January 13, 2014
Authored by: Brandon Neuschafer
On January 13, 2014, FDA announced that it would begin accepting adverse event information on dietary supplements electronically. This policy applies to voluntarily-submitted information as well as information where reporting is mandatory (information submitted via the 3500A and 3500 forms). As stated by FDA:
Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462), the manufacturer, packer, or distributor of a dietary supplement whose name appears on the label of a dietary supplement marketed in the United States is required to report to the FDA any serious adverse events received regarding their dietary supplement products when used in the United States.
Reporting of dietary supplement adverse events is critically important in protecting consumers’ health and safety. The FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product specific registration requirement, adverse event reporting is invaluable in