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In retrospect, it all seems so predictable. Put an unregulated industry hawking largely ineffective or unproven products on a free-wheeling medium, and false claims are sure to proliferate. In this case, the industry is dietary supplements and the medium the Internet.
Dietary supplement consumption is increasing massively in the U.S. Sales in 2001 totaled $18 billion. The increase in use — 380% between 1990 and 1997 — didn’t just happen because consumers suddenly recognized the usefulness...
In retrospect, it all seems so predictable. Put an unregulated industry hawking largely ineffective or unproven products on a free-wheeling medium, and false claims are sure to proliferate. In this case, the industry is dietary supplements and the medium the Internet.
Dietary supplement consumption is increasing massively in the U.S. Sales in 2001 totaled $18 billion. The increase in use — 380% between 1990 and 1997 — didn’t just happen because consumers suddenly recognized the usefulness of these products. It is instead the result of the deliberate deregulation of the industry under the Dietary Supplement Health Education Act of 1994 (DSHEA). This law allows producers to make claims of a supplement’s impact upon bodily “structures and functions,” but not to make specific health claims for the product. So, according to the framers of this act, it is now okay for a dietary supplement manufacturer to claim that its product “builds healthy bones,” but not that it “prevents osteoporosis.” This is the kind of distinction only a lawyer could love. Under DSHEA, structure/function claims require no evidence of safety or effectiveness whatsoever (although they are supposed to include a disclaimer noting that the Food and Drug Administration has not evaluated them). Health claims, by contrast, require pre-approval from the FDA.
What better place to make baseless claims than the largely lawless Internet, used by 140 million in the U.S., about two-thirds of whom have sought health information. It was a match made in heaven.
Recently, researchers at Harvard decided to examine the claims made by dietary supplement manufacturers on the Internet (Journal of the American Medical Association 2003; 290:1505-9). They used the five most common Internet search engines to identify web sites on the eight dietary supplements with the largest sales in 2000. They then analyzed the health content of all sites on the first page of their search results. The results demonstrate the ugly and dangerous consequences of reckless deregulation.
Seventy-six percent of the sites either sold a product or provided direct links to a site that did. Only 22% of those sites provided a medical reference of any kind. Eighty-one percent made some claim regarding health and 55% of these claimed to prevent, diagnose, treat or cure a specific disease — precisely the kind of claim banned by the FDA. Half of those making health claims omitted the FDA-required disclaimer.
Critical safety information was frequently omitted. For example, only 39% of sites for kava kava, a plant from the South Pacific used for relaxation, insomnia and menopausal symptoms, mentioned the life-threatening liver toxicity caused by the drug. Others made long strings of fanciful claims: “The herb valerian is most effective in treating a wide range of stress conditions such as irritability, depression, fear, anxiety, nervous exhaustion, hysteria, delusions, and nervous tension...The herb is especially useful for treating shingles, sciatica, neuralgia, multiple sclerosis, and epilepsy.” No wonder it’s selling like hot cakes.
The result of this profusion of misleading, unsupportable and just plain false claims is that consumers are left in the lurch. DSHEA does not require dietary supplement manufacturers to register with the government, let alone to prove safety, effectiveness or even that the amount of “active” ingredient claimed is actually in the product. Even if the FDA had the will to enforce the little authority it has (see related story, p. 12 about non-enforcement regarding prescription drug ads), the sheer number and variety of claims makes the task insurmountable.
The time has long passed for DSHEA to be repealed. It has proved unworkable (except for filling
the ever-deepening pockets of conscienceless profiteers) and in some cases it has proved dangerous: over 100 deaths have been linked to the dietary supplement ephedra alone. In the meantime, consumers are best served by simply avoiding these products (other than vitamins and minerals) and by sticking with products that actually offer proof of safety and efficacy, when they need a drug at all: FDA-approved, over-the-counter and prescription medications (except for those for which we advise Do Not Use).
