Big Steps Ahead for the Nanotech IndustryAugust 1, 2007
Last week, FDA announced the publication of a report by the Agency’s Nanotechnology Task Force (“NTF”) that recommends that FDA develop guidance and take other steps to address regulatory and scientific issues related to nanotechnology. Nanotechnology is an emerging field of applied science and technology covering a broad range of topics in which the primary unifying theme is the control of matter on a scale 1/100,000th the thicknes of a sheet of paper (or one billionth of a meter). FDA announced the creation of the NTF in August 2006 and charged it with “determining regulatory approaches that encourage the continued development of innovative, safe and effective FDA-regulated products that use nanotechnology materials.” In October 2006, the NTF held a public meeting to discuss some of the issues discussed in its report.
The NTF report acknowledges that although products incorporating nanotechnology pose regulatory challenges similar to those posed by other FDA-regulated products using new technologies:
[t]hese 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.
As such, the NTF report recommends that FDA take several actions. First, with respect to scientific issues, the NTF “recommends strengthening FDA’s promotion of, and participation in, research and other efforts to increase scientific understanding, to facilitate assessment of data needs for regulated products,” for example, by “[a]ssessing data on general particle interactions with biological systems and on specific particles of concern to FDA,” and “[c]ollecting/collating/interpreting scientific information, including use of data calls for specific product review categories.” Second, with respect to regulatory policy issues, the NTF recommends that FDA:
[i]ssue guidance to sponsors regarding identification of the particle size for:
- Products subject to premarket authorization, including OTC drugs (when a new monograph or amendment to a monograph is being proposed), and food and color additives (in petitions to approve new additives or to amend existing approvals); and
- Products not subject to premarket authorization but for which the sponsor is required to provide notice (such as dietary supplements containing certain new dietary ingredients), or may choose to provide notice (such as a GRAS notification).
In addition, although several comments were submitted to the FDA docket established for the October 2006 NTF meeting urging the disclosure (in labeling) of the presence of nanoscale materials in FDA-regulated products, the NTF recommends otherwise:
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 [NTF] does not believe there is a basis for saying that, as a general matter, a product containing nanoscale materials must be labeled as such.
In May 2006, prior to the creation of the NTF, the International Center for Technology Assessment (“CTA”) submitted a citizen petition to FDA requesting that the Agency create a new regulatory framework to address nanoscale particles –one that treats all nanoparticles as new substances subject to nano-specific paradigms of health and safety testing, and labeling requirements. In addition, CTA requests, among other things, a product recall and development moratorium for sunscreens and cosmetics using nanoscale materials. Although FDA has not substantively responded to the petition, clearly the NTF report is urging a more tempered FDA approach to nanotech products at this time.