What do I need to keep in mind when using information from the SN/AEMS? Reporting is voluntary and the information is as reported by the professional. This means that:

• Only adverse events reported to FDA will be in the SN/AEMS. If an event occurred but is not reported to FDA, it will not be in the database. Absence of information does not necessarily mean a particular product or ingredient has not been or is not likely to be associated with an adverse event.
• 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.
• The total number of adverse events cannot be used to estimate the rate of occurrence in the population. Not all adverse events are reported, and there are no reliable data on population use patterns.
• Reporting of an adverse event may be affected by many factors, including length of time a product or ingredient has been marketed or publicity.
• Comparisons of the safety of one product versus another cannot be directly obtained from these data. The available information may not be complete enough to make this comparison.
• The inclusion of a product as a special nutritional in the SN/AEMS does NOT necessarily represent its legal/regulatory status. The available information may not be complete enough to make this determination.