FDA Says No New Labeling or Regulations for Nanotech Products
CHICAGO (Reuters) -- The Food and Drug Administration on Wednesday said the rising number of cosmetics, drugs and other products made using nanotechnology do not require special regulations or labeling.
The recommendations come as the agency looks at the oversight of products that employ the design and use of particles as small as one- billionth of a meter. There are fears by consumer groups and others that these tiny particles are unpredictable, could be toxic and therefore have unforeseen health impacts.
A task force within the FDA concluded that although nano-sized materials may have completely different properties than their bigger counterparts, there is no evidence that they pose any major safety risks at this time.
"We believe we do not have scientific evidence about nano-sized materials posing safety questions that merit being mentioned on the label," said Dr. Randall Lutter, FDA's associate commissioner for policy and planning, during a briefing with reporters.
As least 300 consumers products, including sunscreen, toothpaste and shampoo are now made using nanotechnology, according to a Woodrow Wilson International Center for Scholars report.
The technology is also being used in medicine, where scientists are developing tiny sensors that detect disease markers in the body, and in the food industry, which is using it to extend shelf life in food packaging.
The FDA now treats products made with nanotechnology the same way it handles all products -- requiring companies to prove safety and efficacy before their product can come to market.
But some product categories, such as cosmetics, foods and dietary supplements are not subject to FDA oversight before they are sold, which already worries some advocates. Producing them with nanotechnology adds another layer of concern.
The International Center for Technology Assessment, a nonprofit policy group that is suing the FDA calling for more oversight over the technology, said the recommendations lack teeth.
"Nano means more than just tiny. It means these materials can be fundamentally different, exhibiting chemical and physical properties that are drastically different," said George Kimbrell, staff attorney at the group. "The consumer is being made the guinea pig."
The group sites studies showing certain types of the particles can cause inflammatory and immune system responses in animals as an example of possible dangers.
The FDA said it will soon issue guidance documents for industries using nanotechnology, which include pharmaceutical companies, medical device makers and consumer products firms.
Lutter said the task force concluded that nanotechnology is not substantially different from earlier emerging technologies such as biotechnology or irradiation.
Copyright 2007 Reuters Ltd.