Writing in the journal Science, Hamburg said the FDA’s approach to the regulation of nanotech products will be product-specific and science-based, and referred industry to draft guidance on nanotechnology, released in June last year. At that time, the Food and Drug Administration (FDA) said the guidance was a “first step toward providing regulatory clarity on FDA’s approach to nanotechnology”.
According to the interagency National Nanotechnology Initiative, nanotechnology is “the understanding and control of matter at dimensions between approximately 1 and 100nm, where unique phenomena enable novel applications”. But while Hamburg acknowledges the importance of identifying what could be described as a nanomaterial, she says it is difficult to pin down a meaningful definition.
“Although one definition for “nanomaterial” may offer meaningful guidance in one context, that definition may be too narrow or broad in another. For this reason, FDA is not at this time adopting a regulatory definition of nanotechnology,” she wrote.
Hamburg added that the agency does not categorically judge all products involving nanotechnology as “intrinsically benign or harmful” but that advances may be “unpredictable, rapid and unevenly distributed across product applications and risk management tools”, as with other emerging technologies. Therefore, the agency has chosen to take a product-focused approach, at least initially.
“Technical assessments will be product-specific, taking into account the effects of nanomaterials in the particular biological and mechanical context of each product and its intended use,” she wrote.
“…Industry must work with current information in product development, and monitor products once marketed.”
The approach may become more nuanced in the light of experience, new scientific information, and public input, she added.
Until then, Hamburg advised industry and new product developers to bear in mind factors related to nanomaterials’ size and properties, and to consult the agency early in the NPD process to address any uncertainties.
“Regulating an emerging technology is not a unique problem but rather a regularly encountered challenge,” she said.
Internationally, many regulatory agencies are considering whether they should develop regulatory definitions for nanotechnology, and whether their existing frameworks are applicable for regulating nanomaterials. In October last year, the European Commission defined nanomaterials as: “A natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1nm-100nm”.
Vol. 336, pp. 299-300 10.1126/science.1205441
“FDA’s Approach to Regulation of Products of Nanotechnology”
Author: Margaret Hamburg