Experts analyze PFAS results in FDA infant formula safety review

A recent government survey indicates that the infant formula supply in the U.S. is generally safe. However, experts and health officials suggest further measures to enhance the safety of this product, which is consumed by two-thirds of infants in the country.

The Food and Drug Administration’s analysis of 312 formula samples revealed the presence of per- and polyfluoroalkyl substances, or PFAS, also known as “forever chemicals.” Among the samples tested, five types of PFAS were identified, with PFOS being the most prevalent, found in half of the samples. Notably, 95% of these samples contained PFOS levels below 2.9 parts per trillion (ppt).

Yet, the implications of these findings remain somewhat unclear, as the FDA has not provided detailed explanations. This leaves parents concerned, considering that increased exposure to PFAS—man-made chemicals used in nonstick cookware and stain-resistant products—has been associated with health issues such as elevated cholesterol, kidney and testicular cancer, and diminished vaccine effectiveness.

STAT consulted with two experts for their insights: Alex Bogdan, a toxicologist with the Minnesota Department of Public Health who has researched PFAS in infant formula, and Katie Pelch, a senior scientist at the National Resources Defense Council, an environmental advocacy organization.

These interviews have been edited for brevity and clarity.

What are the major takeaways for parents from the FDA’s PFAS results? 

Pelch: The presence of PFAS-free formula products is positive news, demonstrating that PFAS-free production is achievable. However, since the FDA does not disclose which brands have concerning PFAS levels, consumers are unable to make fully informed choices when purchasing formula.

Bogdan: It is promising that only a few PFAS were detected and at relatively low levels. Nonetheless, improvements are needed. The federal government and states should implement laws and regulations to decrease unnecessary PFAS usage and reduce environmental contamination.

One thing that I found confusing on the FDA results page is a graphic that says “95% of samples had PFAS levels at or below 28 ppt.” Wouldn’t 28 ppt be high, compared to the 4 ppt maximum contaminant level (MCL) set by the EPA? What do you make of the statistic that 5% of samples were above that cutoff point?

Bogdan: I also found this graphic somewhat confusing when compared to the data spreadsheets. The FDA’s data presentation could have been clearer.

The 4 ppt MCLs set by the EPA are specific to PFOS and PFOA, not all PFAS. PFOA was not detected in any formulas, and PFOS was found at a maximum of 6 ppt. MCLs consider a lifetime of drinking water, whereas infant formula is only consumed for a limited time before transitioning to other foods.

Except for one sample, the 5% of samples above 28 ppt were all PFBA but below the limit of quantitation, meaning the FDA detected PFBA but couldn’t accurately quantify it.

Thus, the 5% statistic’s accuracy is questionable. This is why samples below the quantitation limit are often not reported numerically, as it complicates interpretation.

Even if the maximum PFBA concentration (34 ppt) is correct, not all PFAS have the same potency. Available data indicates that PFBA is significantly less toxic than PFOS.

The Minnesota Department of Health establishes health-based guidance values for drinking water contaminants. The MDH’s guidance value for PFBA is 7,000 ppt, far exceeding any levels detected by the FDA. The EPA does not have an MCL for PFBA.

Looking at the data, do you see any patterns on the formulas that had higher levels of PFAS?

Bogdan: Powdered soy-based formulas often contained PFBA, a short-chain PFAS. This is not surprising, as short-chain PFAS absorb more easily into plants than long-chain PFAS like PFOS. Again, it is important to note that all formulas testing positive for PFBA were below the quantitation limit.

Dairy-based formulas generally contained PFOS. This is expected because PFOS transfers efficiently into milk. Approximately 60% of dairy-based formulas tested contained PFOS.

There was less overlap than anticipated. Typically, only one type of PFAS was found in a given formula. Some dairy-based formulas contained both PFBA and PFOS, with lower PFBA levels compared to soy-based formulas.

How important is it to lower the levels of PFAS in formula, and what can be done to do so?

Pelch: Reducing PFAS levels in formula is crucial, as formula is the sole nutrition source for many infants, who consume it multiple times daily for months. It is concerning that some levels reported are high, and frustrating that manufacturers and the FDA are not required to disclose these findings. Manufacturers should rigorously clean up their supply chains and production methods to eliminate PFAS and other toxins.

Bogdan: PFAS in formula primarily originates from the raw materials used in production, such as milk and soy. To reduce PFAS in the final product, efforts must focus upstream, like reducing PFAS in cows and soybeans. This requires minimizing overall environmental PFAS by restricting or banning non-essential uses and addressing PFAS-contaminated biosolids often used as fertilizer.

What should be the U.S. standard on PFAS in formula?

Bogdan: The standard should be as low as achievable, though this poses challenges. Policy changes outside formula manufacturing, such as banning non-essential PFAS uses and limiting PFAS-contaminated biosolid use in agriculture, may be necessary.

Pelch: The aim should be to have no PFAS in formula. Fortunately, the test results show that it is possible for manufacturers to maintain PFAS levels below detection limits. Therefore, the standard should align with the detection limit.

Notably, the FDA test screened for only 30 PFAS, while the class contains tens of thousands.

What are the potential effects or concerns about PFAS for infants?

Bogdan: PFAS can impact infants’ immune systems, one of their most sensitive areas. Epidemiological studies indicate a correlation between lower post-vaccination antibody levels and higher PFAS blood levels in young children. However, these studies have not linked this to increased disease incidence.

Parents should recognize that formula is not the only PFAS exposure source for their children. They can take simple steps to reduce exposure, such as avoiding stain-resistant children’s products and regularly cleaning household dust. Dust can significantly contribute to PFAS exposure, especially for infants and toddlers who crawl and frequently put their hands in their mouths.

Anything else you think the public should know? 

Pelch: Infants are particularly vulnerable to toxic chemicals due to their small size and ongoing rapid development. Therefore, it is essential to minimize exposure to all contaminants.

The results and FDA reporting do not account for the water used to reconstitute powdered formulas. Parents should verify with their local water providers to ensure PFAS testing and address potential contamination. Filters that treat PFAS are available (ensure performance sheets confirm PFAS treatment) and must be properly maintained.

STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.