Guidance for Industry: Safety of Nanomaterials in Cosmetic Products
This document provides 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. The guidance document 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 safety considerations regarding the use of specific nanomaterials in cosmetic products with FDA. This guidance is not applicable to other products regulated by FDA, including over-the-counter and prescription drugs and medical devices.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in our guidances means that something is suggested or recommended, but not required.
Nanomaterials are used in a variety of FDA-regulated products because of their unique properties, imparting potential advantages to products considered for development. Such materials, due to their nanoscale size, can have chemical, physical, and biological properties that differ from those of their larger counterparts. Such differences may include altered magnetic properties, altered electrical or optical activity, increased structural integrity, or altered chemical or biological activity (Ref. 1). These new or altered properties may affect the performance, quality, safety, and/or effectiveness, if applicable, of a product that incorporates that nanomaterial.
In July of 2007, FDA issued a report prepared by its Nanotechnology Task Force (“Task Force”). The Task Force report presented an assessment of scientific and regulatory considerations relating to the safety and effectiveness of FDA-regulated products containing nanomaterials and made recommendations in light of these considerations (Ref. 2). Specifically, with respect to cosmetic products, the Task Force recommended that we issue guidance describing safety issues that manufacturers should consider to ensure that cosmetic products made with nanomaterials are safe and not adulterated. We are issuing this guidance as part of our ongoing efforts to implement the Task Force recommendations (Ref. 2).
The Task Force also recommended that FDA request submission of data and other information addressing the effects of nanomaterials in those products that are not subject to premarket authorization, such as cosmetic products. On September 8, 2008, FDA held a public meeting to discuss such data and information, along with related scientific and regulatory issues concerning nanotechnology. FDA considered the information obtained at, and subsequent to, the public meeting in developing this guidance. We also considered information provided by the cosmetic industry to the International Cooperation on Cosmetics Regulations (ICCR), publications and information regarding recent advances in nanotechnology, and other authoritative guidance/ reports regarding the safety of nanomaterials (Refs. 3, 4, 5, 6). This guidance also refers to other relevant reports, such as the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials “Preliminary Review of OECD Test Guidelines for their Applicability to Manufactured Nanomaterials” (Ref. 7), the Scientific Committee on Consumer Safety (SCCS) “Guidance on the Safety Assessment of Nanomaterials in Cosmetics” (Ref. 8), and relevant ICCR reports, such as on the “Currently Available Methods for Characterization of Nanomaterials,” and “Principles of Cosmetic Product Safety Assessment.” (Refs. 9, 10).
FDA has not established regulatory definitions of “nanotechnology,” “nanomaterial,” “nanoscale,” or other related terms. In June 2014, FDA issued a guidance for industry titled “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology” (Ref. 1). As described in that guidance, at this time, when considering whether an FDA-regulated product involves the application of nanotechnology, FDA will ask: (1) whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1 nm to 100 nm); and (2) whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, that are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer (1,000 nm). We will apply these considerations broadly to all FDA-regulated products, including cosmetic products.
The application of nanotechnology may result in product attributes that differ from those of conventionally-manufactured products, and thus may merit particular examination. However, we do 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, we consider the characteristics of the finished product and the safety for its intended use. Our consideration of nanotechnology applications in cosmetic products in this document is consistent with the agency guidance (Ref. 1) and with the broader federal guidance on regulatory oversight of emerging technologies (Ref. 11) and nanotechnology (Ref. 12).