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On June 24, 2014, FDA issued three final guidance documents and one draft guidance to provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products.
Among these four documents, three are related to foods. In particular, the Guidance for Industry: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology discusses FDA’s overarching regulatory policy for nanotechnology in all FDA regulated products. The Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives discusses how a manufacturing process change, including using nanotechnology, could affect the safety assessment and regulatory status of a food ingredient or food contact substance. The draft Guidance for Industry: Use of Nanomaterials in Food for Animals discusses specific issues related to the use of nanotechnology in food for animals.
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Authored by Martin Hahn and Xin Tao.