In December 2006, President George W. Bush signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA), which amended the Federal, Food, Drug and Cosmetic Act. The 2006 law requires the manufacturer, packer or distributor of a dietary supplement (whose name appears on the label) to submit to FDA any report of a “serious adverse event” associated with the product used in the U.S. The report must be accompanied by a copy of the label on or within the retail packaging of the dietary supplement.
A serious adverse event is defined in the law as an adverse event that results in a death, a life-threatening experience, an inpatient hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly or birth defect. Also meeting the definition is an adverse event that requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described above, such as death or an inpatient hospitalization.
The information must be submitted to FDA within 15 business days after the serious adverse event report is received.
Companies (manufacturers, distributors and packers) whose name appears on the dietary supplement label — described in the law as the “responsible person” — must maintain records related to each report of an adverse event received for a period of 6 years. And FDA has the right to review these adverse events during its inspections.
Mandatory, Voluntary Reporting of AERs
An FDA guidance published in September 2013 discusses the above referenced statutory requirements and provides instruction on the use and submission of serious adverse event reports through the FDA Safety Reporting Portal (SRP). Per FDA, the online portal streamlines the process of reporting product safety issues to the agency. Manufacturers, distributors and packers of dietary supplement products also have the option to submit their report by mail using the Form FDA 3500A.
Consumers, patients and healthcare professionals also can voluntarily report adverse events to FDA. This can be done through FDA’s online reporting portal as well or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
CAERS Database
The Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS) is a database that contains information on food, dietary supplement and cosmetic product adverse events submitted to FDA.
The database is designed to support the FDA’s post-marketing safety surveillance program for cosmetics, foods and dietary supplements.
CAERS functions as the primary post-market surveillance database for CFSAN-regulated products, including dietary supplements. The system receives both mandatory reports from industry and voluntary reports from consumers and healthcare providers. CAERS data is made publicly available quarterly, containing demographic information, product details, symptoms and outcomes.