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

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.

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

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 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.”

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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 which 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,” said Sara Brenner, acting FDA commissioner, 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 due to the COVID-19 pandemic, a large market recall of the items, and supply chain challenges.

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,” said Dr. Mark R. Corkins, professor of pediatrics at the University of Tennessee Health Science Center in Memphis, 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, all of which pose a risk of significant harm to a child’s future.

“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 solely faced 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,” said Hakim Bouzamondo, a vice president at Abbott, in a statement to Consumer Reports.

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.