FDA Publishes Draft Nanotechnology Guidelines, Invites Feedback

The U.S. Food and Drug Administration (FDA) has published “Draft Guidance for Industry, Considering
Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” and is asking for
feedback from the industrial and public sectors. The draft guidelines present a list of criteria —
including the size and properties of nanomaterials used — to help determine whether nanotechnology
is used in a FDA-regulated product.

The draft guidance is an outgrowth of recommendations made in 2007 by the FDA’s
Nanotechnology Task Force, formed in 2006 to identify potential effects of nanomaterials used in
FDA-regulated products and look into ways to evaluate those effects. The National Nanotechnology
Initiative — a federal research and development program that coordinates the nanotechnology-related
activities of a number of federal agencies — defines nanotechnology as “the understanding and
control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel

“Our goal is to regulate these products using the best possible science,” said FDA
Commissioner Dr. Margaret A. Hamburg. “Understanding nanotechnology remains a top priority within
the agency’s regulatory science initiative and, in doing so, we will be prepared to usher science,
public health, and FDA into a new, more innovative era.”

“Nanotechnology is an emerging technology that has the potential to be used in a broad array
of FDA-regulated medical products, foods, and cosmetics,” said Dr. Carlos Peña, FDA’s director of
emerging technology programs. “But because materials in the nanoscale dimension may have different
chemical, physical, or biological properties from their larger counterparts, FDA is monitoring the
technology to assure such use is beneficial.”

Although FDA has not yet identified particular safety issues related to nanotechnology
applications in FDA-regulated products, it is keeping watch because certain nanomaterials are of
potential concern.

FDA-regulated products that might involve the application of nanomaterials on or in textile
materials include tissue engineering scaffolds and certain other implantable medical devices, and
antimicrobial materials, among other products.

The draft guideance and other related resources are available at

June 21, 2011