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  1. Nanotechnology Programs at FDA

Nanotechnology Fact Sheet

Contents

Nanotechnology Overview

Nanotechnology is an emerging technology that has the potential for use in a broad array of FDA-regulated products, including medical products, foods and cosmetics.  Nanomaterials, developed using nanotechnology, are measured in nanometers — equal to about one-billionth of a meter — so small that they cannot be seen with a regular microscope.  These nanomaterials can have different chemical, physical, or biological properties than their conventionally-scaled counterpart materials used in many products regulated by FDA.

FDA has long encountered the combination of promise, risk, and uncertainty that accompanies emerging technologies. Nanotechnology is not unique in this regard. The very changes in biological, chemical and other properties that can make nanotechnology applications so exciting also may merit examination to determine any effects on product safety, effectiveness, or other attributes. Understanding nanotechnology remains a top FDA priority.  FDA is monitoring the evolving science and has a robust research agenda to help assess the safety and effectiveness of products using nanotechnology.

Strong science is critical to FDA’s ongoing review of the products it regulates.  FDA is investing in a nanotechnology regulatory science program to further enhance FDA’s scientific capabilities, including developing necessary data and tools to identify properties of nanomaterials and assess the impact they may have on products.  In general, the agency considers the current framework for safety assessments sufficiently robust  and flexible to be appropriate for a variety of materials, including nanomaterials.

FDA is maintaining a product-focused and science-based regulatory policy to appropriately regulate products using this emerging technology.  Legal standards vary among various product-categories that FDA regulates.  FDA will regulate nanotechnology products under existing statutory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction.  The Agency is taking a prudent scientific approach to assess each product on its own merits, and does not make broad, general assumptions about the safety of nanotechnology products.

FDA’s Action on Nanotechnology

In 2006, the acting Commissioner of Food and Drugs charged FDA's Nanotechnology Task Force with issuing a report to determine regulatory approaches that would enable the continued development of innovative, safe, and effective FDA-regulated products that use nanoscale materials.  The Nanotechnology Task Force was asked to identify and recommend ways to address any knowledge or policy gaps that exist to better enable the agency to evaluate safety aspects of FDA-regulated products that contain nanoscale materials.  The Nanotechnology Task Force published the report in July 2007 and, among other things, the report presented recommendations to the Commissioner for actions the agency can take in furtherance of its mission to protect and promote the public health.  Please click here to view the full report.

Since this report published, FDA issued several guidance documents on topics relating to application of nanotechnology in FDA-regulated products.  While guidance documents do not create or confer any rights for or on any person and do not operate to bind FDA or the public, they do represent FDA's current thinking on a topic.  Click here for more information about FDA's nanotechnology guidance documents.

FDA’s Approach to Regulation of Nanotechnology Products

FDA will continue to regulate nanotechnology products under its existing statutory and regulatory authorities, in accordance with the specific legal standards applicable to each type of product under its jurisdiction.  FDA intends to ensure transparent and predictable regulatory pathways grounded in the best available science.

  • FDA does not make a categorical judgment that nanotechnology is inherently safe or harmful.  We intend our regulatory approach to be adaptive and flexible and to take into consideration the specific characteristics and the effects of nanomaterials in the particular biological context of each product and its intended use.
  • Particular approaches for each product area will vary according to the statutory authorities.  The scope and issues covered in the product-specific guidance documents reflect this approach.
  • FDA’s nanotechnology regulatory science research portfolio focuses on understanding interactions of nanomaterials with biological systems; and on the adequacy of testing approaches for assessing safety, effectiveness, and quality of products containing nanomaterials.
  • FDA’s regulatory policy approach is consistent with relevant overarching U.S. government policy principles, and supports innovation under appropriate oversight.

Industry remains responsible for ensuring that its products meet all applicable legal requirements, including standards for safety — regardless of the emerging nature of a technology involved in the manufacturing of a product.  FDA encourages industry to consult with the Agency early in the product development process to address any questions related to the safety, effectiveness, or other attributes of products that contain nanomaterials, or about the regulatory status of such products.  Early consultations with FDA facilitate a mutual understanding of the specific scientific and regulatory issues for nanotechnology products.  Click here for more information on FDA's approach to regulation of nanotechnology products.

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