FDA Issues Guidance on Whether Products Contain Nanomaterials

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Yesterday, the U.S. Food and Drug Administration released a draft of guidance outlining the agency’s view on whether regulated products contain nanomaterials or involve the application of nanotechnology.

The draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” is available online and open for public comment. The FDA notes this draft represents the first step toward providing regulatory clarity on the FDA’s approach to nanotechnology.

Nanotechnology is a rapidly emerging field of research and development. Potential applications include use in cosmetics, improved food packaging, improved drug delivery. Almost $14 billion in research and development has been invested in the National Nanotechnology Initiative (NNI) since its inception in FY 2001.

The FDA and other federal agencies need to understand and manage the relevant risks of nanotechnology. An important first step is establishing a definition of “nanotechnology,” “nanoscale” or related terms. To date, the FDA has not done so, but is attempting to do.

The term “nanotechnology” most commonly is used to refer to the engineering (i.e., deliberate manipulation, manufacture or selection) of materials that have at least one dimension in the size range of approximately 1 to 100 nanometers.

NNI describes nanotechnology as "the understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications."

Size may not be enough for the definition, as the appearance of unique properties can also occur even where the material or end product itself is not within the nanoscale range.

Some definitions of nanomaterials also include criteria related to physical or chemical characteristics (e.g. size distribution, shape, charge, or the ratio of surface area to volume) or to the display of unique or novel properties or "nanoscale phenomena."

Based on FDA's current scientific and technical understanding of nanomaterials and their characteristics, the agency believes that evaluations of safety, effectiveness or public health impact of such products should consider the unique properties and behaviors that nanomaterials may exhibit.

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At this time, when considering whether an FDA-regulated product contains nanomaterials or otherwise involves the application of nanotechnology, FDA will ask:

  1. Whether an engineered material or end product has at least one dimension in the nanoscale range (approximately 1 nm to 100 nm); or
  2. 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.

“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, MD, Commissioner of Food and Drugs. “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.”

As the President's Council of Advisors on Science and Technology noted, "In the absence of sound science on the safe use of nanomaterials and of technologies and products containing them, the chance of unintentionally harming people and the environment increases. At the same time, uncertainty and speculation about potential risks threaten to undermine consumer and business confidence." Accordingly, the Federal Government has significantly increased funding on the environmental, health and safety dimensions of nanotechnology, from $37.7 million in FY 2006 to $123.5 million in FY 2012.

In 2006, the FDA formed the Nanotechnology Task Force, charged with identifying and addressing ways to better enable the agency to evaluate possible adverse health effects from FDA-regulated nanotechnology products.

The agency issued a report by the task force in 2007 that recommended that the FDA issue additional guidance and take steps to address the potential risks and benefits of drugs, medical devices and other FDA-regulated products using nanotechnology.

FDA will develop additional guidance documents related to specific products or product categories in the future, as needed.

The FDA has a robust regulatory science agenda to develop the tools, methods and expertise necessary to evaluate products that contain nanomaterials or otherwise involve the use of nanotechnology. The FDA’s regulatory science portfolio focuses on generating data needed to ensure the safety and effectiveness of products using nanomaterials, with an emphasis on products the use of which could present the greatest potential risk to public health.

FDA released 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 United States Trade Representative. (available as a pdf file here).

Source
Food and Drug Administration: Draft Guidance for Industry

National Nanotechnology Initiative Website

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