Field Notes

Small.

"Small is small, small is different, small is hard to predict." So said Dr. Philippe Martin of the European Commission at the FDA's recent public meeting on nanotechnology. The meeting, called by the FDA to receive information rather than provide it, was held at the National Institutes of Health on October 11 and was attended by around five hundred people. They came to hear from industry, government, consumer groups, advocates, and civil society about developments in nanotechnology pertaining to FDA-regulated products, as well as concerns about them.

Nanotechnology—an amorphous term—generally refers to the manipulation of matter at the nanoscale. One nanometer equals one billionth of a meter. Many materials, structures, and devices classified as "nano" are generally from one to one hundred nanometers in size. (For the sake of comparison, a human hair is about eighty thousand nanometers in diameter.) At this small size, matter often behaves differently, which can be useful for creating strong, light, flexible materials and structures so tiny they can invade cancer cells.

Some products are already on the market. An inventory created by the Woodrow Wilson International Center for Scholars contains over three hundred and twenty nanotechnology consumer products, including paints, fabrics, sports equipment, dietary supplements, sunscreens, and drugs. The single largest product category in the Wilson inventory is cosmetics.

The FDA regulates cosmetics, as well as food additives, dietary supplements, and, of course, drugs, biologics, and medical devices, but perhaps not as much as expected. While the FDA requires premarket safety and efficacy testing of drugs, it does not review or preapprove cosmetic products or ingredients and can remove a cosmetic from the market only if it is unsafe or misbranded. Many at the meeting argued that the FDA did not have sufficient human and financial resources to do its current job properly, let alone to undertake additional regulation of nanotechnology.

The Hastings Center recently received a contract from the NIH to think about ethical issues in nanotechnology. I attended the FDA meeting to see how safety, governance, and public engagement are playing out. My impression was of a promising technology about which much is unknown, and of significant disagreement about what to do in the face of this uncertainty.

The calls for additional oversight, more funds for risk research, and better communication with the public flow, I think, from the fact that we know little about how nanomaterials interact in the short and long term with humans, animals, and the environment. The desire not to repeat mistakes associated with wonder products like asbestos and DDT led some speakers to urge caution, and this was echoed by Dr Martin. Using the example of gold—which, reduced to nanosize, has properties quite unlike regular gold—he argued that when facing the unknown, we must assume danger. But others contended that unless we have proof that specific nanoparticles are dangerous, we must continue to develop and sell them. Any move to slow down nanotechnology, they say, risks placing the United States at an economic and developmental disadvantage. And with over a billion federal dollars devoted to nanotechnology research a year, the stakes are anything but small.