The Safety Reporting Portal is a convenient, secure, and efficient method for letting FDA know when consumers, health professionals, or industry members find a problem with a dietary supplement. This new reporting method is an all-electronic version of the MedWatch 3500, 3500A, and 3500B forms, (used by industry and consumers to report problems with FDA regulated products) tailored exclusively for dietary supplements.
For Consumers and Health Professionals:
If you or your patient experience an adverse health-related event that you suspect is related to a dietary supplement, or find defects in the quality or safety of a dietary supplement, you can submit a voluntary report through the Safety Reporting Portal.
After logging in or choosing to report as a guest, choose “Start a new report” and choose “Dietary Supplement Report(voluntary)…”
Members of the dietary supplement industry may now use the reporting form on the Safety Reporting Portal to meet the reporting requirements established in section 761 of the FD&C Act.
After logging in or choosing to report as a guest, choose “Start a new report” and choose “Dietary Supplement Report(mandatory)…”
If You Need Assistance:
If you have any further questions about reporting on dietary supplements, please contact DSRSupport@fda.hhs.gov. For technical support with the Safety Reporting Portal, please contact Support.SRP@jbsinternational.com.
For information on how to report a problem with food, visit How to Report a Problem with Food.