FDA working to establish nanotechnology guidelines

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The FDA has released a draft correspondence establishing a framework for the regulation and oversight of nanotechnology. Made available on its website on June 9, the document is a collaborative product between the National Economic Council, the Office of Management and Budget, the Office of Science and Technology Policy and the Office of the U.S. Trade Representative.

“This document is intended to summarize generally applicable principles relevant to promoting a balanced, science-based approach to regulating nanomaterials and other applications of nanotechnology in a manner that protects human health, safety and the environment without prejudging new technologies or creating unnecessary barriers to trade or hampering innovation,” the authors wrote.

Nanotechnology—the science of manipulating materials on an atomic or molecular scale—is said to promise new materials and applications for a wide variety of fields, including medicine, IT, aerospace, energy and more. Defined by the National Nanotechnology Initiative as “the understanding and control of matter at dimensions between approximately one and 100 nanometers, where unique phenomena enable novel applications,” the technology will be subject to FDA scrutiny.

The FDA correspondence outlines the agency’s position on whether regulated products contain nanomaterials or involve the application of nanotechnology.

“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said FDA Commissioner Margaret A. Hamburg, MD. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”

According to the FDA, products subject to premarket review will be scrutinized according to criteria outlined in the draft guidance. For products not subject to premarket review, the agency is urging manufacturers to consult with the agency early in the development process.

Among some of the framework noted in the draft, federal agencies will base decisions on best scientific evidence, develop information on the potential effects of nanomaterials to human health and the environment, develop information openly and with stakeholder and public participation, and mandate risk management actions, among many others.

The draft correspondence is available online and is open for public comment, according to a press release from the agency. The FDA’s draft correspondence can be found here.