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Perspectives on FDA’s Regulation of Nanotechnology
February 1, 2010

From household appliances to prescription drugs, nanotechnology will have an impact on everyday lives worldwide. Nanotechnology is the science and technology of the production and manipulation of materials at nanoscale levels of approximately 100 nanometers or smaller. A paper in a recent issue of Comprehensive Reviews in Food Science and Food Safety, published by the Institute of Food Technologists, discusses the emerging challenges and potential solutions generated by nanotechnology.

Nanotechnology has recently been elevated to the forefront of scientific innovation, as it is poised to revolutionize numerous industries and fields of study, such as electronics, medicine, materials engineering and information technology.

Harvard Law School researcher Brianna Sandoval presents some of the most promising applications in the areas of consumer products regulated by the U.S. Food and Drug Administration (FDA), including new over-the-counter drugs, medical devices, cosmetics, food and food packaging. Science research shows that materials engineered at the nanoscale level can exhibit fundamentally different properties from the same material in its customary form.

Despite the incredible social and economic potential of nanotechnology, the FDA faces numerous hurdles in the regulation of these products and both the government and private industry have put billions of dollars into nanotechnology research and development.

“Global R & D spending reached $9.6 billion in 2005, and sales of nano-based products reached $32 billion,” according to Ms. Sandoval. It is potentially a highly lucrative market; consequently, there is increased awareness and funding dedicated to nanotechnology as well as commitment to understanding the possible environmental, health and safety impacts.

Although the FDA has not yet developed a new regulation guide to provide standards for reliable and consistent safety testing on nanotechnology materials, the agency is investing immense amounts time and resources, including developing cross-agency collaboration to research, evaluate and regulate the development, production, marketing, use and disposal of nanomaterials.

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