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U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Scientific Analysis and Support
August 29, 2002

Letter to Stakeholders

Announcing CAERS -
the CFSAN Adverse Event Reporting System


Dear Stakeholders:

I am pleased to announce that the Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN), is currently developing a new, comprehensive system for tracking and analyzing adverse event reports involving foods, cosmetics and dietary supplements. This step is made possible in part by funds provided by Congress in our Fiscal Year 2002 appropriations. The new CFSAN Adverse Events Reporting System (CAERS) will eventually replace the patchwork of existing adverse event systems that were maintained by individual Offices within CFSAN. The agency will use the CAERS system as a monitoring tool to identify potential public health issues that may be associated with the use of a particular product already in the marketplace. Information gathered in CAERS will also assist FDA in the formulation and dissemination of CFSAN's post-marketing policies and procedures.

Today, as a first step in the CAERS roll-out, this announcement serves as notification to a new process which will affect adverse event report processing by the Center. CFSAN will be writing a letter to notify companies that a report of an illness or injury allegedly associated with the use of one of their products was received by the Center. This letter notification is provided to companies for information, but it also allows FDA to share its knowledge of an event concerning a company's product. A sample notification letter is attached. To assist CFSAN in protecting consumer health, we, in turn, encourage companies to share with us information that is relevant and useful concerning adverse events that companies may be aware of involving their product. The company letter notification process will begin for adverse event reports received on or after September 16, 2002. CFSAN's internal adverse event systems will continue to operate. CAERS is expected to be pilot tested this year and to be operational by May 2003.

On a related matter, CFSAN is currently evaluating under CAERS how best to provide adverse event data to the public on a user-friendly website. The current CFSAN website, the Special Nutritional Adverse Event Monitoring System for dietary supplements, has not been added to or updated since 1999. The information previously available on the dietary supplement website was very limited and was provided in a manner that made it difficult for users to appropriately interpret adverse events. Accordingly, that site has now been removed.

To trade associations, please forward copies of this letter to your members. We will also send copies to the trade press and post on our website at www.cfsan.fda.gov. Thank you.


Joseph A. Levitt
Center for Food Safety And Applied Nutrition

Sample CAERS Notification Letter August 29, 2002; Updated September 23, 2002


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