FDA NEWS RELEASE

For Immediate Release: April 20, 2012 Media Inquires: Curtis Allen, 301-796-0393, curtis.allen@fda.hhs.gov Consumer Inquiries: 888-INFO-FDA

FDA issues draft guidance on nanotechnologyDocuments address use of nanotechnology by food and cosmetics industries

Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.

Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers particles so small that they can not be seen with a regular microscope. The technology has a broad range of potential applications, such as the packaging of food or altering the look and feel of cosmetics.

The two draft guidance documents are: Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives and Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.

The food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:

The cosmetic product draft guidance discusses the FDAs current thinking on the safety assessment of nanomaterials when used in cosmetic products.Key points include:

Both guidances encourage manufacturers to consult with the agency before taking their products to market. Such consultation can help FDA experts address questions related to the safety or other attributes of nanotechnology products, or answer questions about their regulatory status.

Strong science is critical to FDAs ongoing review of the products it regulates. FDA is investing in an FDA-wide nanotechnology regulatory science program to further enhance FDAs scientific capabilities, including developing necessary data and tools to identify properties of nanomaterials and assess the impact they may have on products.

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FDA issues draft guidance on nanotechnology