AHPA Questions FDA on Bitter Orange AERs

SILVER SPRING, Md.--The American Herbal Products Association (AHPA) is asking the Food and Drug Administration (FDA) to explain apparent discrepancies in the number and type of adverse event reports (AERs) linked to Citrus aurantium (bitter orange). The AHPA request was filed following several media reports claiming FDA reported it has received 169 bitter orange AERs.

AHPA filed a Freedom of Information Act (FOIA) request with FDA to obtain copies of any AERs regarding dietary supplements containing bitter orange. The association received and analyzed 147 reports, and found:

* 52 of the reports were apparent duplicates or did not provide any information to confirm bitter orange was an ingredient in the product;

* 70 reports were associated with products that contained both bitter orange and ephedra, which has since been removed from market by FDA as an ingredient with an unreasonable risk of illness or injury; and

* All but one of the remaining reports involved products that contained both bitter orange and a caffeine source.

AHPA noted the single AER involving a product containing bitter orange with neither ephedrine nor caffeine was received five years ago from a 74-year-old woman; the woman was taking three separate herbal products and five prescription drugs, and her adverse event was "felt very unwell, weak" and later, edema.

"It appears as if FDA is willing to regulate by anonymous press release and to be quite cavalier in its approach to truthfully informing the public about the safety profile of bitter orange," said Michael McGuffin, president of AHPA (www.ahpa.org). "It was apparent in my conversation with the agency that FDA officials knew that many of these reported adverse reactions were associated with products that also contained ephedrine alkaloids when they provided numbers to the media, but did not consider it to be important to disclose that information. That information is material, and FDA's failure to disclose it makes their unqualified statements misleading in the extreme."