Posted June 26, 2014
The Food
and Drug Administration (FDA) issued three final guidances and one draft
guidance that provide more regulatory clarity on the use of nanotechnology in
FDA-regulated products, according to press release available here.
Seattle Pi also published an article available here
and Nanotechnology Now here.
One
guidance addresses the agency’s approach for all regulated products, and the
other two guidances and the draft guidance provide specific guidelines for
areas of foods, cosmetics, and food for animals, respectively.
Nanotechnology
allows scientists to create, explore, and manipulate materials on a scale
measured in nanometers, which are small particles that cannot be seen under a
regular microscope. The technology has a “broad range of applications, such as
improving the packaging and altering the look and feel of cosmetics.”
Nanoparticles
are defined as those less than 100 nanometers wide, which is one billionth of a
meter. For example, a human hair is 80,000 nanometers and a sheet of paper is
100,000 nanometers, according to Seattle
Pi.
The FDA
does not issue a judgment that nanotechnology is safe or harmful. The guidance
documents encourage manufacturers to consult with the agency before taking
their products to market. Early consultations help to facilitate a “ mutual
understanding about specific and regulatory issues relevant to the
nanotechnology product, and help address questions related to safety,
effectiveness, public health impact, and/or regulatory status of the product,”
according to Nanotechnology
Now.
Food
companies are studying nanoparticle coatings as a preservative and in reduting bacterial contamination in some foods, according to Seattle
Pi.
“Our goal remains to ensure transparent and predictable
regulatory pathways, grounded in the best available science, in support of the
responsible development of nanotechnology products,” said FDA Commissioner
Margaret A. Hamburg, M.D, in the release.
“We are taking a prudent scientific approach to assess each product on its own
merits and are not making broad, general assumptions about the safety of
nanotechnology products.”
For more information on the three guidances, visit the FDA’s
press release available
here.
