A new report from the Project on Emerging Nanotechnologies (PEN) questions FDA’s ability to regulate the safety of dietary supplements using nanomaterials due to a lack of information, resources and statutory authority.

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 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 Schultz, a co‐author of the report and a former FDA official.

According to the report, current law requires supplement manufacturers to disclose limited information about their products, and information is typically only available when dietary supplement manufacturers tout the use of nanotechnology when marketing their products.

“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 is spending less than $1 million annually to study the direct impact of nanoscale materials on the gastrointestinal tract.

Andrew Shao, PhD, vice president, scientific and regulatory affairs, with the Washington, D.C.-based Council for Responsible Nutrition (CRN) said nanotechnology applies to various industries, not just the supplement market, and commended FDA for “taking the initiative to explore what, if any, guidance or regulations for nanotechnology may be appropriate across all of its regulated industries.”

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.

“We question the true motives behind this report from the Project on Emerging Nanotechnologies (PEN), which provides a very limited amount of useful information on nanotechnology and paints a misleading picture by implying that only one industry faces questions about nanotechnology,” said Dr. Shao. “This report masquerades as a legitimate review of the use of nanomaterials in dietary supplements but in reality it seems to be an attempt to explain the authors’ views on dietary supplement regulations and their suggestions for change.”

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

Dr. Shao said, “as far as we are aware, there are no specific safety issues associated with the use of nanotechnology. There is one area of agreement with the report: that FDA could use more resources to better do its job; however, adequate agency funding and nanotechnology are not specific to dietary supplements—these issues affect all industries regulated by FDA. We encourage FDA to evolve with emerging technologies, such as nanotechnology, and welcome further dialogue with the agency on how to proceed with reasonable regulation of these new technologies—regulation that is able to be implemented by the industry, enforced by the agency and would benefit consumers.”