FDA Makes it Easier to Report Safety Problems Associated with Dietary Supplements

Posted 13 January 2014 | By Alexander Gaffney, RAC 

Manufacturers and sponsors of dietary supplement products in the US will now have a new, more streamlined method of reporting adverse events to the US Food and Drug Administration (FDA), officials said today.

In a 13 January 2014 announcement, FDA's Center for Food Safety and Applied Nutrition (CFSAN) wrote that the agency is now accepting online submission of voluntary and mandatory supplement adverse event reports.

Previously, Forms FDA-3500 and -3500A, the forms used to report adverse events to FDA, needed to be manually submitted in paper form.

The new system will allow for online, digital submission, reflecting the platform's ease of use as well as the huge number-more than 85,000-of dietary supplement products now available in the US.

FDA said it has sent form letters to all manufacturers, packers and distributors of dietary supplements, "encouraging them to use the new capability," which can be accessed through SafetyReporting.HHS.Gov.

Healthcare providers and others will also be able to use the system, FDA said.


CFSAN Update


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