Document xzvOBL8gaX09xBqBEKe0Yb16G

- o * rtEAtt y DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service Food and Drug Administration College Park, MD 20740 CAERS Disclaimer FDA's Center for Food Safety and Applied Nutrition's (CFSAN's) Adverse Event Reporting System (CAERS) is a post-market surveillance system that collects reports about adverse and product complaints that are allegedly related to CFSAN-regulated products. These products include conventional food (and beverages), dietary supplements, infant formulas and cosmetics. The adverse event reports about a product and the total number of adverse event reports for that product in CAERS only reflect information AS REPORTED and do not represent any conclusion by FDA about whether the product actually caused the adverse events. The attached reports are what have been entered into CAERS during the requested dates (the search date used was the CAERS entered date, as opposed to other dates such as the FDA Received Date or CAERS Received Date, etc). The reports submitted to FDA vary in the quality and reliability of the information provided. Some reports to FDA do not necessarily include all relevant data, such as whether an individual also suffered from other medical conditions or used other products or medications at the same time. Reports may not include accurate or complete contact information for FDA to seek further information about the event, or complainants may choose not to participate in a follow-up investigation. When important information is missing from a report, it is difficult for FDA to fully evaluate whether the product caused the adverse event or simply coincided with it. There also may be duplicate reports in CAERS for the same adverse event because multiple people (such as an injured consumer and a health care provided who treated him or her) may have submitted reports. Because CAERS is constantly updated with new information, the number of reports for a given product and the content of individual reports may change over time.