FDA Task Force publishes Nanotech report
including recommendations for how to address the regulatory
challenges posed by the increasing use of nanoscale materials.
The FDA called the Task Force in October 2006 in order to address the issues of consumer safety and the regulation of products containing nanoscale materials, which are becoming increasingly common and available to the average consumer.
A general finding of the report is that 'nanoscale materials present regulatory challenges similar to those posed by products using other emerging technologies' ; however the Task Force recognises that these challenges may be magnified as the properties of a material might change as it approaches the nanoscale range.
The report recognised the authority the FDA has over products that require pre-market authorisation, such as drugs, although it suggests that the agency requests information and data if any already approved product is being altered to include nanoparticles, or if the concentration of nanoparticles is increased.
However, the Task Force expressed concern over the ability of the agency to obtain information about the presence of nanoparticles in products that do not require pre-market authorisation, such as personal care products.
In these cases it recommends that the FDA ask for the submission of information regarding product safety, whilst calling for greater cooperation between the FDA and manufacturers concerning product safety.
Importantly, however, the report does not recommend that the FDA introduce a system of compulsory labeling regarding the presence of nanoparticles in products not subject to pre-market authorisation.
This is because 'current science does not support a finding that classes of products with nanoscale materials necessarily pose greater safety concerns', writes the report.
The Task Force hope that these recommendations will enable innovation and enhance transparency of the agency's regulatory process, while protecting the public health.
Nanotechnology has been heralded as a potentially major breakthrough for personal care formulators, proving to be particularly effective in the delivery of active ingredients as smaller molecules are able to penetrate the skin's dermal layers more effectively.
Moreover, the use of nanotechnology is becoming increasingly common in consumer products in general, with more than 500 hundred products being recorded in the inventory published by the Wilson Center's Project on Emerging Nanotechnologies.
Cosmetics products represent the second largest category in the inventory emphasising the effect that any change in FDA regulations will have on the industry.
