FDA Grapples with Nanotechnology
On June 24, 2014, the Food and Drug Administration (FDA) released three final guidance documents addressing the agency’s general approach to nanotechnology and its use by the food and cosmetics industries, as well as a draft guidance on the use of nanomaterials in food for animals.
These guidance documents reflect FDA’s understanding of nanomaterials as an emerging technology of major importance with the potential to be used in novel ways across the entire spectrum of FDA- regulated products.
The documents suggest that FDA plans to approach nanotechnology-related issues cautiously, through an evolving regulatory structure that adapts to manufacturers’ changing uses of this technology. FDA has not established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale,” or other related terms. The guidance documents provide a framework for factors FDA will consider in evaluating a product’s safety.
Rather than categorizing all products involving the use of nanotechnology as intrinsically either benign or harmful, FDA will consider on a case-by-case basis the characteristics of the finished product and the potential safety concerns for its intended use. FDA cautions manufacturers against assuming that a product containing nanomaterials is safe simply because larger particles of the same material have been established as safe. The agency encourages manufacturers to establish the safety of nanomaterials based on data relevant to the nanoscale version of the material and to consult the agency early and regularly with questions related to proper substantiation of product safety.
The FDA guidance documents are incredibly complex. This is not surprising in view of the complexity of the issues involved. Emerging nanotechnologies are being used in numerous industry sectors, including food and cosmetics. Companies utilizing them are urged to study carefully the FDA guidance documents.