FDA Draft Guide on Identifying Nanotechnology in Regulated Products
The Food and Drug Administration has released a draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” to provide manufacturers, suppliers, importers and other industry stakeholders with greater certainty about the use of nanotechnology.
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FDA states that a notice of availability of this draft guidance will be published in the Federal Register, and comments will be due within 60 days of publication (by August 15, 2011).
(Nanotechnology, the science involving manipulation of materials on an atomic or molecular scale, is an emerging technology with a broad range of potential applications, such as increasing bioavailability of a drug, improving food packaging and in cosmetics. Nanotechnology generally involves materials made up of particles that are at least one billionth of a meter in size.)
FDA Names Characteristics to Consider When Identifying Nano Products
The draft guidance outlines FDA's view on whether regulated products contain nanomaterials or involve the application of nanotechnology. FDA names certain characteristics that may be considered when attempting to identify applications of nanotechnology in regulated products, such as:
- whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or
- 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.
FDA states that these considerations would apply not only to new products, but also may apply when manufacturing changes alter the dimensions, properties, or effects of an FDA-regulated product or any of its components. Additionally, they are subject to change in the future as new information becomes available, and to refinement in future product-specific guidance documents.
FDA to Apply Final Guidance Points to Premarket Review Products
For products subject to premarket review, the FDA intends to apply the points contained in the draft guidance, when finalized, to better understand the properties and behavior of engineered nanomaterials.
Manufacturers Should Consult FDA for Non-Premarket Review Products
For products not subject to premarket review, FDA will urge manufacturers to consult with FDA early in the product development process so questions related to the regulatory status, safety, effectiveness or public health impact of these products can be adequately addressed.
(FDA is releasing its document in coordination with the “Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials” issued on June 9, 2011, jointly by the Office of Science and Technology Policy, Office of Management and Budget, and the U.S. Trade Representative, which is available here.
See ITT's Online Archives or 04/05/11 news, 11040528, for BP summary of a recent FDA meeting on a International Cooperation on Cosmetics Regulations (ICCR) Nanotechnology Working Group report, among other things.
See ITT's Online Archives or 08/20/10 news, 10082031, for BP summary of FDA's announcement of an September 2010 Medical Device Nanotechnology Workshop.)
The complete draft guidance is available here.
A Q&A document on this guidance is available here.
FDA's nanotechnology Web page is available here.
FDA's Federal Register notice of availability of the guidance (FR Pub 06/14/11) is available here.