Monday, June 20, 2011

FDA's Nanotechnology Guidance

Nanotechnology is the science of manipulating materials on the nanoscale.  “Nanotechnology,” “nanoscale,” and related terms lack definitions in U.S. food law. However, common use of the term “nanotechnology refers to the engineering (deliberate manipulation, manufacture, or selection) of materials that have at least one dimension in the size range of approximately 1 to 100 nanometers.
Nanotechnology is an emerging technology that has the potential to be used many products, including drugs (e.g., to increase bioavailability) and foods (e.g., to improve food packaging). Nanoscale materials can have different chemical, physical, or biological properties compared to their conventionally scaled counterparts. These materials warrant further regulatory attention because the properties and phenomena of nanoscale materials can affect safety, effectiveness, performance, and quality of the materials. 
Rather than define nanotechnology, FDA issued draft guidance on nanotechnology that defines when the agency increase product scrutiny based on the application of nanotechnology. Specifically, FDA will ask:
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.
Note that FDA is interested in the engineered nanoscale materials and the application of nanotechnology as distinguished “from those products that contain incidental or background levels of nanomaterials or those that contain materials that naturally occur in the nanoscale range. FDA is particularly interested 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. This is distinct from 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.”
FDA’s product focused review is similar to the agency’s regulatory policy for recombinant DNA techniques (GMOs). As with GMOs, FDA does not categorize the technology as either benign or dangerous. A product’s final attributes determine the outcome of FDA’s review. However, the agency considers the process of a product’s development as a part of the means for determining the attributes of the final product.

FDA’s draft guidance, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology, Draft Guidance for Industry (June 2011) is available here

1 comment:

andieclark said...

This nanotechnology guidance is very important so that people will have a basis. It's also important that they ready their FDA advisory committee preparations in case of emergencies.