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FDA Releases Draft Guidance Toward Nanotech Regulation

Posted: June 15, 2011

The US Food and Drug Administration (FDA) has released a draft guidance to provide regulated industries with greater certainty over the use of nanotechnology, which generally involves materials consisting of particles at least one billionth of a meter in size. According to the agency, nanotechnology is an emerging technology with a broad range of potential applications, such as increasing the bioavailability of a drug and improving food packaging; it is also applied in cosmetics, most notably in sun care.

The draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” outlines the agency’s view on how to identify whether regulated products contain nanomaterials or involve such technologies. Specifically, the agency names certain characteristics such as the size of nanomaterials used and the exhibited properties of those materials, which may be considered when attempting to identify applications of nanotechnology in regulated products.

“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said Margaret A. Hamburg, MD, Commissioner of Food and Drugs, in a press statement. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”

According to the FDA, for products subject to premarket review, it intends to apply the points contained in the draft guidance, once finalized, to better understand the properties and behavior of engineered nanomaterials; for products not subject to premarket review, the FDA will urge manufacturers to consult with the agency early in the product development process so questions related can be adequately addressed.

The points outlined in the draft guidance that the FDA will consider include: