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FDA releases initial results from extensive study on infant formula safety

Regulators said results from the Operation Stork Speed initiative show an "overwhelming majority" of infant formulas meet high safety standards.
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A little over a year after U.S. regulators unveiled the Operation Stork Speed initiative with a goal of improving baby formula safety and supply, the first round of testing results have now been released.

The U.S. Food and Drug Administration (FDA) announced Wednesday that its "largest and most rigorous examination" of baby formulas on the market found that "an overwhelming majority" of samples had undetectable or very low levels of contaminants.

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“We tested more infant formula than ever before, and the results are clear: most products meet a high safety standard — but even small exposures matter for newborns,” said Health and Human Services Secretary (HHS) Robert F. Kennedy, Jr. “We will hold manufacturers accountable, and give parents honest, transparent data they can trust. Protecting our children’s health is nonnegotiable.”

Parents in the U.S. have widely relied on formula to feed their babies for decades. An estimated 75% of U.S. infants consume formula during the first six months of their life, with about four in ten receiving it as their only source of nutrition, according to the Centers for Disease Control and Prevention.

The Operation Stork Speed initiative was announced in March of last year to address weaknesses in the U.S. baby formula system — particularly regarding safety and nutritional standards, as well as supply availability and reliability. It is the first comprehensive nationwide examination of U.S. baby formula ingredients in over 25 years.

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As part of the initiative, the FDA said it studied more than 300 different infant formula samples from retailers nationwide, including powders, ready-to-feed liquids, and concentrated liquids. The agency said those samples generated more than 120,000 data points for things like lead, mercury, cadmium, arsenic, pesticides, phthalates and so-called forever chemicals.

The FDA noted that small amounts of contaminants may still be present in some foods — including infant formula and breast milk — because they are naturally occurring or introduced into the environment through human activities. The agency said that's why it will continue to test infant formula and is engaged with manufacturers on ways to lower contaminants as part of the FDA's Closer to Zero initiative.

“You can judge a society by how it treats its most vulnerable members. That’s why we’re doing everything in our power to make sure our babies and infants have safe, high quality formula options that are backed by a resilient supply chain,” said FDA Commissioner Marty Makary. “The results of this study are encouraging. We will continue to advance formula innovation and safety for the millions of families who depend on it.”

Key findings from the FDA's infant formula product testing can be found here.