The Herbal Frontier

By Jacqueline Stenson

Walk into your local health-food store or pharmacy and you're likely to find herbal remedies that may ease depression, help you sleep better, even fight prostate cancer. You might also find a product that has absolutely no effect, despite labeling claims to the contrary, or worse yet, causes serious adverse reactions, possibly even death. How can you be assured you're buying a safe and effective remedy?

"We have what I call a mess," says one of the nation's leading authorities on herbal medicine Dr. Varro E. Tyler, a professor emeritus of the Purdue University School of Pharmacy, and author of many articles and several books on botanical therapies. "The consumer is bewildered," he says. "They go into a store and see 14 brands of echinacea. Which one has been tested? The consumer has no way of telling the difference." "Who takes responsibility? Who oversees this industry? Right now, there is nobody," says Paul Root Wolpe, a bioethicist at the University of Pennsylvania Center for Bioethics. The fact that increasing numbers of Americans are relying on dietary supplements to cure everything from colds to cancer has many in the medical community worried that the loose regulation enjoyed by the supplement industry since 1994 is resulting in many consumers wasting their money and taking unnecessary risks with their health. Recent reports of dangerous products on the market have fueled concerns.

Now, health advocates are calling for increased oversight of the industry, ranging from quality control efforts to standardize the ingredients in products to the establishment of an independent panel to review whether each product is safe and effective. Preliminary efforts aimed at better oversight are beginning - some of them even supported by segments of the industry.

Controversial Law

As a result of the Dietary Supplement Health and Education Act (DSHEA), passed by Congress in 1994, herbs and other supplements do not have to prove they are safe or effective before they can be sold in the United States. Backed by a powerful industry lobby and pushed heavily by Sen. Orrin Hatch of Utah, home to many supplement makers, DSHEA established a new class of product, the dietary supplement, which is considered neither food nor drug and is not subject to the regulatory hurdles that prescription and over-the-counter medicines must go through. A broad category, dietary supplements include vitamins, minerals, herbs, amino acids and other substances that are not intended as a substitute for food.

And while supplement makers do not have to conduct large-scale clinical trials to prove the efficacy of their products, they can make "structure/function" claims. So, for instance, a label could say that a product supports a healthy immune system or helps maintain cardiovascular health, but not that it fights AIDS or treats heart disease - specific health claims that are illegal.

Structure/function claims must be accompanied by a disclaimer stating that the product has not been evaluated by the FDA and is "not intended to diagnose, treat, cure or prevent any disease." Manufacturers are required to have some evidence to back their claims, should the FDA ask to see it. Still, many companies get away with making unsubstantiated, sometimes outlandish, claims. "Certain segments of the industry keep pushing the envelope," Tyler says.

The FDA has the authority to pull any supplement from the market that is unsafe or makes false labeling claims, but the burden of proof falls to the agency, which has said it is too understaffed to effectively police this booming industry. The FDA declined repeated requests for an interview for this article.

The Federal Trade Commission has the primary responsibility for ensuring that supplement advertising is accurate - and that, too, is no small task, says Rich Cleland, a senior attorney with the FTC's division of advertising practices. "There are tens of thousands of products out there," he says. "We can't monitor the advertising for all of these products. We simply do not have the resources for that."

Instead, the FTC focuses its attention on misleading advertising for products touted as treatments for serious illnesses such as cancer or AIDS, he says. Over the last few years, an FTC effort dubbed "Operation Cure.All" has resulted in more than a thousand warnings being sent to supplement advertisers making false claims on the Internet - "the medium of choice for the modern snake-oil salesman," Cleland says. "The effect is to turn every local marketer into a national and global marketer."

Whether buying supplements online or in the store, it's "buyer beware," Cleland warns. "Current law is not really protecting consumers," he says. "The level of evidence required to get unsafe products off the market is very high. So the public is essentially being used as a guinea pig here."

Many in the industry, however, fault the government, saying that officials simply don't enforce existing law. "We encourage FDA to take rapid action when warranted," says John Hathcock, vice president of nutritional and regulatory science at the Council for Responsible Nutrition, a Washington, D.C.-based trade group representing supplement makers. "I think the law is strong enough when enforced, but I don't think the law is well enforced."

As with the mainstream medical community, Hathcock says his group also is frustrated by cases where consumers are harmed because a supplement is spiked with a prescription medication or contaminated with pesticides or heavy metals such as lead and mercury. "The industry is hurt by the bad apples in the barrel, and we'd like to see them taken out."

Soaring Sales

Meanwhile, consumers interested in a "natural" approach to health care and often fed up with conventional treatments are jumping on the alternative medicine bandwagon in record numbers. A recent nationwide survey by the American Dietetic Association showed that an estimated 40 percent of adults use herbal remedies and more than 80 percent take vitamin and mineral supplements. And since DSHEA passed, sales of herbs and other dietary supplements have jumped from $8.6 billion in 1994 to $16 billion last year.

There's no question that some dietary supplements are beneficial. The government advises women of child-bearing age to get 400 micrograms a day of folic acid from fortified foods and/or supplements to help prevent birth defects. And doctors and nutritionists commonly recommend calcium and various other supplements for people who cannot get such nutrients through their diets. In addition, there's mounting evidence that other types of supplements help, including glucosamine for osteoarthritis, St. John's wort for depression and an herbal remedy called PC-SPES for prostate cancer.

Although herbal medicine has been practiced for thousands of years in Eastern countries, only recently has it begun to catch on in the United States, and there has been surprisingly little large-scale research. But some doctors, interested in knowing more about the supplements their patients are taking, are conducting clinical trials, and the federal government is funding several big studies of various supplements, with the first results due out this year.

"I think herbs are very promising," says Mark Blumenthal, founder and executive director of the American Botanical Council, a nonprofit herbal research group in Austin, Texas, and an associate professor at the University of Texas College of Pharmacy. "I think more clinical trials are going to vindicate and validate herbal medicines."

The Risks

While experts say most herbs are probably safe if taken as directed, a number of recent reports have documented the potential dangers of these remedies. Side effects can range from allergic reactions to seizures and death, and some can cause dangerous interactions with standard medicines. Other concerns are that supplements may be impure or that patients taking them are forgoing proven care.

In February, a jury awarded $13.3 million to an Alaskan woman who had a stroke after taking a weight-loss supplement that contained the herb ephedra plus ephedrine, a synthetic version of the herb that is not allowed to be sold in a supplement. The product, AMP II Pro Drops, is marketed by E'Ola International of St. George, Utah.

Earlier cases against ephedra and ephedrine have been settled out of court and others are pending, but the Alaskan case is the first to go to trial.

In a study published last December in The New England Journal of Medicine (NEJM) and commissioned by the FDA, ephedra, also known as ma huang and taken by an estimated 12 million Americans a year for weight-loss, body-building and other uses, was linked to high blood pressure, heart attack, stroke, seizure and death among otherwise healthy people.

But industry officials were quick to discredit the report, saying there is no proof that ephedra is unsafe when properly manufactured and taken at recommended doses by people without conditions such as heart disease and diabetes, in whom complications may result.

While the ephedra debate continues, some say the Alaskan case is significant and could trigger more lawsuits against supplement makers. "You throw blood in the water and the sharks are gonna circle," Hathcock says.

Ephedra has caused the most concern, but other herbs have been associated with serious risks as well.

A study in NEJM last June linked the Chinese weight-loss herb aristolochia fangchi to kidney failure and urinary tract cancer in a group of Belgian patients.

In an editorial accompanying the study, former FDA commissioner Dr. David A. Kessler, now dean of Yale School of Medicine, said the fact that U.S. consumers could buy aristolochia is another reason why Congress should amend DSHEA - a law that he fought hard against when in office.

"Congress has shown little interest in protecting consumers from the hazards of dietary supplements, let alone from the fraudulent claims that are made, since its members apparently believe that few of these products place people in real danger," wrote Kessler.

Following the report, the FDA stopped the importation of the aristolochia and asked distributors to recall products containing it, although that doesn't guarantee it is not on some shelves. The United Kingdom, Canada, Australia and Germany all ban the herb.

Kessler noted other documented cases of supplements causing harm, including links between comfrey and liver problems, and yohimbe and both seizures and kidney failure.

Additional reports have found that herbal remedies often do not contain the amount of the active ingredient listed on the label, with some products containing only trace amounts and others super-high doses. And researchers are beginning to learn that supplements can cause troubling interactions with standard medicines. St. John's wort, for instance, can interfere with oral contraceptives, AIDS and cancer drugs, and medications that prevent organ rejection in transplant recipients.

Critics of DSHEA say one of the key problems is that the FDA cannot take the necessary steps to protect consumers from dangerous supplements before they come to the market. "Congress has put the FDA in the position of being able to act only after the fact and after substantial harm has already occurred," Kessler wrote.

What Next?

The industry says it polices itself by setting quality control and labeling standards for manufacturers to follow. But some say that's akin to letting the fox watch the hen house.

Many health experts are calling for an independent panel to review dietary supplements for safety and efficacy, a system similar to Germany's Commission E, which has approved more than 250 herbal remedies.

"The Germany method is certainly the best," says Tyler. "They demand absolute proof of safety and a 'reasonable' proof of efficacy. If they could do that in the United States, it would be ideal."

"For the most part, supplements are not unsafe and some of them may provide some benefit, but there's also a lot of hype that goes on because they're loosely regulated," says David Schardt, an associate nutritionist at the Center for Science in the Public Interest, a consumer advocacy group in Washington, D.C. "We think there should be more oversight over the claims these companies can make."

While some industry representatives say they would support an independent review panel, they are adamant that supplements should never be regulated as strictly as drugs - and they lobby hard to keep it that way.

"A third of Americans use herbal products and we don't see the kind of incidence of side effects that would suggest a wide problem," says Michael McGuffin, president of the American Herbal Products Association in Silver Spring, Md.

"I think it would be really valuable for there to be a panel of qualified experts who could review the new and emerging data on a plant and come up with a statement of the evidence for that plant and allow it to be sold without the disclaimer that is currently required by federal law," McGuffin says.

In January 2000, the FDA issued a 10-year "dietary supplement strategy" aimed at fully implementing DSHEA and "providing consumers with a high level of confidence in the safety, composition and labeling of dietary supplement products," according to its Web site.

As part of that effort, last fall the FDA gave a two-year, $1 million grant to the National Academy of Sciences (NAS), an independent research arm of the government, to establish a protocol for evaluating herbs.

"What we are to do is to bring together an expert group that would look at issues related to safety and role in health of dietary supplements and put together a proper framework for how they ought to be evaluated," says Allison A. Yates, a registered dietitian and director of the food and nutrition board at the Institute of Medicine, a division of the NAS.

The FDA also is working to set Good Manufacturing Practices (GMPs) for dietary supplements, which are expected to be released sometime this year. Both industry groups and the medical community sees GMPs as a step in the right direction toward standardizing and improving the quality of herbal products.

Getting What You Pay For

Another positive step, they say, is a new effort by the United States Pharmacopeia, an independent group that sets quality standards for prescription and over-the-counter drugs. Responding to industry demand, the USP is launching a pilot program aimed at creating a national certification system for dietary supplements. Manufacturers meeting USP requirements would be able to carry a certification mark on their labels, which would indicate to consumers that a supplement contains what the label says it does - and nothing else.

"The certification mark would mean that the company has followed good manufacturing practices, we've reviewed the tests that they applied to their products and also that the quality of the ingredients is there," says USP general counsel Joseph Valentino. "We would also do some post-market surveillance and test some products to make sure the system is working."

While many say increased oversight of the supplement industry is needed to protect the public health, just how much and by whom is a highly controversial issue that is unlikely to be easily resolved.

"As a medical practitioner, I wish we would have more labeling that warned patients about interactions [with other drugs] and cases in which they shouldn't take a supplement," says Dr. Mary L. Hardy, medical director of the integrative medicine medical group at Cedars-Sinai Medical Center in Los Angeles, who regularly prescribes herbal therapies.

But, she says, "you don't need to standardize every cup of chamomile tea you drink to relax before going to bed."

Copyright © 2001 MSNBC.

This article posted April 22, 2001.