Food

Dietary Supplements - Adverse Event Reporting

Using the Safety Reporting Portal to Submit Reports

The FDA has created, through the Safety Reporting Portal (SRP), a convenient secure, and efficient method for letting FDA know when industry or consumers finds 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:

If you 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 SRP.

To submit a report as a consumer, follow the link to the SRP homepage. After logging in or choosing to report as a guest, choose “Start a new report” and choose “Dietary Supplement Report(voluntary)…”

For Industry:

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.

To submit a report as required by section 761 of the FD&C Act, follow the link to the SRP homepage. 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 through the SRP, please contact DSRSupport@fda.hhs.gov. For technical support with the SRP, please contact Support.SRP@jbsinternational.com.

The Safety Reporting Portal can be accessed at http://www.SafetyReporting.hhs.gov.  

For information on how to report about other FDA regulated products, visit how to reported about other FDA regulated products.

You may also download MedWatch 3500, 3500A, and 3500B forms.

Page Last Updated: 01/10/2014
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