FDA Publishes Nanotechnology Draft Guidance

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The agency is asking for public comment on what are its first steps towards better characterizing nanotechnology-related materials.

FDA on Thursday published its first draft guidance on nanomaterials. This is the agency’s first step towards informing interested parties on what characteristics could be considered when identifying commercial applications of nanotechnology.

The guidance, entitled “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” is available online and open for public comment.

Nanotechnology deals with materials smaller than 100 nanometers. Commercial interest in the technology has increased in recent years, with increased bioavailability of ingredients and greater efficacy with less material as potential benefits in food and dietary supplement industries.

Toxicology risks are intimately tied to the nanotechnology discussion (some of which have been outlined here) and, in 2006, FDA established the Nanotechnology Task Force to better understand such concerns.

“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, MD, FDA 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.”