As other emerging technologies have in the past, nanotechnology poses questions regarding the adequacy and application of regulatory authorities. The then Acting Commissioner of the Food and Drug Administration (FDA) initiated the Nanotechnology Task Force (Task Force) in 2006 to help assess these questions with respect to FDA's regulatory authorities, in light of the current state of the science for nanotechnology. This report offers the Task Force's initial findings and recommendations to the Commissioner.
The report includes:
- A synopsis of the state of the science for biological interactions of nanoscale materials;
- Analysis and recommendations for science issues; and
- Analysis and recommendations for regulatory policy issues.
The report addresses scientific issues as distinct from regulatory policy issues in recognition of the important role of the science in developing regulatory policies in this area, rapid growth of the field of nanotechnology, and the evolving state of scientific knowledge relating to this field.
The report also addresses the need to evaluate whether the tools available to describe and evaluate nanoscale materials are sufficient, and the development of additional tools where necessary.
Task Force Mission
Definitions for Nanotechnology and Related Terms
Organization of this Report
State of the Science of Nanotechnology Relevant to FDA
Issue: Understanding Interactions of Nanoscale Materials with Biological Systems
Issue: Adequacy of Testing Approaches for Assessing Safety and Quality of Products Containing Nanoscale Materials
Regulatory Policy Issues
Issue: Ability of FDA to Identify FDA-Regulated Products that Contain Nanoscale Materials
Issue: Scope of FDA's Authority Regarding Evaluation of Safety and Effectiveness
Issue: Permissible and Mandatory Labeling
Issue: National Environmental Policy Act