IOM Releases Draft Prototype Monograph for Chaparral

WASHINGTON--The first draft prototype monograph was released by the Committee on the Framework for Evaluating the Safety of Dietary Supplements, and the public comment period is now open. The committee, which is under the Institute of Medicine (IOM), reported that the prototype is intended to be a concise rather than comprehensive literature review on the safety--and not the benefits--of chaparral, the first herb 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 reported that possible adverse effects included hepatotoxicity and tumor stimulation. In terms of "hypothetical drug interactions," as the committee termed it, individuals consuming chaparral may be at an increased risk for drug- or alcohol-induced liver damage. And although many studies have shown chaparral's main lignan, NDGA, to have antioxidant properties, it may also inhibit apoptosis (normal cell death) and may have the potential to mutate cells.

The committee named sources of chaparral, as well as how the herb is identified and processed. It also discussed how the botanical is currently marketed to consumers, including as a therapy for cancer, arthritis and acne.

The draft included information on past regulatory actions involving chaparral products. The committee discussed the labeling found on chaparral products and mentioned that members of the American Herbal Products Association (AHPA) began listing a warning on chaparral products in 1995 after the Food and Drug Administration (FDA) issued a warning in 1992 about the herb's potentially deleterious effects.

"The most interesting part of this document is how the industry will approach this monograph, not the specific content on chaparral," said Michael McGuffin, AHPA president, who had just received the monograph. "We'll be looking at the monograph with an overall perspective--what they say about chaparral and also how they're addressing an approach to the safety review of botanicals. Is it organized in a meaningful manner, is it free of bias, and is it inclusive of all the information that needs to be included?"

A draft form of the draft prototype monograph can be found here. Public comment will be accepted from Aug. 22 to Sept. 23 and can be directed to Marilee Shelton or Allison Yates. It is expected that the draft will be modified following input from various stakeholders, including industry, government agencies and the public. The committee did not offer a conclusion about the herb because the monograph was just a draft.

Committee members and consultants involved in developing the draft are scheduled to meet Aug. 30 to 31 at the National Academies. For those interested in speaking at this meeting, contact Vivica Kraak at [email protected] or (202) 334-2928 by Aug. 28.