January 13, 2014
WASHINGTONDistributors, manufacturers and packers of dietary supplements now can submit AERs (adverse event reports) through an electronic filing system, FDA announced Monday.
Companies can submit the AERs through the Safety Reporting Portal 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," Daniel Fabricant, director of FDA's Division of Dietary Supplement Programs, wrote in a notice to the industry.
The electronic filing system represents an alternative to the MedWatch 3500A paper form. Fabricant said there are no other changes to existing reporting requirements.
FDA is encouraging the industry to adopt the electronic reporting system, although the agency will continue to accept paper submissions as well.
The Dietary Supplement and Nonprescription Drug Consumer Protection Act requires that supplement firms submit serious AERs like death and a life-threatening experience associated with their products. FDA also accepts voluntary AERs for less serious illnesses that are linked to dietary supplements.
"Reporting of dietary supplement adverse events is critically important in protecting the health and safety of consumers," Fabricant stated in the notice. "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."
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