FDA issues draft guidance on nanotechnology

April 20, 2012

A draft guidance document that addresses the use of nanotechnology by the food industry was issued April 20 by the U.S. Food and Drug Administration (FDA). Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured in nanometers—particles so small that they can’t be seen with a regular microscope.

The draft guidance—“Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes, including Emerging Technologies, on the Safety and Regulatory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”—describes the factors manufacturers should consider when determining whether changes in manufacturing processes, including those involving nanotechnology, create a significant change that may:

  • affect the identity of the food substance;
  • affect the safety of the use of the food substance;
  • affect the regulatory status of the use of the food substance; or
  • warrant a regulatory submission to FDA.

The guidance encourages 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. Strong science is critical to FDA’s ongoing review of the products it regulates. FDA is investing in an FDA-wide nanotechnology regulatory science program to further enhance FDA’s scientific capabilities, including developing necessary data and tools to identify properties of nanomaterials and assess the impact they may have on products. The FDA’s current thinking concerning nanomaterials for food use is not intended to provide guidance to manufacturers about the use of nanomaterials in other products, such as drugs or medical devices, regulated by the FDA.

Electronic or written comments can be submitted on the draft guidance within 90 days of the publication of the notices of availability in the Federal Register. Electronic comments should be submitted to http://www.regulations.gov.

Press release