FDA Seeks Public Comment On Draft Guidance On The Use Of Engineered Nanomaterials Or The Application Of Nanotechnology In Food And Drugs

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Food safety is in the news again, with German sprouts and French ground meat accounting for scores of recent deaths in Europe due to two e. coli bacteria strains.
United States Food, Drugs, Healthcare, Life Sciences
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Originally published on The Nano Newswire

Food safety is in the news again, with German sprouts and French ground meat accounting for scores of recent deaths in Europe due to two e. coli bacteria strains. Spanish cucumbers were wrongfully accused. Spanish cucumber farmers are now insolvent.

While food safety is of vital importance to all of us, any scientific intervention into the food chain is understandably viewed with the highest public skepticism. Examples include sterilization by gamma radiation (don't ask why the small containers of milk for coffee in diners don't have to be refrigerated), genetically modified seeds; the use of antibiotics, steroids or other additives in cattle feed; and the spraying of fruit with any number of chemicals.

Coincidentally, on June 14, 2011, the U.S. Food and Drug Administration has Published Draft Guidance on nanotechnology used in FDA-regulated products (almost by definition, food and drugs). See Federal Register Docket Number FDA-2010-D-0530.

While the FDA has yet to establish regulatory definitions of "nanotechnology" and related terms, the FDA will ask the following questions in its inquiry:

  1. Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1-100 nanometers)
  2. Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimensions, even if these dimension fall outside the nanoscale range, up to one micrometer.

The FDA believes that evaluations of safety, effectiveness or public health impact of such products should consider the unique properties and behaviors that nanomaterials may exhibit.

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