Echinacea. Kava kava. St. John’s wort. Ten years ago, few Americans outside the natural health community had ever heard of these exotic botanicals. Today herbs like these are household words, comprising the fastest growing segment of a $15 billion a year dietary supplement industry. Herbal products now are widely available in supermarkets and pharmacies, sold as ingredients in capsules, teas, brand-name vitamins and even special formulas for children. Millions of Americans regularly use herbal remedies in hopes of relieving a variety of health problems, from the common cold to Crohn’s disease.
At one time such a flood of herbal health products into the American mainstream would have been impossible. Until 1994, the Food and Drug Administration classified most herbal remedies as either “food additives” or “drugs.” In either case, manufacturers had to meet strict, sometimes prohibitive, FDA standards before placing their products on the market.
But the Dietary Supplement Health and Education Act of 1994 (DSHEA) changed all that. Herbal remedies and many other products formerly regulated as food additives or drugs are now classified in a special food category called “dietary supplements.” The upshot of this legislation is that manufacturers can now market herbal remedies and other supplements without first obtaining FDA approval of their safety and efficacy. This applies even to supplements with powerful chemical properties, such as St. John’s wort. Despite its considerable antidepressant qualities, this herb is regulated as a food, not a drug, and therefore has never passed through the rigorous approval process required of pharmaceutical products.
DSHEA supporters claim that dietary supplements have a long history of safe use and should be available to informed members of the public who wish to exercise all their health options. Congress prefaced the act itself with the conclusion that “consumers should be empowered to make choices about preventive healthcare programs based on data from scientific studies of health benefits related to particular dietary supplements….Dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare.”
Dietary supplement proponents also contend that the FDA has in the past repeatedly overstepped its bounds in attempts to regulate herbs and other natural products. Sen. Orrin Hatch of Utah, the foremost congressional champion of the dietary supplement cause, advances this position. “Today,” he announced immediately before the Senate vote on DSHEA, “we honor the wishes of 100 million people, consumers of dietary supplements, people who simply want the ability to lead healthy lifestyles without the constant intervention of one tiny agency which is possessed by a regulatory zeal equaling none.”
Among the instances of “regulatory zeal” to which he objected was one celebrated case which became a rallying cry for the pro-supplement constituency — the United States vs. An Article of Food. In 1988, FDA agents seized two drums of black currant oil from Viponte Ltd., seeking to prevent them from manufacturing that product in capsule form. The FDA never argued that the oil itself was hazardous, but rather that it would be “adulterated” through its encapsulation with gelatin and glycerin, turning the otherwise harmless oil into a “food additive not generally recognized as safe.” The 7th U.S. Court of Appeals rejected the FDA’s argument in 1993, declaring that the FDA had “not shown that black currant oil is unsafe or adulterated in any way” and dismissing the FDA’s logic as an “Alice-in-Wonderland approach.”
If the FDA’s campaign against dietary supplements had gone too far on occasion, critics argue that the regulatory pendulum has now swung dangerously to the other extreme. “Basically it is a great, uncontrolled experiment with the American public as the guinea pigs,” said Gilbert Ross, M.D., medical director for the American Council on Science and Health, an educational consortium of scientists and physicians that regularly contributes articles and editorials to drkoop.com.
“Now instead of having to show that a substance is safe and effective before being marketed, there is no such restriction and the FDA can only come in to restrict a substance if it has been shown to be dangerous.”
Former FDA Commissioner David Kessler echoes these thoughts in a recent New England Journal of Medicine editorial. “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. Nor does the public understand how potentially dangerous these products can be.”