FDA study finds no developmental toxicity with bitter orange

FDA study finds no developmental toxicity with bitter orange

A new study—funded by the Food & Drug Administration (FDA) and National Center for Toxicological Research—has found that high dosages of bitter orange did not produce maternal or fetal toxicity in rats—even when combined with caffeine.

A new study—funded by the Food & Drug Administration (FDA) and National Center for Toxicological Research—has found that high dosages of bitter orange (Citrus aurantium) and its primary amine, p-synephrine, did not produce maternal or fetal toxicity in rats—even when combined with caffeine.

Developmental Toxicity of Citrus aurantium in Rats (Hansen, et al.) was published in the May 2011 issue of BIRTH DEFECTS RESEARCH Part B: Developmental and Reproductive Toxicology. The purpose of the study was to determine if relatively pure p-synephrine or p-synephrine present as a constituent of a bitter orange extract produced developmental toxicity in rats.

Researchers orally administered bitter orange or pure p-synephrine—in dosages up to 100 mg per kilogram of body weight—to female rats for 20 days beginning on day one of pregnancy. Among these dosages was a combination of 50 mg p-synephrine and 25 mg caffeine per kilogram of body weight. All of these dosages represent 60 to 200 times the daily amount of bitter orange or p-synephrine typically found in dietary supplements. No adverse effects or developmental toxicity were observed for any dosage of bitter orange and p-synephrine—even when administered in conjunction with caffeine.

"We are very pleased to see an FDA study corroborating the safety of bitter orange and p-synephrine when used in combination with caffeine," said Bob Green, president of Nutratech, Inc., maker of Advantra Z, a patented bitter orange extract. "In the past year, there has been an abundance of new research that continues to support the safety of bitter orange. So now critics have turned their attention to bitter orange/caffeine combinations. The positive findings of this developmental toxicity study directly address these concerns."

Birth Defects Research (www.interscience.wiley.com/journal/bdrb), an official publication of the Teratology Society, is a comprehensive resource of original research and reviews in fields related to embryo-fetal development and reproduction. The peer-reviewed journal is published in three parts: Part A: Clinical and Molecular Teratology, Part B: Developmental and Reproductive and Part C: Embryo Today: Reviews.

Nutratech, Inc., is a premier supplier of cutting-edge, popular, and patented nutraceutical ingredients for weight loss and fitness. Its proprietary bitter orange extract, Advantra Z, is the industry’s leading patented thermogenic ingredient. Headquartered in West Caldwell, N.J., the company is known for its industry advocacy and commitment to scientifically supported raw materials. For more information on Nutratech and Advantra Z, visit the company’s web site at www.nutratechinc.com

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