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FDA sees nanotech challenges in every product category it regulates

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.


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Source:http://www.nanotechproject.org/82


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