This letter is to inform you that the Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) has received a report of an illness or injury allegedly associated with the use of one of your products. A consumer or health care professional either identified your firm in the adverse event report or the product label disclosed your firm as the manufacturer. There is no certainty that a reported adverse event can be attributed to a particular product or ingredient. The available information may not be complete enough to make this determination. A redacted copy of the Adverse Event Report (AER) is attached. To maintain confidentiality, the report has been redacted of any information that could be used to identify the consumer.
CFSAN has a voluntary adverse event reporting system to address adverse reports called CAERS (CFSAN Adverse Events Reporting System). The agency uses this 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. FDA is providing this information to notify you that an adverse event report has been received and, as with all such reports, will be processed according to our standard operating procedures. To assist CFSAN in protecting consumer health, we encourage you to share with us information that is relevant and useful concerning this adverse event or others that you may be aware of involving your product. Please send your information to: CAERS, (HFS-702), 5100 Paint Branch Parkway, College Park, MD 20740.
The Agency may receive additional information about this adverse event in the future. If you wish to inquire about this information, you can receive copies of the publicly available information, if any, collected by the agency on this adverse event by filing a Freedom of Information Act (FOIA) request. All FOIA requests must be in writing and should be mailed to the following address: Food and Drug Administration, Division of FOI (HFI-35), 5600 Fishers Lane, Rockville, MD 20857. Or requests may be sent via fax to: (301) 443-1726. Additional information about FOIA can be found on FDA's web site, http://www.fda.gov/foi/foia2.htm and in FDA's FOIA implementation regulations, 21 CFR Part 20.
Kenneth J. Falci, Ph.D.
Letter to Stakeholders - Announcing CAERS, the CFSAN Adverse Event Reporting System August 29, 2002