FDA Issues Final Guidance on Use Of Nanotechnology in Regulated Products

June 27 — The Food and Drug Administration June 24 announced new guidance to provide greater regulatory clarity for industry on the use of nanotechnology in FDA-regulated products, including drugs, devices, cosmetics and food.  

The agency issued a final guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” which makes final a 2011 draft. In a press release, the agency said the final document “outlines overarching considerations for all FDA-regulated products, identifying points to consider when determining whether a product involves the use of nanotechnology. It is intended to help industry and others identify when they should consider potential implications for regulatory status, safety, effectiveness or public health impact that may arise with the application of nanotechnology in FDA-regulated products.”

‘Different Modes of Action.'

In this final guidance, the agency said that nanotechnology “can be used in a broad array of 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 affect the look and feel of cosmetics).”

A footnote said that the application of nanotechnology may also affect the classification of a product: “For example, nanomaterials used in medical products may function through different modes of action than larger-scale materials with the same chemical composition, which may affect the classification of the product, for example as a drug or device.” The agency also published on June 27 a Federal Register notice about the guidance (79 Fed. Reg. 36,534).

The agency June 24 also issued the final versions of two other draft guidances issued in April 2012 addressing the use of nanotechnology in foods and cosmetics. In addition, the FDA issued a draft guidance for comment, on the use of nanomaterials in food for animals; comments on the draft are due Sept. 10.

According to the FDA's website, nanotechnology allows scientists to create, explore and manipulate materials measured in nanometers (billionths of a meter). “Such materials can have chemical, physical, and biological properties that differ from those of their larger counterparts,” the agency said.

Also on the agency website, the FDA said it “does not make a categorical judgment that nanotechnology is inherently safe or harmful. We intend our regulatory approach to be adaptive and flexible and to take into consideration the specific characteristics and the effects of nanomaterials in the particular biological context of each product and its intended use.”

The final guidance on determining whether an FDA-regulated product involves nanotechnology is at http://www.fda.gov/RegulatoryInformation/Guidances/ucm257698.htm. The June 27 Federal Register notice for this guidance is at http://www.gpo.gov/fdsys/pkg/FR-2014-06-27/html/2014-15033.htm.

Additional information, including links to all the other guidance documents, is at http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm