Katherine Bourzac

A View from Katherine Bourzac

FDA Initiative Will Emphasize Nano Safety

Yesterday, the FDA announced a new nanotechnology initiative.

  • March 11, 2009

Yesterday, the U.S. Food and Drug Administration (FDA) announced the creation of a nanotechnology initiative in collaboration with the eight Texas academic institutions that make up the Houston-based Alliance for NanoHealth. (These include Rice University, the University of Texas, and the M.D. Anderson Cancer Center.)

So far, not many details have been released. The FDA’s announcement describes the initiative’s goal as “to help speed development of safe and effective medical products.” The statement also emphasizes the need to “expand knowledge of how nanoparticles behave … and to facilitate the development of tests and processes that might mitigate the risks associated with nanoengineered products.”

This is good news for environmental and consumer groups concerned that research on the potential toxicity of nanomaterials hasn’t been keeping pace with research on their applications.

There are certainly large gaps in our knowledge about these materials, and filling them in will be no small task. The Environmental Protection Agency (EPA) has taken the stance that nanostructured materials shouldn’t be regulated differently from conventional materials with the same chemical structure. But of course size matters in nanotech–that’s the reason people are excited about its applications to begin with, and assuming that toxicity isn’t affected by these materials’ size and shape doesn’t make sense. The diversity in size, shape, and composition of nanomaterials makes it impossible to make blanket statements about their safety. Hopefully, the FDA program will help make sense of these complex questions.

Information gathered under the FDA program, according to the statement, will be in the public domain. Let’s hope this promise is one with more teeth in it than the EPA’s. Much of the information submitted to that agency’s voluntary nanomaterials program has been classed as “confidential business information” and is not available to the public.

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