FDA to Regulate Nanotechnology

FDA will consider public comments on nanotechnology regulations

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Most of us haven't given much thought to nanotechnology, the science behind manipulation on an atomic or molecular scale. However, the U.S. Food and Drug Administration is taking a first step toward regulating the emerging technology.

The FDA has released a draft designed to provide regulated industries with greater certainty about the use of nanotechnology. The technology, which generally involves materials made from particles that are one billionth of a meter in size, has become more popular with its use increasing to include bioavailability of a drug, in cosmetics and in improved food packaging.

"Nanotechnology is so small it can't be viewed with the human eye."

The new guide, in which the agency announces a regulatory definition of nanotechnology, outlines the FDA's view on whether regulated products contain nanomaterials or involve the application of nanotechnology.

It is available online and open for public comments. As a first step the agency plans to work with industry officials to determine if their focus is an appropriate starting place.

In the document, the agency named certain characteristics including the size of nanomaterials used and the properties of those materials that could be considered when working to identify applications of nanotechnology in regulated products.

The FDA would later use these guidelines to better understand properties and behavior of engineered nanomaterials during premarket reviews. The agency will encourage manufacturers to consult with them early in the production process to address regulatory status, safety, effectiveness and public health for products that are not subject to the premarket review.

The FDA formed the Nanotechnology Task Force, which identifies ways to better enable the agency to evaluate possible adverse health effects from FDA-regulated nanotechnology products, in 2006. The task force proposed the additional guidance the following year.


Reviewed by: 
Review Date: 
June 10, 2011
Last Updated:
June 13, 2011