Hundreds of nanotech 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, http://www.fdli.org/.
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.