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FDA Addresses Nanotechnology in Food
11/14/2006
WASHINGTON—
The Food and Drug Administration (FDA) assembled a task force to look into the role the agency should play in drug and food products featuring nanotechnology. The task force, comprised of various scientific exerts, met Oct. 10 to discuss how to best find balance in the oversight of products containing submicroscopic particles, including drugs, foods, cosmetics and medical devices.
Nanotechnology involves particles generally less than 100 nanometers in diameter; by comparison, a sheet of paper is 100,000 nanometers thick, and a human hair is 80,000 nanometers thick. Popular in electronics, energy and medicine, manipulating or manufacturing materials at this atomic or molecular level can produce many advantages to food products, including valuable food additives, shrunken fat particles and antimicrobial-coated packaging. To date, about 20 percent of all products feature nanotechnology, but only about 14 percent of the global food market involves nanotechnology. Still, there are very few studies showing long term safety, and consumers have been wary of scientific explorations in food, as evidenced by the backlash against genetically modified (GM) foods. FDA (www.fda.gov) reported it does not consider nanotechnology foods inherently unsafe, but the small particles do come with some safety risks. Among the concerns voiced by the task force are the varying property changes possible in changing a particle’s size by a few nanometers; and the ability of some shrunken particles to pass through the blood brain barrier, which they wouldn’t ordinarily accomplish. Many experts suggested the goal is for FDA to find the balance between risk and benefit, a charge with which FDA has struggled in regards to drugs and dietary supplements. Chief among regulatory concerns is the lack of resources FDA has currently and would have to address nanotechnology oversight. Kathy Jo Wetter, ETC Group, said FDA is understaffed, underfunded and not equipped to handle nanotechnology, adding that hundreds of nano products have already sneaked onto the market with little oversight. “The agency doesn’t have people trained specifically in nanotech,” said Michael Taylor, a former deputy commissioner for policy at the FDA and now a professor at the University of Maryland School of Medicine. “They need to build up staff of people who know as much about nanotech as the companies developing the products.” Much of the meeting was spent discussing nanotechnology in cosmetics and personal care products. “In vitro tests of skin cells are not adequate to determine where these particles go in the body,” said John Balbus, director of health programs at the advocacy group Environmental Defense. However, others argued the existing regulatory system is adequate, and the gaps in scientific data on nanotechnology do not automatically deem these products unsafe. “The science does not yet mandate draconian action,” said Martin A. Philbert, a toxicology professor and executive director of the Center for Risk Science and Communication at the University of Michigan School of Public Health. He said toxicity could come from manufacturing aids, and risk could be diminished by coating nanoparticles. There is no need to panic,” Philbert counseled. “At present, the benefits of nanoscale materials greatly outweigh the risks,” he said. The task force is due to deliver a full report to FDA within nine months.
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