FDA seeks comments on nanotechnology draft guidance.May 3, 2012 -
U.S. FDA has issued 2 draft guidance documents that address use of nanotechnology by food and cosmetics industries. According to FDA, food draft guidance describes factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create significant change in identity, safety, or regulatory status of food substance. Cosmetic draft guidance discusses safety assessment of nanomaterials when used in cosmetic products.
FDA Seeks Comment on Draft Guidance on Use of Nanotechnology by Food and Cosmetics Industries
(Archive News Story - Products mentioned in this Archive News Story may or may not be available from the manufacturer.)
American National Standards Institute (ANSI)
25 West 43rd Street, 4th Floor
New York, NY, 10036
Press release date: April 26, 2012
The U.S. Food and Drug Administration (FDA) - a member of the American National Standards Institute (ANSI) - has issued two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries.
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According to FDA, the food draft guidance describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology,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 The cosmetic product draft guidance discusses the FDA's current thinking on the safety assessment of nanomaterials when used in cosmetic products.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:
Draft Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients That Are Color Additives; Availability
Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability