One month after the European Food Safety Authority (EFSA) published its first guidance document for addressing potential risks arising from engineered nanomaterial (ENM) applications in food and feed, the U.S. Food and Drug Administration (FDA) released its draft of guidance outlining the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology.
While the draft guidance, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology," is the first step toward providing regulatory clarity on the FDA's approach to nanotechnology, it does not offer a legal definition of nanotechnology.
FDA Commissioner Margaret A. Hamburg, M.D., said the agency wants to discuss nanotechnology points with industry to create a starting place. Specifically, the agency named certain characteristics, such as the size of nanomaterials used and the exhibited properties of those materials, that may be considered when attempting to identify applications of nanotechnology in regulated products.
For products subject to premarket review, the FDA intends to apply the points contained in the draft guidance, when finalized, to better understand the properties and behavior of engineered nanomaterials. For products not subject to premarket review, the FDA will urge manufacturers to consult with the agency early in the product development process so questions related to the regulatory status, safety, effectiveness or public health impact of these products can be adequately addressed.
FDA will develop additional guidance documents related to specific products or product categories in the future, as needed. FDA wants to understand how changes in physical, chemical or biological properties seen in nanomaterials affect the safety, effectiveness, performance or quality of a product that contains such materials.
While the draft guidance, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology," is the first step toward providing regulatory clarity on the FDA's approach to nanotechnology, it does not offer a legal definition of nanotechnology.
FDA Commissioner Margaret A. Hamburg, M.D., said the agency wants to discuss nanotechnology points with industry to create a starting place. Specifically, the agency named certain characteristics, such as the size of nanomaterials used and the exhibited properties of those materials, that may be considered when attempting to identify applications of nanotechnology in regulated products.
For products subject to premarket review, the FDA intends to apply the points contained in the draft guidance, when finalized, to better understand the properties and behavior of engineered nanomaterials. For products not subject to premarket review, the FDA will urge manufacturers to consult with the agency early in the product development process so questions related to the regulatory status, safety, effectiveness or public health impact of these products can be adequately addressed.
FDA will develop additional guidance documents related to specific products or product categories in the future, as needed. FDA wants to understand how changes in physical, chemical or biological properties seen in nanomaterials affect the safety, effectiveness, performance or quality of a product that contains such materials.
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