Rein on Natural Nostrums
Once merely an emblem of the counterculture, alternative medicine has become big business, grossing $18 billion in annual sales. But as a Times series last week showed, while drugstore shelf space for vitamin, mineral and herbal supplements has nearly tripled in the last three years, government oversight of the industry remains nearly nonexistent.
At the root of the problem is a 1994 law that allows manufacturers to make elaborate, quasi-medical claims for products that are regulated loosely, like food, rather than under the strict regime of prescription drugs. The law has fueled the alternative medicine boom by allowing manufacturers to make unsubstantiated claims about how their products help improve, as some claim, “the structure or function of the human body.”
Even respected alternative medicine advocates like James Gordon, a former National Institutes of Health researcher, concede that while the law technically prohibits medical claims, its “structure/function” clause is vague enough to allow such claims. For example, while herbal remedy St. John’s wort cannot be described as an “anti-depressant,” it can be called a “mood enhancer” or “energizer.” And while a packager of saw palmetto cannot call the processed red berries a “treatment for enlarged prostate,” it can suggest that “saw palmetto is useful in maintaining a healthy prostate.”
The Food and Drug Administration can solve part of the problem by adopting the Dietary Supplement Labeling Commission’s recent recommendation that the wording of the 1994 law be revised to ensure that manufacturers make “truly dietary claims that do not imply use in preventing or treating disease.” But the fundamental solution lies in enforcing two basic standards:
* The label on the bottle should accurately reflect what’s in the bottle; exact amounts must be specified and there must be no contaminants. A Times-commissioned study found that three out of 10 tested brands of St. John’s wort had no more than about half the potency listed on the label. And in an analysis of several samples of the dietary supplement 5-HTP released last week, Mayo Clinic scientists found traces of a chemical they say is linked to a sometimes deadly immune system disease. Working with the National Institutes of Health’s Office of Alternative Medicine and the private pharmacy standards group U.S. Pharmacopeia, the FDA should devise purity standards and then enforce them through regular inspections of manufacturing plants.
* Manufacturers should be required to present the FDA with genuine evidence of efficacy before they are allowed to make labeling claims. The requirements need not be as rigorous as those for prescription drugs, but they should not be as low as those allowed in some European countries. In 1988, for instance, a German company successfully argued that its “natural diarrhea remedy” should be approved because an obscure 1930s lecture had alluded to reports that some soldiers had found the remedy effective during World War I. That remedy was plain old dirt.
Alternative medicine’s growth stems partly from Americans’ openness to nontraditional remedies, which Western physicians sometimes dismiss too readily. But until the government extends regulatory oversight to these remedies, some unscrupulous manufacturers are sure to take advantage, seeing open minds as merely a way of opening wallets.
