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Regulating Nanotechnology

Mon, 02/23/2009 - 09:40
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(Project on Emerging Technologies and Food and Drug Law Institute: Washington) -- In 2007, the global market for goods incorporating nanotechnology totaled $147 billion. Lux Research projects that figure will grow to $3.1 trillion by 2015.

Is the Food and Drug Administration (FDA) equipped to meet the emerging regulatory challenge of dietary supplements that use engineered nanomaterials? The short answer is no, according to a report by the Project on Emerging Nanotechnologies (PEN). The ability of the FDA to regulate the safety of dietary supplements using nanomaterials is severely limited by lack of information, lack of resources and the agency's lack of statutory authority in certain critical areas, according to PEN.

The report, “A Hard Pill To Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements,” details the main problems at FDA in regulating nano-enabled dietary supplements and offers a host of recommendations for improving oversight of such products.

“Historically, the regulation of dietary supplements has been a significant challenge for the FDA, and the fact that some of those products are now being manufactured using nanotechnology creates an additional layer of complexity,” says William B. Schultz, a coauthor of the report and a former FDA official.

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