As coordinator of the U.S. standardization system, ANSI invites any interested U.S. stakeholder to review the files and submit their comments directly to FDA by July 24, 2012.
According to FDA, the food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change in the identity, safety, or regulatory status of the food substance. The cosmetic product draft guidance discusses the FDA's current thinking on the safety assessment of nanomaterials when used in cosmetic products.
Both documents encourage manufacturers to consult with the agency before taking their products to market. Such consultation can help FDA experts address questions related to the safety or other attributes of nanotechnology products, or answer questions about their regulatory status.
"Understanding nanotechnology remains a top FDA priority. FDA is strengthening the scientific tools and methods for evaluating food products, cosmetics, drugs and medical devices," said FDA Commissioner Margaret A. Hamburg, M.D. "We are taking a prudent scientific approach to assess each product on its own merits and to not make broad, general assumptions about the safety of nanotechnology products."
FDA has also published a nanotechnology fact sheet.
Instructions for submitting comments can be found in the following Federal Register notices:
For more information, read FDA's April 20 press release.