Posted June 26, 2014
The Food and Drug Administration (FDA) issued three final guidances and one draft guidance that provide more regulatory clarity on the use of nanotechnology in FDA-regulated products, according to press release available here. Seattle Pi also published an article available hereand Nanotechnology Now here.
One guidance addresses the agency’s approach for all regulated products, and the other two guidances and the draft guidance provide specific guidelines for areas of foods, cosmetics, and food for animals, respectively.
Nanotechnology allows scientists to create, explore, and manipulate materials on a scale measured in nanometers, which are small particles that cannot be seen under a regular microscope. The technology has a “broad range of applications, such as improving the packaging and altering the look and feel of cosmetics.”
Nanoparticles are defined as those less than 100 nanometers wide, which is one billionth of a meter. For example, a human hair is 80,000 nanometers and a sheet of paper is 100,000 nanometers, according to Seattle Pi.
The FDA does not issue a judgment that nanotechnology is safe or harmful. The guidance documents encourage manufacturers to consult with the agency before taking their products to market. Early consultations help to facilitate a “ mutual understanding about specific and regulatory issues relevant to the nanotechnology product, and help address questions related to safety, effectiveness, public health impact, and/or regulatory status of the product,” according to Nanotechnology Now.
Food companies are studying nanoparticle coatings as a preservative and in reduting bacterial contamination in some foods, according to Seattle Pi.
“Our goal remains to ensure transparent and predictable regulatory pathways, grounded in the best available science, in support of the responsible development of nanotechnology products,” said FDA Commissioner Margaret A. Hamburg, M.D, in the release. “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.”
For more information on the three guidances, visit the FDA’s press release available here.
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