Bitter Orange Not Responsible for Adverse Events, Review Says

Nutratech (West Caldwell, NJ) is pointing industry attention to a new review published in the Journal of Functional Foods that found that bitter orange (Citrus aurantium) extract was not responsible for a history of adverse events alleged against the ingredient.

From April 2004 to October 2009, FDA received 22 adverse-event reports (AERs) involving products claimed to contain bitter orange. During this time, ten clinical case reports were also conducted and published on products containing bitter orange or its predominant alkaloid p-synephrine.

The Journal of Functional Foods review, conducted by Sidney Stohs of Creighton University Medical Center’s School of Pharmacy and Health Professions, examined these cases and found that all of the products were poly-herbal and poly-alkaloidal.

As a result, “The conclusion that bitter orange extract and p-synephrine are responsible for adverse events presented in these reports is unjustified,” Stohs concluded.

He attributed this opinion to the “presence of confounding factors, the paucity of detailed information in many reports, current knowledge of the pharmacokinetic and adrenoreceptor-binding properties of p-synephrine, the high probability of concurrent but independent events, knowledge of dose-response relationships, and the widespread use of bitter orange extract-containing supplements and p-synephrine-containing juice and food products.”

“We are very pleased to see the scientific community corroborating the safety of bitter orange,” said Bob Green, president of Nutratech, which produces its Advantra Z patented bitter orange extract ingredient.

“There is a lot of misinformation about bitter orange that has been perpetuated even by authoritative sources that, for whatever reason, have simply repeated provocative and unconfirmed headlines rather than delve into the extensive research supporting both the safety and efficacy of this tried-and-true ingredient,” he added.

Green also said that on average since 1969, only four AERs citing better orange have been reported per year, and that none were shown to be caused by bitter orange. He says that bitter orange has been used medicinally throughout the world for thousands of years and is considered a Generally Recognized as Safe food ingredient by FDA.

Green also pointed to an article published in the American Herbal Products Association’s Report newsletter whose review of bitter orange AERs also could not establish bitter orange as the cause of AERs, citing that other ingredients were involved, as well as health and lifestyle factors.

The Journal of Functional Foods review, published online November 18, can be viewed here.