The Food and Drug Administration (FDA) has issued a Draft Guidance for Industry document which gives nanotechnology stakeholders their first insight into FDA’s thinking about the probable scope of future regulation of nanotechnology by FDA.      

FDA will take “size and functionality” into account when it determines whether a product contains nanomaterials or involves nanotechnology. FDA has also carefully avoided providing a  definition of nanomaterials. “The draft guidance does not establish a regulatory definition of the term ‘nanotechnology’ or any related vocabulary. Over time, we plan to issue more specific guidances tailored to particular products or classes of products.”

When considering whether an FDA-regulated product contains nanomaterials or involves the application of nanotechnology, FDA will in future ask:

1.       Whether an engineered material or end product has at least one dimension in the nanoscale range (1 - 100 nanometers).

2.       Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects attributable to its dimensions, even if these fall outside the nanoscale range, up to one micrometer.

3.       These considerations will apply not only to new products, but also where manufacturing changes alter the dimensions, properties or effects of a material or its components, says the FDA.

To assist in understand the background for this document, we have posted this week’s Whitehouse Memorandum – “Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of the Application of Nanotechnology and Nanomaterials”.

We have also posted the March 11 Whitehouse Memorandum - “Principles for Regulation and Oversight of Emerging Technologies”


We also add this perspective on “Nano-Scale” for our non-scientist readers:

The size of a Human Red Blood Cell is about 10,000 nm in diameter

The size of a typical E. coli bacterium is about 3,000 nm X 1,000 nm

A Rabies virus would measure about 170 nm X 70 nm

A Prion would measure about 200 nm X 20 nm

A Rhinovirus or Poliovirus would measure about 30 nm in diameter

Citation: Tortora, MICROBIOLOGY, 10th Ed., Benjamin Cummings, 2010