The U.S. Food and Drug Administration (FDA) has released draft guidance describing “the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology.” Published in conjunction with a June 9, 2011, nanotechnology memorandum authored by the Office of Science and Technology Policy, Office of Management and Budget, and U.S. Trade Representative, the FDA guidance aims “to provide regulated industries with greater certainty about the use of nanotechnology” and names “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.”

Once finalized, the guidance will help FDA better understand the properties and behavior of engineered nanomaterials, and assist manufacturers early in the development process “so questions related to the regulatory status, safety, effectiveness or public health impact of these products can be adequately addressed.” The agency will accept public comments on the draft document for 60 days after publication in the Federal Register.