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FDA: No need to flag all nanotechnology
2007-07-25
Food, drugs, medical devices and cosmetics that contain minuscule engineered particles don't necessarily need special labeling to alert consumers, a federal task force recommends. The Food and Drug Administration should consider each product using nanotechnology on a case-by-case basis, an agency task force said in a report being issued Wednesday. An outside expert called the recommendation a good first step. The FDA is considering how it should regulate these products, which are made with tiny particles measured by the nanometer, or billionth of a meter. By comparison, a human hair is about 80,000 nanometers across. Submicroscopic nanoparticles increasingly crop up in FDA-regulated products like sunscreens, glare-reducing eyeglass coatings and antimicrobial wound dressings. The task force recommended that FDA boost its understanding of the science and improve its now-limited ability to detect nanoparticles in both the body and the products it regulates. It doesn't call for -- and the agency says it doesn't need -- additional regulatory authority. Nor does the agency believe products incorporating the technology are inherently riskier in a way that would require across-the-board labeling. "At this point, we lack an ability to say that nanoscale alone raises safety concerns worthy of putting on the label," said Randall Lutter, the agency's deputy commissioner for policy. A nanotechnology expert said the report essential defers the labeling issue. "The agency has got to grapple with that issue," said Andrew Maynard, chief science adviser to the Project on Emerging Nanotechnologies, funded by the Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts. Maynard said it's not enough to say an ingredient is in a product. Producers should disclose whether it's at a nano scale if its size causes it to act in a new or different way, he said. In general, the FDA has sufficient regulatory authority over food additives and drugs to address any special concerns the use of nanotechnology might raise, the task force found. But FDA authority over other cosmetics, dietary supplements and food ingredients is less comprehensive. For those products, the agency should request safety data from companies that are using nanoscale materials in those products and issue safety guidelines for those companies, the report said. FDA commissioner Dr. Andrew von Eschenbach said he endorsed the report and its recommendations. ___ On the Net: FDA regulation of nanotechnology: http://www.fda.gov/nanotechnology/
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