Tuesday, August 14, 2007

RE: Nanotechnology Report of the US FDA, Jule 25, 2007 - HIGHLY RECOMMENDED

Nanotechnology: A Report of the U.S. Food and Drug Administration, Nanotechnology Task Force, July 25, 2007, http://www.fda.gov/nanotechnology/taskforce/report2007.pdf.

If you are following the debate over nanoproducts, you simply must read this report. Even if you do not agree with the conclusion, this is an important document.

The report admits "products might change repeatedly as size enter into or varies within the nanoscale range." At the same time concluding "the agency's authorities are generally comprehensive" though admitting "for products not subject to premarket authorization requirements...oversight capacity is less c0mprehensive." I have been working on a new piece that looks at the two approaches to protecting safety: standards versus screening. There was a seminal article on this subject in the Virginia Law Review by Peter Huber in 1983 entitled The Old-New Division in Risk Regulation and it might be worth re-examining as we get deeper into reforms appropriate for dietary supplements, cosmetics, and food ingredients. I hope to have a draft of this piece which I am presenting at NanoTX (http://www.nanotx.biz) in October out soon.

I have a few closing concerns relating to this report.
  • On pp. 5-6 the call on the task force included a consideration of "appropriate vehicles for communicating with the public about the use of nanoscale materials in FDA-regulated products" was completed poorly.

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