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January 28, 2009

PEN Report Faults FDA Regulation of Nanotechnology-Based Dietary Supplements

Lynn L. Bergeson

On January 14, 2009, the Project on Emerging Nanotechnologies (PEN) released a report entitled A Hard Pill To Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements, which describes problems at the Food and Drug Administration (FDA) in regulating nano-enabled dietary supplements and offers recommendations for improving oversight. According to the report, FDA’s ability to regulate the safety of such dietary supplements “is severely limited by lack of information, lack of resources and the agency’s lack of statutory authority in certain critical areas.” The authors note that, under current law, supplement manufacturers must disclose only limited information about their products, and the information available is the result of manufacturers promoting their use of nanotechnology when marketing their products. PEN states that, according to its inventory of federal environmental, health, and safety research on nanotechnology, the U.S. government provides less than $1 million annually to study the direct impact of nanoscale materials on the gastrointestinal tract.