Task Force Prods FDA to Address Nanotechnology

WASHINGTON—FDA’s Nanotechnology Task Force released a report recommending the agency consider developing guidance to address the benefits and risks of using nanotechnology in FDA-regulated products. FDA (www.FDA.gov) and 22 other federal agencies are part of the National Nanotechnology Initiative, a federal research and development program established to coordinate the multiagency efforts in nanoscale science, engineering and technology. The Task Force was initiated by FDA Commissioner Andrew von Eschenbach, M.D., in 2006.

The Task Force Report warns nano-size materials potentially could be used in most product types regulated by FDA, which could present challenges similar to those posed by products using other emerging technologies. The report noted the problems with nanotechnology may be complicated by the fact that properties relevant to product safety and effectiveness may change as size varies within the nanoscale.

Calling for transparent, consistent and predictable regulatory pathways, the task force noted the potential for rapid development in the field, recommending FDA consider issuing guidance to clarify, among other issues, what information companies would provide FDA about products, as well as when the use of nanoscale materials may change the regulatory status of particular products. As with other FDA guidance, draft guidance documents would be made available for public comment prior to being finalized.

“Nanotechnology holds enormous potential for use in a vast array of products,” said von Eschenbach, who endorsed the Task Force Report and its recommendations on July 23. “Recognizing the emerging nature of this technology and its potential for rapid development, this report fosters the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials.”

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