FDA announces new adverse event reporting portal

FDA announces new adverse event reporting portal

Agency launches convenient, secure, efficient method for submitting mandatory and voluntary dietary supplement adverse event reports.

The U.S. Food and Drug Administration (FDA) is pleased to announce the launch of a convenient, secure, and efficient method for submitting mandatory and voluntary dietary supplement adverse event reports (currently the 3500A and 3500 forms, respectively). Electronic reporting forms, able to be completed and submitted entirely online, have been added to the Safety Reporting Portal (SRP) for reporting in accordance with the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. L. 109-462). FDA has been successfully using the SRP website to receive individual and industry submitted adverse event reports involving FDA-regulated products for years.

The SRP, available at safetyreporting.hhs.gov, allows reporters to submit reports using either non-registered (“Guest”) or “Registered” accounts. Those who chose to create registered accounts will have the additional convenience of saving partially completed reports, certain information pre-populated into new reports, and the ability to review their reporting history online. For mandatory reporters, other than a new electronic alternative to the MedWatch 3500A paper form, this announcement signifies no changes to the existing reporting requirements.

Reporting of dietary supplement adverse events is critically important in protecting the health and safety of consumers. FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product registration requirement, adverse event reporting is instrumental in identifying harmful products. FDA is encouraging industry to adopt this electronic reporting mechanism for its improved convenience and efficiency to both industry and FDA. FDA will continue to accept paper 3500A/3500 forms in accordance with current law.

If you wish to provide comments or have further questions regarding this new electronic method of reporting, we welcome your suggestions and are eager to improve the system to best meet your needs as a mandatory reporter of dietary supplement adverse events. For Inquiries related to the online form, please select “Contact US” on the SRP home page, which will take you to the Dietary Supplements Reporting Support section. For Safety Reporting Portal technical assistance, please contact: [email protected] For inquiries specific to Dietary Supplements, please contact:  Dr. Robert Mozersky (e-mail: [email protected])

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