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Posted: January 23, 2008
FDA beginning to address nanotechnology regulatory concerns
(Nanowerk News) Hundreds of nanotechnology products, including foods, medicines and medical devices, now have reached
the market, and their number will grow exponentially in the years ahead.
But the main regulating body, the Food and Drug Administration, is just
beginning to address the unique issues presented by this groundbreaking
technology, according to an Insighter article, written by Beryl Lieff
Benderly, posted on the Food and Drug Law Institute's website,
In a July 2007 report, a special FDA nanotechnology task force
concluded that, while the agency has the capability to meet these
challenges, it needs to take specific action soon to get ready. However,
according to the Insighter article, FDA has not made public its plans for
responding to the task force report. "We are beginning the planning for the
priority activities defined in the task force report," FDA spokesperson
Crystal Rice told FDLI.
"FDA has not done much, if anything, publicly.... They are in an
information- gathering and internal assessment phase," said Julia A. Moore,
Deputy Director of the Project on Emerging Nanotechnologies at the Woodrow
Wilson International Center for Scholars (WWC) in Washington, D.C., during
an interview for the Insighter article. Nonetheless, "I'm very sure that
they are doing things. This is a high priority of [Commissioner Andrew] von
Eschenbach and the agency," she continued. "It's really a matter of making
sure that they have the resources and the expertise and... of taking a look
at their statues and ensuring that they are nano-ready."
Many "nano materials will turn out to be good and wonderful and
beneficial," Moore said. Given the newness and complexity of nano
techniques and materials, however, "it would be unprecedented" if they did
not present some risks, she continued. Despite this, "there has not been
major investment" in looking for such risks, and FDA "needs to have the
resources and the capacity to explore them."
Other experts also question FDA's current nano preparedness. Regulating
the Products of Nanotechnology: Does FDA Have the Tools It Needs?, a report
by former FDA Deputy Commissioner for Policy Michael R. Taylor published in
2006 by the WWC nanotechnology project, states that "FDA is not 'nano
ready'" because "gaps exist in FDA's legal toolbox" and "FDA lacks
necessary resources." But, Taylor adds, "Even within its current authority
and resources, FDA can and should take some immediate steps to address the
first wave of nanotechnology products now entering the market, including
perhaps the most fundamental one of setting the criteria for determining
when a nanoscale material is 'new for legal and regulatory purposes' and
'new for safety evaluation purposes.'"
The Food and Drug Law Institute and the Woodrow Wilson Center Project
on Emerging Nanotechnologies, in partnership with Burdock Group and Arizona
State University, are sponsoring the 1st Annual Conference on
Nanotechnology Law, Regulation and Policy Feb. 28-29, in Washington, D.C.
Nanotechnology News and Small Times are offering marketing assistance in
the landmark meeting.
The full text of the Insighter piece is posted at http://www.fdli.org.
Founded in 1949, FDLI publishes the award-winning, peer-reviewed Food
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