Nanomaterials a Regulatory Challenge for FDA, Report Concludes

January 14, 2009

FDA’s ability to regulate the safety of dietary supplements using nanomaterials is inadequate due to a lack of information, resources and statutory authority in certain areas, according to a new report released by the Project on Emerging Nanotechnologies (PEN; Washington, DC).

FDA’s ability to regulate the safety of dietary supplements using nanomaterials is inadequate due to a lack of information, resources and statutory authority in certain areas, according to a new report released by the Project on Emerging Nanotechnologies (PEN; Washington, DC).

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

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

Supplement manufacturers are required to disclose limited information about their products under current law, and what information is available is a result of nanotechnology marketing by manufacturers, says 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," said Lisa Barclay, also a co-author of the report.

According to an inventory of federal environmental, health and safety research on nanotechnology maintained by PEN, the U.S. government spends less than $1 million annually to study the direct impact 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," said David Rejeski, PEN's director.

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