Lisa Woolworth, 34, a Chicago paralegal, is a self-confessed pill popper. She takes a dozen different ones a day: a multivitamin; bee pollen with ginseng (“good for inflammation and pain,” she says); a mixture of carnitine and glutathione; Echinacea (herbal “immune boosters”); lecithin (“good for absorbing fats and for brain function”), and antioxidant tablets that combine vitamins A, C, E and selenium and zinc (partly to “counteract” her smoking). To help her sleep, she also gulps down an herbal liquid (“it’s like a nervous-system relaxer”). It adds up to $120 a month-a big bill but, Woolworth says, a small price for her health. “If I take them every day,” she says, “I feel pretty damn good.”
Is she really getting her vitamins? She may think so, but she can’t be sure. Even though nearly half of all Americans take some dietary supplement daily, virtually no federal manufacturing rules cover this $4 billion-a-year industry. Vitamins, minerals, herbal preparations and amino acids fall into a regulatory gray area, between food and drugs. And that means that no one is watching over an enormous range of products: everything from Flintstones vitamins to Ultra Male, which boasts that it contains “ground raw bovine prostate.” Although some concoctions could have dangerous side effects, there’s no law requiring manufacturers to put warnings on the label.
All that may change soon. NEWSWEEK has learned that on June 15, the FDA will propose new rules that call for full disclosure on labels of vitamins and minerals. At the same time, the agency will announce a serious inquiry into herbals-not rosemary and thyme but potent brews used as an alternative to pharmaceuticals. The FDA will also raise serious questions about the nutritional value and safety of the fast-growing amino acid portion of the industry (some of these products are aimed at body-builders and dieters), which may lead to some supplements’ being pulled off store shelves and recategorized as drugs requiring a prescription. “We’re not looking to deprive anyone of taking what they want,” says FDA Commissioner David Kessler, “but we believe that what’s in the bottle should be safe, and claims shouldn’t be made that can’t be substantiated.”
The dietary-supplement industry, which has resisted regulation for decades, vows to fight back-as do those consumers who trust these products more than prescription drugs. Both say the FDA’s proposals are extreme and will either drive prices up or drive companies out of business. “There are people in the [FDA] . . . who are totally out of touch with contemporary research in this field,” says Alexander Schauss, executive director of Citizens for Health, a consumer-advocacy group. “There just is virtually no risk associated with dietary supplements. We might as well take aspirin off the market because people die of aspirin overdoses.” Manufacturers have mounted a massive public-relations campaign to convince consumers that, as one press release claims, “if the FDA has its way, you won’t be able to buy chamomile tea without a prescription.”
The FDA started zeroing in on dietary supplements in the late 1980s after doctors traced an epidemic of unusual and serious symptoms to L-tryptophan, an amino acid. “The issue was a sleeping dog that we didn’t kick,” says Michael Taylor, the FDA’s deputy commissioner for policy, “but it got up and started barking at us. Now we’re going to have to take account of them.” L-tryptophan was banned in 1990. Since the outbreak, 37 people have died and 5,000 have been injured by what some researchers think was contamination in the manufacturing process. Since then, doctors at the Mayo Clinic have reported new cases among patients who took other supplements, including an amino acid and niacin.
Purity is also a critical issue for people afflicted with genetic disorders involving a vitamin, mineral or amino acid deficiency. Their lives depend Oil a reliable supply of these substances. “In the marketplace today, the general public doesn’t know what brand to trust, and what not to trust,” says Dr. Jess Thoene of the University of Michigan, an expert on these rare diseases.
In fact, the potency and purity of dietary supplements can vary widely-even from pill to pill within the same bottle. Doctors at Duke University recently examined 12 bottles of L-carnitine and found that most samples contained 60 percent or less of the substance. More than half of the brands were indigestible by humans: in other words, it was going in one end and out the other. The researchers also looked at samples of vitamins B, and B, and found that up to 20 percent of the pills were not digestible. Again, money down the toilet.
People assume supplements are safe because they’re sold over the counter, often on the supermarket shelves, or because they’re marketed as health food. Their lure is their distance from conventional treatment, which some people distrust. Cynthia Attwood, a Labor Department attorney, started taking L-tryptophan in 1989 because she was having trouble sleeping and she thought it would be a nonnarcotic sleep aid. But after a few weeks, she started having “excruciating” muscle pain and soon was unable to work. It took doctors months to pin the blame on L-tryptophan. “I never thought it was going to harm me,” says Attwood, who’s still in pain. “I thought this was something like what was naturally in milk to help you sleep.”
Because they’re unaware of possible complications, people often treat supplements more like food than medicine, leaving them within easy reach of children. The packaging doesn’t have to be tamper-proof, either; young children can get at them as easily as a box of raisins. In 1991, 56,331 calls to poison centers around the country were questions about vitamins and minerals. Of 18 deaths reported, most were young children who had taken iron pills prescribed for their parents, according to the American Association of Poison Control Centers. This spring, three Denver toddlers were in critical condition after swallowing a Chinese herbal product, Jin Bu Huan, that came in a colorful, child-friendly package. The “natural remedy” turned out to be a powerful central-nervous-system depressant.
The children have since recovered-because doctors knew they had been poisoned. But many people who take dietary supplements don’t tell their doctors what pills they’re popping, leaving themselves vulnerable to potentially dangerous interactions. Products containing calcium, for example, could reduce absorption of antibiotics. The herb Ma Huang, a popular ingredient in natural energy-boosting products, rarely discloses that it is a bronchodilator. In asthmatics and other people, it could lead to tremors, anxiety and uncontrolled shaking.
While some products are dangerous only in large doses, others are risky to certain people. For example, chamomile is in the ragweed family and can cause an allergic reaction or an asthma attack. Consumers can’t count on labels to tell them if a product could be hazardous. A few weeks ago, Tampa, Fla., police seized several thousand pills containing what was supposed to be a Chinese herbal pain remedy called Tung Sheuh. Drug experts said the pills actually contained the chemical equivalent of Valium.
Manufacturers of dietary supplements say these problems are the exception, not the rule, in their business. “There is a small segment of the industry whose activities need to be curtailed,” says J. B. Cordaro of the Council for Responsible Nutrition, which represents the 66 biggest producers of vitamins and minerals. He says his group makes recommendations to members for product warnings, but admits not all companies comply. “It puts them at a competitive disadvantage in the market-place,” he says. “If my label lists the chemical names of ingredients, and your product doesn’t do that, that gives the impression that your product is ’natural’ and mine is not.” Mandatory rules of some kind would be better; then, “everyone is equal.”
The biggest conflict is over what benefits dietary supplements can claim on their labels, and how manufacturers need to prove these claims. Truth is a relative term here. The FDA would like products to make claims only if there’s “substantial” scientific evidence behind them; in other words, general agreement among scientists. But the manufacturers and some consumers think that will keep promising new therapies out of consumers’ hands. A few years ago, the FDA was criticized for keeping experimental AIDS drugs out of the hands of desperate patients. “Dietary supplements are on the cutting edge,” says Gerald Kessler (no relation to the FDA’s Kessler), president of the Nutritional Health Alliance, which includes health-food stores and herbal manufacturers. “What we want is reasonable science.” Gerald Kessler, who makes Ultra Male, argues that the industry should be able to make health claims if there is any data at all to back the assertion.
Supplement-industry critics say consumers have to be able to rely on scientific claims made on labels. Laymen “can’t be left to judge the veracity of the study,” says Bruce Silverglade, legal director of the Center for Science in the Public Interest. “If future studies don’t prove something to be true, no one is going to get their money back, and in the end, the consumer is going to feel ripped off.”
After the FDA report is released, the vitamin wars will move to Capitol Hill. In 1990, Congress passed the Nutrition Labeling and Education Act, which requires more detailed labeling of food and dietary supplements. The supplement industry rallied against it. With the help of Sen. Orrin Hatch, whose state of Utah is home to the largest number of supplement manufacturers, they won a one-year moratorium, ending in December (food products had to comply this year). During this grace period, the supplement industry has helped write bills sponsored by Hatch and Rep. Bill Richardson of New Mexico that require at least some data about content and quality on product labels.
Both sides-the FDA and the industry-now say that it’s up to consumers to decide how much freedom or protection they want. That’s only fair, since no matter how the issue is settled, the consumers will end up paying for it–either with higher bills or with their health.
