US FDA lacks resources to regulate nanotechnology
21 August 2007
Washington, USA. The US Food and Drug Administration
(FDA) Nanotechnology Task Force has released a report, Nanotechnology,
that recommends the agency consider developing guidance and taking other
steps to address the benefits and risks of drugs and medical devices using
The report addresses regulatory and scientific issues and
recommends the FDA consider development of nanotechnology-associated
guidance for manufacturers and researchers.
"Nanotechnology holds enormous potential for use in a vast array of
products," said Commissioner of Food and Drugs Andrew von Eschenbach, MD,
who endorsed the Task Force Report and its recommendations. "Recognizing the
emerging nature of this technology and its potential for rapid development,
this report fosters the continued development of innovative, safe and
effective FDA-regulated products that use nanotechnology materials."
The Task Force reports that nanoscale materials potentially could be used
in most product types regulated by FDA and that those materials present
challenges similar to those posed by products using other emerging
technologies. The challenges, however, may be complicated by the fact that
properties relevant to product safety and effectiveness may change as size
varies within the nanoscale.
The report also says that the emerging and uncertain nature of
nanotechnology and the potentially rapid development of applications for
FDA-regulated products highlight the need for ensuring transparent,
consistent, and predictable regulatory pathways.
Anticipating the potential for rapid development in the field, the report
recommends consideration of agency guidance that would clarify, for example,
what information to give FDA about products, and also when the use of
nanoscale materials may change the regulatory status of particular products.
As with other FDA guidance, draft guidance documents would be made available
for public comment prior to being finalized.
In addition, the report says the FDA should work to assess data needs to
better regulate nanotechnology products, including biological effects and
interactions of nanoscale materials. The agency also should develop in-house
expertise and ensure consideration of relevant new information on
nanotechnology as it becomes available, according to the report. FDA should
evaluate the adequacy of current testing approaches to assess safety,
effectiveness and quality of nanoscale materials.
FDA under resourced
According to the Project on Emerging Nanotechnologies Director David
Rejeski, "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."
"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," 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."
The nanotechnology market is
estimated to grow to $2.6 trillion in manufactured goods globally by 2014.
Overall, the FDA regulates products that are worth nearly $1.5 trillion
annually and that account for almost 25% of US consumer spending,
"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," said Rejeski.
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.
Download/view the report, Nanotechnology. A Report of the US Food and
Drug Administration Nanotechnology Task Force:
For an in-depth analysis of the FDA's nanotechnology readiness, see the
October 2006 report, Regulating the Products of Nanotechnology: Does FDA
Have the Tools It Needs? This report was commissioned by the Project on
Emerging Nanotechnologies, and is available at:
The online inventory of manufacturer-identified nanotechnology consumer
products being sold, maintained by the Project on Emerging Nanotechnologies:
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