By Tim Cahill:
Yesterday the FDA’s Nanotechnology Task Force released its report on the scientific and regulatory challenges related to the use of nanotechnology in products regulated by the FDA. As reported in our July 10, 2007 post, the Task Force’s report did not call for additional FDA regulatory authority in this area. The Task Force concluded that the use of nanomaterials in products regulated by the FDA presents challenges similar to those products using existing technologies and other emerging technologies. Further, the Task Force determined that the current science on nanotechnology does not suggest that products using nanomaterials require additional labeling.
The Task Force, however, did recognize that the unique properties of nanomaterials could at some point create challenges with respect to product safety and effectiveness. To that end, the Task Force recommended the consideration of agency guidance that would clarify what information manufacturers should provide to the FDA about products utilizing nanotechnology and would clarify the circumstances under which the use of nanomaterials would change the regulatory status of particular products. The report also recommends that the FDA assess its data needs to better regulate nanotechnology products, develop in-house expertise on nanotechnology issues, and create mechanisms that will ensure the consideration of new nanotechnology information as it becomes available. Finally, the report encouraged the FDA to evaluate the adequacy of current testing approaches to assess the safety, effectiveness, and quality of nanoscale materials.
The Task Force’s report can be found here.