FDA Issues Draft Guidance on When Use Of Nanomaterials Might Prompt Regulation

Draft guidance to inform industries developing nanoengineered products about the approach the Food and Drug Administration will take in regulating those goods was published June 14 in the Federal Register (76 Fed. Reg. 34,715).

FDA is seeking comment on the guidance, which “is intended to help industry and others identify when they should consider potential implications for regulatory status, effectiveness, or public heath impact that may arise with the application of nanotechnology in FDA-registered products.”

The guidance applies to all FDA-regulated products, including items such as food-contact materials, cosmetics, and sunscreens that can be made with nanotechnologies, an FDA spokesman confirmed June 10.

The guidance is part of a package of proposed or final policies toward nanoengineered products that federal agencies released in conjunction with a White House memo providing overarching principles for regulating nanomaterials (35 CRR 582, 6/13/11).

The guidance does not provide a regulatory definition of nanotechnology.

Factors to be Considered in Nanotechnology Design

Instead, the draft document describes factors the agency will consider to determine whether a product may be designed with nanotechnology.

These factors include whether an engineered material or product has at least one dimension in the nanoscale, which is described as ranging from 1 nanometer to 100 nanometers, and whether the material exhibits specific properties that could affect its function or toxicity.

Such novel properties could be important even if the material is up to 1,000 nanometers in size, FDA said.

Factors FDA would consider include whether the size or special properties enhance the protection offered by food packaging materials or better detect pathogens.

“For products subject to premarket review, the FDA intends to apply the points in the draft guidance, when finalized, to better understand the properties and behavior of engineered nanomaterials,” the agency said in an announcement of the document.

“For products not subject to premarket review, the FDA will urge manufacturers to consult with the agency early in the product development process so questions related to the regulatory status, safety, effectiveness, or public health impact of these products can be adequately addressed,” it said.

Comments on FDA's draft guidance is due by Aug. 15. Comments should be marked docket number FDA-2010-D-0530 and submitted at http://www.regulations.gov.

By Pat Rizzuto

The draft guidance is available at http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm .

FDA also published questions and answers concerning its draft guidance. They are available at http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/ucm258391.htm .