Seville orange row refuses to blow over
American Herbal Products Association (AHPA) adding its voice to the
industry backlash against a review article published last week
which suggested that the use of citrus aurantium, or seville
orange, as a substitute to ephedra may do more harm than good to
help people lose weight, reports Philippa Nuttall.
The article, written by Adriane Fugh-Berman and Adam Myers, researchers at Georgetown University, and published in the September issue of Experimental Biology and Medicine, claimed there was no scientific evidence to support the use of this herb for losing weight and that it may even be dangerous for the consumer's health.
However, the supplements industry has deemed the report unfair and unfounded.
"There is no legitimate basis for the negative coverage that bitter orange (Citrus aurantium) is receiving," Michael McGuffin, president of the AHPA told NutraIngredientsUSA.
The AHPA believes the FDA has made the situation worse by providing the media with "confusing, conflicting and inaccurate" information about the number of adverse event reports (AERs) that the agency has received associated with bitter orange (Citrus aurantium), during the last few months.
The AHPA noted that on the separate occasions, the FDA gave out conflicting information about complaints made against bitter orange supplements.
In April, the New York Times reported that an unnamed FDA spokeswoman said 85 adverse reactions - and 7 deaths - had been associated with this ingredient. Then, at the beginning of July, Food Chemical News reported that Barbara Schneeman, the new director of the FDA's office of nutritional products, labeling, and dietary supplements, tallied 169 bitter orange AERs. This was followed two weeks later by a report in the the Los Angeles Times citing a "spokeswoman for the [FDA]" as its source for the fact that 169 "reactions" had now been "linked" to bitter orange.
McGuffin categorically denies that this is the case. "There have been absolutely zero adverse event reports submitted to the FDA associated with products that contain only bitter orange," he said. McGuffin added that the FDA had shown that it was willing to identify AERs for products that contained ephedra and bitter orange as "associated with bitter orange" without disclosing the material information that these products contained ephedra.
He told NutraIngredientsUSA that he thought this "mess" could have been avoided if the federal AER system for dietary supplements was subject to the same kind of management, controls and policies that the agency invests in its drug AER system.
"I also believe that part of the solution is to complete the legislative process of establishing a mandatory requirement to submit serious AERs to FDA, because when the entire industry has an interest in FDA's effective management of this system the agency will be more responsive to our input," he added.
McGuffin felt that now would also be an appropriate time to further the research on this supplement.
"Because bitter orange has not been historically used for weight loss it is important that there be additional research to follow up on the preliminary studies that have been conducted," he said.
