Nanotechnology regulatory science research involves the use of specific tools needed to characterize and detect nanomaterials in FDA-regulated products as well as development of new methods to analyze or confirm the size and properties of nanomaterials in toxicology studies. To address these approaches, the National Center for Toxicological Research (NCTR) is developing analytical tools and procedures to quantify nanomaterials in complex matrices and conducting toxicity studies on nanomaterials.
Current NCTR nanotechnology regulatory science research focuses on two program areas:
- Evaluating Potential Toxicity of Nanomaterials in FDA-Regulated Products
At present, a limited number of studies assessing the toxicity of nanoparticles are available for use in risk assessments of nanomaterials. A key issue in evaluating the utility of nanomaterials is assessing their potential toxicity, either due to their inherent chemical composition or as a consequence of their nanoscale properties. Areas of research include evaluating the genotoxicity of engineered nanoparticles or materials that are used in various FDA-regulated applications ranging from tissue engineering to cancer targeting.
- Modernizing Toxicology Approaches to Enhance Product Safety
The NCTR nanotechnology research aids in the development of guidelines for the safe and effective use of nanomaterials in drugs, devices, foods, cosmetics, and dietary components. With the recent establishment of the premiere state-of-the-art NCTR/ORA Nanotechnology Core Facility, NCTR scientists can now conduct research to determine the relationship of material constitution, size and shape on the toxic potential of nanomaterials.
Other work includes evaluating the potential health effects of skin exposure to nanomaterials and a risk assessment on gut uptake of nanoscale zinc oxide. Research is also in progress to support the food safety system, such as determining the disposition of silver nanomaterials once administered to the stomach.
For further information:
NCTR/Office of Scientific Coordination - Nanotechnology
Food and Drug Administration
3900 NCTR Road
Jefferson, AR 72079