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The FDA must regulate nano-engineered materials as unique substances

Comments of Consumers Union At the FDA Nanotechnology Public Meeting
Break out Session on Prescription Drugs, including biological drugs,
animal drugs and over-the-counter (OTC) drugs, including Sunscreens

by Carolyn Cairns
Program Leader

September 8, 2008
Consumers Union appreciates the opportunity to comment once again on the need for FDA to regulate nano-engineered materials as unique substances, which may pose different biological risks than their larger counterparts. It has been 2 years since FDA’s first public meeting on this issue and over a year since the Task Force report was issued. In the meantime many new products have reached store shelves with untested engineered nano-materials (ENMs). We hope FDA will use the results ofthis meeting to greatly accelerate regulatory efforts and that we won’t be here two years from now, still waiting for action to be taken.
In my comments today I will discuss both what we do know about the unique hazards associated with nanomaterials, and what we yet need to know in order to ensure that their use in foods, drugs and cosmetics is safe. FDA’s delay in making nano-specific safety testing a pre-requisite for approval impedes the development of critical analytical tools needed to characterize the presence, toxicity and fate of ENMs already in commerce.
FDA should not approve nanoscale ingredients in the face of such ignorance, particularly for widespread, exposure-intensive applications of questionable medical benefit.
Consumers Union has been investigating potential risks and benefits from nanomaterials in consumer products for several years and our comments are based on our own research and tests of several nano-enabled products, including sunscreens. Our recommendations about the type of analytical data that FDA should be demanding for pre-market approval of new drugs and over-the-counter treatments can be summarized as follows:
I. Treat nano-materials as new across the board and drop Generally Recognized as Safe (GRAS) status for all nanoscale ingredients.
2. Require all nanomaterials to be characterized according to features known to impact safety (such as size, charge, shape and surface coatings and purity) using validated testing and standardized nomenclature.
3. Build product-specific risk analysis procedures to assess the direct and indirect impacts and fate of nanomaterials in the systems in which they will be used including their interactions with excipients.
4. Where results of product-specific exposure, toxicity and efficacy tests are available for safety analysis, ensure that they accurately reflect the true conditions in which the products will be used.
For the full comments, click here (PDF format).