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Hawai'i CFS

FDA Releases Final Guidance on Nanotechnology in Food

June 25, 2014
Center for Food Safety

Recommendations begin to address hole in oversight but legally binding regulations are needed

Yesterday, the U.S. Food and Drug Administration (FDA) released final guidance to companies that use nanotechnologies in food products. The FDA recommends that companies consult with the agency before taking products to market and warns that nanotechnology products may require additional safety review on a case-by-case basis.

“FDA’s recommendations make it clear that nanochemicals constitute a new food technology. It's good that the agency recognizes a need for careful review, but the agency should take a more active approach. Under these guidelines, companies will consult with the FDA, but the FDA will not review products for safety,” said Jaydee Hanson, senior policy analyst for Center for Food Safety. “Guidances alone are not sufficient to account for the novel risks of nanotechnology. FDA must issue mandatory regulations.”

FDA also stated that current products would not be allowed through a fast-track process known as “generally recognized as safe” (GRAS). However, FDA did not announce that nanochemicals could not ever be considered “GRAS”.

“FDA should categorically state that GRAS approval cannot be used for nanochemicals in foods. We know far too little about the human health and environmental effects of this technology to allow it to slip into our food without rigorous assessment,” said Hanson. 

The food industry has already incorporated nanomaterials into foods, dietary supplements and “food contact substances,” including cutting boards, plastic containers and sandwich bags. Companies are also using nanotechnologies as food additives, as flavor/taste modifers, and for preservation through nano antimicrobials.

Nanoparticles in food or food packaging can gain access to the human body via ingestion, inhalation, or skin penetration. When ingested, their small size allows them to circulate through the body and reach potentially sensitive target sites such as bone marrow, lymph nodes, the spleen, the brain, the liver, and the heart.

Center for Food Safety has been active in pressuring the agency to regulate nanotechnology in food for nearly a decade. In 2006, Center for Food Safety’s sister organization, the International Center for Technology Assessment, petitioned FDA for mandatory regulations of nanotechnology in food and later sued the agency over its failure to respond.

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