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Groups Petition FDA to Regulate Novel, Potentially Hazardous Nanomaterials in Infant Formula

February 10, 2022
Center for Food Safety

WASHINGTON—Yesterday, Center for Food Safety and International Center for Technology Assessment formally petitioned the Food and Drug Administration (FDA) to regulate nanomaterials in infant formula. The groups request that FDA immediately take the steps necessary to properly regulate nanoscale ingredients and prohibit all engineered nano ingredients in formula until they are demonstrated to be safe for infants.

"FDA has known for five years that many U.S. infant formulas contain nanochemical additives that the agency has not approved," said Jaydee Hanson, policy director at Center for Food Safety. "It is time for FDA to act to make infant formula safe from these toxic additives. Europe keeps them out of infant formula—we should too."

Compared to their bulk material counterparts, nanomaterials can have fundamentally different health and environmental impacts which creates new oversight challenges for regulatory agencies. 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 by Arizona State University found nanomaterials in infant formula manufactured by four companies: Gerber, Enfamil, Well Beginnings, and Similac. The materials are mostly used for their brightening/whitening, anti-caking, and flow-enhancing properties.

FDA must ensure infant formulas are safe and meet certain nutritional requirements. Before any infant formula can be sold, the manufacturer must first register with FDA and provide a notice. Once a formula is on the market, any changes to the contents of the formula must be reported to FDA.

In the petition, the groups are urging FDA to enact new regulations directed at the agency's oversight of nanomaterials, including that any infant formula undergo rigorous testing for the presence of nanomaterials and that the products be labeled as containing nanotechnology. Additionally, FDA should declare all currently available infant formulas containing engineered nanoparticles as adulterated and issue a recall. Lastly, use of nanomaterials in infant formula should not be approved using the "Generally Recognized as Safe" (GRAS) loophole.

Recently, various agencies of the European Union, including the European Food Safety Agency (EFSA), have raised serious health questions about both the nano and the bulk forms of certain chemicals, such as hydroxyapatite and titanium dioxide, which are found in infant formulas in the U.S. An EFSA panel recently concluded that titanium dioxide can no longer be considered safe as a food additive due to concerns over genotoxicity.


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