HerbalGram: Bitter Orange Safe

WEST CALDWELL, N.J.Bitter orange extract is safe for human consumption, and Consumer Reports challenge to the safety of this ingredient is without scientific basis, according to an article by Harry G. Preuss, MD, FACN, CNS, MACN, and Sidney J. Stohs, PhD, FACN, CNS, ATS, FASAHP in the Winter 2011 issue of the American Botanical Councils HerbalGram.

The article, "The Safety of Bitter Orange (Citrus aurantium) and p-Synephrine" provides a scientific analysis of the chemistry and safety of bitter orange, drawn from 59 clinical research studies and other reference sources.  In the article, Preuss and Stohs explain bitter orange contains the dominant amine p-synephrine, which is similar to m-synephrine found in ephedrine, but works differently in the body.  P-synephrine increases thermogenesis and lipolysis, but does not affect blood pressure. Unlike m-synephrine, it does not cross the blood brain barrier into the central nervous system.

The authors note more than 100 million doses of dietary supplements containing bitter orange have been consumed in the United States without serious incidents shown to have been caused by bitter orange. Additionally, research studies have not reported any serious or significant adverse events directly attributable to bitter orangenor did they demonstrate adverse cardiovascular or neurological events.

The article also examines the role of the U.S. federal governmentspecifically, FDAs misreporting of bitter orange adverse event reports (AERs)in contributing to concerns about the safety of bitter orange.  Upon examining the scientific data, including independent analyses of AERs filed with the FDA beginning in 1969, Preuss and Stohs found no credible adverse events could be directly attributed to bitter orange.

Bob Green, president of Nutratech Inc., commented, "Since we introduced Advantra Z, our patented bitter orange extract, 15 years ago, research has consistently supported both its safety and efficacy," said, exclusive worldwide distributor of Advantra Z.  And that is in spite of the fact that bitter orange has been one of the medias favorite 'whipping boys.'  Its heartening when scientists go on the record, telling people to look past the hype and focus on the data behind this tried-and-true weight management/sports nutrition ingredient."