FDA Says It Might Change Infant Formula Requirements

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Regulators are conducting the first comprehensive review of the requirements since 1998.

The Food and Drug Administration (FDA) may change its nutrient requirements for infant formula, including floating the possibility of adding new mandated nutrients, the agency said on May 13.

The agency started a review of the nutrients that are currently in formula, in what regulators described as the first comprehensive review since 1998.

Through a request for information, the FDA is beginning its review by asking the public to provide data on six questions, including whether to adjust the required minimum and maximum levels for nutrients and what other nutrients regulators should mandate.

People have until the end of Sept. 11 to respond.

“You can’t Make America Healthy Again if we don’t fix what nourishes our youngest and most vulnerable Americans,” Health Secretary Robert F. Kennedy Jr. said in a statement.

Dr. Marty Makary, the FDA’s commissioner, added: “Protecting our most vulnerable is not just a moral duty—it is our responsibility. For many children, infant formula is their only source of nutrition. That’s why it’s absolutely crucial to continually assess the nutrition standards and incorporate gold standard science to ensure we are providing the safest, most effective nutrition possible.”

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The Federal Food, Drug, and Cosmetic Act requires that infant formulas contain protein, fat, essential fatty acids, and a number of vitamins and minerals such as vitamin A and calcium. Collectively, the ingredients are called nutrients.

The law also says that the nutrients shall be reviewed every four years by the health secretary “as appropriate.” During such a review, “the Secretary shall consider any new scientific data or information related to infant formula nutrients, including international infant formula standards,” the law states. “The Secretary may revise the list of nutrients and the required level for any nutrient required by the table.”

Researchers have found that most infant formulas sold in the United States contain added sugar, mainly derived from corn, rather than lactose, which is drawn from cow milk. Consumer Reports also said in March that testing of infant formulas showed arsenic and lead in some brands at potentially harmful levels.
The FDA’s review is part of what officials are calling “Operation Stork Speed,” an effort announced in March to make sure Americans have access to high-quality formula for infants.

Abbott Nutrition and Reckitt Benckiser-Mead Johnson produce just under 80 percent of the infant formula in the United States as of 2019, according to Euromonitor Passport data. The companies did not respond to requests for comment by publication time.

Perrigo, another major manufacturer, referred an inquiry to the Infant Nutrition Council of America (INCA).

“INCA members use safe, high-quality ingredients that are scientifically proven to provide the nutrients needed to support healthy infant growth and development—and industry stays dedicated to following the latest developments in health science and clinical research to support healthy infant growth and development,” a spokesperson for the council told The Epoch Times in an email.

“INCA members remain committed to working with HHS and the FDA on Operation Stork Speed to ensure domestic infant formula products continue to meet the highest standards for nutrition and safety, and today infant formula products undergo extensive research, stringent testing, and strict regulatory approval prior to going to market.”

Original News Source Link – Epoch Times

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