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FDA report reveals its approach to nanotechnology-enabled product approvals

A report from the FDA's Nanotechnology Task Force outlines the agency's regulatory approach toward nanotechnology-enabled products

A report from the FDA's Nanotechnology Task Force has outlined the agency's regulatory approach toward nanotechnology-enabled products, which includes healthcare treatments.

The report highlights the impact nanotechnology has on every area of FDA responsibility, which includes drugs, drug delivery systems, cosmetics, medical devices and food products. Overall, the agency regulates products that are worth nearly USD 1.5tn annually and account for almost 25 per cent of US consumer spending.

The report says that the FDA must be sure 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. It goes onto criticise the FDA for not being 'nano-ready' for the products on the market today and having the capacity to deal with the more advanced nanotechnology applications expected in the next five to 10 years.

Chief science advisor on the Project on Emerging Nanotechnologies, Dr Andrew Maynard, said: "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. The Task Force report clearly states that size matters in making risk management decisions. 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 concluded: "The 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."

The report detailing the FDA's readiness to regulate nanotechnology can be accessed here: http://www.nanotechproject.org/82.

30th July 2007

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