FDA updates event system
Applied Nutrition (CFSAN) has released information on its new
system for tracking adverse event reports on foods, cosmetics and
dietary supplements.
The US Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) has released information on its new system for tracking adverse event reports on foods, cosmetics and dietary supplements.
The CFSAN Adverse Events Reporting System (CAERS) will eventually replace the patchwork of existing adverse event systems maintained by individual Offices within CFSAN and is expected to be pilot tested this year and operational by May 2003.
The agency will use the CAERS system to identify potential public health issues that may be associated with the use of a particular product already in the marketplace.
The CFSAN said the step was made possible in part by funds provided by Congress in 2002.
New procedures will see CFSAN writing letters 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 centre. The letter notification also allows FDA to share its knowledge of an event concerning a company's product.
It is also encouraging companies to share information 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 16 September 2002. CFSAN's internal adverse event systems will continue to operate.
The body is also 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.
