As nanotubes, buckyballs and other minute particles enter the stream of commerce, FDA has watched for indications that its intervention may be necessary. Last month the agency issued a statement that the time has come for it to take a closer look at the impact of nanotech on public health, saying that it will hold a meeting on the topic in the fall, the specific date and place not yet determined..

The agency said that that at this point, the intent is to gather “further information about current developments in uses of nanotechnology materials in FDA-regulated products.” However, the release goes into scant further detail.

The docket information page at FDA’s web site states that the agency wants to see “whether there are particular safety or regulatory issues associated with any FDA-regulated products or product classes.”

The agency’s press release follows by about a week the announcement that authorities in Germany had completed a preliminary review of a toxic reaction to an aerosol bathroom surface sealant, primarily when it was used in a confined space. Nanotechnology is bound to run into problems as it makes its way into medical devices, and the consumer sector already may serve as an indicator of such difficulties.

Nearly 100 people in Germany reported severe respiratory problems in connection with an aerosol product called Magic Nano, designed to repel dirt and water from glass and ceramic surfaces. While most of the victims recovered promptly, Germany’s Federal Institute for Risk Assessment (BfR) stated that consumers should avoid the product, which is designed to seal glass and ceramic tile against water and dirt. Kleinmann (Sonnenb hl, Germany) makes Magic Nano, which may could go down in med-tech chronicles as the first nano-panic product.

Aerosols are capable of reducing fluids to “a droplet size of 10 micrometers,” according to BfR, which could induce the effects seen. Ten micrometers are equivalent to 10,000 nanometers. Most definitions of nanometric scale run up to only 100 nanometers.

The case clearly suggests two big questions about the frequently bannered “nano” health sector and its big potential for bringing new products – and a lot more money – to med-tech: How much do we know about what new “nano”-materials actually might do in the human body? – and, What do we know about how to test their activity, good or bad, in the human body. The answer to both questions is, perhaps, “not much.”

— Mark McCarty, Washington Editor