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1546-2080 Online :: 1546-203X Print
FDA Issues Draft Guidance on Use of Nanotechnology in Food and Food Packaging
Volume 9, Issue 2


Authors:
Lynn C. Tyler

Abstract:
The Food and Drug Administration’s 2012 Draft Guidance covering the intentional incorporation of nanoscale particles into food and food packaging products recommends a prior safety assessment of such products using tests validated for nanoscale materials. Scientific studies to date have shown that some nanomaterials can be toxic, while others are not, and that it can be difficult to predict in advance whether any particular material will or will not be toxic, even based on tests for their microscale or macroscale counterparts. Any effect on safety will likely lead to an effect on regulatory status as well, making it prudent, if not required, to obtain FDA’s approval prior to marketing the product. FDA appears to be aligning itself with scientific and regulatory consensus, adopting a case-by-case approach to the approval and regulation of nanomaterial inclusion into food and food packaging products. Companies already putting these materials to commercial use in the food industry would do well to first complete a comprehensive, scientific safety assessment; otherwise, they are incurring a substantial regulatory and litigation risk.

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