FDA scientists conduct cosmetic safety research and stay abreast of research by scientists elsewhere, because any action FDA takes on cosmetic safety must be based on reliable information.
- Science and FDA’s Role in Cosmetic Safety
- FDA Scientists: Who They Are and What They Do
- FDA Lab Surveys of Cosmetics on the Market
- Additional Information
Under U.S. law, cosmetic products and ingredients do not need FDA approval before they go on the market. The exception is color additives (other than those used in most hair dyes). Companies and individuals who market cosmetics have a legal responsibility to ensure the safety of their products. In order to take action for safety reasons against a cosmetic on the market, we need reliable information showing that it is unsafe when consumers use it according to the directions in the labeling or in the customary or expected way.
FDA scientists involved in cosmetic safety include toxicologists, chemists, biologists, microbiologists, epidemiologists, and physicians. To address safety concerns or provide information to support regulatory actions or guidance related to cosmetics, FDA scientists will--
- conduct research,
- survey cosmetic products on the market and evaluate the findings,
- monitor reports of adverse events associated with cosmetic products,
- collaborate with scientists elsewhere in government and academia, such as the National Center for Natural Products Research at the University of Mississippi, and
- keep up with the research of other scientists.
In evaluating cosmetic safety, FDA scientists consider factors such as--
- whether a cosmetic is likely to be inhaled, swallowed, or absorbed through the skin,
- how often it is generally used,
- how long it stays in contact with the body (for example, do people leave it on their skin or quickly rinse it off?), and
- vulnerable people, such as children, the elderly, or people with compromised immune systems or other significant medical issues.
You can find the work of FDA scientists published in scientific journals such as ACS Nano, Analytical Methods, Biomaterials, Cutaneous and Ocular Toxicology, Food and Chemical Toxicology, Journal of Applied Toxicology, Journal of Chromatography A, Journal of Cosmetic Science, Journal of the American Chemical Society, Journal of the Society of Cosmetic Chemists, Nanoscale, and Soft Matter.
FDA periodically buys cosmetics to analyze them, especially if we’re aware of a potential problem. For example, we might be looking for contaminants, such as lead or harmful microorganisms, or monitoring levels of certain ingredients. Sometimes FDA scientists analyze the products, and sometimes the work is done by a contract laboratory. Depending on what we learn, we can use the information to--
- alert consumers
- support regulatory actions
- issue guidance for industry
FDA does not have the resources to sample and analyze all cosmetics on the market. Instead, we focus on particular safety concerns.
- Alpha Hydroxy Acids
- Bacteriological Analytical Manual (BAM), Chapter 23: Microbiological Methods for Cosmetics
- Color Additives and Cosmetics
- Color Additives: The Chemistry of Color Additives
- Potential Contaminants
- Lipstick and Lead: Questions and Answers
- Lipstick and Lead: FDA's Testing Method
- Tattoos & Permanent Makeup