Lack of FDA Regulation

People are unaware that suppliers of ephedra products are virtually free to make health claims about the substances that have no scientific basis. People are also unaware of the potentially deadly side effects of these products. Dietary supplements are routinely marketed without undergoing a safety review by FDA.

A law known as the Dietary Supplements Health and Education Act or "DSHEA," prevents the FDA from regulating these products. Prior to the DSHEA, dietary supplements were in regulatory limbo. The FDA claimed it had the power to regulate them and tried to make the manufacturers and suppliers prove their safety claims for their products.

The DSHEA reduced the FDA's and federal control over these products, compared with food and drugs, which are subjected to strict regulation and compliance mointering by the FDA. Under the DSHEA, dietary supplements like ephedrine are loosely defined as products intended to supplement the diet. These supplements contain herbs, minerals, amino acids, vitamins and combinations of these things. The supplement industry can sell any product that meets that definition in stores and its supplier can make claims about its alleged healthful qualities.

Increased Use

Herbal usage in the United States has increased dramatically since the passage of the DSHEA. In 1997, 60 million Americans spent $3.24 billion on herbs for reasons such as migraines, hypertension, depression, weight loss, and sexual stamina. An estimated 15 million adults are at risk for potential herb-drug interactions.

Deceptive Marketing

The deception occurs when the supplements industry selects brand names or uses wording on labels such as "fat burner" or "detoxifies" or "natural viagra" or the "#1 rated herbal" for impotence or "herbal fen-phen" to suggest the impossible. Under DSHEA, a herbal product label can state the way the product is intended to affect "the structure or function" of the body but cannot claim its use for a specific disease. Manufacturers use creative borderline language that complies technically with the law, but is generally confusing and deceptive. For example, one manufacturer claims its product "promotes regularity" instead of "treats constipation." How many consumers can discern the difference? Rather than stating Echinaeu "treats the flu" one manufacturer deftly says its product "promotes wellness during the flu season." These types of misleading claims are apparently permissible under the new laws and mislead consumers into believing these products are safe, when many clearly can have serious side effects.

Ephedrine

Some companies have named their ephedrine tablets after illegal street drugs such as "Ecstasy" and "Black Beauties," as well as brand names such as Easy Trim, Advocare, Metabolite, Metab-Rx Ultar, Epitonin, Chinese Ephedra, Metabolife 356 and Ripped Fuel. Other manufacturers have taken a more subtle approach to sell their ephedrine products. These companies make representations that they are vitamin or nutrition companies that sell only "natural" diet supplements. Drug companies have taken advantage of the current status of ephedrine and have attempted to produce a "legal" amphetamine by mixing ephedrine with other stimulants such as caffeine. Ephedrine use is highly popular among college students and people who work out. Most remain completely unaware of the potential dangers of these products.

Natural Herbs

People continue to believe that because herbs are "natural" they are therefore, harmless. However, many herbal remedies are dangerous. Many can interact with prescription medication. Some herbs become toxic if taken with certain drugs, and fatal herb-drug interactions can occur.

"Herbs are not regulated the same as other dietary supplements," says Donald D. Hensrud, M.D., a consultant in preventive medicine and endocrinology at Mayo Clinic in Rochester, Minn. "This means they can be misidentified, contaminated or contain multiple ingredients. There is no quality control for herbs."

"Patients electing to use herbal supplements for a serious disease in place of proven therapy are truly taking their lives in their own hands," says Thomas P. Moyer, Ph.D., director of the toxicology laboratory at Mayo Clinic, Rochester. "The growing trend of self-therapy is very concerning."

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Excerpts from an article on the dangers of herbal supplements from
Journal of The New England Journal of Medicine

Now, with the increased interest in alternative medicine, we see a reversion to irrational approaches to medical practice, even while scientific medicine is making some of its most dramatic advances. Exploring the reasons for this paradox is outside the scope of this editorial, but it is probably in part a matter of disillusionment with the often hurried and impersonal care delivered by conventional physicians, as well as the harsh treatments that may be necessary for life-threatening diseases.

Fortunately, most untested herbal remedies are probably harmless. In addition, they seem to be used primarily by people who are healthy and believe the remedies will help them stay that way, or by people who have common, relatively minor problems, such as backache or fatigue. Most such people would probably seek out conventional doctors if they had indications of serious disease, such as crushing chest pain, a mass in the breast, or blood in the urine. Still, uncertainty about whether symptoms are serious could result in a harmful delay in getting treatment that has been proved effective. And some people may embrace alternative medicine exclusively, putting themselves in great danger. In this issue of the Journal, Coppes et al. describe two such instances.

Also in this issue, we see that there are risks of alternative medicine in addition to that of failing to receive effective treatment. Slifman and her colleagues report a case of digitalis toxicity in a young woman who had ingested a contaminated herbal concoction. Ko reports finding widespread inconsistencies and adulterations in his analysis of Asian patent medicines. LoVecchio et al. report on a patient who suffered central nervous system depression after ingesting a substance sold in health-food stores as a growth hormone stimulator, and Beigel and colleagues describe the puzzling clinical course of a patient in whom lead poisoning developed after he took an Indian herbal remedy for his diabetes. These are without doubt simply examples of what will be a rapidly growing problem.

What about the FDA? Shouldn't it be monitoring the safety and efficacy of these remedies? Not any longer, according to the U.S. Congress. In response to the lobbying efforts of the multibillion-dollar "dietary supplement" industry, Congress in 1994 exempted their products from FDA regulation. (Homeopathic remedies have been exempted since 1938. Since then, these products have flooded the market, subject only to the scruples of their manufacturers. They may contain the substances listed on the label in the amounts claimed, but they need not, and there is no one to prevent their sale if they don't. In analyses of ginseng products, for example, the amount of the active ingredient in each pill varied by as much as a factor of 10 among brands that were labeled as containing the same amount. Some brands contained none at all.

Herbal remedies may also be sold without any knowledge of their mechanism of action. In this issue of the Journal, DiPaola and his colleagues report that the herbal mixture called PC-SPES (PC for prostate cancer, and spes the Latin for "hope") has substantial estrogenic activity. Yet this substance is promoted as bolstering the immune system in patients with prostate cancer that is refractory to treatment with estrogen. Many men taking PC-SPES have thus received varying amounts of hormonal treatment without knowing it, some in addition to the estrogen treatments given to them by their conventional physicians.

The only legal requirement in the sale of such products is that they not be promoted as preventing or treating disease. To comply with that stipulation, their labeling has risen to an art form of doublespeak (witness the name PC-SPES). Not only are they sold under the euphemistic rubric "dietary supplements," but also the medical uses for which they are sold are merely insinuated. Nevertheless, it is clear what is meant. Shark cartilage (priced in a local drugstore at more than $3 for a day's dose) is promoted on its label "to maintain proper bone and joint function," saw palmetto to "promote prostate health," and horse-chestnut seed extract to "promote... leg vein health." Anyone can walk into a health-food store and unwittingly buy PC-SPES with unknown amounts of estrogenic activity, plantain laced with digitalis, or Indian herbs contaminated with heavy metals. Caveat emptor. The FDA can intervene only after the fact, when it is shown that a product is harmful.

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