On June 9, 2011, the United States Food and Drug Administration
("FDA")
released draft guidance intended to "provide regulated
industries with greater certainty about the use of
nanotechnology."
The
draft guidance, entitled "Considering Whether an
FDA-Regulated Product Involves the Application of
Nanotechnology," outlines the FDA's current views on
whether regulated product contain nanomaterials or involve the
application of nanotechnology. The document identifies
certain characteristics to be considered in identifying
applications of nanotechnology in regulated products, such as the
size of the nanomaterials and their exhibited properties.
Although the draft guidance does not purport to establish a
regulatory definition of nanotechnology, the FDA considers it to be
the first step toward providing "regulatory clarity"
regarding the FDA's approach to nanotechnology.
The FDA considers it critical to "understand how changes in
physical, chemical or biological properties seen in nanomaterials
affect the safety, effectiveness, performance or quality of a
product that contains such materials. The draft guidance is
currently open for public comment.
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