HHS, FDA to Focus on Improving Nutritional Quality of Infant Formula

The United States suffered a severe formula shortage in 2022 in the aftermath of the pandemic, supply chain issues, and a large recall.

Health Secretary Robert F. Kennedy Jr. in Washington on Feb. 26, 2025. Andrew Harnik/Getty Images

The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) are taking steps to make sure American families have an adequate supply of high-quality infant formula, according to a March 18 announcement.

“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,” HHS Secretary Robert F. Kennedy Jr. said in a statement from the agency announcing the launch of Operation Stork Speed.

“Helping each family and child get off to the right start from birth is critical to our pursuit to Make America Healthy Again.”

The announcement follows President Donald Trump’s proclamation last month establishing the Make America Healthy Again Commission and pledging to bring American life expectancy back on par with the life expectancies of other developed countries.

The presidential action orders agencies to urgently address health concerns facing children.

“In 2022, an estimated 30 million children (40.7 percent) had at least one health condition, such as allergies, asthma, or an autoimmune disease,” it said.

“To fully address the growing health crisis in America, we must re-direct our national focus, in the public and private sectors, toward understanding and drastically lowering chronic disease rates and ending childhood chronic disease.”

This will require “fresh thinking” on issues such as nutrition, overreliance on medication, food and drug quality, physical activity, and the effects of new technological habits, according to the statement.

Reviewing Formula Nutrients

As part of Operation Stork Speed, the FDA intends to kick-start a nutrient review process over the coming months that will be the “first comprehensive update and review of infant formula nutrients by the FDA since 1998.”

In addition, the agency is set to increase testing “for heavy metals and other contaminants in infant formula and other foods children consume.”

FDA is looking to encourage companies to work with the agency on matters related to labeling products clearly and ensuring better transparency. The agency is also encouraging corporations to develop new infant formulas.

“Whether breastfed, bottle fed, or both, the rising generation must be nourished in a way that promotes health and longevity over the course of their lives,” acting FDA Commissioner Sara Brenner said in a statement.

The agency plans to collaborate with the National Institutes of Health and other relevant organizations on research related to health outcomes of feeding formula to children.

These actions aim to ensure that “a strong supply of the sole source of nutrition for formula-fed babies and children remains available for one of our nation’s most vulnerable populations,” HHS said.

The United States experienced a severe shortage of infant formula in 2022 because of the COVID-19 pandemic, a large market recall of the items, and supply chain challenges.

In fall 2022, about 35 percent of parents reported finding it difficult to secure infant formula for children, according to the U.S. Census Bureau. The shortage issue persisted into the summer of 2023, with 20 percent of parents reporting challenges in finding the products.

Contaminants Found

A review of 41 baby formulas, conducted by nonprofit consumer advocacy Consumer Reports and published on March 18, found that many of the items carried contaminants such as arsenic, lead, and PFAS, also known as forever chemicals, which could pose risks to infants.

Some of the products had arsenic levels exceeding the limits set by the Environmental Protection Agency for municipal drinking water.

“Arsenic in high levels, of course, is a poison,” Dr. Mark R. Corkins, professor of pediatrics at the University of Tennessee Health Science Center in Memphis, said in a statement. “Over time, it increases your risk for certain cancers. So, long term, arsenic is a big concern.”

Lead was found in “almost all the formulas,” the review said. Lead exposure is a serious concern as it is linked to lower IQ, behavioral issues, and attention-deficit/hyperactivity disorder.

“Because of the way it affects brain development, when you’re talking about kids, in the short term I worry more about lead,” Corkins said.

Abbott Nutrition, which manufactures Similac and EleCare, and Mead Johnson, the producer of Enfamil, challenged the test results.

Trace levels of heavy metals can be found across the food supply chain and are not a problem faced solely by infant formula manufacturers, they said.

“Abbott has a multi-step quality process in place for heavy metals to ensure that levels satisfy all relevant regulatory requirements in all countries we serve,” Hakim Bouzamondo, a vice president at Abbott, said in a statement to Consumer Reports.

Meanwhile, a recent study that investigated sugar content in 73 infant formula products discovered that almost all contained added sugars rather than lactose, a healthier alternative found in breast milk.

In many of the items, up to 90 percent of carbohydrates came from added sugar. Authorities do not recommend added sugar for children below the age of 2 years.

Researchers warned that the presence of added sugars in infant formula could make children prefer sweet tastes, thus posing a risk of obesity and other issues later in life.

Operation Stork Speed was introduced following Kennedy’s meeting with the CEOs of top infant formula manufacturers, according to a March 18 HHS post on social media platform X.