place a lot more focus on creating standards for baby formulas that more closely resemble human breast milk.The FDA layoffs come amid cuts in health agencies, and experts are worried about the future of food safety and health care. The HHS has said it will cut 20,000 employees, 28 divisions to 15, and ten regional offices to five, while centralizing certain functions. 

Food safety under threat?

In recent news, reports say the US FDA halted milk quality testing and is leaving food safety inspections to state and local authorities.

“Reporting indicates that the Trump Administration is planning to dramatically change the way food safety inspections take place. We cannot play games with food safety. Congress and the US people need all the facts about what the FDA is planning and how they will make sure that we do not lose any effectiveness or coverage,” comments Congresswoman Shontel Brown.

“This isn’t complicated: fewer FDA food safety inspections would mean more outbreaks, more illnesses, and more preventable deaths. E. coli doesn’t care about budget cuts or arbitrary FDA layoffs. The FDA has a responsibility to protect our food supply, especially across state lines. Handing that duty off to state and local agencies that may not have the resources is a potentially unsafe move that puts families in Northeast Ohio and across the US at risk.”

Early this year, the US Government Accountability Office called for the FDA to strengthen inspection efforts to protect the food supply.

Brown expresses concern about the administration, calling it “reckless and chaotic” with its “break-first, ask-later approach,” which she believes ignores real-world impacts. “One thing we should definitely not break is food safety.”

“I’m deeply committed to the safety and integrity of our food supply chain. Trust and transparency are critical to maintaining food safety.”