U.S. FDA report on Nanotechnology
The report includes:
- A synopsis of the state of the science for biological interactions of nanoscale materials;
- Analysis and recommendations for science issues; and
- Analysis and recommendations for regulatory policy issues.
The report addresses scientific issues as distinct from regulatory policy issues in recognition of the important role of the science in developing regulatory policies in this area, rapid growth of the field of nanotechnology, and the evolving state of scientific knowledge relating to this field. Rapid developments in the field mean that attention to the emerging science is needed to enable the agency to predict and prepare for the types of products FDA may see in the near future.
A general finding of the report is that nanoscale materials present regulatory challenges similar to those posed by products using other emerging technologies. However, these challenges 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. In addition, the emerging and uncertain nature of the science and potential for rapid development of applications for FDA-regulated products highlights the need for timely development of a transparent, consistent, and predictable regulatory pathway.
The report’s initial recommendations relating to scientific issues focus on improving scientific knowledge of nanotechnology to help ensure the agency’s regulatory effectiveness, particularly with regard to products not subject to pre-market authorization requirements. The report also addresses the need to evaluate whether the tools available to describe and evaluate nanoscale materials are sufficient, and the development of additional tools where necessary.
The report assesses the agency’s regulatory authorities to meet any unique challenges that may be presented by FDA-regulated products containing nanoscale materials. This assessment focused on such broad questions as whether FDA can identify products containing nanoscale materials, the scope of FDA’s authorities to evaluate the safety and effectiveness of such products, whether FDA should require or permit products to be labeled as containing nanoscale materials, and whether the use of nanoscale materials in FDA-regulated products raises any issues under the National Environmental Policy Act.
The Task Force concluded that the agency’s authorities are generally comprehensive for products subject to pre-market authorization requirements, such as drugs, biological products, devices, and food and color additives, and that these authorities give FDA the ability to obtain detailed scientific information needed to review the safety and, as appropriate, effectiveness of products. For products not subject to pre-market authorization requirements, such as dietary supplements, cosmetics, and food ingredients that are generally recognized as safe (GRAS), manufacturers are generally not required to submit data to FDA prior to marketing, and the agency’s oversight capacity is less comprehensive.
The report also makes various recommendations to address regulatory challenges that may be presented by products that use nanotechnology, especially regarding products not subject to pre-market authorization requirements, taking into account the evolving state of the science in this area. A number of recommendations deal with requesting data and other information about effects of nanoscale materials on safety and, as appropriate, effectiveness of products. Other recommendations suggest that FDA provide guidance to manufacturers about when the use of nanoscale ingredients may require submission of additional data, change the product’s regulatory status or pathway, or merit taking additional or special steps to address potential safety or product quality issues.
The report recommends seeking public input on the adequacy of FDA’s policies and procedures for products that combine drugs, biological products, and/or devices containing nanoscale materials to serve multiple uses, such as both a diagnostic and a therapeutic intended use. The Task Force also recommends encouraging manufacturers to communicate with the agency early in the development process for products using nanoscale materials, particularly with regard to such highly integrated combination products.
The guidances the Task Force is recommending would give affected manufacturers and other interested parties timely information about FDA’s expectations, so as to foster predictability in the agency’s regulatory processes, thereby enabling innovation and enhancing transparency, while protecting the public health.