A TOUGH PILL TO SWALLOW

By HENRY MILLER

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Herbal dietary supplements (also known as nutritional supplements, but correctly known as botanicals), once dismissed as hippie fare, are now celebrated for their supposed potential to cure virtually any ailment. The growing popularity of supplements has proven profitable for their manufacturers. But recent disclosures related to certain supplements have prompted greater scrutiny of the industry, and there is an emerging consensus that the current regulatory regime is too lax. Before we decide, though, that the answer is full-scale government regulation, with all of its attendant costs and consequences, we should adopt an intermediate solution: independent, non-governmental oversight.

You or someone you know almost certainly has tried an herbal dietary supplement. About one-third of Americans use products like echinacea (said to stop a cold), ginseng (said to boost vitality) and St. John's wort (said to relieve depression). Indeed, thousands of such products cram the shelves of health food stores, food markets and pharmacies nationwide. They also are easily available through mail order catalogs and on the Internet. Since supplements are a big business -- there is about $5 billion in retail sales annually, and the retail market is growing about 18 percent a year -- it is not surprising that major pharmaceutical companies are adding supplements to their product lines.

This explosive growth in the availability of dietary supplements poses a threat to public health reminiscent of that posed by nineteenth century "snake oil." Many are known to be toxic, carcinogenic or otherwise dangerous. Serious known side effects include blood-clotting abnormalities, high blood pressure, life-threatening allergic reactions, cardiac arrhythmias, liver failure and exacerbation of autoimmune diseases. The American Society of Anesthesiologists has issued a warning to consumers to stop taking herbal supplements at least two to three weeks before any scheduled surgery, in order to avoid dangerous interactions with the drugs used for anesthesia. In February, two research letters in the British journal The Lancet identified important new side effects from herbal supplements. One described interference with an AIDS drug, a protease inhibitor called indinavir, that could lead to treatment failure. The other discussed acute rejection in two heart transplant patients caused by a metabolic interaction between St. John's wort and the immune suppressant drug cyclosporin. Shortly thereafter, government regulators warned diabetics to avoid five brands of Chinese herbal products because they illegally contain potent prescription drugs that have caused dangerous drops in blood sugar. With some large retailers now selling new higher-potency formulations, and more consumers taking large doses for long periods, safety problems are likely to increase.

Remarkably, this looming threat to scores of Americans is not addressed by current federal food and drug regulations. The combination of a well-organized industry and a quiescent Congress resulted in legislation exempting herbal dietary supplements from strict regulation by the 1994 Dietary Supplement Health and Education Act. The legislation prevented federal regulators from requiring assurance that botanicals are either safe or effective, that the information about dosage on the label is correct, or even that the substance named on the label actually be in the container. The FDA made the situation even worse in January of this year, adopting a regulation that allows supplement manufacturers to assert all manner of dubious health claims (so long as the manufacturer does not claim to prevent or treat a disease). For example, a manufacturer may claim that its product treats premenstrual syndrome. However, only a few herbal supplements have been shown to be at all efficacious (including saw palmetto for treating enlarged prostate glands and gingko biloba for improving memory in Alzheimer's patients).

The combination of the health risk posed by certain supplements and the current relaxed regulatory regime is a recipe for a public health catastrophe. It could take the form of a rash of cases of organ failure or death in healthy persons, perhaps from a product that contains a far more active ingredient than is indicated on the label, or from a highly toxic additive. In the wake of such an occurrence and the inevitable media scrutiny and public outcry, Congress could feel pressured to reclassify herbal dietary supplements as drugs. But this would have unintended consequences. The concomitant investment of time and money -- currently it takes 12 to 15 years and an investment of $500 million for FDA approval of the average drug today -- for approval of herbal dietary supplements would be prohibitive for their manufacturers, and severely restrict consumers' access to a wide array of non-traditional medicines.

There is a more sensible approach to the current state of affairs, and it should be seriously considered now, before a more serious incident involving supplements compromises common sense. This involves voluntary oversight by an independent -- but non-governmental -- regulator. Models for such a mechanism already exist. One example is the Nationally Recognized Testing Laboratories (NRTLs), the prototype of which is Underwriter's Laboratories -- a large, not-for-profit organization that tests and certifies a wide spectrum of products, many of which present inherent potential hazards to life and property. The NRTLs use hundreds of discrete standards, or guidelines, to certify product safety (but not effectiveness, except in a few special cases where the two factors are inextricably linked, such as those of fire extinguishers and smoke detectors). NRTLs are accredited by the Department of Labor. Although this accreditation certifies their independence, I do not believe FDA accreditation of the entity overseeing herbal supplement manufacturers would be necessary so long as the manufacturers maintained an arm's length relationship from the regulator.

Another existing model is the group of organizations that certify plant seeds sold to agricultural producers or growers. This process is intended to ensure seed quality or consistency. In California, for example, oversight is performed by the non-profit California Crop Improvement Association (CCIA), which provides a voluntary quality-assurance program for the maintenance and increase of crop seed. Each variety of seed that enters this program is evaluated for its unique characteristics, such as pest-resistance, adaptability, uniformity, quality and yield. Seed movement is monitored from field harvest, through the conditioning plant, and into the bag. Voluntary mechanisms of self-regulation such as the testing labs and seed certification organizations involve certification that products meet certain chemical, physical or biological standards, and could be adapted for effective oversight of dietary supplements. Moreover, such voluntary self-regulation likely could be accomplished without involving federal regulators.

The introduction of rigorous non-governmental regulation would benefit all concerned parties. Voluntary certification would protect the long-term interests of participating manufacturers by bolstering their claims that they make a premium product. Certification also could provide an advantage to manufacturers forced to defend personal-injury lawsuits in the event of a mishap -- a kind of "regulatory compliance" defense. And, most important, consumers would be assured that the products bearing this Good Housekeeping-like stamp of approval had met certain standards of purity, potency and quality (and perhaps also the broader criteria of safety and efficacy, if the organization were charged to evaluate those standards -- a key consideration in light of the potential side effects and dangerous interactions I mentioned earlier). With more information and guidance on how to understand this information, consumers would be able to make more informed, safer choices in their selection of supplements, and the supplements themselves would continue to be widely available. The alternative -- to call them drugs and regulate them into oblivion -- isn't in anyone's best interests.


Henry I. Miller, a medical doctor, is a senior research fellow at Stanford University's Hoover Institution. From 1979 through 1994, Dr. Miller was an official of the FDA. He can be reached at miller@hoover.stanford.edu.

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