Adverse Event Reporting: How to Report a Cosmetic-related Problem to FDA
If you’ve had a reaction to a cosmetic product, FDA wants to know. The law doesn’t require cosmetic companies to report problems to FDA, so the information you report is very important to help FDA monitor the safety of cosmetics on the market.
FDA can’t provide medical advice, so the first step is to contact your health care provider if you need medical help.
What Kinds of Problems to Report
You can report any reaction related to a cosmetic, from a minor rash or headache to an illness that put you in the hospital. You can even report something that didn’t cause a reaction, but alerted you to a problem with the product, such as a bad smell or other sign of contamination.
How to Report a Problem
You can report a problem with a cosmetic to FDA in either of these ways:
- Contact MedWatch, FDA’s problem-reporting program, on the Web or at 1-800-332-1088, or file a MedWatch Voluntary report online
- Contact the consumer complaint coordinator in your area.
Who Should Report a Problem
A consumer, a health care provider, or a salon professional can report a problem. It helps if only one person files a report on each incident.
What Information to Provide in Your Report
When you contact FDA, include the following information in your report:
- the name and contact information for the person who had the reaction
- the age, gender, and ethnicity of the person who used the product
- the precise name of the product and the manufacturer a description of the reaction—and treatment, if any
- the healthcare provider’s name and contact information, if medical attention was provided
- when and where you bought the product
What FDA Will Do with Your Report
We will keep your report confidential.
We may call you or your healthcare provider to learn more.
We will add the report to our database so that we can see if other people are reporting the same problem.
We will then look for reports related to the same product or similar ones. FDA scientists will use the information to determine if the product has a history of problems and represents a public health concern that needs to be addressed.
We can’t act on every report we receive, but we check all reports to see if we need to take action to protect public health.
What Kinds of Products Are Cosmetics
Here are some examples:
- face and body cleansers
- moisturizers and other skin lotions and creams
- baby lotions and oils
- hair care products, dyes, conditioners, straighteners, perms
- hair removal creams
- nail polishes
- shaving products
- perfumes and colognes
- face paints and temporary tattoos
- permanent tattoos and permanent makeup
Consumer Update: “Bad Reaction to Cosmetics? Tell FDA”
Video: Bad Reaction to Cosmetics? Tell FDA!