Bitter Orange Not Cause of AERs

WEST CALDWELL, N.J.The Journal Of Functional Foods (JFF) found bitter orange a natural ingredient commonly found in dietary supplements, fruits and juices was not responsible for adverse events presented in the 22 reports received from April 2004 to October 2009 (DOI:10.1016/j.jff.2010.10.003).This is the second assessment of adverse event reports (AERs) citing bitter orange (Citrus aurantium) that could not establish the botanical extract as the cause of reported adverse events.

The JFF article, authored by Sidney J. Stohs, School of Pharmacy and Health Professions, Creighton University Medical Center, Omaha, NE, reported from April 2004 through October 2009, FDA received 22 AERs involving products reported to contain bitter orange. During this same time, 10 clinical case reports were published involving adverse events associated with products that contained bitter orange. A review of these AERs shows that all products involved were poly-herbal and poly-alkaloidal in composition, and states, the conclusion that bitter orange was responsible for adverse events presented in these reports is unjustified," based on:

We are very pleased to see the scientific community corroborating the safety of bitter orange," said Bob Green, president of Nutratech Inc., maker of Advantra Z, a patented bitter orange extract. 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."

Green noted there has been an average of only four AERs citing bitter orange per year since 1969 and none were shown to have been caused by bitter orange. He also said bitter orange has been used medicinally throughout the world for thousands of years and considered a GRAS (generally recognized as safe) food ingredient by FDA for decades.