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HHS and FDA Prioritize Enhancing Nutritional Quality in Infant Formula


In 2022, the United States faced a significant infant formula shortage as a result of the pandemic, supply chain disruptions, and a major recall.

According to a March 18 announcement, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) are implementing measures to ensure that American families have access to a sufficient supply of high-quality infant formula.

“The FDA will utilize all available resources and powers to guarantee that infant formula products are safe and nutritious for the families and children who depend on them,” stated HHS Secretary Robert F. Kennedy Jr. in a statement announcing the initiation of Operation Stork Speed.

“It is essential to provide every family and child with the right start from birth as part of our goal to Make America Healthy Again,” Kennedy remarked.

This announcement follows President Donald Trump’s proclamation from the previous month, which established the Make America Healthy Again Commission, committing to restore American life expectancy to levels comparable with other developed nations.

The presidential directive instructs agencies to promptly tackle the health issues facing children. “In 2022, approximately 30 million children (40.7 percent) experienced at least one health condition, including allergies, asthma, or autoimmune diseases,” it stated.

“To effectively combat the escalating health crisis in America, we must shift our national focus, both in public and private sectors, towards comprehending and significantly reducing rates of chronic disease, particularly among children.”

This initiative will necessitate “fresh thinking” on topics like nutrition, overreliance on medications, food and drug quality, physical activity, and the impact of new technological habits, as mentioned in the statement.

Reviewing Formula Nutrients

As part of Operation Stork Speed, the FDA plans to commence a nutrient review process in the upcoming months, marking the “first comprehensive update and evaluation of infant formula nutrients by the FDA since 1998.”

Moreover, the agency will enhance testing “for heavy metals and other contaminants in infant formula and other foods consumed by children.”

The FDA aims to foster collaboration with companies to improve product labeling and ensure greater transparency. The agency is also encouraging the development of new infant formulas.

“Regardless of whether infants are breastfed, bottle-fed, or both, it’s crucial that the next generation receives nourishment that supports their health and longevity throughout their lives,” stated Sara Brenner, acting FDA commissioner.

The agency intends to work with the National Institutes of Health and other relevant organizations on research concerning health outcomes associated with formula feeding in children.

These initiatives are designed to guarantee that “a robust supply of the primary source of nutrition for formula-fed babies and children remains accessible for one of the most vulnerable populations in our nation,” asserted HHS.

The severe infant formula shortage in the United States during 2022 was attributed to the COVID-19 pandemic, a major recall of products, and ongoing supply chain issues.

In the fall of 2022, approximately 35 percent of parents reported difficulty in obtaining infant formula for their children, based on data from the U.S. Census Bureau. This shortage continued into the summer of 2023, with 20 percent of parents still facing challenges in sourcing these products.

Contaminants Found

A review of 41 baby formulas conducted by the nonprofit organization Consumer Reports, published on March 18, revealed that many products contained harmful contaminants such as arsenic, lead, and PFAS—commonly referred to as forever chemicals—that could pose risks to infants.

Some products were found to have arsenic levels surpassing the limits set by the Environmental Protection Agency for municipal drinking water.

“High levels of arsenic are toxic,” stated Dr. Mark R. Corkins, a professor of pediatrics at the University of Tennessee Health Science Center in Memphis. “Over time, it increases your risk of certain cancers. Long-term exposure to arsenic is a significant concern.”

Lead was detected in “almost all the formulas,” according to the review. Lead exposure raises serious issues since it is associated with lower IQ, behavioral problems, and attention deficit hyperactivity disorder, all of which can lead to significant risks to a child’s future.

“Given its impact on brain development, in the short term, I am more concerned about lead when it comes to children,” Corkins expressed.

Manufacturers such as Abbott Nutrition, which produces Similac and EleCare, and Mead Johnson, the maker of Enfamil, disputed the test findings.

They argued that trace levels of heavy metals are found throughout the food supply chain and do not solely affect baby formula manufacturers.

“Abbott has implemented a multi-step quality process to regulate heavy metals and ensure that levels comply with regulatory requirements in every country where we operate,” remarked Hakim Bouzamondo, a vice president at Abbott, in a statement to Consumer Reports.

Furthermore, a recent study on 73 infant formula products indicated that nearly all contained added sugars rather than lactose, which is a healthier option found in breast milk.

In many instances, as much as 90 percent of carbohydrates derived from added sugar were present in these products. Authorities do not recommend added sugar for children under the age of 2.

Researchers cautioned that the inclusion of added sugars in infant formula could lead to a preference for sweet flavors in children, resulting in a higher risk of obesity and other health concerns in the future.

Operation Stork Speed was initiated following Kennedy’s discussions with the CEOs of major infant formula manufacturers, as highlighted in a March 18 HHS post on the social media platform X.



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