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U.S. Food and Drug Administration Launches New AER Tracking System

The U.S. Food and Drug Administration has launched a new system to report and monitor adverse events reports involving foods, cosmetics and dietary supplements. The new system, under the FDA's Center for Food Safety and Applied Nutrition (CFSAN), is called CFSAN Adverse Events Reporting System (CAERS).

Under the new system, CFSAN will write a letter of notification to the company listed on the product label when the CAERS system receives an adverse event report of illness or injury allegedly associated with the use of a company's product.

The CAERS system will enable FDA to identify potential public health issues associated with a particular product already in the marketplace. FDA will use the information gathered from the system to assist in the formulation and dissemination of CFSAN's post-marketing policies and procedures.

FDA encourages companies to share information with the agency that is relevant and useful concerning adverse events that companies may be aware of involving their product.

The CAERS system replaces the Special Nutritionals/Adverse Event Monitoring System (SN/AEMS) created in 1998. The SN/AEMS website, which included adverse event reports on dietary supplements, has been removed from the FDA website. FDA is currently evaluating how best to incorporate the adverse event data received from the CAERS system into a website for public use.

The CAERS system will be pilot tested this year and is expected to be operational by May 2003. It may not be on the FDA website until 2004. In the meantime, CFSAN's internal adverse event collection and evaluation systems will continue to operate.


[American Herbal Products Association. FDA Announces New Adverse Events Reporting System for Dietary Supplements, Food and Cosmetics [press release] 2002 August 29]