WASHINGTON – Draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are at least one billionth of a meter in size, has been released by the US Food and Drug Administration. The guidance outlines the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology.

A science involving manipulation of materials on an atomic or molecular scale, nanotechnology is an emerging technology with a broad range of potential applications, such as improving food packaging, among other things.

TitledConsidering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, the draft guidance is available online and open for public comment. It represents the first step toward providing regulatory clarity on the FDA’s approach to nanotechnology.

FDA 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.

“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret Hamburg, MD, Commissioner of Food and Drugs. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”

Regarding products subject to pre-market review, the FDA intends to apply the points contained in the draft guidance, when finalized, to better understand the properties and behavior of engineered nanomaterials.

FDA said it will develop additional guidance documents related to specific products or product categories in the future, as needed. The agency said it is critical for them 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.

FDA is releasing its document in coordination with the Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials issued on June 9, jointly by the Office of Science and Technology Policy, Office of Management and Budget, and the United States Trade Representative.