For the better part of the past decade, alternative approaches to health care have been encroaching on the prevailing medical model. Acupuncture, homeopathy, naturopathy, and other "complementary" therapies are no longer dismissed as quackish pursuits of New Age pioneers. And it's the rare pharmacy that doesn't stock a healthy inventory of vitamin and herbal supplements. Indeed, according to recent surveys, about half the U.S. adult population now takes some form of dietary supplement, creating a market that tops $4 billion a year.
The savvy consumer can select any number of herb or vitamin alternatives to high-priced pharmaceuticals: St. John's-Wort for Prozac; melatonin for sleep aides; fish oil as a substitute for aspirin and other anti-inflammatory drugs; Vitamin E and selenium for heart disease and various cancers; milk thistle for liver diseases. These natural alternatives represent billions of dollars in lost profits each year for the pharmaceutical industry. And since there appears to be no way for drug companies to corner the market on nonpatentable agents, a new strategy is emerging: Take control away from the consumer.
Spearheading this effort is a little-known international agency called the Codex Alimentarius Commission, a Rome-based organization established in 1961 by the United Nations. Codex Alimentarius is Latin for "food and nutrition code." But under the guise of protecting public safety through standardization of food, nutrient, and botanical codes, the commission is regarded by many as a means for the pharmaceutical industry to eventually make all supplements available by prescription only.
As Mitch Fleisher reports in Alternative Therapies (May 1998), the commission is considering a number of major rule changes that could directly affect the cost and availability of many vitamin and herbal supplements. Among the proposals:
- No herb, vitamin, mineral, or natural agent could be sold for preventive or therapeutic reasons. (The Dietary Supplement Health and Education Act of 1994 already prohibits label claims related to the diagnosis, treatment, or prevention of disease in the United States, unless the claimed benefit relates to a nutrient deficiency disease.)
- Supplements could still be sold as "food," but only if they do not exceed the dosage levels set by the commission. This means that consumer access to supplements would be limited to the RDA dosage, which is designed merely to prevent nutritional deficiency diseases in most of the population. The RDA, deemed outmoded by most nutritionists, is not designed to promote optimal health or to prevent chronic diseases such as cancer.
- Supplements without an RDA (chromium, selenium, bioflavonoids, coenzyme Q10, for example) would be classified as drugs; therefore, it would be illegal to sell them without a prescription. This includes the majority of currently available supplements.
- All new supplements would be required to undergo the Codex approval process before becoming available. All others would be banned.
These rules were originally proposed by a German Codex delegation sponsored by three drug companies: Hoechst, Bayer, and BASF. And, in fact, elements of the Codex proposals already exist as law in Germany and Norway. In Germany, a number of high-potency agents are available only through pharmacists, and the prices are exorbitant. As recently as 1996, for example, one could buy vitamin C in 500 mg tablets. Today the highest concentration available is 200 mg; only pharmacists can sell the higher dose supplement. Vitamin E capsules cannot exceed 45 IU; vitamin B1 cannot exceed 2.4 mg.
Supplements are even more restricted in Norway. There, any nutrient supplement that exceeds the RDA is considered a drug. As a result, a vast number of natural agents are either not available or available only by prescription, at great cost. "In Norway, you must pay very high prices for supplements that otherwise can only be found on the black market," says John Hammell of the International Association for Health Freedom.
In Canada, earlier Codex proposals pertaining to herbal supplements are already in place. Such common herbs as garlic, ginger, and licorice are considered to be foods when they're sold as spices, but they become drugs once any claims are made for a therapeutic or health-promoting effect. Herbs with medicinal effects that have been extensively substantiated in the biomedical literature include aloe vera, echinacea, gingko biloba, ginseng, goldenseal, and milk thistle. All these agents are now branded by Canadian officials as either "a drug," "a drug even in the absence of claims," or "a new drug with claims."
To understand how the Codex reforms could play out in the United States, you need only to recall the case of tryptophan. Once sold as a natural sleep aid for under $20 a bottle at health food stores, tryptophan was banned by the FDA in 1990 after a contaminated batch from a Japanese company caused 1,550 cases of a blood disorder known as eosinophilia-myalgia syndrome. Today, the same tablet (in the same dose and quantity) is available only by prescription at a cost of more than $120. Under new Codex guidelines, other currently harmless supplements would be replaced by themselves, but sold as expensive, over-the-counter prescription drugs.
Codex opponents admit that we need a regulatory system that ensures public access to safe, effective, and pure supplements. But, as Fleisher notes, "Such regulatory oversight, both national and international, will only be effective if it is undertaken in a spirit of cooperation and with the full representation of all parties affected. This should include the natural health care product industry, the pharmaceutical industry, conventional and alternative/complementary medical organizations, government agencies, consumer interest groups, and the general public.”