Calls for FDA to pay more attention to products made with nanotechnology

Oct 11 2006

At a meeting called by the U.S. Food and Drug Administration (FDA), consumer and environmental groups have called for the FDA to pay more attention to products made by using nanotechnology.

Nanotechnology is the design and use of particles as small as one-billionth of a meter, in real terms by comparison a human hair, is about 80,000 nanometers across.

However nano-size materials can have completely different properties from larger versions, such as unusual strength or the ability to conduct electricity and the consumer groups are saying that while nanotechnology offers immense promise for a vast range of products, the FDA needs to make sure they are safe for humans and for the planet.

The new technology promises new medicines to treat diseases or delivery systems to get drugs to body parts that are hard to reach.

Apparently dozens of cosmetics and a handful of drugs made with nanomaterials are on the market with little being done to track their use or safety.

Kathy Jo Wetter of the action group ETC (Erosion, Technology and Concentration), an organization that tracks the impact of new technologies, says though the FDA has treated drugs made with nanotechnology the same way it handles others, which means companies must provide evidence of safety and effectiveness before they reach the market, when it comes to cosmetics, foods and dietary supplements, that is not the case as they are not subject to FDA oversight before they are sold -- with or without nanoparticles.

While to date no harm has been documented, concerns have arisen that the tiny particles are unpredictable and could have unforeseen impacts in the human body or in the environment and the FDA is being called upon to provide a closer oversight.

However many experts believe the agency is ill-equipped to regulate the new technology along with it's other responsibilities and the new nano-enabled drugs and medical devices could place a burden on an agency that is already struggling to cope.

In defence the FDA says it has created an internal task force on nanotechnology, and had called the meeting to learn what scientific issues the agency should address.

Dr. Randall Lutter, the FDA's associate commissioner for policy and planning says the task force is due to report to the commissioner in nine months time.

According to the FDA, nanotechnology is used to produce biological products such as vaccines, blood products, tissues, cosmetics, devices, foods for humans and animals, dietary supplements, drugs, Radiation Emitting Electronic Products, color additives and combination products i.e., drug-device, drug-biologic, and device-biologic products.