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FDA Nanotechnology Task Force sees no need for general labelling
Published: Wednesday 25 July 2007
Today, the US Food and Drug Administration’s Nanotechnology Task Force released a report urging the FDA to consider developing guidance for manufacturers and researchers, as well as taking other steps to address the benefits and risks of drugs and medical devices using nanotechnology.
The FDA’s Task Force Report on Nanotechnology addresses the following regulatory and scientific issues:
- Understanding Interactions of Nanoscale Materials with Biological Systems
- Adequacy of Testing Approaches for Assessing Safety and Quality of Products Containing Nanoscale Materials
- Ability of FDA to Identify FDA-Regulated Products that Contain Nanoscale Materials
- Scope of FDA's Authority Regarding Evaluation of Safety and Effectiveness
- Issue: Permissible and Mandatory Labeling
- National Environmental Policy Act
The Task Force report highlights that, unlike any other emerging technology, the regulatory challenges pose by nanotechnology ‘may be magnified both because nanotechnology can be used in, or to make, any FDA-regulated product, and because, at this scale, properties of a material relevant to the safety and (as applicable) effectiveness of FDA regulated products might change repeatedly as size enters into or varies within the nanoscale range.’
The Task Force concludes that the FDA's ‘authorities are generally comprehensive for products subject to premarket authorization requirements, [while its] oversight capacity is less comprehensive [in the case of] products not subject to premarket authorization requirements.’
‘Because the current science does not support a finding that classes of products with nanoscale materials necessarily present greater safety concerns than classes of products without nanoscale materials, the Task Force does not believe there is a basis for saying that, as a general matter, a product containing nanoscale materials must be labeled as such. Therefore the Task Force is not recommending that the agency require such labeling at this time. Instead, the Task Force recommends that the agency take the following action: Address on a case-by-case basis whether labeling must or may contain information on the use of nanoscale materials.’
Follow these link to download the full FDA Nanotechnology Task Force Report, or find out more about the FDA Nanotechnology Task Force.