Originally published on The Nano Newswire
On June 9, 2011, the Food and Drug Administration (FDA) issued a Draft Guidance on nanotechnology. The Draft Guidance explicitly sets forth two Points to Consider: "1. Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or 2. Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer." The points of consideration reflect the FDA's viewpoint that "evaluation of safety, effectiveness or public impact of such products should consider the unique properties and behaviors that nanomaterials may exhibit." But how did the FDA arrive at its publication of a Draft Guidance? And where does the Draft Guidance fit into the regulatory landscape?
The FDA generally regulates on a product-by-product basis and has authority over products "including foods, cosmetics, drugs, devices, veterinary products, and tobacco products some of which may utilize nanotechnology or contain nanomaterials." While most of the laws that govern the FDA were written prior to the advent of nanotechnology, many offer the "flexibility to accommodate products made with new technologies or containing new kinds of materials." In 2006, the FDA announced the formation of an internal Nanotechnology Task Force (Task Force). Andrew C. von Eschenbach, then Commissioner of Food and Drugs, stated "[a]s this exciting new area of science develops, FDA must be positioned to address both health promotion and protection challenges that [nanotechnology] may present. Through this task force, we are leveraging our expertise and resources to guide the science and technology in the development of nanotechnology-based applications." The Task Force was thus charged with determining regulatory approaches towards FDA-regulated products that use nanomaterials and was specifically asked to submits its findings and recommendations to the Commissioner.
In October 2006, the Task Force held a public meeting to help the FDA further its understanding of nanomaterials and their usage in FDA-regulated products. The Task Force's official report was submitted in July 2007 and contained "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." Notably, the Task Force's report did not adopt a precise definition of "nanoscale materials" or "nanotechnology," nor did it recommend that the FDA adopt a formal definition of those terms at that time.
Ultimately, the Report did not recommend that the FDA create a special regulatory framework for nanotechnology, but did encourage the FDA to "issue additional guidance to provide greater predictability of the pathways to market and for ensuring the protection of public health." In September 2008, the FDA initiated a second public meeting to collect a variety of data as suggested by the Task Force's 2007 report.
Until the FDA's recent publication of the Draft Guide, it had largely continued its information-gathering behind-the-scenes. And while the Draft Guidance refers to itself as a "first step" towards developing a regulatory framework, it reflects the agency's continuing efforts over the last 5 years to amass data on issues of nanotechnology. Just recently, the FDA drew criticism for sidestepping nanotechnology regulations in its new sunscreen rules that were announced on June 14. Stay tuned to Part II of this commentary where we'll discuss the current regulatory landscape of nanotechnology.
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