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The U.S. Food and Drug Administration (FDA) has published "Draft Guidance for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology," and is asking for feedback from the industrial and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The draft guidance is an outgrowth of recommendations made in 2007 by the FDA’s Nanotechnology Task Force, formed in 2006 to identify potential effects of nanomaterials used in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 applications."

"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.