FDA and herb supporters meet halfway - Food and Drug Administration

Vegetarian Times, April, 1995 by Eric Patterson

MIGHT THE U.S. FOOD and Drug Administration (FDA) be coming around to the validity of using herbs for healing? Thirty FDA staff members and roughly 300 members of the herbal community, including herbalists, manufacturers, growers and researchers, met recently at a symposium examining the role of herbs in U.S. health care; though FDA and herb advocates have long been adversaries, both sides say the meeting was positive.

The symposium, titled "Botanicals: A Role in U.S. Health Care?" was organized by the National Institutes of Health's Office of Alternative Medicine. Among FDA's attendees were Freddie Ann Hoffman, M.D., deputy director of the medicine staff in the Office of Health Affairs, and Robert Temple, M.D., who reviews new drugs for FDA approval. The assemblage discussed ways in which botanicals are used, how to assess their safety and effectiveness, methods of quality control and how the United States might adopt European regulatory models for herbs.

"I talked to many FDA people who were very surprised by the caliber of scientific opinion that supported the use of herbs," says Rob McCaleb, president of the Boulder, Colo.-based Herb Research Foundation.

The FDA's method of regulating herbs attracted the most heated discussion. Under current law, if an herb or herbal product carries a health claim on its label, the FDA may decide to consider it a drug and require it to pass a clinical trial, the same benchmark required of prescription and over-the-counter drugs. But in many European countries, an herb may carry a health claim without going through such trials, though a scientific panel must first be convinced the product is safe and reasonably effective; a long history of use without side effects may be considered sufficient proof of safety.

Yet without scientific study that includes a control group, history of use does not really prove an herb is effective, argued FDA representatives. Conducting such a study would be difficult, because "with so many different ingredients in an herb or an herbal product, you might not know the active ingredient," Hoffman says. "It's very difficult to assess efficacy when something is not a single entity."

Regardless of the issues the FDA currently has with herbs, the way the agency regulates them is going to change, thanks to the Dietary Supplement Health and Education Act, passed last October. Previously, the FDA classified most herbs and herbal products as food additives, which required manufacturers to provide proof that a product was safe. Now, the products are classified as dietary supplements, and the burden of proving a product unsafe rests with the FDA. Also under the act, a presidential commission will decide what claims the FDA will allow on labels. The act has yet to go into effect, however, because its rules have not been completed and published in the Federal Register. The FDA currently is writing the rules; a spokesperson says the agency has no timetable for when they will be done.