The FDA’s Center for Food Safety and Applied Nutrition’s Adverse Event Reporting System (CAERS) represents one of the few existing surveillance mechanisms.

Here’s a list of the 6 most frequently used and how they rate for reports of adverse events.

First, the details.

  • CAERS data from 1999 to 2003 involving adverse effects for the 6 most frequently used supplements were reviewed.
    • Echinacea
    • Garlic
    • Ginkgo biloba
    • Ginseng
    • Peppermint
    • St. John’s wort

And, the results.

  • Reports involving ginseng were most frequent.
  • St. John’s wort had the least frequently reported adverse events.
  • Gastrointestinal and neurologic problems were the most common adverse events for single-ingredient supplements.

The bottom line?
The abstract and brief press report from FunctionalIngredients are disappointing in what they report.

The authors concluded that the “number of reports is relatively small, validation is incomplete, and some inconsistencies within reports were found.”

Based on this, CAERS is “potentially as effective as other passive surveillance methods.” However, this system may “under-represent adverse events associated with supplements.”

5/28/08 20:09 JR

Hi, I’m JR

John Russo, Jr., PharmD, is president of The MedCom Resource, Inc. Previously, he was senior vice president of medical communications at, a complementary and alternative medicine website.