FDA Releases Q&A on Using Adverse Event Reports to Monitor Cosmetic Safety

Constituent Update

December 8, 2016

It’s not an exaggeration to say that everyone uses cosmetics, be it shampoo, mouthwash, a moisturizer or deodorant. The FDA monitors cosmetics on the market to ensure that they are safe for consumers.

One way in which FDA finds out about a safety issue is when an adverse event report (AER) is filed by a consumer, manufacturer, or health care professional. An adverse event could be any problem experienced when using a cosmetic product. On Tuesday, Dec. 6, 2016, FDA announced that it is making public certain data that the agency’s Center for Food Safety and Applied Nutrition (CFSAN) receives about adverse events associated with the use of its regulated products, which include cosmetics.

Linda Katz, M.D., MPH, director of FDA’s Office of Cosmetics and Colors, talks about some of the safety issues involving cosmetics, how FDA is responding to them, and how consumers interested in safety data about cosmetics can best use information in the CAERS database.

For More Information:

• Why FDA Is Making Data Extracted from Reports of Adverse Events for Foods and Cosmetics Available to the Public