Report Issued by Project on Emerging Nanotechnologies Takes Aim at Dietary Supplements

By Ricardo Carvajal –      

A report issued by Project on Emerging Nanotechnologies ("PEN"), a partnership between the Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts, concludes that FDA is not prepared to effectively regulate dietary supplements that use “engineered nanomaterials” due to a lack of information, insufficient resources, and inadequate statutory authorities.  The report is especially critical of FDA’s apparent inability to take quick action against dietary ingredients for which manufacturers lack adequate substantiation of safety, and cites as an example FDA’s multi-year effort to get ephedrine alkaloids off the market. 

The report recommends that Congress authorize FDA to: (1) require registration of all dietary supplements that contain “engineered nanoparticles;” (2) establish safety standards for such supplements; (3) review, and require a demonstration of safety for, all such supplements on the market; (4) require premarket safety testing of such supplements; and (5) require reporting of all adverse events for such supplements.  The report asks that these additional authorities be coupled with adequate funding to enable their implementation.  The report references the National Nanotechnology Initiative's definition of nanotechnology, but does not explicitly define the terms "engineered nanomaterials" or "engineered nanoparticles," nor does it take on the question of how those terms should be defined for regulatory purposes.

The report follows closely on the heels of a statement by PEN urging FDA to issue guidance that addresses the question of how existing “generally recognized as safe” ("GRAS") and food additive regulations apply to nanomaterials.  That statement quotes Andrew Maynard (PEN’s chief science advisor) as saying that, “The time may come, when the body of scientific evidence demonstrating the safety of a nanoscale food additive is sufficient to meet the GRAS standard. But the science is not close to meeting that level of confidence now.”