According to Project on Emerging Nanotechnologies
Director David Rejeski, “Today, FDA took a step forward in
fulfilling its responsibilities for nanotechnology oversight. If
nanotechnology regulation was a baseball game, FDA has scored the first
run in the first inning. But the agency must act rapidly to adopt and
fully implement the Nanotechnology Task Force’s
recommendations. Without moving quickly and building on the
recommendations in the Task Force report, FDA will not be able to keep
pace with today’s rapidly developing nanotechnology market or
engender consumer and investor confidence in emerging
products.”
Just released, this is the first report from the Food and Drug
Administration’s Nanotechnology Task Force about the
agency’s regulatory approach toward
nanotechnology—an exciting new field of engineering and
science that is estimated to grow to $2.6 trillion in manufactured
goods globally by 2014. As the Task Force report highlights,
nanotechnology impacts every area of FDA
responsibility—drugs, drug delivery systems, cosmetics,
medical devices, and food products. Overall, the agency regulates
products that are worth nearly $1.5 trillion annually and that account
for almost 25 percent of US consumer spending.
“Today, there are more than 500
manufacturer-identified nanotechnology consumer products being sold.
These can be found in an online inventory maintained by the Wilson
Center’s Project on Emerging Nanotechnologies (see: www.nanotechproject.org/consumerproducts),”
said Rejeski. “The number of listed products has more than
doubled in a year. It does not include nanotech consumer products which
companies do not identify as such, or the hundreds of nano raw
materials, intermediate components, and industrial equipment items
currently used by manufacturers.”
“In light of this fast-rising commercialization, FDA
needs to make certain that it has the tools, resources and information
necessary to ensure the safety of novel products before they enter the
market, and to detect and move swiftly to correct any problems that may
arise. Given the agency’s insufficient
resources—which for two decades have not kept pace with
inflation—making sure that FDA has the capacity to safely
manage nanotechnology must be the shared responsibility of Congress and
our political leaders,” argued Rejeski. “The agency
must be ‘nano-ready’ for the products on the market
today and able to deal with the more advanced nanotechnology
applications expected in the next 5-10 years.”
“Many of the first generation of nanotechnology
products now on the market are in sectors where FDA’s
statutory authority is weakest—areas like cosmetics and
dietary supplements,” stated Project on Emerging
Nanotechnologies Chief Science Advisor Andrew Maynard. “The
Task Force report clearly states that size matters in making risk
management decisions. Because the chemical, physical and biological
properties of nanoscale materials are often different from their larger
counterparts, they potentially lead to different safety issues. The
report’s recommendations that FDA provide clear
nanotechnology-associated guidance for manufacturers in all areas of
agency responsibility are an important move towards ensuring the
benefits of nanotechnology are realized without undue risk,”
Dr. Maynard said. “FDA is limited in its oversight
of nanotechnology by the dearth of available risk research data on
nanomaterials. Because the agency is resource-starved, there are scant
funds for FDA to conduct its own regulatory-relevant risk research. It
is critical that FDA—and other regulatory
agencies—have the means necessary to evaluate which
nanomaterials are harmful and which are not. This is an issue that
Congressional leaders from both parties have called on the federal
government to address urgently,” said Maynard.