Nanotechnology Draft Guidance
June 10, 2011
Dear International Colleague:
The U.S. Food and Drug Administration released draft guidance to provide regulated industries with greater certainty about the use of nanotechnology, which generally involves materials made up of particles that are at least one billionth of a meter in size. This guidance will be available online and open for public comment. It represents the first step toward providing greater regulatory clarity on the FDA’s approach to nanotechnology.
Nanotechnology, the science involving manipulation of materials at the nanoscale, is an emerging technology that has the potential to be used in a broad array of the FDA-regulated products, including medical products (e.g. to increase bioavailability of a drug), foods (e.g., to improve food packaging) and cosmetics (e.g. to change reflectivity). Materials at the nanoscale can have different chemical, physical, or biological properties compared to their conventionally-scaled counterparts.
Over time, the agency plans to issue more specific guidances tailored to particular products or classes of products. These actions are consistent with the 2007 FDA Nanotechnology Task Force’s science and policy recommendations to the Commissioner (available online at http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/
The Press Release is available online at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm258377.htm.htm
We hope this information is useful to you and we appreciate your support of the U.S. FDA and its mission.
Murray M. Lumpkin, M.D., M.Sc.