Nanotech regulatory woes continue

pill.bmpThe ever-vocal Project on Emerging Nanotechnologies, based in Washington, DC, is the latest organisation to produce a report bemoaning the lack of regulation of engineered nanoparticles in commercial products (press release).

This time, the US Food and Drug Administration are under fire for not being up to the task. The report “A hard Pill to Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements” pulls no punches, kicking off in the summary with the following: “This paper addresses the issue of whether FDA is equipped to meet the emerging regulatory challenge of dietary supplements that use engineered nanomaterials. The short answer is no.”

The three main problems the report authors, William Schultz from legal practice Zuckerman Spaeder and his colleague Lisa Barclay, identify include:

1. FDA does not have the capacity to identify nano-based dietary supplements that are being developed and marketed, unless manufacturers submit to the pre-market notification process for new dietary ingredients.

2. To the extent that FDA is aware of nano-based dietary supplements, it has little regulatory authority over them.

3. Even if it were granted increased regulatory authority, FDA lacks the scientific expertise and resources to effectively regulate nanomaterials in supplements.


This is yet another reminder that nanotechnology needs to be properly overseen, a message that report after report hammers out time and again. Late last year in the UK, the Royal Commission on Environmental Pollution offered the same, but more general, criticism (see Be scared. A little bit), echoing concerns raised by the Royal Society and Royal Academy of Engineering some four years previous.

It is often the Environmental Protection Agency, in the US at least, that is criticised for being weak on this issue (see Clock ticking for US nanotech companies), although this agency subsequently seemed to be getting somewhere (see Getting tough on makers of tiny tubes). Earlier this week, EPA published its interim report on its voluntary reporting scheme, saying that it was successful, but “gaps” still exist in safety data. This leads one to think that they are thinking of making the scheme mandatory, which might be a good thing.

The reports can keep coming, but what is needed is plenty of research to give the regulators some oomph. The UK research councils and EPA are “finalising details” of such a programme; details which will be very interesting to see. Watch this space…

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