On June 24, 2014, the Food and Drug Administration (FDA) issued four guidance documents—three final and one draft—related to the use of nanotechnology in regulated products. These documents, though non-binding, provide useful insight into the FDA's views on the relationship between nanotechnology and the existing regulatory structure.
The three final guidance documents are: (1) Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; (2) Safety of Nanomaterials in Cosmetic Products; and (3) Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that Are Color Additives. The first guidance provides an overview of the FDA's approach to the regulation of nanotechnology products. The other two address specific areas: cosmetics and manufacturing changes in the production of food and food contact substances. FDA also issued a draft guidance entitled Use of Nanomaterials in Food for Animals.
These guidance documents are significant because they represent a final policy clarifying the FDA's general approach to nanotechnology. Prior to the finalization of these documents, organizations relied on their own understandings of the interaction between nanotechnology and existing regulations. The new guidance documents provide a common jumping-off point for all designers, developers, and manufacturers in the field. In the coming years, the agency will likely issue additional product- or process-specific guidance documents, in the vein of the final guidance concerning the use of nanotechnology in cosmetics and the manufacturing process for food and food contact substances. There are currently no guidance documents specific to drugs or medical devices, and there is not yet final guidance on the use of nanotechnology in food for animals. As the trend toward nanotechnology continues, product-specific guidance will become increasingly important. Both companies and regulators will need to determine whether an application of nanotechnology is truly novel or whether it can be addressed by traditional regulatory mechanisms. Industry members should consider their own products, regulatory history, and design and development processes—along with FDA guidance—in determining how their use of nanotechnology fits into the larger regulatory framework.