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Aug. 28, 2000 -- As herbal supplements have grown into a multibillion dollar industry in the last few years, medical science has struggled to keep up, leaving many consumers and health care professionals with more questions than answers about the safety and effectiveness of these products. Now, private firms and advocacy groups are stepping in to help bridge the information gap.
For example, a company called Consumerlab.com does regular analyses of plant-based supplements, allowing manufacturers that meet its standards to use the Consumerlab seal of approval on their labels. Among the supplements it recently has tested are ginseng, ginkgo biloba, and saw palmetto.
Consumer Reports magazine also is expanding its botanical testing program. In a report on saw palmetto in the September issue, for instance, the authors suggest that the 100-year-old remedy may reduce symptoms of noncancerous prostate disease -- but only if you choose a brand that contains enough of the active ingredient. They also suggest that a lack of government regulation leaves consumers insufficiently protected against mislabeling and substandard manufacturing.
Not surprisingly, consumer advocates applaud these efforts. "The market is so chaotic that taking herbal supplements is like playing roulette," Stephen Barrett, MD, a retired psychiatrist and founder of the nonprofit group Quackwatch.com, tells WebMD. "It's mainly because the Dietary Supplement Health and Education Act of 1994 weakened the Food and Drug Administration. In fact, a recent survey showed that over 70% of consumers think the government should be more involved in regulating herbal products."
Alternative medicine experts share Barrett's concerns. "Given the lack of federal regulation, consumerism is moving things in the right direction, but we've still got a ways to go in getting the word out," says James Dillard, MD, DC, an assistant professor at New York's Columbia University and director of alternative medicine for Oxford Health Plans. "Research shows that self-prescribing is up and physician office visits are down."
The self-care revolution is driving this trend, says John Renner, MD, president of the National Council for Reliable Health Information and a professor of family practice at the University of Missouri in Kansas City. "Many adults want to make their own decisions about health care, but there's not a lot of unbiased information on herbal products, so consumer investigations are filling the void," he tells WebMD. "They also have a way of allowing quality to rise to the top."
Industry insiders agree. "The entire industry shouldn't have to bear the burden of a few bad apples, so we welcome these consumer investigations," says Mike McGuffin, president of the American Herbal Products Association, a trade group in Silver Springs, Md. "But it's distorting to say that there's a lack of government regulation. DSHEA fixed a system that was broken, resulting in new manufacturing practices, cautionary labeling, and ingredients facts panels" -- lists of ingredients that are now required on supplement labels.
Unlike prescription and over-the-counter medications, herbal supplements don't have to go through a formal approval process that requires manufacturers to prove their safety. The 1994 law puts the burden on the FDA to prove that a particular supplement is unsafe and should be taken off the market. It also allows supplement makers to distribute literature about their products without any FDA review of their statements.
FDA Commissioner Jane Henney, MD, has said that the DSHEA provides all the legal authority necessary for the FDA to protect public health. And the FDA's Center for Food Safety and Applied Nutrition offers information about herbal supplements and their reported side effects and interactions on its web site.
Consumer advocates say that's not enough, though. "The success of the pharmaceutical industry was built largely on standardization, so we should have the same strict regulations for standardizing herbal products," says Charles Inlander, president of the People's Medical Society in Allentown, Pa. "And we're just not forcing the issue enough with manufacturers."
In response to such concerns, US Pharmacopeia (USP) has set its sights on herbal supplements. Started by physicians in 1820, the nonprofit organization sets quality standards for drugs, vitamins, and dietary supplements. But due to the chemical complexity and natural variation of herbs, USP scientists have their work cut out for them. So far, they have set standards -- which cover quality, strength, purity, packaging, and labeling -- only for feverfew, ginger, gingko, ginseng, St. John's Wort, and saw palmetto.
So how do you decide if an herbal supplement is right for you?
One way is to refer to The BioNutritional Encyclopedia (BNE), a free computer service now available only at GNC stores. Developed by a team at Houston's Baylor College of Medicine, BNE uses a color-coded system indicating "stop," "caution," and "go" to indicate how much research has been conducted for more than 200 dietary supplements.
Green means that one or more good-quality studies have been done in people; yellow suggests that early data from human studies looks promising; orange indicates that only animal studies have been done; and red means little data on the supplement is available.
"Right now, only 25% of the listings are green or yellow, but we'll update them as new information becomes available," says BNE reviewer Paul Lachance, PhD, a professor of nutrition science and executive director of the Nutraceuticals Institute at Rutgers University in New Brunswick, N.J.
You also can make informed decisions about herbal supplements by following this advice from doctors, scientists, consumer advocates, and industry insiders:
To keep pace with public interest, physicians should know as much about natural products as they do about pharmaceuticals, Columbia's Dillard tells WebMD.
"In Germany, 25% of all prescriptions are for natural products because doctors learn all about them in medical school," he says. Fortunately, many American medical schools now include such training as well.
For more information, visit the Center for Food Safety and Applied Nutrition web site at www.foodsafety.gov.