Health and Me

Rachel V Thomas

Major FDA Study Confirms Baby Formula In US Safe, Testing to Continue

The infant formula available on the US market is safe, according to results from the largest and most rigorous study by the Food and Drug Administration (FDA), released today.

Breast milk is widely known as the gold standard and optimal source of nutrition for infants whenever possible. However, as per the CDC, roughly 75 per cent of US infants are dependent on formula for the first six months, and for nearly 40 per cent, it is the exclusive source of nutrition.

The FDA noted that across 300 samples tested, an overwhelming majority had undetectable or very low levels of contaminants, affirming that the US infant formula supply is safe. But the federal agency plans to follow up with additional testing.

“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 Robert F. Kennedy, Jr., in a statement.

“We will hold manufacturers accountable and give parents honest, transparent data they can trust. Protecting our children’s health is nonnegotiable," he added.

The study included more than 300 infant formula samples representative of products sold at retail across the US and included powders, ready-to-feed liquids, and concentrated liquids.

The samples were rigorously tested and analyzed in FDA laboratories. The results show that the overall levels of contaminants in the infant formula samples tested were low.

However, the FDA noted that it is following up with additional testing as part of the agency’s ongoing robust monitoring and oversight efforts and will take additional action where appropriate.

This includes conducting further testing, including for additional contaminants, continuing to engage with manufacturers on measures to reduce the levels of contaminants to as low as possible, and working to establish action levels for contaminants in infant formula.

Also read: <a href="https://www.healthandme.com/health-wellness/young-kids-more-vulnerable-to-heat-stress-aiims-experts-caution-against-sugary-drinks-and-chips-article-154199506" data-type="tilCustomLink">Young Kids More Vulnerable To Heat Stress; AIIMS Experts Caution Against Sugary Drinks And Chips</a>

“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.”

<h2>Why Was The Baby Formula Tested?</h2>

Formula is made to imitate human breast milk and usually comes from cow milk or soy. According to the present FDA guidelines, every infant formula product is required to have 30 nutrients essential for infants in specific proportions. 

Yet, the technology of infants' digestion and nutrition requirements has progressed immensely, leading experts to wonder if the standards are yet sufficient.

Read more: <a href="https://www.healthandme.com/health-wellness/donald-trumps-discolored-left-hand-triggers-health-speculation-expert-explains-article-154200172" data-type="tilCustomLink">Donald Trump’s Discolored Left Hand Triggers Health Speculation: Expert Explains</a>

In 2025, the FDA in 2025 began conducting a comprehensive review of infant formula ingredients in the face of increasing parental distrust and industry trends, which indicate that existing rules might not be completely in accordance with recent worldwide research on infant feeding.

Some of the main issues that were considered during the testing include the possibility of iron content, added sugars, and seed oils.

Health Conditions A-Z

health

robert f. kennedy

Baby Formula

Infant Formula

Breast milk

marty makary

food and drug administration

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The infant formula available on the US market is safe, according to results from the largest and most rigorous study by the Food and Drug Administration (FDA), released today.Breast milk is widely known as the gold standard and optimal source of nutrition for infants whenever possible. However, as per the CDC, roughly 75 per cent of US infants are dependent on formula for the first six months, and for nearly 40 per cent, it is the exclusive source of nutrition.The FDA noted that across 300 samples tested, an overwhelming majority had undetectable or very low levels of contaminants, affirming that the US infant formula supply is safe. But the federal agency plans to follow up with additional testing.“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 Robert F. Kennedy, Jr., in a statement.“We will hold manufacturers accountable and give parents honest, transparent data they can trust. Protecting our children’s health is nonnegotiable," he added.How Was The Study Conducted? The study included more than 300 infant formula samples representative of products sold at retail across the US and included powders, ready-to-feed liquids, and concentrated liquids.The samples were rigorously tested and analyzed in FDA laboratories. The results show that the overall levels of contaminants in the infant formula samples tested were low.However, the FDA noted that it is following up with additional testing as part of the agency’s ongoing robust monitoring and oversight efforts and will take additional action where appropriate.This includes conducting further testing, including for additional contaminants, continuing to engage with manufacturers on measures to reduce the levels of contaminants to as low as possible, and working to establish action levels for contaminants in infant formula.Also read: Young Kids More Vulnerable To Heat Stress; AIIMS Experts Caution Against Sugary Drinks And Chips“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.” Why Was The Baby Formula Tested?Formula is made to imitate human breast milk and usually comes from cow milk or soy. According to the present FDA guidelines, every infant formula product is required to have 30 nutrients essential for infants in specific proportions. Yet, the technology of infants' digestion and nutrition requirements has progressed immensely, leading experts to wonder if the standards are yet sufficient.Read more: Donald Trump’s Discolored Left Hand Triggers Health Speculation: Expert ExplainsIn 2025, the FDA in 2025 began conducting a comprehensive review of infant formula ingredients in the face of increasing parental distrust and industry trends, which indicate that existing rules might not be completely in accordance with recent worldwide research on infant feeding. Some of the main issues that were considered during the testing include the possibility of iron content, added sugars, and seed oils.