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FDA outlines policy for overseeing nanotechnology

Published on NewsOK Modified: June 24, 2014 at 3:05 pm •  Published: June 24, 2014
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WASHINGTON (AP) — Federal regulators want to hear from companies using tiny, engineered micro-particles in their products, part of an effort to stay abreast of the growing field of nanotechnology.

The Food and Drug Administration issued final recommendations Tuesday for companies using nanotechnology in products regulated by the government, which can include medical therapies, food and cosmetics. FDA regulators want companies to consult with them before launching nanotechnology products, though the decision whether to go to market will essentially rest with manufacturers.

The FDA doesn't make a judgment call on the overall safety of nanotechnology or even define the term.

"We are taking a prudent scientific approach to assess each product on its own merits and are not making broad, general assumptions about the safety of nanotechnology products," said FDA Commissioner Margaret Hamburg, in a statement.

Industry groups generally define nanoparticles as those less than 100 nanometers wide. A nanometer is one billionth of a meter. A human hair, for example, is 80,000 nanometers thick, while a sheet of paper is 100,000 nanometers.

These submicroscopic particles have been increasingly showing up in FDA-regulated products, including food packaging, sunscreens, skin lotions and glare-reducing eyeglass coatings. The technology also has potential uses in medicine, though the new FDA documents focus specifically on food and cosmetics.

The guidelines for food makers suggest any manufacturing changes involving nanoparticles could require submitting additional data to show that the changes don't affect the safety or identity of the food. Under longstanding regulations, food companies aren't required to seek regulatory approval for products containing established ingredients and materials, such as caffeine, spices and various preservatives.

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