This post was co-authored by Nina Hwang.
Friends of the Earth US, an environmental non-profit that NRDC often works with, recently commissioned a laboratory at Arizona State University (Tempe) to analyze six baby formula samples for the presence of engineered nanoparticles. The full report can be found here. The formulas included popular brands purchased from grocery stores around San Francisco, California. Troubling findings include the detection of hydroxyapatite nanoparticles in several samples.
At first glance, hydroxyapatite isn’t something I’d normally shy away from. A naturally occurring mineral form of calcium apatite, hydroxyapatite is an essential component for strong bone and teeth. It also has some important biomedical applications, including as a filler to replace amputated bone or a coating for hip replacements. Although we don’t know for sure, it seems like the hydroxyapatite is added to baby formula to provide calcium for developing healthy bones and teeth.
However, form matters! There are many different crystalline phases of the mineral and the body may react differently to each form. The concern with the type of hydroxyapatite detected in the baby formula is that they are needle-like particles. Toxicology studies have found that exposure to needle-like nano-hydroxyapatite can lead to a number of adverse effects including mutagenicity and genotoxicity, toxic effects on organs, and eye irritation.
The European Commission’s Scientific Committee on Consumer Safety (SCCS) has released an official opinion on oral cosmetic products containing up to a maximum of 10% of nano-hydroxyapatite. The SCCS said, “In summary, based on the information available, SCCS considers needle-like nano-hydroxyapatite as a concern in relation to potential toxic effects” (SCCS 2016, page 32). The report noted many data gaps and poor quality of existing data, ultimately concluding that, "needle-shaped nano-hydroxyapatite should not be used in cosmetic products” (SCCS 2016, page 35).
If needle-like nano-hydroxyapatite is too dangerous for use in cosmetic products geared for adults, then it definitely should not be used in products for consumption by babies that are still developing and often more vulnerable to harmful effects of chemicals.
There are calcium-containing compounds, such as calcium carbonate and calcium citrate, which are verified by the US EPA to be low concern chemicals that can be used in infant formula (US EPA DfE SCIL). Better and safer choices are readily available—companies should move away from use of needle-like nano-hydroxyapatite where people could be exposed.
The US Food and Drug Administration (FDA) requires baby formula to meet certain nutritional requirements and to be free of pathogens or other “adulterants” or harmful substances. We believe that to truly ensure the safety of baby formula products, FDA should not allow the use of nano-form of hydroxyapatite in baby formula until sufficient data is available to prove that they are safe.
In addition to better government oversight, product manufacturers should avoid unsafe or inadequately tested ingredients like nanomaterials, and retailers should insist upon full disclosure of ingredients for the products they sell. The public has the right to make informed safe choices for our families.
Says FOE in its report, "The groundbreaking analysis of nanomaterials in baby formula by Friends of the Earth is meant to inspire greater public scrutiny, industry accountability and government regulation of nanotechnology, particularly in the food sector." We hope it succeeds!
 ASU wanted to be sure that the detected needle-like nanoparticles did not form as a result of the sample preparation process during the analysis. To confirm that these nanoparticles were intentionally added to the baby formula, the laboratory also analyzed two food-grade hydroxyapatite (HA) products using the same sample preparation process. The first contained only needle-like HA and the second product contained primarily spherical-shaped HA. The analysis resulted in images of needle-like HA in the first product and spherical-shaped HA in the second product—as expected—demonstrating that the observed needle-like form of HA in the baby formula products is real, and not an artifact of the laboratory sample preparation process.
 Formula may not be "adulterated," or contain harmful substances. As FDA states, "What substances may be used in infant formulas? Substances used in food, including infant formula, must be safe and lawful. Substances that may be used in infant formulas are food ingredients that are generally recognized as safe (GRAS) for use in infant formula and those that are used in accordance with the FDA's food additive regulations (FFDCA 201(s) and 409)."