Support Grows for New Medicinal-Herb Rules
To baby boomers weaned on herbal teas, plant remedies may sound like a logical, healthful alternative to man-made drugs. They are available without a prescription, are relatively inexpensive and, because they’re all-natural, are usually considered safe.
A few are not safe, however, and since the Food and Drug Administration regulates herbs as food and not as drugs, consumers have had no way of knowing which herbs have therapeutic value and which don’t.
Now a move is on the way to get the FDA to change. A coalition of scientists, herb advocates and industry members, including the American Botanical Council and the American Herbal Products Assn., is proposing new regulatory categories for medicinal herbs.
“The health and pocketbooks of Americans are suffering,” says Dr. Varro Tyler, an herbal expert and professor of pharmacognosy--natural products--at Purdue University, Indiana. “Without proper regulation, people ingest herbal pills that may make them sick, or they get ripped off by unscrupulous manufacturers who sell herbs without active ingredients.”
Since manufacturers of medicinal herb products are not allowed to make drug-related claims, Tyler adds, consumers are also missing out on useful and inexpensive over-the-counter medicines already approved in Europe. Moreover, no side-effect listings or warnings are allowed on herb-product labels. As sales of medicinal herbs rise (they are estimated to have been at least $500 million last year and $2.2 billion conservatively in Europe), the need to take a new look at herb labeling has become urgent.
Many consumers buy medicinal herbs on the basis of outdated information. One commonly consulted book in health-food stores gives a recipe for cough drops made with coltsfoot, a known carcinogen. Another book recommends that arthritic swelling can be reduced through drinking pokeroot tea, which is poisonous. Comfrey, used for bronchial and intestinal disorders, was found to be toxic to the livers of animals years ago, yet it was still a best-selling herb as recently as last year.
Whether an herb is good or bad for you becomes irrelevant when there’s no guarantee that you’re getting the herb you’re paying for. Mislabeled products are commonplace, since manufacturers themselves are sometimes uncertain about what they’re selling. The plant Cimicisuga racemosa, for example, used as an expectorant, has at least 20 common names, among them black snakeroot. To confuse the issue further, three other plants found in the same area of South Carolina are also known as black snakeroot.
Then there are the herbal products whose therapeutic qualities have actually been cooked out during processing. In studies, American and Canadian feverfew products were determined to contain very low levels of the major active ingredient.
There are also incompetent growers, suppliers and manufacturers who sell mislabeled or adulterated products, warns Dr. Dennis Awang, who heads the natural products section of Canada’s Health Protection Branch, which is similar to the FDA.
To make matters even more bewildering, regardless of how safe a medicinal herb may be--and the majority are safe--misuse can still create problems. Drinking large amounts of lobelia tea to deter smoking can cause vomiting, for example. Prolonged use of senna leaf or cascara sagrada bark, both natural laxatives, can lead to dependence.
To counter widespread misinformation about herbs, the ABC, a nonprofit educational group, regularly reports on them in its quarterly journal, Herbal-Gram.
Setting up a system for regulating herbs, however, will be complicated. Because herbs can’t easily be patented, most manufacturers are reluctant to do the costly safety and efficacy testing required.
Because of a nutrition labeling law passed last year by Congress, however, herbal products may soon be allowed to carry preventive health claims if the manufacturer can prove to the FDA that the claims are valid. The agency plans to publish what it needs as evidence. But the long-term goal of the herbal coalition is to push Congress to create a system in the FDA that would allow manufacturers to make therapeutic claims.
The group, modeling its recommendations on German and Canadian herbal-drug laws, proposes two new categories within the FDA’s drug division: One, phytomedicine (plant medicine), would monitor herbs that have undergone extensive clinical testing to support claims of safety and efficacy; the second, traditional medicine, would regulate herbs that carry claims based on historical use and anecdotal evidence.
