FDA to increase testing for heavy metals in infant formula

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is honing in on infant formula in his food safety review.

RFK Jr. says the U.S. Food and Drug Administration (FDA) will further test formula brands for heavy metals after some concerning results from Consumer Reports (CR) were released earlier this week. “The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,” Kennedy said in a statement. HHS is calling the plan “Operation Stork Speed.”

On Tuesday, CR revealed the results of testing on 41 types of powdered formula, from major labels such as Enfamil and Similac to smaller startups like Bobbie. Brands were tested for heavy metals including arsenic, lead, BPA, acrylamide, and PFAS. Per the report, the results were “concerning” with “about half of the samples” that were tested containing “potentially harmful levels of at least one contaminant.” 

However, the formula wasn’t heavy-metal-ridden across the board. The report noted that the “other half of the samples showed low or no levels of concerning chemicals—showing that there are many good options on the market.”

The Agency for Toxic Substances and Disease Registry rates arsenic as the most toxic substance in the environment. When it came to the formula with the highest level of the substance, Abbott Nutrition’s EleCare Hypoallergenic took the top slot. The formula had 19.7 parts per billion (ppb). The second highest level was found in Similac Alimentum at 15.1 ppb (also made by Abbott). The Environmental Protection Agency (EPA) limits arsenic in municipal drinking water to 10 ppb. 

Abbott told CR in a statement, per the report, that the company had questions about CR’s methodology, and noted that heavy metals are found in the natural environment and may therefore show up in “trace amounts” in any food products, and even in breast milk. “We look forward to working with the secretary, the FDA, and the scientific and medical communities to continue to make infant formulas even closer to breast milk and support the aims of Operation Stork Speed,” Scott Stoffel, divisional vice president of external communications and public affairs at Abbott, told Axios in a statement.

While RFK Jr. campaigned on some heavily controversial ideas, such as vaccine scepticism, health officials seem to be greeting the investigation into infant formula warmly. “It’s very encouraging to see the FDA issue this announcement immediately after Consumer Reports shared our findings about contaminants in infant formula,” said Brian Ronholm, head of food policy for CR. “We look forward to seeing the details of how they intend to implement the plan, and we hope the FDA is provided adequate resources and staffing to actually follow through on their promises.”

As it stands, it’s tough for parents to know which brand of formula to choose. That’s especially true because some of the most well-known brands seemed to be the ones with the highest rates of heavy metals. Four main formula companies—Nestlé, Abbott, Perrigo, and Reckitt—dominate the market, though in recent years some smaller startups, such as MyHeart and Bobbie, have emerged. In 2022, after a major formula recall kicked off a formula shortage, the newer brands hoped to help meet demand and create more natural formulas. Bobbie was listed in the new reports “best” formulas, and MyHeart was listed in the “good” category. 

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