New Infant Formula Test Results Are Released by the FDA
While the FDA didn't name any brands, the data generally lines up with the findings of CR’s two-part investigation into infant formula safety
The Food and Drug Administration has tested over 300 infant formula samples for heavy metals and other toxic chemicals, and says that its results, released on Wednesday, April 29, show that the U.S. market is safe. CR’s experts applauded the release, but also said that some of the test results, as well as the safety thresholds the agency used to evaluate them, raised concerns.
“Across the products tested, an overwhelming majority of samples had undetectable or very low levels of contaminants, affirming that the U.S. infant formula supply is safe,” the agency wrote in a press release, adding that “the FDA 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.”
How the FDA’s Results and CR’s Results Compare
In both rounds of infant formula tests, CR found some concerning results and some positive signs as well. When we evaluated powdered formulas, about half of the samples contained potentially harmful levels of at least one contaminant, such as lead or arsenic, both of which can harm children’s health and development. When we evaluated liquid formulas, about two-thirds of the samples contained arsenic at or above our level of concern.
But our tests also showed many good options, indicating that the infant formula industry can achieve low or nondetectable levels of these contaminants. The FDA’s data generally lines up with CR’s test results, but the agency didn’t name the brands of formula in its tests.
Another distinction between the two projects is that CR used lower—in other words, more protective—exposure limits to assess potential health risks from many of the contaminants. We used the most protective metrics available to assess possible risk, given the high stakes inherent in a baby’s first food. The FDA contextualized its test results in terms of regulatory limits rather than health-protective limits.
For instance, when CR tested infant formulas for lead, our “level of concern” was based on California’s Maximum Allowable Dose Level (MADL) set by the state’s Office of Environmental Health Hazard Assessment, which is 0.5 mcg per day. Our estimates of potential health risks took into account how much formula an infant consumes daily. The FDA, by contrast, compared lead levels to the Environmental Protection Agency’s drinking water limit, which is 10 parts per billion (ppb), without reference to the amount of formula an infant consumes in a day.
CR used the Oral Reference Dose (RfD) for inorganic arsenic set by the EPA, 0.06 mcg per kilogram body weight per day, to assess the potential risks of inorganic arsenic in the formulas we tested. By contrast, the FDA only reported total arsenic and didn’t provide any information on levels of the different forms of arsenic (organic arsenic vs. inorganic arsenic, which is more toxic). The agency also didn’t provide any additional exposure or risk assessment of the measured arsenic levels beyond the overall conclusion that the U.S. infant formula supply is safe.
“The FDA’s results indicate that some infant formulas contain contaminant levels that are high or approaching CR’s exposure limits, which remains a point of concern,” says Sana Mujahid, PhD, senior manager of food safety research and testing at CR. “While the FDA compared their lead findings to the EPA drinking water standard, they have not yet fully assessed the broader implications of the measured contaminants, especially considering infants can be exposed to these contaminants through other sources.”
In addition to formula, babies can be exposed to lead, arsenic, and other contaminants through the water used to mix powdered formula, from the other foods they eat, and other sources in their home and outdoor environments. Experts confirm that there’s no safe level of lead exposure for babies.
Questions Raised by the FDA’s Report
Besides the EPA’s regulatory limits for drinking water, it’s not clear what other regulatory or health-based exposure limits it used to assess potential risks from the measured contaminants. Some of the FDA’s levels of comparison raised questions.
The FDA’s PFAS results summary states that 95 percent of the infant formula samples in its tests had PFAS levels below 28 parts per trillion (ppt). But the EPA drinking water standard for several PFAS compounds is much lower than that, at either 4 or 10 ppt, and CR’s experts says that even those levels are much too high.
The FDA also tested infant formula for phthalates, which are endocrine-disrupting chemicals often associated with plastic production. In its release, the agency said that over half of the samples didn’t contain any detectable phthalates, but among the samples that did, one of the most commonly detected was DEHP. This compound has been linked to health risks at levels well below EPA limits, and there is currently no FDA limit on DEHP in food.
“The FDA detected PFAS in most samples, consistent with our own findings,” Mujahid says. “They also identified phthalates in several products. Although 95 percent were at or below 116 ppb, some of the specific phthalates detected are known to be highly toxic.”
What Should Happen Next?
CR’s experts say it’s a promising start that the FDA has fulfilled its pledge to test infant formula for contaminants and that it has made its comprehensive test results public. At the same time, they urge the agency to take the necessary next steps to keep the formula industry accountable.
“It would be disappointing if the FDA didn’t proceed with any meaningful regulatory action, such as establishing public health-based limits for contaminants,” says Brian Ronholm, head of food policy for CR. “Their tests and our tests clearly demonstrate that nondetect levels are feasible.”
Parents may be surprised to learn that infant formula manufacturers aren’t legally required to test their raw ingredients or their final products for the contaminants that CR and the FDA found in these evaluations. Many companies do test their ingredients and products, but they aren’t required to share their test results with either the FDA or their customers.
And unlike infant formula sold in the EU, Canada, Australia, and New Zealand, there are still currently no limits on the levels of these contaminants allowed in infant formula in the U.S.
