August 10, 2006
Yesterday, Dr. Andrew C. von Eschenbach, acting commissioner, FDA, announced the formation of an internal FDA Nanotechnology Task Force. The task force will help determine regulatory approaches that encourage continued development of FDA-regulated products, including foods and beverages, that use nanotechnology materials (see http://www.fda.gov/bbs/topics/NEWS/2006/NEW01426.html for the full press release).
The task force will identify and recommend ways to address any knowledge or policy gaps that exist to help FDA evaluate possible adverse health effects that might result from FDA-regulated products that use nanotechnology materials. FDA will continue to address product-specific nanotechnology issues on an ongoing basis.
"As this exciting new area of science develops, FDA must be positioned to address both health promotion and protection challenges that it may present," reported von Eschenbach in the FDA press release. "Through this task force, we are leveraging our expertise and resources to guide the science and technology in the development of nanotechnology-based applications." Among other initiatives, this new task force has been charged with:
* Assessing the current state of scientific knowledge pertaining to nanotechnology materials;
* Evaluating the effectiveness of FDA's regulatory approaches;
* Exploring opportunities for using nanotechnology materials to develop safe and effective products, including foods and animal feeds;
* Strengthening FDA's relationships with other federal agencies participating in the National Nanotechnology Initiative (http://www.nano.gov/), including the National Institutes of Health (NIH), the Environmental Protection Agency (EPA), and USDA, as well as with foreign government regulatory bodies, international organizations, healthcare professionals, industry, consumers, and other stakeholders to gather information regarding nanotechnology materials used or that could be used in FDA-regulated products;
* Considering appropriate vehicles for communicating with the public about the use of nanotechnology materials in FDA-regulated products.
FDA is planning to hold a public meeting on Oct. 10 to discuss and learn more about nanotechnology materials and issues surrounding the emerging technology (for complete details, see http://www.fda.gov/OHRMS/DOCKETS/98fr/06n-0107-nm00002.pdf). The task force has been asked to submit its initial findings and recommendations to FDA's acting commissioner within nine months of this public meeting.
The National Nanotechnology Initiative, a U.S. government R&D coordinating program, defines nanotechnology as "the understanding and control of matter at dimensions of roughly 1 to 100 nanometers (nm), where unique phenomena enable novel applications." A human hair is about 80,000 nm in width.
Materials made in the nanoscale size range can often have different chemical or physical properties than their larger counterparts, including altered magnetic properties, altered electrical or optical activity, increased structural integrity, and increased chemical and biological activity. Because of these properties, nanotechnology materials have great potential for use in a vast array of products. Also, because of some of their special properties, they may pose different safety issues than their larger counterparts.
For more on FDA and nanotechnology, see http://www.fda.gov/nanotechnology/.
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