Commentary: Herbal Remedies: This Market Is A Bit Too Free

Bill J. Gurley figured that testing dietary supplements containing the popular herb ephedra for harmful effects would be a straightforward task. After all, the labels list the amount of each active ingredient, so the University of Arkansas pharmacologist would know the doses.

But when Gurley analyzed the supplements, he got a big shock. Not only do the contents of many products vary sharply from their labels, different batches of the same supplement contain widely different levels of ingredients. A sample of one product contained 2.4 times more ephedrine than tablets from another bottle. Another batch had 50% more active ingredients than the label claimed. "We said, `My God, this is pretty scary,"' Gurley says.

TRAGIC. Tens of millions of Americans are buying ephedra supplements--and yet, no one really knows how safe they are, or even what's in them. The consequences can be tragic. In early August, the U.S. Public Health Service held an open meeting to hash over scores of reports of people killed or harmed by products containing the herb. For instance, Barbara Michal, founder of a group named Halt Ephedrine Abuse Today (HEAT) blames the supplement for killing her 24-year-old son Kristopher in 1997. Indeed, companies have already quietly settled several lawsuits brought by those who blame ephedra for everything from insomnia and heart attacks to stroke and seizures. Dozens more are pending.

Yet the tales of the purported victims aren't likely to result in regulation any time soon. The estimated $12 billion dietary supplement industry has powerful congressional friends. In 1994, Senator Orrin G. Hatch (R-Utah) spearheaded the passage of a law that lets supplement companies sell almost anything they want. Although a few states such as Texas have required stronger warning labels, Federal lawmakers are weighing a measure, sponsored by Pat Roberts (R-Kan.) in the Senate and Richard M. Burr (R-N.C.) in the House, that would exempt both food and supplement makers from many state rules.

To be sure, for most dietary supplements the lack of regulation doesn't do harm, save perhaps to consumers' wallets. One big exception may be ephedra. Extracted from plants of the genus Ephedra and often known as ma huang, ephedra has been used for more than 5,000 years in China to relieve nasal congestion and asthma. For those conditions, it has offered relief. But today we have better, safer drugs. "Medicine moved past ma huang a century ago," says Dr. Raymond L. Woosley, chair of the pharmacology department at Georgetown University. "There's absolutely no reason to supplement your diet with ephedra."

Moreover, the Chinese never imagined that Americans would push the stuff as a "natural" mood enhancer, energy booster, or diet aid. Ephedrines, the druglike chemicals found in the herb, cause "feel-good" substances to be released in the brain and suppress appetite. But pharmacologists have known for decades that ephedrines increase heart rates and blood pressure, potentially leading to problems such as heart attacks and cardiac arrhythmia. Worrisome new details have emerged from recent studies. Hong Kong toxicologists showed, for instance, that ephedra can harm brain cells in the test tube. Another study, by Dr. George Ricaurte, a neurologist at Johns Hopkins University School of Medicine, found that ephedrine caused damage in key nerve cells of primate brains similar to that caused by methamphetamine or "speed," a close chemical cousin.

All of which worries the Food & Drug Administration. Ephedra-containing supplements "continue to be a serious public-health concern," says the agency's Dr. Lori Love. But the FDA doesn't have the resources to crack down on companies whose product ingredients don't match the label. The industry also has been able to block the FDA and many states from taking even small regulatory steps such as limiting doses. In Texas, it fought off a proposal to make ephedra available only by prescription. Until recently, the FDA hasn't been able to follow up on sketchy reports of harm to learn if the injuries or deaths were caused by ephedra or were merely coincidental. "It's been a Catch-22," gripes one FDA policy official. "They say we don't have the data, and they didn't give us the budget to get the data." Given the lack of government action, the only people fighting the industry are the lawyers, says California plaintiffs' attorney John E. Tiedt. He has some 14 cases and is trying to organize a class action.

QUALITY CONTROL. Industry execs argue that the FDA already has the power both to shut down shady companies peddling ephedra as a legal high and to impose better quality-control standards. Beyond that, they say, no new regs are needed. Moreover, how can scientists claim that ephedra is dangerous if the FDA has received only about 1,100 reports of injuries from the millions of people who have taken it? asks Jerry L. McLaughlin, research chief at Nature's Sunshine Inc. in Provo, Utah. "The total incidence of adverse effects is very small," he argues.

That's cold comfort to critics. The FDA's reporting system spots just the tip of the iceberg, so the real total is likely to be orders of magnitude higher. Indeed, there's more than enough evidence now to support taming the wild frontier of dietary supplements. The FDA should move ahead with proposed quality-control rules, so that the stuff in the bottle actually matches what's claimed on the label. And it should also mandate stronger warning labels about potential harmful effects. If the agency doesn't, "sooner or later there will be many, many people injured," warns Georgetown's Woosley. It's time to protect naive Americans from their mistaken impression that a "natural" product can't hurt them.