The ability of the Food and Drug Administration (FDA) to regulate
the safety of dietary supplements using nanomaterials is severely
limited by lack of information (Translation: the field is so new that there is little hard evidence to go on), lack of resources and the agency's lack
of statutory authority (the ability to accept or ban a pratice, within their current scope, and the total lack of an agency that does have the authority to collaborate with) in certain critical areas, according to a new
expert report released by the Project on Emerging Nanotechnologies
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
"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," says William B. Schultz, a co-author
of the report and a former FDA official.
Little is known about the use of engineered nanoparticles in
the dietary supplement market, and even less in known about the possible effects that swallowing nanotechnoogy could have on the human body. 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
co-author of the report.
Of course, this lack of information could have something to do with a lack of research. U.S. government is spending less than $1 million annually
to study the direct impact of nanoscale materials on the
gastrointestinal tract. To be honest however it would make more sense, in the current fiscal situation, to require private industry to do the testing and simply analyze the results and process carefully.For now, however, they seem to be getting away with minimal to no testing.
"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.