FDA Releases At-A-Glance Guide on AERs

COLLEGE PARK, Md.FDA released an "At-A-Glance" adverse event report (AER) document designed to outline the reporting requirements for the natural product industry and other useful information as it pertains to serious AERs. The two-page document gives a quick overview AERs including the who, what, how and when of submitting an AER.

Per the Dietary Supplement and Nonprescription Drug Consumer Protection Act, enacted on Dec. 22, 2006 and enforced on Dec. 22, 2007, manufacturers, packers and distributors of dietary supplements in the United States are required to report information about serious adverse effects associated with the use of supplements to FDA. The company whose name appears on the label of the supplement is required to report serious adverse events. According to the law, a dietary supplement label must include contact information (the domestic address or phone number) for the supplements manufacturer, packer or distributor.

FDA said the definition of a dietary supplement, for the purposes of reporting an adverse event, is a product intended to supplement the diet and includes vitamins; minerals; herbs or other botanicals; amino acids; any dietary substance for use by man to supplement the diet by increasing total dietary intake; and any concentrate, metabolite, constituent, or extract or any combination of such an ingredient.

A company must report any health-related event associated with the use of a dietary supplement that is adverse," meaning it results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or a medical or surgical intervention to prevent such an outcome.

The company must submit the AER and any follow-up reports on new medical information to FDA no later than 15 business days after the event. AERs and related records, such as all forms, attachments, updated medical information, and communication between the company and the person who notified it of the event, must be maintained for a period of six years, according to the At-A-Glance" document.

The document gives instructions on where to find AER forms, what sections to fill out, which additional materials to include and where to send it once its complete.

In the document, FDA also noted submitting a serious AER will not be construed by the agency as an admission that the dietary supplement involved caused or contributed to the adverse event being reported.