IOM Releases Draft Prototype Monograph for Chaparral 40626

IOM Releases Draft Prototype Monograph for Chaparral

WASHINGTON--The first draft prototype monographwas released by the Committee on the Framework for Evaluating the Safety ofDietary Supplements, and the public comment period is now open. The committee,which is under the Institute of Medicine (IOM) (www.iom.edu),reported that the prototype is intended to be a concise rather thancomprehensive literature review on the safety--and not the benefits--ofchaparral, the first of six herbs to be reviewed.

Within the draft, the safety data of the herb was assessed,including information gathered from historical uses, human clinical data,adverse event reports and animal studies. From these records, it was reportedthat possible adverse effects included hepatotoxicity and tumor stimulation. Interms of "hypothetical drug interactions," as the committee termed it,individuals consuming chaparral may be at an increased risk for drug- oralcohol-induced liver damage. And although many studies have shown chaparral'smain lignan, NDGA, to have antioxidant properties, it may also inhibit apoptosis(cell death) and may have the potential to mutate cells.

The monograph also includes sources of chaparral, as well as howthe herb is identified and processed. It also discussed how the botanical iscurrently marketed to consumers, including as a therapy for cancer, arthritisand acne.

The draft included information on past regulatory actionsinvolving chaparral products. The committee discussed the labeling found onchaparral products and mentioned that members of the American Herbal ProductsAssociation (AHPA) began listing a warning on chaparral products in 1995 afterthe Food and Drug Administration (FDA) issued a warning in 1992 about the herb'spotentially deleterious effects.

"The most interesting part of this document is how theindustry will approach this monograph, not the specific content onchaparral," said Michael McGuffin, AHPA president. "We'll be lookingat the monograph with an overall perspective. Is it organized in a meaningfulmanner, is it free of bias, and is it inclusive of all the information thatneeds to be included?"

Public comments will be accepted until Sept. 23.