FDA and Nanotech Regulation: The Smaller it is, the Longer it Takes
Apparently, the smaller something is, the longer it takes to talk about. This is the axiom currently employed by FDA, illustrated by the agency’s recently published guidance on nanomaterials in cosmetics and foods (5 years in the making). While the European Union already requires companies to prove a product containing any nanotech materials is safe before the product can be sold to consumers, FDA has sat on the sidelines, forcing many industries to wait for some kind of guidance from FDA on how to proceed.
Slow to Speak
Back in 2007, FDA issued the Nanotechnology Task Force Report1 that merely recommended that FDA further investigate and evaluate nanotechnology science and related safety issues. In June 2011, FDA issued Draft Guidance for Industry entitled, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology.”2 However, that guidance only contains FDA’s thinking on determining whether FDA-regulated products contain nanomaterial or otherwise involve the application of nanotechnology. In other words, by June 2011, the extent of FDA’s substantive regulatory actions in this area amounted to the proposal of a non-binding draft definition of what FDA might consider to be “nanotechnology” at some unspecified time in the future. Industry was left, once again, in a world of uncertainty, waiting for something concrete.
Recently, FDA has taken a “big” step toward supplying industry with guidance on how to proceed with respect to nanotechnology. In April 2012 FDA published guidance3 related to the safety of nanomaterial in cosmetics and foods. In short, the new guidance indicates that FDA is thinking that nanomaterial raises enough safety concerns that new safety tests and studies will be required for every substance, even if the same substance at a larger scale has been previously determined to be safe. The guidance also states that substances previously considered Generally Regarded As Safe (GRAS) for food or cosmetics may not be safe at the nano-scale.
It is clear that FDA plans to require a whole new set of studies and safety investigations for nanomaterial. It is also clear that FDA can’t do anything quickly. If it’s taken this long to arrive at the point of draft guidance then one can only assume that it will take even longer to create substantive regulation for nanotech. By the time FDA produces it’s regulations the humans might already be at war with the robots anyway. Only John Conner knows.
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