Regulating nanotechnology

The FDA proposes the first set of regulations for nanotechnology and asks for feedback from the scientific community.

By | June 15, 2011


The US Food and Drug Administration (FDA) issued a draft guidance yesterday (June 14th) for the regulation of nanotechnology, a field that has exploded since the government began to explicitly support nanotechnology research through the National Nanotechnology Initiative in 2000. The aim of the draft guidance is to initiate a discussion with those involved in the development of nanomaterial, in order to establish safety standards without hampering innovation.

The draft guidance was written in accordance with two memos issued by the White House last week and in March, containing a set of principles for regulation. A main discussion point of the guidance is how nanomaterials should be defined. Nanomaterials are generally classified by a size of 1 to 100 nanometers in at least one dimension, but characteristics such as charge, shape, and the ratio of surface area to volume can all influence the material's properties, and should thus be taken into account when categorizing different types of nanoparticles. "A focus on novel properties and phenomena observed in nanomaterials may ultimately be more useful than a categorical definition based on size alone," write the authors of last week's White House memo.

But the FDA's guidance merely raises this point without actually providing a strict definition, leaving open the question of what materials will be subject to the final regulation. Some companies were hoping for a few more specifics. “What we really need is a concrete set of standards,” Reyad Sawafta, CEO of the nanotechnology company Quartek, told Industry Week. “We need to know that if we pass these tests, we can effectively commercialize these products."

The guidance, with its accompanying set of frequently asked questions, is available for comment until August 15 at, by following the instructions in the document.

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