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Rational Inquiry -Volume 6 Number 2

Food Supplements and Herbal Medications

By Edvard A. Hemmingsen

The proliferation of so-called health foods, dietary supplements, herbal remedies and similar "natural products" has been quite remarkable in recent years. Almost any bookstore has a plethora of books on the shelves concerning the presumed benefits and even the therapeutic and medicinal values of these products, far outnumbering the books on science and medicine-combined.

Apparently, people buy these books, read them, and buy the products they recommend. Most of these products are commonly available and are often prominently displayed in supermarkets, drugstores, and natural products specialty stores in expensive locations. Forceful marketing with heavy advertising has skyrocketed their yearly sales into tens of billions of dollars, and still rising [1]. Yet, most of them appear to be of little or no value. Certainly, those that have been tested by scientific approaches rarely have been found to yield the benefits claimed. And some of the promotions of these products are or border on plain fraud.

About ten years ago, Congress began to consider legislation that would prevent health fraud and protect the public from the marketing of dangerous substances. Regulations and controls existed for drugs, where drug is defined as a substance "intended for use in the diagnoses, cure, mitigation, treatment, or prevention of disease . . . and articles (other than food) intended to affect the structure or function of the body." [2]. Nothing could (and essentially still cannot) be put on the label of a product that has not been substantiated within the context of this definition. Many members of Congress wanted, among other things, to place restrictions on unsubstantiated claims that could be made in advertising. The legislation considered would have made it illegal to advertise and otherwise promote nutritional and therapeutic claims that were not permissible on a productís label.

The food supplement industry did not want any further restrictions placed on their products, and how they could be promoted and marketed, even if such restrictions were designed to protect the public from potential hazards. They mounted an intense campaign to get legislation more to their liking passed, by lobbying and campaign contributions to key members of the Congress. From 1995 to 2000, the four largest food supplement companies paid $7.7 million to congressional campaigns, out of which $326,000 were lavished on five important members alone [1] with Orrin Hatch (R-Utah) and Robert Wexler (D-Florida) the largest recipients. In addition, large sums were spent by the companies on political action committees, lobbying and similar functions.

The payback has not been subtle. The Dietary Supplement Health and Education Act of 1994 (DSHEA) was passed [3], and finalized in 1997. Rather than strengthening Federal control of what was sold as useless or dangerous "dietary supplement", it weakened a variety of regulations. One important feature of the act was the redefinition of "dietary supplement". This allowed minerals, vitamins, herbs, certain hormones, extracts and many other consumable products to be sold as supplements rather than as drugs. And it could be done with claims of preventative and therapeutic benefits as long as these claims were not stated on the productís label when sold. The industry was free to make such claims in advertising, in print, or on the airwaves, in books and other literature, or in any other devisable way. As would be expected, this has been done with abandon.

DSHEA made possible the sale and distribution of potentially dangerous or useless substances in other ways by altering the functions and authority of the FDA. Most importantly, the FDA has to prove that a substance is unsafe before it can be banished, and substances that are useless are protected as long as they are harmless. Previously, it was the responsibility of the marketers to show that their products were safe for consumption and contained the ingredients in the amounts listed on the label. The FDA, however, had no mechanism for taking on the burden of proof, and the funds and facilities for doing so were not part of the legislation. In fact, the FDA continued to be maintained on a shoe-string budget.

This opened another door for the industry to walk through. Whatever system is established for its oversight within the present laws can be overwhelmed by a continuous introduction of new products on the market. There are a lot of plant species to be tapped and many more folk medicine traditions to be explored! The industry has taken advantage of this situation so graciously handed to them by Congress. Being largely free of restraints, even more clever things than they have done so far are undoubtedly yet to come. For example, whereas there is still some control on the sale of products labeled with such terms as "cure", "treat", or "prevent disease" and on the use of such terms in advertising (according to the provisions of the Nutrition Coordinating Act of 1991 [4]), terms such as "improve", "support", "provides relief", "effective against", "protects" are outside these controls. That exclusion leaves room for a lot of creative, but false or misleading claims.

Thus, DSHEA has been very damaging to efforts improve truth in advertising and labeling in the many products marketed for consumption. By passing this act, the Congress denied the public its right to know the efficacy of purportedly medicinal products, or their toxicity, purity, actual content, the contaminants present, or their potential interaction with safe, approved over-the-counter and prescription drugs. The word "natural" supposedly offers adequate protection for the public.

It is one thing for the supplements to be useless. After all, a fool and his money are soon parted. But it is quite another thing to realize that popular herbal remedies and supplements are not harmless, inert substances which can be consumed without concern. Emerging strong scientific evidence shows that some interfere harmfully with traditional, proven medication, in some cases leading to fatalities. Others contain carcinogenic substances and the toxic alkaloids common in plants. The dogma which some subscribe to-that drugs of plant origin automatically are good, but those derived from petroleum or minerals are bad-certainly has no basis in fact.

Numerous cases of serious drug interactions have been confirmed in mainstream scientific medical journals. Just to give a few examples. Gingko biloba has been claimed to be a memory enhancer, but it interferes with insulin secretion and is dangerous to diabetics. It also has a blood thinning effect and can cause internal hemorrhaging in patients taking anti-clotting medication. St. Johnís wort appear to have some beneficial effect in cases of mild or moderate depression, but it interacts badly with some anti-depressants. It can cause more immediately life-threatening situations because it affects enzymes and increases elimination of certain immunosuppressing drugs on which survival may depend. Echinacea (extracts) presumably can stimulate immune processes, but can cause problems in people with a suppressed immune system and in those who have an autoimmune disease. Yet, the marketers of these substances often refer to them as "health products", no less.

Weight loss aids are among the most popular herbal substances sold. A claim for some is that they can burn off fat by elevating metabolism by means of stimulants like caffeine and ephedrine. (They do so slightly, but far less than light exercise). One such product is made by San Diego-based Metabolife. This company sells diet pills containing ephedrine as a key ingredient; total sales approached $1 billion last year. Scientists at the University of California last year published a study [5] that tied ephedrine-based products to numerous cases of death and serious injury, mostly from heart attacks, strokes and other cardiovascular problems, and from seizures. The U.S. Food and Drug Administration says that at least 54 people have died over the past five years and about a thousand have reported serious medical problems after taking ephedrine-containing products [6].

Last year, Assembly woman Susan Davis in San Diego sponsored a law that would require ephedrine-based products to carry warning labels and the list of actual ingredients in California. The law passed the State legislature but was vetoed by Governor Gray Davis-after he accepted $100,000 in contributions from Metabolife [6].

Overall, the area of food supplements and herbal remedies is a minefield which must be navigated with great caution. There are few warnings of where the mines are. That is not to say that among the dangerous or useless products, some may be beneficial and useful. Some of the drugs and medications used today in main steam scientific medicine were originally derived from plants, and others no doubt will be discovered and used after scientific testing for efficacy and safety. The "natural products" industry should be required to take at least some of these steps. The scientific medical community and others would welcome proper testing of such products, followed by standardization of doses for those that are found to be useful.

The public should have the right to know if the product sold is both safe and effective, contains the listed ingredients, is free of contaminants, and is capable of interacting adversely with other medications. Will this happen in the near future? Do not bet on it. Some efforts have been started in Congress to rectify the most disastrous consequences of legislation passed in previous sessions. Perhaps there are enough members left in Congress who are more concerned about the welfare of the public than the profits of the industry, and the part of these profits that goes to their re-election efforts.

In the meantime, if you want to use herbal medications, or other types of "alternative medicine", see your doctor first, and seek appropriate authoritative information [7].

References and Notes

1. U.S. News and World Report, Feb. 12, 2001.

2. Food, Drug, Cosmetic, and Device Enforcement Amendments of 1991. Http://thomas.loc.gov (do query).

3. Dietary Supplement Health and Education Act of 1994. Http://vm.cfsan.fda.gov/~dms/dietsupp.html

4. Federal Trade Commission Act, or Nutrition Coordinating Act of 1991. Http://thomas.loc.gov (do query).

5. C. A. Haller and N. L. Benowitz, New England Journal of Medicine, Vol. 343, pp.1833-8, Dec. 21,2000.

6. San Diego Union-Tribune, Nov. 7, 2000.

7. Note. More detailed analyses of some of the issues discussed in this article, and on "alternative medicine" in general, can be found at www.quackwatch.com, the website of Stephen Barrett. Examples of other sites which have information about the health issues raised here are www.ncahf.org, www.nutritionnewsfocus.com, and various government agencies. Some have searchable databases for information:

www.cfsan.fda.gov (FDA Center for Food Safety & Applied Nutrition);

www.nlm.nih.gov (Has MedlinePlus)

www.nih.gov/health

www.healthfinder.gov



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