Regulating Nanotechnology

(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.

Little is known about the use of engineered nanoparticles in the dietary supplement market. Current law requires supplement manufacturers to disclose limited information about their products, and what information is available is a result of dietary supplement manufacturers touting the use of nanotechnology when marketing their products, according to the report.

“While it is not possible to precisely determine the prevalence of dietary supplements using engineered nanoparticles, it is likely that the public's exposure to these products will grow significantly in the next several years,” says Lisa Barclay, also a coauthor of the report.

According to an inventory of federal environmental, health, and safety research on nanotechnology maintained by PEN, the U.S. government is spending less than $1 million annually to study the direct effect of nanoscale materials on the gastrointestinal tract.

“It is not clear that the supplement industry is conducting the rigorous testing needed either to understand the effects of nanoscale ingredients in its products or to back up the product claims. This means that consumers are potentially exposed to unknown risks that should be balanced with the possible benefits of taking these supplements,” says David Rejeski, PEN's director.

Another area highlighting regulation of the manufacturing of nanoparticles is its effects on workforces, researchers, and consumers. Attorneys Jesse Ash, Antony Klapper, and James Wood note in a Feb. 3, 2009, "Food and Drug Law Institute Insighter" article “Nanotechnology: Reducing Liability Exposure when Risks Are Unknown,” that a recent study indicated that certain types of carbon nanotubes, graphite-based structures commonly used in nanotechnology applications, resemble and behave like asbestos fibers.

The authors of the article state that, “some scientists wonder whether engineered nanomaterials will become the next asbestos.”

As light as plastic and stronger than steel, carbon nanotubes will likely see use in a variety of new applications, including medical nanodevices. However, based on toxicity studies, scientists found that inhaling long, thin multiwalled carbon nanotubes had the potential to cause lung disorders similar to those caused by exposure to asbestos.

The authors conclude that because there are many unanswered questions regarding risk, it is essential that companies follow the principles of good product stewardship activities and good risk management strategies in the design and manufacturing of products made with engineered nanomaterials.

For further information, visit www.nanotechproject.org/supplements/ and www.fdli.org/insighter/articles/Ash-Klapper-Wood-020309.pdf.

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