Adverse Event Agents

In addition to other label requirements, dietary supplements sold in the United States must provide the contact information of the person responsible for receiving reports of adverse events related to taking or using the supplement.  These adverse events must then be reported to the United States Food and Drug Administration.

The adverse agent contact information on your label must be either (1) a United States mailing address, or (2) a United States toll free telephone number.  The responsible person must be located within the United States.  If the label does not include a U.S. address or phone number, the product is misbranded and may be denied entry into the U.S.  US Imports can serve as the agent for purposes of this required adverse event reporting. 

What is the definition of an adverse event?

An adverse event is an undesired experience that occurs after using or taking a dietary supplement. These experiences can vary from mild, unexpected symptoms to extreme reactions. Risks can vary depending on the dietary supplement and ingredients in the product. While adverse events are typically more common in prescribed medication, they are still possible in dietary supplements.  Regardless of the severity of an adverse event, dietary supplement manufacturers and vendors must provide adverse event contact information on their labels to allow for consumer reports..

How does the FDA collect adverse event reports?

If a serious adverse event is reported, the responsible person must report that information to the FDA. The responsible person could be the manufacturer, distributor, or packer of a dietary supplement, or an agent identified on the label. In the case of a serious adverse event, the report must be submitted to the U.S. FDA by the supplement company within 15 days after the initial report is received.  Foreign business with products for sale in the United States, must appoint an agent in the United States to gather adverse event reports.

How US Imports can help

Without the proper method to collect adverse event reports, sellers of dietary supplements may face disciplinary actions by the FDA.  For importers, failure to include a U.S. address for adverse event reporting may cause the FDA to deny entry into the U.S.  US Imports can serve as your company’s Adverse Event Agent to collect and forward consumer reports directly to you.