Policy, nanotechnology

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 nanotechnology.

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 As with other FDA guidance, draft guidance documents would be made available for public comment prior to being finalized.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.

"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.

Further information

Download/view the report, Nanotechnology. A Report of the US Food and Drug Administration Nanotechnology Task Force:
PDF: www.fda.gov/nanotechnology/taskforce/report2007.pdf
HTML: www.fda.gov/nanotechnology/taskforce/report2007.html

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:  www.nanotechproject.org/82/ 

The online inventory of manufacturer-identified nanotechnology consumer products being sold, maintained by the Project on Emerging Nanotechnologies: www.nanotechproject.org/consumerproducts

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