Nanotechnology promises to alter the way drugs are delivered within the body, allow for new diagnostics and medical devices and even add shimmer to cosmetics. But for the U.S. Food and Drug Administration, the development of nanotechnology also presents new regulatory challenges.

A report issued this week from the FDA's Nanotechnology Task Force concedes that regulating nanoscale materials, like other new materials, will be tricky. But it also warns that weighing the benefits and risks of these new materials, which scientists are still struggling to understand, could pose unique problems. For products such as drugs and medical devices—over which the agency has pre-market review and approval authority—regulation may be less of a problem than for food and cosmetics, for which there is no such review process, the task force said.

The task force shied away from tough recommendations. Instead, it concludes the FDA should gather more information on nanotechnology and its effects on the properties of materials before pushing any slate of regulations. As such, the report highlights an ongoing struggle within the agency to balance the demands of industry and patient advocates to deliver innovative new products to the market in a timely manner against concerns about the agency's ability to protect public safety and whether it has adequate resources to do that job.

The lack of any apparent strong action plan triggered criticism from the International Center for Technology Assessment, a bi-partisan, nonprofit group. "It makes it more likely," said George Kimbrell, a staff attorney for the group, "that nanotech is going to be added to this list of FDA's regulatory failures to the detriment of human health and the environment."

Others, though, saw the task force report as a measured and reasonable starting point for addressing how to regulate a technology about which much is still not known.

"The science is relatively uncertain at the moment. What it tells us is that some of these new nanomaterials behave differently than conventional products, but we're not quite sure to what extent that is going to lead to new and unusual risks," said Andrew Maynard, chief science advisor for the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies. "If we talk about a precautionary approach, you can also talk about a cautionary approach of not running too fast before we understand where we are running to with nanotechnology and nanotechnology oversight."

Rapid Development Pace
The report said the agency may have adequate authority to meet these challenges. But because of the evolving state of the science, it may be necessary to assess on an individual basis whether sufficient evidence exists to show that products satisfy the legal and regulatory standards, the report said.

Nanotechnology involves working with materials at an atomic or molecular level with particles that are as small as one billionth of a meter, roughly 80,000 times smaller than the width of a human hair. At such sizes, scientists can change the natural properties of a material, alter its conductive, magnetic, optical or other qualities to meet the needs of a specific application.

The science and applications of nanotechnology are developing at a very rapid pace. According to the report, by 2002 the number of scientific publications on nanotechnology grew to 22,000 with more than 1,900 patent applications. That compared to just 1,000 publications and 200 patent applications filed in 1990. The task force said that reflects new discovery and investment that will likely fuel changes in products falling under the FDA's authority.

Risk Questions Remain
The task force said that products with nanoscale materials don't present a greater risk than products without them. The report concludes that there is no basis for requiring products containing nanoscale materials in general be identified as such in their labels. Instead, it argues the agency should address such matters on a case-by-case basis.

The task force also recommended the FDA continue to pursue regulatory approaches that take into account the potential importance of material size and the evolving state of the science. But it warned that while one definition for "nanotechnology," "nanoscale material," or a related term or concept may offer meaningful guidance in one context, that definition may be too narrow or broad to be of use in another.

Patrick Lin, research director for The Nanoethics Group at California Polytechnic State University, said while in theory nanotechnology poses a risk to the environment, health and safety, it would be premature to implement a strict regulations.

"It's a tough balance to strike. What the FDA did was a sensible compromise," said Lin. "On one hand it did acknowledge there may be something here to worry about in the future and we have to look at this on a case by case basis and on the other hand it didn't rush to judgment."