The Food and Drug Administration (FDA) has issued for public comment draft guidance for industry relating to the safety of nanomaterials used in cosmetic products. While comments may be submitted at any time, to be considered as FDA finalizes the guidance, they should be submitted no later than July 24, 2012.
Noting that it has not adopted a formal definition of nanotechnology, nanoscale or related terms, the agency recognizes that “[t]he application of nanotechnology may result in product attributes that differ from those of conventionally manufactured products, and thus may merit examination.” Still, FDA “does not categorically judge all products containing nanomaterials or otherwise involving application of nanotechnology as intrinsically benign or harmful. Rather, for nanotechnology-derived and conventionally manufactured cosmetic products alike, FDA considers the characteristics of the finished product and the safety for its intended use.”
The guidance further provides an overview of the agency’s general framework for and points to consider in assessing the safety of nanomaterials in cosmetic products. FDA encourages those using nanomaterials in cosmetic products, “either a new material or an altered version of an already marketed ingredient,” to meet with FDA “to discuss the test methods and data needed to substantiate the product’s safety, including short-term toxicity and other long-term toxicity data as appropriate.” See Federal Register, April 25, 2012.