FDA monitors the use of nanotechnology and the use of nanoscale materials in cosmetics. FDA also conducts and keeps abreast of related research. Consumers and manufacturers are interested in this information as well.
FDA does not have a legal definition for nanotechnology. However, when scientists talk about nanotechnology they are usually referring to the manipulation of material of extremely small size, usually at dimensions between 1 and 100 nanometers. A nanometer is one-billionth of a meter. For example, the head of a pin is about 1 million nanometers wide. A human hair is about 80,000 nanometers wide.
Although nanoscale materials account for only a very small portion of cosmetic ingredients, their use is growing.
Firms and individuals who market cosmetics have a legal responsibility to make sure their products and ingredients, including nanoscale materials, are safe under labeled or customary conditions of use, and that they are properly labeled. Under U.S. law, cosmetic products and ingredients do not need FDA approval before they go on the market. The one exception is color additives (other than coloring materials used in coal-tar hair dyes), which must be approved for their intended use.
The following are some resources on nanotechnology, from FDA and elsewhere:
FDA Information on Nanomaterials in Cosmetics
- Guidance for Industry: Safety of Nanomaterials in Cosmetic Products
- Fact Sheet: Nanotechnology
- Application of Nanotechnology to Cosmetics and Foods: Webinar produced in cooperation with the National Science Teachers Association
From International Cooperation on Cosmetics Regulation (ICCR)
- Safety Approaches to Nanomaterials in Cosmetics: Report of the ICCR Working Group (PDF 2.25 MB)
- Report for the International Cooperation on Cosmetics Regulation: Characterization of Nanomaterials II - Insolubility, Biopersistence and Size Measurement in Complex Media, April 2013 (PDF - 1.25MB)
- Characterization of Nanomaterials II - Insolubility, Biopersistence and Size Measurement in Complex Media (PDF) (PDF - 1.1MB)
- Report of the Joint Regulator - Industry Ad Hoc Working Group on Characterization of Nanomaterials on Currently Available Methods for Characterization of Nanomaterials (available in PDF) (PDF - 283 KB)
- Report on the 2011 Associations Survey of Nanomaterials Used in Cosmetic Products, June 3, 2011 (available in PDF) (PDF - 285KB)
National Nanotechnology Initiative
- Consumer Product Safety Commission Statement on Nanotechnology (available in PDF) (PDF - 42KB)
- Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health
Nanotechnology at the National Institutes of Health
- Environmental Protection Agency Nanotechnology and Nanomaterials Research