FDA Issues Draft Guidance on Safety of Nanomaterials in Cosmetic Products


FDA issued a Draft Guidance for the industry—Safety of Nanomaterials in Cosmetic Products—providing "guidance to industry and other stakeholders (e.g., academia, other regulatory groups) on FDA's current thinking on the safety assessment of nanomaterials in cosmetic products. It is intended to assist industry and other stakeholders in identifying the potential safety issues of nanomaterials in cosmetic products and developing a framework for evaluating them. This guidance also provides contact information for manufacturers and sponsors who wish to discuss with FDA safety considerations regarding the use of specific nanomaterials in cosmetic products."

The document doesn't establish legally enforceable responsibilities but rather describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. 

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 not be seen with a regular microscope. The technology has a broad range of potential applications, such altering the look and feel of cosmetics.

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.

FDA has also provided a fact sheet on nanotechnology.  

Here's a look at the nanotechnology landscape a year ago.