FDA needs industry support on nanotechnology
industry to show its support for an increased budget for the
federal agency, following a report last week denouncing its
capacity to properly regulate nanotechnology products.
In a report commissioned by the Woodrow Wilson Center's project on emerging nanotechnologies, University of Maryland School of Medicine professor Michael Taylor concluded the US Food & Drug Administration's resource base is severely eroded. Taylor discussed the effect this could have on dietary supplements and cosmetics with NutraIngredients-USA.com.
Taylor said that the report was issued leading up to the FDA's upcoming first public meeting on nanotechnology in order to add to the discussion, and perhaps spur industry to support a badly needed FDA budget hike.
"This was just intended to begin the discussion," said Taylor.
He suggested that budgetary constraints pose more of an obstacle to uncovering the potential risks of nanotechnology than any regulatory issues could.
"The larger problem is FDA's shrinking budget," said Taylor, pointing out that if the federal agency is not financially able to fulfill its mandate this could adversely affect nanotechnology products across the board.
On the issue of whether FDA post market regulation of dietary supplements hinders safety checks for nanotechnology, Taylor said he does not think changes are needed and instead called for industry participation in the FDA discussions.
"People who want those benefits to be available need to address possible safety questions while also not letting FDA be an obstacle to innovation," said Taylor.
The dietary supplement industry is regulated by the Dietary Supplement Health and Education Act (DSHEA), which is part of the Food and Cosmetics Act.
Unlike pharmaceuticals, which must go through a series of pre-market approvals, finished dietary supplements need no pre-market approval. Only ingredients not marketed in the US before October 1994 must be approved by the FDA before being used in consumer products.
"I think for dietary supplements FDA has at least a partial tool," suggested Taylor on the subject of regulation. "Nanoscale ingredients could be categorized as a new ingredient."
Taylor was clear, however, that dietary supplements and cosmetics are not at more risk than any other products that may use nanotechnology.
"One thing that we emphasized is that no category [of products using nanotechnology] is more risky than another," said Taylor. "It is about FDA and its readiness to answer questions."
