Americans are embracing dietary supplements like never before. Last year we spent over $5 billion on compounds ranging from ordinary multivitamins to exotic herbal products. We hope they'll prevent or cure our ills, put us to sleep or make us alert, turn us into powerful athletes or help us shed pounds without decreasing our caloric intake or exercising more.
Since many supplements are touted as "natural," we assume that they must be safe. But swallowing all these pills and powders has resulted in some tragedies:
- In 1989-90, more than 1500 people became seriously ill, and about 30 died after taking a defective preparation of L-tryptophan, an amino acid sold to improve sleep.
- Many people have experienced permanent nerve damage from large doses of vitamin B6, which is promoted to relieve premenstrual syndrome and other maladies.
- In 1995, a woman required a liver transplant after consuming large quantities of chaparral tea, and another died after taking penny royal oil to induce an abortion.
- Also in 1995, researchers reported that 10,000 IU
of supplemental vitamin A could cause birth defects when taken early in pregnancy.
- Just this year, the Journal of the American Medical Association reported on a man who suffered hair loss, pathological changes to his nails and extreme fatigue after taking selenIU
m supplements containing up to 1,000 times more of this mineral than the label indicated.
- And several young people died after taking products such as Herbal Ecstasy and Cloud 9, which contain the stimulant drug ephedrine. They were looking for a legal, 'natural' high.
But here's the irony: As evidence mounts that some supplements can cause illness or even death, a recent law, the Dietary Supplement and Health Education Act, has left consumers less protected than ever from such tragedies. Also known as the Hatch Act (after Utah Senator Orin Hatch, who championed it), this law allows dietary supplements to be marketed with no prior testing of their safety or effectiveness.
Conflicts involving supplements and how to regulate them is nothing new. Twenty years ago, in response to supplement industry-generated pressure, Congress passed the Proxmire Amendment to the Food, Drug, and Cosmetic Act. This amendment prevented the FDA from regulating supplements unless they are inherently dangerous or the manufacturer makes illegal therapeutic claims for them.
In the early 90's, as part of an effort to tighten Federal control over supplements, FDA Commissioner Kessler set up a Dietary Supplement Task Force to make recommendations about changes in the law. The health-food industry reacted with a publicity campaign designed to frighten people into believing that the FDA wanted to make supplements such as vitamin C available only by prescription and to otherwise drastically restrict access to supplements. The campaign, featuring a TV commercial in which actor Mel Gibson had his medicine cabinet raided by Federal storm troopers, prompted consumers to swamp their congressmen with an unprecedented number of phone calls and letters. Congress responded to the resulting public outrage by passing the Dietary Supplement and Health Education Act of 1994 (the Hatch Amendments) .
Under the Hatch Act, nutritional supplements are not classified as foods, drugs or food additives. Instead, the law created a new legal category, known as dietary supplements, comprising vitamins, minerals, herbs, amino acids and anything else that had previously been sold as a 'supplement,' plus anything found in any natural plant in any quantity, however small.
Most important of all, the new law means that manufacturers need no longer worry about FDA demands that they prove their products are safe and effective (as is required of drugs) or even merely safe (as is required of food additives). Instead, the law shifts the burden of proof to the FDA, which must prove that a product is unsafe before it can order it off the market.
As in the past, supplements also aren't required to meet the labeling standards demanded of drugs. For example, supplement makers don't have to list all their products' ingredients on their labels and don't have to test their ingredients for purity. Such omissions are especially unfortunate when it comes to herbs. Dr. Varro Tyler, noted pharmacognocist at Purdue University notes that the common name "snakeroot" is used to describe at least six different plants. "Even if consumers learn about the proper uses of herbal remedies," he says, "they have no way to tell whether the herb in the bottle is one they're really looking for."
Labels on herbs or vitamins still can't boast that the products will prevent or cure a disease only drugs are allowed to make those claims. But now, supplement labels are allowed to state that the product can have a beneficial effects on a structure or function of the body.
For example, the label on a bottle of vitamin A can't include the oft-made claim that vitamin A cures cataracts (it can't ). But it can say that vitamin A is necessary for normal vision. The implication for consumers, of course is that vitamin A might be good for a host of serious vision problems. Such grandiose claims, while still forbidden on labels, are often spelled out much more explicitly in pamphlets and other literature offered in stores where supplements are sold.
When devising labels describing how their products affect the body's structure or function, supplement makers can pretty much say what they want. Under the new law, they must submit labeling claims for FDA approval but they needn't wait for approval before putting those claims on labels. Non-approved claims are allowed to appear, as long as they're accompanied by the statement that 'FDA has not reviewed or approved this claim.'
Although manufacturers are supposed to have evidence that claims can be substantiated, they don't have to show their evidence unless claims are challenged by regulators. This means that manufacturers have a virtually free hand until someone notifies the authorities that there is a serious problem.
In addition, supplement makers are under no legal obligation to disclose the possible negative health effects of their products. Some manufacturers do list adverse effects voluntarily on their product labels but most don't, as ACSH found after checking the labels of 12 brands of vitamin A in six health food and drug stores in New York City (see Table 1). A young woman purchasing vitamin A would learn from only two of the 12 brands that high doses could cause birth defects; none tells her what the dangerous level is. Unfortunately, vitamin A exerts its toxic effects mainly during the first eight weeks of pregnancy a time when many women don't even know they're pregnant. With a clear warning, a woman trying to become pregnant or aware that she might become pregnant would know to avoid large doses of the supplement.
Labels of herbal preparations present similar problems. When we looked at the labels of several of the herbal products listed in the sidebar, we found that most had no warnings. For example, four out of five brands of aloe had no warning nor did seven of eight brands of licorice nor any of three brands of chamomile.
How Should the Law be Reformed?
Improvements in labeling could help reduce the risks posed by dietary supplements. These improvements wouldn't hinder the public's access to supplements but would provide consumers with the information they need when buying the products:
- Health claims made on supplement labels should be required to meet the same scientific standards as those permitted on food products.
- If overdoses of a supplement can produce toxicity, manufacturers should be required to state the level above which toxic effects may occur and describe the side effects that may occur from overdoses.
- If it's not known whether a product is safe for certain vulnerable groups, such as children or pregnant or lactating women, that information should be included on the label.
- If a dietary supplement can interfere with the action of a commonly used medication, that interaction should be listed on the label or in literature accompanying the product.
- If a label describes the traditional uses for herbs or other products, the label must also state whether scientific research has substantiated such uses.
- The scientific botanical names of herbal products should be given on the labels. The manufacturer must be able to demonstrate that this information is correct, i.e. that if a label claims an herb is Ginseng panax, the manufacturer must be able to show that this is indeed what's in the bottle. This could be done by having an expert attest to the identity of the plant, or by demonstrating some unique chemical component of the plant, if such exists.
One legal effect of the 1994 Hatch Amendments is to differentiate dietary supplements from drugs. But as a practical matter, both supplements and drugs may pose risks as well as offer benefits. Consumer should have the right to buy supplements, but their choice should be an informed one. That will be possible only when supplement labels reveal much more information about the potential risks associated with these products.
Some Herbal Teas and Remedies that May Have Dangerous Side Effects*
- Aloe: strong irritant cathartic; can induce diarrhea
- Chamomile: can induce allergic reactions in those sensitive to ragweed, golden rod and other plants
- Chaparral: can have acute toxic effects on liver
- Comfrey: contains compounds toxic to liver; especially found in roots
- Foxglove: has digitalis-like activity (a commonly used heart medication)
- Ginseng: long term use may mimic corticosteroid poisoning
- Horse chestnut: contains toxic coumarin glycosides
- Licorice root: may cause increased blood pressure, water and sodIU
- Mandrake: contains a strong hallucinogen (may sometimes be sold as ginseng)
- Mistletoe: may raise blood pressure, should be avoided by those taking monoamine oxidase inhibitors.
- Sassafras: contains safrole, a potent carcinogen (banned in foods)
- Senna: can cause diarrhea; strong cathartic
- Woodruff: can interfere with blood clotting, can cause liver damage
- Vinca: contains toxic compounds that may damage liver
*Source: Pronsky, ZM. Food Medication Interactions. 8th ed. 1993. Food-Medication Interactions, Pottstown, PA.
Ruth Kava, PH.D., R.D., is Director of Nutrition at The American Council on Science and Health.
(From Priorities Vol. 8, No. 3, 1996)