January 22, 2010 – A new American Herbal Products Association (AHPA) report provides AHPA members with valuable insight into the Food and Drug Association’s (FDA) review policy for evaluating dietary supplement adverse event reports (AERs), including serious adverse event reports (SAERs).

On November 10, 2009, the Food and Drug Administration (FDA) invited the American Herbal Products Association (AHPA) and other trade organizations to a meeting to discuss the agency’s approach to evaluating AERs and SAERs. The meeting, held on December 10 and attended by AHPA President Michael McGuffin and AHPA General Counsel Anthony Young, provided a description of how the agency evaluates AERs and SAERs.

This information – as well as additional comments of interest made by FDA staff and an appendix of referenced documents – is now available to members in a report prepared by AHPA’s McGuffin and Young. “While the information does not constitute agency policy, this insight into FDA’s thinking is extremely valuable,” said McGuffin. “Dietary supplement companies may use the report to help fashion their own procedures to analyze data in parallel with FDA.”

The report is based solely on information provided by FDA personnel at the December 10 meeting, and includes:

• A step-by-step description of the agency’s review policy
• Criteria used to identify a “signal” that a dietary supplement may pose a risk to public health
• The point at which FDA notifies a company that it believes one or more of its products represents a significant or unreasonable risk to public health

The report is free to AHPA members and is available by signing on to the AHPA Web site with your member password, and then accessing the report at http://www.ahpa.org/Default.aspx?tabid=211. Any member that encounters a problem in obtaining the report, or any non-member interested in obtaining the report, should contact Devon Powell (dpowell@ahpa.org; 301-588-1171 x102).