When it comes to infant formula, the safety of every bottle is non-negotiable. That’s why the U.S. Food and Drug Administration just completed the most comprehensive and rigorous testing of infant formula for chemical contaminants in our nation’s history.
We analyzed more than 300 products and generated over 130,000 data points, screening for the contaminants that parents are most concerned about: heavy metals, such as lead, mercury, cadmium and arsenic; pesticides, including glyphosate and glufosinate; per- and polyfluoroalkyl substances, known as PFAS; and phthalates.
The results are clear — and a relief. The U.S. infant formula supply is safe, with the overwhelming majority of products showing undetectable or extremely low levels of these substances. While breast milk is widely recognized as the gold standard, millions of parents and caregivers depend on formula. For these families, the results from our testing are reassuring.
Here’s a sample of the results: No pesticides were detected in 99% of samples, and 1% had fewer than 0.25 parts per billion. For the heavy metals we tested, all samples were well below Environmental Protection Agency requirements for drinking water. PFAS and plasticizers had similarly reassuring results.
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Despite these positive results, there is more work to be done for Operation Stork Speed — our mission to enhance the safety and nutrition of infant formula — to be a success.
Supply chain failures, bureaucratic sluggishness and outdated regulatory standards continue to strain the trust families place in the food system. Under President Donald Trump, we’re prioritizing babies over bureaucracy, so families can have confidence in what they feed their children.
Our “Babies First” approach rests on three essential pillars: safety, availability and quality.
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To ensure the safety of infant formula, we will continue to use every available tool to drive contaminant levels as low as possible. This work does not end with a single round of testing. The FDA will continue to monitor infant formula products, expand our data collection, and apply the latest scientific tools to ensure standards remain as strong tomorrow as they are today, including through the establishment of action levels. We will test new products as they enter the market, ensure accountability, and share our findings openly with the public.
To promote availability and prevent shortages, we will remove unnecessary regulatory barriers and work with industry to monitor potential supply chain disruptions so that safe, high-quality products can reach store shelves without delay. We’ve also asked Congress to modernize the FDA’s authorities so we can better establish limits for contaminants and address microbiological risks.
As part of this project, we are committed to delivering a greater variety of infant formula product options for the American people to meet demand for products with more natural ingredients and without certain ingredients, such as added sugars, corn syrup and seed oils.
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We are not simply reacting to past challenges. To enhance formula quality for the future, we are modernizing the framework of pediatric nutrition. As part of this effort, we have launched a joint effort with the National Institutes of Health to study how dietary exposures in infancy influence health outcomes across a lifetime. We are also using modern scientific tools to anticipate future innovations and risks and protect the next generation.
Before we came into office, the last comprehensive review of formula nutrients occurred in 1998. That gap is unacceptable — especially in a country that leads the world in scientific innovation. As science evolves, our regulatory framework must evolve with it.
The Trump administration believes that a strong nation begins with its smallest citizens. That’s why we don’t see Operation Stork Speed as just a mission to regulate certain products. It’s a commitment to protect American families and America’s future, grounded in transparency, strength and action.
When it comes to infant formula, the safety of every bottle is non-negotiable. We are committed to putting babies first today and every day.
Kyle Diamantas, J.D. is Deputy FDA Commissioner for Food.