The US Food and Drug Administration (FDA) has launched a dialogue on the regulation of the use of nanotechnology in a new generation of products in industries such as pharmaceuticals, cosmetics and more. To open this dialogue, the FDA has published proposed guidelines, “Draft Guidelines for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” on how it will identify the use of nanomaterials in FDA-regulated products in the Federal Register.
“Our goal is to regulate these products using the best possible science,” says FDA commissioner Margaret A. Hamburg, MD. “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 the FDA into a new, more innovative era.”
The guidelines list considerations on the inclusion of nanotechnology, including the size of the nanomaterials used and what their properties are. And FDA wants industry leaders and the public to weigh-in. Nanotechnology could have a broad range of applications, such as increasing the effectiveness of a particular drug or improving the packaging of food or cosmetics.
“Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated medical products, food, and cosmetics,” says Carlos Peña, director of FDA’s emerging technology programs. “But because materials in the nanoscale dimension may have different chemical, physical, or biological properties from their larger counterparts, the FDA is monitoring the technology to assure such use is beneficial.”
Ritu Nalubola, the FDA’s senior policy advisor and expert on nanotechnology, says FDA-regulated industries are also exploring new uses for nanotechnology. The agency’s goal is to protect and promote public health while supporting innovation. “The FDA has experience with regulating emerging technologies. Challenges of regulating nanotechnology are not unlike those related to other emerging and cross-cutting scientific and policy issues,” Nalubola says.
In order to continue to monitor the development of the inclusion of nanotechnology in consumer products, the FDA is working through its Nanotechnology Task Force, created in 2006, to answer questions on safety, effectiveness, performance and quality in relation to its further integration into products. The proposed guidelines are the first step toward developing policies that guide regulation of products using nanotechnology, and the FDA plans to develop additional guidelines for specific products in the future.
