If Health and Human Services Secretary Robert F. Kennedy Jr.’s Operation Stork Speed is going to deliver, it must maintain rigorous inspection of all the pipelines that feed babies, including the baby formula manufacturers and breast milk banks.
That is according to Peter Pitts, a former Food and Drug Administation (FDA) associate commissioner, who said that the baby formula shortage in 2022 underscored the need to prioritize more staffing and funds to maintain a risk-based management strategy.
Both formula and breast milk are important, viable options, which means they should be backed by strong quality oversight and sound scientific standards to ensure safety and availability, Pitts said.
“The breast milk shortage pointed out that there’s a problem in the supply chain. There’s a problem with oversight. There’s a problem with labeling. It hasn’t been reviewed in years,” Pitts told FOX Business. “We need to make sure that food products like breast milk and baby formula are as robustly regulated as drugs.”
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Kennedy announced on Tuesday that the FDA will implement a series of initiatives aimed at ensuring the ongoing quality, safety, nutritional adequacy and resilience of the domestic infant formula supply. As part of these actions, the FDA will increase testing for heavy metals and other harmful chemicals.
The agency will also permit more personal imports of food products and encourage companies to collaborate with the FDA to improve label transparency. The FDA will also maintain regular communication with consumers and industry stakeholders to ensure transparency, providing updates on nutrients, health outcomes and other significant developments. It will also work with scientific organizations like the National Institutes of Health to address critical research gaps related to the short- and long-term health outcomes of formula feeding during infancy and childhood across the lifespan.
The FDA has good manufacturing practices in place that baby formula manufacturers must follow, Pitts said. However, more frequent and thorough inspections are necessary to avoid the issues that arose when Abbott’s Michigan plant was shut down in 2022 due to contamination, leading to parental fear and diminished faith in the regulatory process, he added.
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“It’s one thing to have regulations on the books, right? It’s another thing to prioritize them,” he said. “Prioritization doesn’t assume guilt of any kind. It is simply an allocation of resources. And if you don’t recognize that there’s a potential problem, you don’t allocate resources to it.”
Pitts also noted that having Operation Stork Speed in place does not impugn the safety of either mean breast milk bank or baby formula manufacturing.
Pitts argued that breast milk banks are a “real regulatory gray zone.” He said that they are not consistently inspected by federal authorities, but they should be.
“If we want to have options, all those options should be safe and effective,” he said.
Abbott told FOX Business that the company is looking forward to working with Kennedy, the FDA and the scientific and medical communities to continue to make infant formulas even closer to breast milk.
“Each ingredient in our formulas is purposefully chosen for the type of baby we’re feeding and their unique dietary needs, and we’re continuously working to get our formulas closer to breast milk.”
Similarly, Reckitt, which owns Mead Johnson, and Danone are looking forward to working in cooperation with Kennedy to continue providing proven safe, high-quality and nutritious infant formula products backed by science to continually improve the health and well-being of infants and young children.
Kennedy’s announcement came one day after a Consumer Reports investigation found “concerning levels” of arsenic and lead in some baby formulas. However, most formulas did not have concerning levels of contaminants, the study showed.
Baby formula manufacturers, including Abbott, also questioned the study’s methods, arguing that comparing powdered infant formula to drinking water standards was inappropriate since powdered formula is diluted before consumption.
Abbott also emphasized that heavy metals naturally occur in the environment, including in soil, water and air. They are present at low levels in many foods, including baby formula and breast milk.
Reckitt, meanwhile, said that all Mead Johnson Nutrition products comply with FDA regulations and noted that specialty formulas test differently from routine ones due to their unique composition.
Bobbie, another brand that was tested by Consumer Reports, told FOX Business that the company has more than 2,000 quality checks on every batch and vets every supplier.
“Bobbie will never cut corners on quality and safety,” the company said. “American babies deserve the highest quality formula and American parents deserve peace of mind.”
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