Nanotechnology generally involves materials made up of particles that are at least one billionth of a meter in size and is used in a range of cosmetic formulations.
This latest guidance announcement outlines the agency's view on whether regulated products contain nanomaterials or involve the application of nanotechnology.
Identification depends on certain characteristics
Specifically, the agency named certain characteristics, such as the size of nanomaterials used and the exhibited properties of those materials that may be considered when attempting to identify applications of nanotechnology in regulated products.
"With this guidance, we are not announcing a regulatory definition of nanotechnology," said Margaret A. Hamburg, M.D., Commissioner of Food and Drugs.
"However, as a first step, we want to narrow the discussion to these points and work with the industry to determine if this focus is an appropriate starting place," she continued.
When considering whether an FDA-regulated product contains nanomaterials or involves the application of nanotechnology, FDA will in future ask:
- Whether an engineered material or end product has at least one dimension in the nanoscale range (1 - 100 nanometers).
- Whether an engineered material or end product exhibits properties or phenomena, including physical or chemical properties or biological effects attributable to its dimensions, even if these fall outside the nanoscale range, up to one micrometer.
Agreeing on a legal definition of nanomaterials that satisfies manufacturers, regulators, enforcement bodies and consumers has proved challenging on both sides of the Atlantic, however.
If a definition concentrates on size alone, it will encompass a vast swathe of perfectly innocuous and naturally-occurring nanomaterials in products, confusing shoppers without serving any useful purpose, point out manufacturers.
But building a definition around ‘insoluble’, ‘manufactured’, or ‘engineered’ nanoparticles is also problematic because of the difficulty of pinning down the precise meaning of these terms, argue lawyers.
Meanwhile, the cost and complexity of the equipment needed to examine materials at this scale – atomic force or scanning electron microscopes, for example – makes enforcement expensive and challenging.
The draft guidance, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology," is available online and open for public comment. It represents the first step toward providing regulatory clarity on the FDA's approach to nanotechnology.