FDA meeting highlights shortfalls on nanotechnology regulation

By Louise Prance

- Last updated on GMT

Related tags Nanotechnology Fda

The need for tighter regulations on the use of nanotechnologies in
unregulated cosmetic and pharmaceuticals was again called into
question at a meeting called by the US Food and Drug Administration
this week.

Kathy Jo Wetter of ETC Group, an organization that tracks the impact of new technologies, said that: 'unfortunately, so far the US government has acted as a cheerleader, not a regulator, in addressing the nanotech revolution. Health and environmental effects have taken a back seat'.

Nanotechnology is the ability to manipulate compounds at an atomic and molecular scale of between one and 100 nanometers and has been met with enthusiasm across a variety of industries. It incorporates molecules as small as one-billionth of a meter, in contrast, a human hair is approximately 80,000 nanometers.

An internal task force was created by the FDA to focus on nanotechnology, with the US meeting being called in order to assess which scientific issues the agency should focus on.

Dr. Randall Lutter, FDA's associate commissioner for policy and planning, said at the meeting: 'It's not only the risks, it's also looking at the potential. There's a lot of opportunity… to bring great things to patients'.

It was established that the task force would meet the commissioner in nine months for planning and policy.

Participants at the meeting agreed that nanotechnology holds promise for a vast range of new medicines and delivery systems to get drugs to body parts that are currently hard to reach.

However, critics have highlighted the gray areas of nanotechnology, stressing that it can affect toxicity and said that the particles should be treated as new, potentially harmful materials and tested for safety accordingly.

This touches on regulation that sees medicinal drugs and pharmaceuticals requiring a series of pre-market approvals, whilst thousands of cosmetics, foods and dietary supplements are not subject to FDA approval. This allows nano-manipulated products onto the market, with little done to track their use or safety.

Nanotechnology has been met with caution due to the fact that materials at nano-size are much more volatile and are more able to conduct electricity than that of larger materials.

The strong call for harsher monitoring of the products made using nanotechnology has met with experts stating that the FDA is ill-equipped to regulate the technology.

David Rejeski, director of the project on emerging nanotechnologies, a group aimed at helping society anticipate and manage effects of nanotechnology, wrote: 'New nano-enabled drugs and medical devices… place burdens on an oversight agency that is already stretched extremely thin'.

Earlier this month University of Maryland School of Medicine professor, Michael Taylor, pointed out that the FDA is restricted in what it can do due to lack of funding under current administration.

He said that the FDA's budget would have to increase by 49 per cent and under President Bush's 2007 FDA budget this funding gap will grow to 56 per cent.

Scientists in France have previously suggested that nanotechnology is harmless, having been used by ancient Egyptians, unknowingly, in hair dye for thousands of years.

The Egyptians were using lead-based chemistry to develop lead sulfide (PbS) nanocrystals with a diameter of 5mm more than 4000 years ago, according to latest research carried out at the centre de recherché et de restauration des musees de France, based in Paris.

This suggests that nanotechnology has been used unknowingly in the cosmetic industry for at least the past 2,000 years.

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