WASHINGTON, DC, July 26, 2007 (ENS) - The risks and benefits of drugs and medical devices using nanotechnology should be subject to guidance by the U.S. Food and Drug Administration, FDA, recommends a new internal report by the agency's Nanotechnology Task Force.

The report recommends that the FDA consider development of nanotechnology guidance for manufacturers and researchers. Draft guidance documents would be open to public comment before being finalized.

"Nanotechnology holds enormous potential for use in a vast array of products," said Commissioner of Food and Drugs Andrew von Eschenbach, MD, who endorsed the Task Force report and its recommendations on Monday.

"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," said von Eschenbach, who initiated the Task Force in 2006.

Scientists and researchers increasingly are working in the nanoscale, creating and using materials and devices at the level of molecules and atoms-1/100,000th the width of a human hair.

Today, there are over 500 company-identified nanotechnology consumer products on the market.

The Task Force reports that nanoscale materials could be used in most types of products regulated by the FDA.

The report finds that "the emerging and uncertain nature of nanotechnology and the potentially rapid development of applications for FDA-regulated products highlight the need for ensuring transparent, consistent, and predictable regulatory pathways."

Anticipating the potential for rapid development in the field, the report says the FDA should work to assess data needs to better regulate nanotechnology products, including biological effects and interactions of nanoscale materials.

The agency should develop in-house expertise and should evaluate the adequacy of current testing approaches to assess safety, effectiveness and quality of nanoscale materials, says the report.

FDA and 22 other federal agencies are part of the National Nanotechnology Initiative, a federal research and development program established to coordinate the multi-agency efforts in nanoscale science, engineering, and technology.

Outside of federal circles, nanotechnology is the subject of the Project on Emerging Nanotechnologies, PEN, column at Nanotechnology Now! PEN is a joint initiative between the Woodrow Wilson International Center for Scholars in Washington, DC, and The Pew Charitable Trusts.

Over the past few years, PEN has collaborated with academia, government, industry, and nongovernmental organizations to look long-term at the development of nanotechnology, to identify gaps in knowledge and regulatory processes, and to develop strategies for closing them.