FDA's Little Meeting

On October 10, ETC Group attended the US Food and Drug Administrations first public meeting on nanotechnology. About 40 people had signed up to make presentations, and we were each given eight minutes to say our piece to the FDAs newly-formed Nanotechnology Task Force. (You can read the text of ETC Groups presentation here.)

It would have been nice to hear a suburban Dad tell the FDA that he wants the agency to require sunscreen companies to label their nano-scale ingredients because his three-year old daughter slathered in sunscreen loves to spend entire summer days splashing in the kiddie pool, but it wasnt that kind of public meeting. It was the kind of meeting where people affiliated with organizations already involved in a debate that only a tiny percentage of the public knows anything about state their views for the record.

ETC Group was in good company. Several other civil society groups including Consumers Union, Environmental Defense, Friends of the Earth, Environmental Working Group and the International Center for Technology Assessment strongly criticized FDA for its failure to act on the scientific consensus that nanotechs size-dependent property changes could have implications for public health. So far, FDA has maintained that particle size is not the issue and that its existing battery of pharmacotoxicity tests is probably adequate for most products the agency regulates.

The Cosmetics Industry (CTFA) was on hand to deliver its own crystal clear message the industry doesnt see a need for a regulatory makeover; everything is just fine, thank you but when Dr. Norris Alderson of the FDA asked if companies would then be willing to hand over their safety studies upon request, it took two CTFA reps to make sure the answer was sufficiently evasive and opaque.

The challenge and for some, the impossibility of regulating the products of a technology that doesnt have a clear definition came up several times throughout the days meeting. Should FDA assess sunscreen or cosmetic ingredient particles that are 101 nm in size differently from those that are 99 nm? It seems like a good question and, in one sense, FDA is right that particle size is not the issue the real issue is size-dependent property changes. And those changes, regardless of whether they occur in particles slightly larger or smaller than 100 nm, should serve as FDAs wake-up call to demand substantiation of safety. Perhaps FDA has been asking the wrong question: Instead of asking companies if they will share their scientific safety data, maybe FDA should be asking them to submit their patent portfolios patent attorneys seem to suffer less from the crisis of uncertainty about whether or not theyre dealing with a novel material.

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