Tentatively, FDA Hones In On A Working Definition of Nanotechnology

By Ricardo Carvajal & Riëtte van Laack –

When the FDA Nanotechnology Task Force issued its report in 2007, it declined to adopt precise definitions of the terms "nanoscale materials" or "nanotechnology," opting instead to take an inclusive approach.  FDA has now issued draft guidance on nanotechnology that again shies away from adopting formal definitions.  Rather, the guidance presents “points to consider” with regard to whether a “product contains nanomaterials or otherwise involves the application of nanotechnology,” namely:

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.

(Emphasis added.)   Notably, the points to consider address only engineered materials or end products, and not “the more familiar use of biological or chemical substances that may naturally exist at small scales, including at the nanoscale, such as microorganisms or proteins.”  This is in keeping with FDA’s interest in “the deliberate manipulation and control of particle size to produce specific properties, because the emergence of these new properties or phenomena may warrant further evaluation” (emphasis in original).  Also worth noting is that the points to consider encompass materials with dimensions beyond 100 nm (usually taken as the upper limit for nanomaterials) to 1000 nm to include agglomerates and aggregates that exhibit dimension-dependent properties relevant to nanomaterials. 

An accompanying FAQ characterizes the guidance as “a first step toward providing regulatory clarity on FDA’s approach to nanotechnology.”  Those who were seeking greater clarity are bound to be disappointed.  The FAQ makes clear that FDA places a premium on flexibility at this early stage, and that the agency has confidence in the adequacy and adaptability of its existing regulatory framework:

FDA’s goal is to develop transparent and predictable regulatory pathways grounded in the best science.  FDA intends to do this with a regulatory approach that is iterative, adaptive and flexible.  FDA does not categorically judge that all products containing nanomaterials or otherwise involving the application of nanotechnology as intrinsically benign or harmful.

FDA is maintaining its product-focused, science-based regulatory policy that allows for variations among product classes and over time as the science evolves.  Products regulated by FDA are subject to different statutory standards for safety, efficacy, or public health impact.  Therefore, acceptable levels of uncertainty and risk may vary among product-classes, even where objective measures of risk are similar.

FDA’s draft guidance was published on the same day as a memorandum from the White House Emerging Technologies Interagency Policy Coordination Committee laying out principles for oversight of emerging technologies that are intended to strike a balance between ensuring safety and encouraging innovation.

Comments on the draft guidance are due by August 14.