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A New Potential Threat in Infant Formula

February 11th, 2022
by Dashel Murawski, Communications and Development Associate
Center for Food Safety

This week, Center for Food Safety (CFS) filed a legal petition with the Food and Drug Administration (FDA) demanding the agency regulate nanomaterials in infant formula. Because infants are particularly vulnerable to food safety risks due to their developing immune systems, using novel, nano-ingredients in infant formula should be heavily researched and regulated. But just what are nanomaterials, what brands of infant formula may contain them, and why should you be concerned?

Nanomaterials are just what they sound like – extremely small particles of materials such as silver, titanium, carbon, and more that are created using various techniques, either by engineering atoms to make structures so small that they can go right into the nucleus of a cell, or by grinding materials down to nanoscale. According to the National Institutes of Health, nanomaterials are characterized by their tiny size, measured in nanometers. A nanometer is one millionth of a millimeter, or, for comparison, approximately 100,000 times smaller than the diameter of a human hair.

While nanomaterials have the potential to be great boons, especially for the medical and electronics fields, their small size also brings about novel health and environmental impacts when compared to their bulk material counterparts. Their radical reduction in size means that seemingly ordinary materials may behave completely differently than in their larger bulk or macro form. Due to their small size, nanoparticles can cross biological membranes, cells, tissues, and organs more readily than larger particles. Once in the blood stream, nanomaterials can circulate throughout the body and can lodge in organs and tissues including the brain, liver, heart, kidneys, spleen, bone marrow, and nervous system. Once inside cells, they may interfere with normal cellular function, cause oxidative damage, and even cell death.

By law, all new formulations of infant formula must be approved by the FDA. CFS's legal petition requests that the FDA immediately take the steps necessary to properly regulate nanoscale ingredients as new ingredients with new properties and prohibit all engineered nano ingredients in formula until they are demonstrated to be safe for infants.

The risks of nanomaterials in infant formula—although not well understood—are alarming in light of existing studies about toxicity, chemical reactivity, and nanomaterials' greater capacity to penetrate biological membranes, as infants are particularly vulnerable to food safety risks due to their developing immune systems. A study conducted at Arizona State University found nanomaterials in infant formula manufactured by four companies: Gerber, Enfamil, Well Beginnings, and Similac. The nanomaterials identified were nano-hydroxyapatite, nano-titanium dioxide, and nano-silicon dioxide. The materials are mostly used for their brightening/whitening, anti-caking, and flow-enhancing properties. Titanium dioxide, in both bulk and nano form, was recently banned in the European Union after scientists raised genotoxicity concerns, deeming it "no when used as a food additive." Similar concerns have also been raised about nano-hydroxyapatite, with the European Commission's Scientific Committee on Consumer Safety concluding that its use in cosmetics can pose a risk to the consumer and should not be allowed.

This is a situation in which the precautionary principle—acting now to avoid potential unforeseen harm later—must be undertaken. Currently, the FDA's existing regulations do not include screening or safety testing of nanomaterials. The FDA must exercise its authority under the Federal Food, Drug, and Cosmetic Act to ensure infant formulas are safe and meet certain nutritional requirements. The FDA should also prohibit all engineered nano ingredients until they are demonstrated to be safe for this vulnerable population. Although the totality of risks associated with allowing nanomaterials to remain in infant formula are not fully understood, the FDA has the responsibility to protect consumers, especially infants, from toxic materials.

CFS has been the leader in addressing the environmental, public health, and food safety impacts of nanotechnology and synthetic biology for 20 years. We undertake domestic and international legal, policy, and legislative actions regarding nanotechnology in order to safeguard human health and the natural environment; ensure that countries adopt adequate regulations for these new chemicals; verify that manufacturers remain responsible for any adverse impacts their products might cause; create transparent oversight and communication regarding the nanotechnologies' effects and social impacts; and foster open, meaningful, and full public participation at every governmental and non-governmental level. 

TAKE ACTION: Join us in telling the FDA to protect babies from nanomaterials in infant formula!

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