If the fact of his death was hard to accept, so was the cause. From talking to her son’s friends, Karen has surmised that they spent the day of March 6 wandering in and out of the beach town’s novelty shops, where they were inundated by flashy signs and posters touting herbal supplements with names like Cloud 9, Herbal Ecstacy (sic) and Ultimate Xphoria. According to the promotions, these little packets of pills would deliver increased energy, “inner visions,” “sexual sensations” and “cosmic consciousness.” Best of all, they were natural, legal and cheap. That night, by Karen’s account, the kids settled on Ultimate Xphoria. The package suggested a dose of four tablets, but most of them followed a store clerk’s advice and took 12 to 15. Pete took just eight, but they hit him hard. Complaining of tingling sensations and a headache, he decided to stay behind at the motel while his pals went out for the evening. They found him dead on the floor when they returned. According to the local medical examiner’s report, he died from the “synergistic effect of ephedrine, pseudoephedrine, phenylpropanolamine and caffeine,” the active ingredients in Ultimate Xphoria.
The product’s distributor, Alternative Health Research Inc. of Tempe, Ariz., isn’t commenting on the incident. But just about everyone else is. Peter Schlendorf’s death was just the latest of several linked to ephedrine-containing compounds. It has alarmed parents and health officials, and it raises new questions about the safety of the largely unregulated nutritional-supplements industry. States and localities are rushing to clamp down on the new herbal stimulants–the state of Florida announced last week that it is banning them altogether–and the Food and Drug Administration is voicing official outrage. “When a 20-year-old dies from taking a product like this, something is very wrong,” says FDA Commissioner David Kessler. “We need to be sure it doesn’t happen again.”
THE QUESTION IS, how? If the supplements craze were confined to a few twentysomethings looking to get high, the issue would be straightforward. But they’re just a small part of the picture. Whether they want to lose weight, gain muscle, soothe nerves or stave off the AIDS virus, Americans are taking up natural remedies as never before. We spend some $6 billion annually on nutritional supplements – everything from vitamins and minerals to herbs, seeds, pollens, oils and enzymes–and the market is growing by 20 percent every year. Critics say this burgeoning industry has run amok and needs regulation. Herb lovers say most natural nostrums are harmless if used sensibly, and they bristle at the prospect of having the government tell them what they can put in their bodies. In the wake of the Florida incident, each camp is accusing the other of bad faith. Unfortunately, they’re both right.
Critics of the industry say the trouble started in 1994, when Congress passed the Dietary Supplement Health and Education Act (DSHEA), cosponsored by Sens. Orrin Hatch and Ted Kennedy. By classifying vitamins, minerals and herbs as food supplements rather than drugs, the bill reduced the FDA’s control over them. Now marketers can’t make explicit health claims for a supplement (“cures cancer”), but they can promote its known effects on the “structure and function” of the body (“protects against cell damage”), and they can give it any name they like (“Tumor Be Gone!”). Unless the FDA can show that the product is dangerous, it can’t restrict sales.
The catch is that many herbs are, in effect, drugs. Ephedra, the key ingredient in Ultimate Xphoria and its kin, is a plant that Chinese physicians have used for 2,000 years to treat upper-respiratory ailments. Its active chemical, ephedrine, is in many decongestants and bronchodilators. But what interested some supplement makers in ephedrine was its stimulant effect. By combining it with caffeine, another natural upper, they created nonprescription speed. For the past couple of years, 80 or so companies have promoted the blend as a safe way to lose weight, boost energy, stay alert or get high. Though hard figures are unavailable, the makers of Herbal Ecstacy say they alone have sold 150 million pills. “Consumers may not realize it,” says Norman Farnsworth, a pharmacognosist (herb expert) at the University of Illinois in Chicago, “but what they’re dealing with here is a medicine.”
And a potent one. Within 20 minutes of taking an ephedrine-based stimulant, users experience a jump in heart rate and blood pressure. In some people, says Purdue University pharmacognosist Varro Tyler, that surge can lead to seizures, heart attacks and strokes. Police Sgt. Charles Nanney of Miami was 28 and in peak physical condition when he started taking an ephedrine-based sports-training formula two years ago. After a few months of popping one or two tablets before his daily workout, one morning he suffered a stroke, which he says caused him permanent brain damage (for which he’s suing the maker and the distributor). His experience, like Peter Schlendorf’s, suggests the new stimulants have an extremely narrow safety margin. But there’s no reason to think that every user is equally vulnerable. Though the products have become staples among truckers, dieters and nightclub kids, the FDA has recorded only 400 health complaints and 15 possible deaths.
No other supplement has caused as much trouble as ephedrine – and for many other widely used remedies, the risks appear negligible. There’s no evidence, for example, that the millions of Americans who take echinacea to prevent colds and flu are in danger. And though countless aging baby boomers now end the day with a few milligrams of melatonin–a naturally occurring hormone touted as an antidote to afflictions from insomnia to the aging process–no one has documented any toxic effects. But several other commonly used herbs are giving health experts the jitters.
Some herb lovers take an extract from the leaves and twigs of chaparral, an evergreen desert shrub, in the hope of preventing cancer, preserving youth or alleviating arthritis. Several medical reports suggest it can damage the liver. One, published last year, involved a 60-year-old woman who’d been taking one or two capsules a day to boost energy. When she upped her dose to six capsules, she developed such severe hepatitis that she required a liver transplant. Many pharmaceuticals–even over-the-counter analgesics–can cause liver damage in susceptible people. But because they’re tested and prescribed at specific doses, risks and benefits are well known. “We don’t have any idea about the magnitude of the risk in chaparral,” says University of Chicago hepatologist Alfred Baker.
Even dicier is comfrey, a coarse, hairy perennial whose leaves and roots have been used in folk medicine for everything from wound healing to blood cleansing. There’s little danger in using a comfrey tincture topically, says Tyler, but taken orally, it’s “definitely hazardous.” Comfrey contains chemicals called PAs (pyrrolizidine alkaloids), which can gum up the vessels in the liver, starving it of blood. Canada has banned it, and most European countries regulate the concentrations in which it’s sold. But comfrey is unregulated in the United States, and readily available in most health-food stores. Says Tyler: “It shouldn’t even be on the market.”
You could also say that about pennyroyal, a member of the mint family whose concentrated extract can cause liver damage, coma, convulsions and death–in amounts of less than a teaspoon. Native Americans once used the leaves (which are far less noxious) for coughs and menstrual cramps. Alternative-medicine enthusiasts tout the extract as a natural way to induce abortion. That’s what 24-year-old Kristina Humphrey had in mind two years ago. Humphrey, a sociology student at San Jose State University, didn’t like the thought of ending her unwanted pregnancy in a cold, impersonal surgical suite, her parents recall. So she bought a container labeled FRESH PENNYROYAL HERB and followed directions that said, “Add 20-40 drops of extract to a small amount of warm water and take 3 times daily as needed” (to avoid “medical claims,” most labels don’t mention what a supplement might be used for).
ONE NIGHT, HER PARENTS SAY, she broke into a cold sweat and crawled into a bathtub hoping to ease a stabbing abdominal pain. When her boyfriend found her unconscious he called paramedics, who rushed her to San Jose Hospital. There, emergency physicians surgically removed what turned out to be an ectopic pregnancy. The fetus hadn’t ruptured her fallopian tube, yet she bled so profusely that she lapsed into a fatal coma. “The cardiac arrest occurred because of shock,” the emergency physician’s report said. “The shock occurred because of abnormal blood clotting ability due to liver damage. The liver damage was caused by pennyroyal.” In a lawsuit against the herb’s packager, Humphrey’s parents are seeking not only money but a clear warning on every bottle sold: “Pennyroyal in tincture form has been known to cause liver damage and should not be used as a substitute for medical abortion under any circumstances.”
Active ingredients aren’t the only ones that can make a supplement dangerous. With no regulation, contamination is always possible. In the late 1980s, 1,500 people got a painful connective-tissue disease called EMS (eosinophilia-myalgia syndrome) after taking the amino acid L-tryptophan as a sleep aid. The illness, which claimed at least 38 lives, was linked to contaminants in a single Japanese brand (the FDA responded by banning L-tryptophan entirely). Contaminants have also turned up in herbal teas. Two years ago officials traced several New York City poisonings, none fatal, to Paraguayan tea that contained belladonna leaves. And even when a supplement is harmless by itself, it can interact with other foods or medications in unexpected ways (chart).
For all the fear they inspire, herbal horror stories are rare. According to the American Association of Poison Control Centers, pharmaceutical products kill roughly 500 people for every person killed by an herb. And while plants cause about 50 nonfatal poisonings each year (that’s if you count all the jade, holly and poinsettia that kids eat by mistake), pharmaceuticals cause about 7,000. “The data just doesn’t support the view that these products cause widespread harm,” says Loren Israel-sen, executive director of the Utah Natural Products Alliance.
The FDA hasn’t exactly discouraged that view in recent weeks. No one faults the agency for the consum-er alert it issued on April 10, urging people to avoid ephedrine-based stimulants (Kessler calls them “street drugs masquerading as dietary supplements”). But supplement makers were outraged two weeks later, when The New York Times portrayed agency officials as complaining that DSHEA, the 1994 congressional act, had left them powerless to police even known poisons such as hemlock “until the bodies piled up.” In fact, the agency can ban any product for which it can show “substantial or unreasonable risk” – not a hard standard to meet where hemlock is concerned. It can also mandate warnings. Last fall, after reviewing the safety of ephedrine, an advisory committee suggested mandatory warning labels for products like Ultimate Xphoria and Herbal Ecstacy–labels describing side effects, drug interactions and the risk of overdose. The agency has done nothing about that recommendation because, says a spokesman, the committee wasn’t specific about how the label should be worded. Kessler says the Schlendorf death “will now allow us to go into court and take regulatory action.”
If the FDA has dropped the ball, so have the supplement makers. In early 1994, the American Herbal Products Association urged its members to suspend sales of chaparral and to place clear warnings on products containing ephedrine. But it later withdrew the chaparral recommendation. And though some ephedrine products do include cautions and dosing instructions, the warnings are vague, inconsistent and voluntary. “We need either self-regulation or government regulation,” says Joseph Pizzorno, the naturopath who heads Seattle’s Bastyr University. For now, it seems we’ll have to settle for mutual finger-pointing.
Herbal remedies that are safe by themselves can have bad effects when combined with other food or drugs. Some examples:
Long-term use of stimulant herbal laxatives such as cascara and senna can increase the potency of the heart medicine digoxin, placing stress on the heart.
When mixed with lithium, a diuretic herb such as birch leaf, dandelion leaf or juniper may increase the drug’s concentration in the bloodstream.
Yohimbe, and herb used as an aphrodisiac and for energy, can cause skin rashes when mixed with a tyramine-rich food such as liver, cheese or red wine. Yohimbe can also cross-react with over-the-counter products containing phenylpropanolamine, such as nasal decongestants and diet aids.
Americans spend more than $6 billion annually on nutritional supplements–$1 billion on herbs and teas alone, and the market is growing by 20 percent a year.
Sales of all supplements (Projections for 1996, in millions)
Diet aids $453 Minerals 720 Herbal supplements 1,007 Sports nutrition 1,429 Vitamins 3,535
