Reporting to CFSAN
FDA's Center for Food Safety and Applied Nutrition (CFSAN) has an Adverse Event Reporting System (CAERS) that can be contacted in any of the following ways:
- By phone at 301-436-2405
- By email at [email protected]
- By mail at
FDA, CAERS, HFS-700, 2A-012/CPK1,
5100 Paint Branch Parkway,
College Park, MD 20740
Reporting to MedWatch
You can report adverse events through FDA's MedWatch Program in any of the following ways:
- Online at www.fda.gov/medwatch/feedback.htm
- By phone at 800-FDA-1088
- By mail with a postage-paid FDA form 3500, available at https://www.accessdata.fda.gov/scripts/medwatch/
- By sending it to
MedWatch, 5600 Fishers Lane, Rockville, MD
20852-9787
or sending it via fax to 1-800-FDA-0178
For non-emergencies related to products purchased via the internet, fill out an online form on FDA's website at www.fda.gov/Safety/ReportaProblem/ucm059315.htm (see link to "Form to Report Unlawful Sales")
How can I reach the FDA or another government agency about my concerns?
Various state and federal agencies employ personnel who can help respond to concerns or questions about adverse reactions. Following is contact information for some of these agencies:
- For emergencies, call FDA at its main emergency number (1-301-443-1240), 24 hours per day.
- For non-emergencies, contact the consumer complaint coordinator at any FDA district office. A complete list of district office phone numbers can be found at:
www.fda.gov/opacom/backgrounders/complain.html.
You may also contact any local poison control center, local or state health agencies, the Department of Health and Human Services, the Federal Trade Commission, the Consumer Products Safety Commission, or the Centers for Disease Control and Prevention, and they will forward your report to the FDA.