Implementation of Mandatory Adverse EventReporting for Botanicals: Are We Collecting and Reporting Meaningful Information?

Subsequent to the passage of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) in 2006, compliance enforcement began in December 2007. Prior to implementation, FDA published guidance documents to advise manufacturers on how best to meet both the letter and the intent of the law. Although many compliance aspects were addressed in the guidance, many questions and challenges remain. One controversy relates to recommended procedures to ensure that meaningful data is collected. Some believe that simply filling in the blanks of the FDA 3500a is all that is required and procedures followed in doing so do not require the assistance of trained medical professionals to properly interview patients and document incidents. The FDA guidance documents present a different view and “strongly” encourage the use of trained medical professionals to respond to, and document all adverse incidents. Other challenges also remain including the fact that there is typically a lack of adequate characterization of herbal ingredients in those incidents where GMP's may be an issue. A recent review of more than 100 published anecdotal supplement adverse events further exemplified this concern when it was determined that the identity as well as the quantitative amount of the putative agent or suspected contaminant was rarely confirmed. Consumer, regulator, and health professional confidence in dietary supplement safety can only be accomplished if both the quality of reports and the confirmation of herbal ingredient quantity/identity for benchmarking capability can be insured. A list of action steps to accomplish this will be presented.