In 1959, a Nobel Prize-winning physicist challenged his colleagues to use submicroscopic particles to manufacture a wide range of products—an idea that captivated the imagination of scientists and inspired the science fiction movies “Fantastic Voyage” and “Innerspace.”
Fifty years later, “nano” (small) technology has moved from the science fiction realm to scientific fact, and federal regulators are laying the groundwork for monitoring a new generation of medical devices, drugs, cosmetics, and other products.
The Food and Drug Administration is continuing a dialogue on nanotechnology begun in 2011 by publishing proposed guidelines on the evaluation and use of nanomaterials in FDA-regulated products.
The first draft guideline, “Draft Guidance for Industry, Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology”, was published in the Federal Register in June, 2011. The FDA is still reviewing and receiving comments on this document from the public.
In April 2012 the FDA is issuing two new draft guidelines for manufacturers of food substances and cosmetics, which are also open for public comment.
FDA Commissioner Margaret A. Hamburg, M.D., says the guidelines provide a starting point for the nanotechnology discussion. “Our goal is to regulate these products using the best possible science,” Hamburg says. “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.”
FDA is working with the White House, the National Nanotechnology Initiative, other U.S. government agencies, and international regulators to focus on generating data and coordinating policy approaches to ensure the safety and effectiveness of products using nanomaterials.