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FDA Falls Behind on Nanotech Dietary Supplements
January 15, 2009
2 Min Read
If a new report from the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies (PEN) is any indication, FDA is far behind on its regulatory efforts in the market for dietary supplements containing nanotechnology-based ingredients. The report, "A Hard Pill To Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements," concludes FDA lacks the information, funding and clear statutory authority in certain areas to regulate supplements with nano-ingredients.
PEN members noted when the project started, there were 11 dietary supplements on the market claiming to use nanoscale ingredients when the project; less than two years later, there are now more than 40 such products. According to the report, this growth contributes to two-thirds of the major problems facing FDA in this market:
FDA does not have the capacity to identify nano-based dietary supplements that are being developed and marketed, unless manufacturers submit to the pre-market notification process for new dietary ingredients.
To the extent that FDA is aware of nano-based dietary supplements, it has little regulatory authority over them.
Even if it were granted increased regulatory authority, FDA lacks the scientific expertise and resources to effectively regulate nanomaterials in supplements.
"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, a co-author of the report and a former FDA official.
Among the solutions, the report suggests increased regulatory authority for FDA, including possible rules such as product registration, establishment of safety standards, market review, pre-market testing, and improved adverse event reporting. It further recommended FDA be given more information on dietary supplement products containing nano-materials and that Congress given increased funding to FDA for better regulation in this market, else consumers will be at "additional, unknowable and potentially serious risk."
"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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