Silver Spring, MD (September 2, 2004) — During the past few months, the U.S. Food and Drug Administration (FDA) has provided the media confusing, conflicting — and inaccurate — information about the number of adverse event reports (AERs) that the agency has received associated with bitter orange (Citrus aurantium). The American Herbal Products Association (AHPA) has evaluated FDA’s records in this matter and has identified the following erroneous representations:

The New York Times reported that an unnamed FDA spokeswoman said 85 adverse reactions — and 7 deaths — had been associated with this ingredient (April 11, 2004).

Food Chemical News reported that Barbara Schneeman, PhD, the new director of the FDA’s Office of Nutritional Products, Labeling, and Dietary Supplements, tallied 169 bitter orange AERs (July 5, 2004).

The Los Angeles Times cited a “spokeswoman for [FDA]”as its source for reporting that 169 “reactions” had now been “linked” to bitter orange (July 19, 2004).

It now appears that none of these numbers are accurate, and that the actual number of reports that FDA has received for products that consist only of bitter orange is zero.

Immediately following the publication of the first of these cited articles AHPA filed a Freedom of Information Act (FOIA) request with FDA to obtain copies of any AERs regarding dietary supplements containing bitter orange. AHPA was subsequently provided with 147 such reports and has now analyzed these to find:

• 52 of the 147 reports received from FDA were either apparent duplicates or did not provide any information to confirm that bitter orange was listed as an ingredient in the product.
• 70 of the received reports were associated with products that actually contained both bitter orange and ephedra. In its recent ban on ephedra the government branded any amount of ephedrine in a dietary supplement as presenting an unreasonable risk of illness or injury. FDA has therefore already assigned ephedrine as the “associated” ingredient for each of these 70 cases and utilized that information as part of the basis on which it has banned ephedrine alkaloids from dietary supplements, but apparently now considers these cases to be “associated” with bitter orange.
• All but one of the remaining reports involved products that contained both bitter orange and a source of caffeine. Thus, only a single adverse event report, received over 5 years ago, was associated with a product that contained bitter orange but did not contain either caffeine or ephedrine. This case involved a 74-year-old woman who had taken three separate herbal formulas, one of which contained “immature bitter orange” as one of its six listed ingredients. The woman’s prior medical history included osteoarthritis, hypertension, and diabetes, and she was taking five prescription drugs. Her adverse experience was recorded as: “Felt very unwell, weak,” and later “lower extremity swelling (2+ edema).”

AHPA President Michael McGuffin has contacted FDA to discuss the apparent misrepresentation of these reports by the agency. “It appears as if the agency 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 McGuffin. “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.”

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The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry. Founded in 1983, AHPA is the recognized leader in representing the responsible core of the botanical products industry, and is comprised of the finest growers, processors, manufacturers, and marketers of herbal products. Website: www.ahpa.org.

Source: American Herbal Products Association (AHPA)
http://www.ahpa.org
Contact: Karen Robin, Director of Communications, krobin@ahpa.org
p.(301)588-1171 ext 107