The big takeaway from the new government study on infant formula is that the U.S. supply is mostly safe. But experts and health officials say more steps can be taken to make the products consumed by two-thirds of U.S. infants safer.
One of the notable findings from the Food and Drug Administration’s testing of 312 formulation samples concerned per- and polyfluoroalkyl substances (PFAS), also known as “forever chemicals.” The FDA detected five PFAS in the samples tested, with the most common, PFOS, found in half of all samples. The majority (95%) of these samples contained less than 2.9 parts per trillion (ppt) of PFOS.
What does that mean exactly? The FDA analysis doesn’t elaborate much on the PFAS results. But parents should wonder, given that high levels of exposure to PFAS, man-made chemicals used in products such as nonstick cookware and stain-resistant clothing and rugs, have been linked to conditions such as high cholesterol, kidney and testicular cancer, and reduced vaccine effectiveness.
STAT emailed two experts to comment on the results: Alex Bogdan, a toxicologist at the Minnesota Department of Public Health who studies PFAS in infant formula, and Katie Pelch, a senior scientist at the National Resources Defense Council, an environmental advocacy group.
These interviews have been edited for length and clarity.
What are the main takeaways for parents from the FDA’s PFAS results?
fur: There have been a number of PFAS-free formula products, which is good news because it shows manufacturers can produce PFAS-free formulas. Unfortunately, FDA test results available online do not specify which brands had relevant levels of PFAS, leaving consumers in the dark and unable to make informed decisions when purchasing infant formula.
Bogdan: It is encouraging that only a small number of PFAS were detected and the level of occurrence was quite low. That said, there is room for improvement, and one of the best ways is for the federal government and states to implement laws and regulations to reduce unnecessary PFAS use and the amount of PFAS entering the environment.
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There is one thing that I found confusing FDA results page is a diagram that says, “95% of samples had PFAS levels below 28 ppt.” Do you think 28 ppt isn’t high compared to the EPA’s Maximum Contaminant Level (MCL) of 4 ppt? What do you think about the statistic that 5% of samples were above that cutoff point?
Bogdan: I also found this diagram a little confusing when comparing it to the data spreadsheet. I think the FDA could have been a little more clear in reporting the data.
The 4 ppt MCL set by the EPA was specific to PFOS and PFOA, not all PFAS. No PFOA was detected in either formulation, and PFOS was detected at a maximum concentration of 6 ppt. The MCL is designed with people drinking water throughout their lives. Compared to a lifetime, infant formula is only consumed for a short period of time before being transferred to other foods.
All but one sample, 5% of the samples reported above 28 ppt were PFBA, but all were below the limit of quantification. So, although the FDA detected PFBA, it could not determine exactly how much PFBA was in the sample.
Therefore, it is difficult to say whether the 5% statistic is accurate. This is one reason why samples below the limit of quantification are often not reported numerically, as they can be difficult to interpret.
It is important to know that even though the maximum reported concentration of PFBA (34 ppt) is accurate, not all PFAS are equally potent. Based on available data, PFBAs have been found to be significantly less toxic than PFOS.
The Minnesota Department of Health develops health-based guidance values for contaminants in drinking water. This is the concentration of a chemical that may pose little or no risk to human health. MDH’s guidance value for PFBA is 7,000 ppt, which is far higher than what the FDA has detected. EPA does not have an MCL for PFBA.
Looking at the data, do you see any patterns in formulas with higher PFAS levels?
Bogdan: Soy-based powdered milks tended to contain PFBA, which is a short-chain PFAS. This is not surprising to me, as short-chain PFAS are known to be absorbed by plants more efficiently than long-chain PFAS, such as PFOS. Again, it is important to note that all formulations that tested positive for PFBA were below the limit of quantification.
Dairy-based milks were more likely to contain PFOS. This is not surprising, as PFOS is known to migrate efficiently into milk. Approximately 60% of dairy-based formulas tested contained PFOS.
There wasn’t as much overlap as I expected. Typically, only one type of PFAS is found in a given formulation. There were some dairy-based formulas that contained both PFBA and PFOS. These tended to have lower PFBA concentrations compared to soy-based formulas.
How important is it to reduce PFAS levels in baby formula and what can be done to do that?
Perch: It is very important to reduce the levels of PFAS in baby formula. For most infants, formula is the only source of nutrition and they are often exposed to the same formula several times a day for many months. While it was shocking to see some of the levels reported, it was frustrating to learn that manufacturers and the FDA are not required to release these results to the public. Manufacturers must work diligently to clean up their supply chains and manufacturing practices to ensure their products are free of PFAS and other toxic substances.
Bodan: PFAS in baby formula primarily comes from the ingredients used to make baby formula (milk, soy, etc.). To lower PFAS in finished milk powder, PFAS must be reduced upstream in the process, such as in the cow or soybean. To achieve this, we need to reduce the overall amount of PFAS in the environment by limiting or banning non-essential uses of PFAS and addressing PFAS-contaminated biosolids, such as those often applied to fields as fertilizer.
What should be the formula for the U.S. standard for PFAS?
Bogdan: As low as possible, but this is difficult. Policy changes beyond infant formula production will also likely be needed, such as banning the use of non-essential PFAS and restricting the use of PFAS-contaminated biosolids in agriculture.
Perch: The goal is to keep the formula free of PFAS. The good news is that the results of this study demonstrate that it is possible for formula manufacturers to keep PFAS levels below detection limits. Therefore, the criteria should be set at the limit of detection.
However, it is worth noting that the FDA test only detected the presence of 30 PFAS, although there are tens of thousands of PFAS in this class.
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What are the potential effects and concerns of PFAS on infants?
Bogdan: One of the most sensitive effects of PFAS on infants and young children is on the immune system. Epidemiological studies in young children have shown an association between lower antibody concentrations and higher blood PFAS levels after vaccination, but importantly, these studies have not shown an increase in disease incidence.
Parents should also be aware that infant formula is just one potential route for PFAS exposure. If you’re concerned about your child’s exposure to PFAS, there are simple steps you can take to reduce PFAS, including avoiding children’s products with stain-resistant treatments and cleaning house dust regularly. Dust can be a surprisingly important source of PFAS exposure, especially for infants and young children, who often crawl on the floor and do hand-to-mouth activities.
Is there anything else you think the public should know?
Perch: Infants are most vulnerable to exposure to toxic chemicals because of their small size and because their bodies are still rapidly developing. This makes it essential to reduce all these pollutants as close to zero as possible.
These results and the report from the FDA do not take into account the ingredients used to reconstitute powdered milk. Parents should check with their public water system to make sure it has been tested for PFAS and that there is no contamination to worry about. If there is contamination, filters that treat PFAS are available (check the performance sheet to make sure your filter is PFAS-compatible). Must be properly maintained.
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