Cerebrum Article

The Great Brain Supplement Free-for-All

Potato chips with St. John’s Wort, snack bars with ginseng, herbal pills claiming to improve our memory: Nutrition supplements are everywhere. If they are natural, we think (or advertisers would like us to think), they must be good.

Gilbert L. Ross, medical director of the American Council on Science and Health, argues that the deregulation of nutrition supplements in 1994 has made the public guinea pigs in an uncontrolled experiment. Not only do products with names like Natrol DHA Neuromins Brain Prep do nothing to make us healthier, smarter, or more energetic, he says; they can actually be dangerous, even lethal. Shouldn’t they be subject to at least as much federal oversight for quality and safety as consumer products such as toasters?

Published: April 1, 2001

Are you old enough to remember when a trip to the drugstore meant filling a prescription, picking up vitamins for the kids, and buying toothpaste? Nowadays, it seems, the shelves are devoted to an encyclopedic array of remedies that promise to keep us young, energetic, free of cancer and heart disease, and sexually prolific. Many of these nostrums, we are assured, will also keep our brains flexible—better prepared to receive new information and to retain all we have stored in them. The agents range from harmless but ineffective tonics to powerful chemicals that are banned in some countries and many states in this country. We find this bountiful pharmacopeia not only at the drugstore but in the health food stores that can be found now on almost every corner. If you do not want to visit a health food store, you can get almost the same choice of “dietary/nutritional supplements” at your supermarket.

It seems almost too good to be true: The right supplement, or combination of them, is the panacea mankind has craved over the millennia, the secret for a long, healthy life. If you believe the advertisements, that is. They seem strangely familiar, these ads. Weren’t similar claims being made in the early decades of the twentieth century, and even before? Potions, oils, and elixirs of health and eternal youth were sold via newspapers, door to door, and at carnivals, by purveyors of magic remedies. Have we not learned anything since the days of the snake-oil salesmen? Or is it that we long for that simpler time, when medical science was more personal, before inconveniences like FDA regulations and double-blind clinical trials complicated our lives? True, our lives are now healthier, and far longer, but also busier and filled with anxiety about how to hang on to our health and vigor. If these come in a bottle, we all want our share.

To a significant degree, Americans have become true believers in these new non-drugs, many of which are actually ancient. Perhaps two-fifths or more of us are taking herbs or botanicals, homeopathic or naturopathic remedies, amino acids, enzymes, vitamins, or minerals, with an eye toward getting or staying well. A 1998 survey by National Public Radio, the Kaiser Family Foundation, and the Kennedy School at Harvard found that half of all adult Americans (some 100 million of us) believe that dietary supplements other than the standard vitamins and minerals are generally good for our health. Eighteen percent of this national sample (38 million) say they use these products regularly. Some of those people are ill, or have good reason to fear becoming ill, but the overwhelming majority are the worried well, trying to stay (or deflect) entropy’s arrow. Not coincidentally, the marketing of these supplements has become big business, both in the United States and abroad. A recent estimate of yearly sales of so-called dietary or nutritional supplements is approximately $15.7 billion, equivalent to about half the total out-of-pocket expenses for all orthodox medical care rendered in America. These substances are promoted to aid weight loss; bolster the immune system, joints, and heart; induce sleep; build muscle; prevent cancer and cognitive decline; preserve memory; lift mood; and enhance sex.

Just what are these dietary/nutritional supplements? How can we explain their tremendous growth over the past few years, when they have been around for a long time? How much of the advertising hype is true?

Regulatory Never-Never Land

Before we can understand the pros and cons of brain supplements specifically—those dietary/nutrition supplements (henceforth DNS) marketed as aids for memory, concentration, intelligence, or prevention of cognitive decline—we must understand the larger story. Starting in the early 1900s, federal laws were passed to protect the public from food-borne illness. Subsequent legislation added drugs and cosmetics to the list of regulated areas, culminating in the establishment of an independent federal Food and Drug Administration in 1927. Catastrophic events, most notably the accidental poisoning deaths of 107 people in 1937 by an antibiotic (sulfanilamide) contaminated with ethylene glycol, led to the fairly stringent pharmaceutical and food-additive regulations we have today—or had, I should say, until 1994.

In the late 1980s, proposals were floated to tighten the FDA’s oversight of food additives and dietary supplements, but nothing much happened until the first President Bush appointed an activist FDA commissioner, Dr. David Kessler, in 1990. Kessler was determined to increase federal oversight of DNS, which at that time were regulated as food additives. They would have to be shown to be “generally recognized as safe” before they could be legally marketed, and they could not make health or disease-prevention claims, as could approved pharmaceuticals.

The FDA plan was to put supplements in the same category as food additives, requiring nutritional labeling and demonstration of safety prior to marketing. The supplement industry rightly perceived a threat to their marketing practices and thus their bottom line. Manufacturers banded together with their supporters in the U.S. Congress, principally Senators Orrin Hatch (R–UT, the home of a good chunk of the DNS industry) and Tom Harkin (D–IA), to try to protect their market. The senators were aided in the House of Representatives by the then-ranking minority member of the Committee on Government Reform, Dan Burton (R–IN), another supplement advocate.

The manufacturers, through their industry group, the Nutritional Health Alliance, organized what is still regarded as one of the consummate letter-writing campaigns in modern times, mobilizing hundreds of thousands of their adherents in 1994. They spread alarm and suspicion of big government, with ads accusing Kessler and the FDA of an imminent ban on all DNS. One ad portrayed Mel Gibson, a DNS fan, as an average citizen whose home is stormed by FDA commandos seeking to seize his “illicit” vitamins. This was nonsense, of course, but had the intended effect.

The resulting law, called the Dietary Supplement Health and Education Act of 1994 (affectionately known as D-SHEA), essentially removed DNS from FDA oversight by creating an entirely new category, neither food nor drug. DNS fell (actually, propelled itself) into a regulatory never-never land, unleashing upon unsuspecting American consumers a new age of health care marketing. Theoretically, there are restrictions: ads for DNS cannot claim to “treat, cure, diagnose, or prevent” any disease or condition but may claim to “support” any “structure or function” of the body. One glance at the aisles of a health food store or drugstore will reveal how little these regulations have restricted the marketing of these items.

The FDA no longer can require, nor even request, manufacturers of DNS to show that the ingredients they are promoting and selling are effective or safe—or even in the bottle—before they offer them to their customers. Outside labs that have assayed samples of various DNS have found wide variations from lot to lot in the concentration of ingredients. While food additives have to be shown (or at least be known) to be safe, and prescription drugs must survive a long, expensive process to prove safety and efficacy, DNS can be distributed to the public with little more than a plant to manufacture pills and a scheme to market them. There are now fewer regulations on supplement safety than on consumer products such as vacuum cleaners and toasters.

Wrecks on the Gravy Train

Sensing the potential for profits, big drug companies have jumped on the supplement gravy train. On average it may take 15 years, 68 trials, and half a billion dollars to get a new chemical approved as a pharmaceutical; it can take as little as a few weeks—and no trials at all—to get your supplement line rolling off the conveyor belt. There are an estimated 1,000 or more supplement manufacturers selling more than 25,000 products in a regulatory Wild West where all Americans are fair game.

What is the price we pay for this turn of events? If a supplement is no better than a placebo, the harm may be purely economic, but what about toxicity? Even approved, fully tested pharmaceuticals can have unpredictable side effects despite appropriate warnings by the prescribing physician. For example, a 1998 study appearing in the Journal of the American Medical Association estimated that about 100,000 hospitalized Americans may have suffered a fatal reaction to drugs during one recent year, 1994.

How many of the 150 million adults—and children—who ingest DNS meet a similar fate? We do not know; no one keeps track. The only method of overseeing is a Good Manufacturing Practices guideline—and adherence to it by the industry is entirely voluntary.

Adverse drug reactions (including fatalities) are supposed to be reported to the FDA’s MedWatch bureau. But there is no required method of reporting, on a nationwide basis, bad reactions to DNS. We must rely on a sketchy patchwork of reports voluntarily called in to regulatory agencies and on the statistics kept by some states. The results are scary.

While the FDA reported just over 2,600 adverse events related to DNS use from 1993 through 1998, the American Association of Poison Control Centers received information on more than 6,900 such events in 1998 alone. Almost two-thirds involved children under six—not surprising, since DNS, unlike pharmaceuticals, tend not to have childproof caps.

A report in the March 19, 2000, Washington Post surveyed evidence from health officials and researchers suggesting that Americans are increasingly suffering ill effects from DNS, not to mention the precious time lost when a person suffering from a potentially life-threatening but curable disease tries to self-treat with such remedies. Victims include adults trying to avoid the hassles of a visit to the doctor, with its tedious HMO paperwork; children whose parents fall for the marketing charisma of the latest energy- or concentration-booster or calming agent; and adolescents seeking to build muscles or lose weight quickly. An amazing 1 out of 5 parents admits to administering one or more supplements to their children, and as many as 2 out of 5 high-school senior boys are taking creatine, said to be a muscle builder. Young people may also get their DNS fix at the soda fountain, where some food chains include herbal ingredients in shakes. These so-called functional foods are ubiquitous; more and more snack foods seem to contain some herbal booster.

Most people who use DNS assume that these products have been tested for safety, efficacy, and quality. Actually, even if an ingredient has some efficacy against a condition, there is no way for a consumer to know whether the bottle purchased actually has enough (or any) of the putative medicine. If that bottle does, the next bottle may not. There is no requirement for strict quality control.

The only actions the FDA can take against a potential DNS problem are to document that the product in question is the likely source of a problem (unlike pharmaceuticals, for which a mere whiff of suspicion will invoke a near-automatic recall) and then issue a consumer advisory, warning the public (with three progressive degrees of urgency) not to use it. These advisories are usually accompanied by a request to the manufacturer to recall the product, which it may, or may not, do. Only in rare situations involving an imminent threat to the public health can the FDA secure a court order to remove the offending substance from the shelves. Since D-SHEA was enacted in 1994, the FDA has not once done this.

All sides agree that the FDA is woefully understaffed and under-funded to monitor the 25,000 DNS on the market (actual and cyber). Yet every attempt to increase funding for this purpose has been defeated, with the assistance of legislators who are often influenced by the political and financial clout of the supplement makers. Does one thing have to do with the other? You decide.

Consider just one example of a DNS with harmful effects, the herbal supplement ephedra, also known as Ma Huang. Beginning in 1995, as reports accumulated from around the country on adverse reactions and even fatalities, FDA Commissioner Kessler tried to have ephedra removed from consumer products. As recently as last August, under a different commissioner, a federally convened hearing on ephedra took testimony from victims of toxic reactions or their survivors. Along with the few victims, however, the testimony of many supplement manufacturers was heard. The result? Nothing was done to restrict ephedra.

Dangerous contaminants periodically show up in batches of DNS. Perhaps the best-known occurrence was in 1988, when a batch of the amino acid L-tryptophan, marketed as a sleep aid, was eventually found to be contaminated with a toxin that caused several hundred cases of eosinophilia-myalgia syndrome, a chronic muscle disorder. Last year, five different Chinese herbals were found to contain dangerous levels of a powerful diabetes drug, potentially capable of causing dangerously low blood sugar levels in unsuspecting users.

People nowadays fear chemicals and distrust science. “Natural” equals “good.” This attitude seems paradoxical, given the degree of health we enjoy. Perhaps it emanates from real and perceived public health failures, such as mad cow disease and thalidomide. In any case, we seem to blame synthetic chemicals for a variety of vaguely defined ills, while believing that, since DNS are sold as natural substances, they must be safe. Not so. Many potent poisons are natural; and many “natural” supplements are actually synthesized in the lab, just as are most pharmaceuticals and other chemical consumer products. For example, some of the “natural” substances marketed to Americans, including hormones such as androgenic steroids, are on the controlled-substances list when a physician prescribes them, but you can pick them up at your health-food store this evening.

Mind Expanders?

Supplement marketers have discovered fertile ground in the perennial human longing for eternal youth, including retaining youthful energy and intellect into old age. One of our greatest fears, outweighing almost any other except, perhaps, fear of cancer, is cognitive decline. In polls, fear of dementia and stroke consistently surpasses fear of heart attack. Hence the huge market for “brain supplements.” Marketers hope to lure aging baby boomers with promises of benefits for mood, memory, concentration, and energy. Is there any real hope for us in these substances so glibly and widely promoted, or is it all hype?

If you have not felt tempted to try a DNS to preserve or improve your mind, it is not for the admen’s lack of trying. I entered terms such as “brain + ‘xyz’ supplement” in a few Web search engines and got anywhere from 1,500 (phosphatidylserine) to more than 30,000 (ginseng) hits. Suffice it to say that there is no dearth of information on brain supplements. Unfortunately, that is part of the problem. The Internet, like the Bible, proffers information to bolster almost any position you might take.

Older Americans are disproportionately affected by the DNS hype. Often they are inadequately nourished because of a combination of limits on mobility, finances, dental disease, lack of sun exposure with resulting vitamin D insufficiency, and inadequate gastric acid production that leads to Vitamin B12 malabsorption and pernicious anemia. Some supplementation is often medically indicated, but senior citizens are susceptible to shrewd marketing aimed at exploiting these needs. To make matters worse, two-thirds of those over 65 take at least one prescription drug daily; one-quarter take three or more. When a DNS is added to this brew, the potential for adverse interactions soars. A survey commissioned by the American Council on Science and Health in 2000 found that more than half of those over 50 reported taking prescription or over-the-counter drugs regularly, and more than half of those who took drugs also took DNS. Thus, more than one-quarter of those over age 50 may be at risk for drug-supplement interactions. The problem is compounded because doctors seldom inquire about their patients’ supplement intake and patients do not volunteer it, even though over two-thirds of older Americans are taking one or more DNS.

What We Are Taking: 14 Popular DNS

Let us look at some popular supplements promoted for their effects on cerebral function. Please remember that, according to D-SHEA, these (like all supplements) are not intended to “diagnose, treat, prevent or cure” any disease or condition. But why would one take a supplement without at least one of those goals in mind?

Ginkgo biloba is an ancient herbal extract that includes chemicals called flaveonoids and terpenoids. Marketed for improving memory and concentration and as an anti-oxidant (the latter supposedly being protective of brain cells), ginkgo is among the most popular remedies on the market, with perhaps 11 million users in this country. It is used as a prescription drug in Germany, where herbal products are evaluated and regulated by a federal agency called Commission E. Studies do show that this herb may slow the progress of some cases of Alzheimer’stype dementia and that it can increase blood flow to the extremities in some cases of impaired circulation, but there is no evidence that it helps in any way to ameliorate age-related cognitive decline, nor does it improve concentration or energy in otherwise normal adults. The toxicity of ginkgo is of concern, as it can interact with anticoagulants to provoke bleeding; it may also interact negatively with anti-depressants.

St. John’s Wort, another popular herbal remedy, is marketed as a tranquilizer/ antidepressant. It too is approved by Germany’s Commission E for use as a drug. Its active ingredient is the chemical hypericum, whose action is thought to be similar to selective serotonin reuptake inhibitors (SSRI), the active ingredient in prescription antidepressants such as Prozac. An analysis published in 1996 in the British Medical Journal found that hypericum was about as effective an antidepressant as the older accepted therapies, tricyclics, and that side effects (photosensitive rash) were generally tolerable. The problems with evaluating this study are that none of the treated patients suffered from severe depression; the evaluated studies were short term, while depression is generally a long-term problem; and quality control of the manufacturing process, as with other DNS, could not be guaranteed.

In other studies, St. John’s Wort lowered the concentration of the immunosuppressive cyclosporine, the heart drug digoxin, the anticoagulant coumadin, and the AIDS drug indinavir. Because of these effects, it has been banned or restricted in several European Union countries, and the respected drug evaluation newsletter The Medical Letter has advised against its use. Nevertheless, St. John’s Wort can be obtained even in supermarkets—as an ingredient in potato chips, among other products. I find this ubiquity especially dangerous because moderate to severe depression, which is at best a terribly unpleasant condition, can be, at worst, lethal. A depressed person should not be self-treating, but under careful medical monitoring.

Ginseng, another extremely popular Asian herb, is termed an “adaptogen” in supplement circles, implying energy-boosting properties  (for example, aphrodisia) and immune “support.” Actually, those in the know believe that the two varieties of ginseng, Siberian and panax, use different modes of action to produce “balance” and increase stamina. Surprisingly, one well-designed study showed some benefit from ginseng in terms of blood sugar control in a small group of non-insulin dependent diabetics, although it may also result in abnormally low blood sugar in nondiabetics. There is no evidence of any improvement in exercise capacity, memory, or sense of well-being. Toxicity of the native herb is uncommon, but it is often adulterated, and its shelf life is brief. It can cause insomnia or palpitations, and has enough estrogenic activity to cause breast tenderness on occasion. It can also elevate levels of the cardiac drug digoxin and interact with anticoagulants such as coumadin.

Kava kava, another German-approved herb, is used as an anti-anxiety agent and mood elevator. Its active ingredients, called kava-lactones, come from the plant piper methysticum. Several studies have demonstrated its efficacy, compared to placebo, as a mild tranquilizer. It has additive effects with other depressant drugs, and therefore should not be taken with sedatives, tranquilizers, or alcohol. If surgery is required, and the surgeon and anesthesiologist are unaware that the patient has been using kava kava, anesthesia may result in dangerous, or even fatal, excessive sedation of the central nervous system.

SAM-e is a naturally occurring chemical that is common in our body’s biochemical reactions, such as the synthesis of amino acids and proteins. Its actual name is s-adenosylmethionine. As a supplement, it arrived here from Europe with much fanfare and its own book-cum-television blitz in 1999, and was hyped as the solution to depression, arthritis, and liver disease—a veritable Triple Crown. The scientific facts fall short. A few small studies from Italy purport to show some efficacy in osteoarthritis, but none of these studies would pass muster to make it into an American science journal. There are also studies showing some benefit in rats with late-stage liver disease and benefit for human patients with a type of liver disease called cholestatic jaundice. Some small European studies demonstrate efficacy in mild depression, again short term. Except for quality issues endemic to DNS and mild gastric upset, there are no known problems such as major toxicity or serious interactions linked to SAM-e use.

Ephedra, as discussed earlier, is an herbal extract widely used to raise energy and promote weight loss. It has not been shown effective for either of these purposes, but it does have mild bronchodilating properties and has been used in several prescription and over-the-counter asthma remedies. Chemically very similar to methamphetamine, ephedra has been associated with an array of toxic effects, some of which have killed the user. From the point of view of brain health, there is no valid reason to use this drug.

GHB/GBL/BD, or gamma hydroxybutyrate, is a natural neurotransmitter that affects serotonin and dopamine. It was marketed as a weight-loss aid, sleep aid, muscle builder, and energy enhancer, but was used mostly as a recreational drug. Gamma butyrolactone and 1,4 butanediol, when ingested, are converted in the body to GHB. All these chemicals have been incriminated in toxic reactions, including deaths, and have been used as “date rape” drugs, since they cause both euphoria and muscle relaxation. In 1999, the FDA issued a warning against the use of GHB (which was still available via the Internet) and GBL. Shortly thereafter, Congress revised the Drug Enforcement Administration scheduling of both drugs to make their possession or sale illegal. Nevertheless, both can still be obtained, and authorities believe their use is increasing on college campuses. There are even Web sites that instruct the amateur chemist in how to produce these drugs at home (“bathtub GHB”). In a pinch, BD is readily available in its guise as an industrial solvent and cleaner.

Ubiquinone/CoQ-10, also marketed as an energy enhancer and support for cardiovascular function, is a natural substance that is an important catalyst in many biochemical actions. No studies demonstrate its efficacy for the purposes for which it is marketed.

Huperzine-A, an herb derived from a Chinese moss, is a cholinesterase inhibitor. No human studies demonstrate any benefit from taking this drug, although other cholinesterase inhibitors have shown some effect on slowing the progress of Alzheimer’s disease.

Phosphatidylserine, a phospholipid component of cell membranes, is another product sold to improve memory and cognitive function. Usually it is part of a combination “brain supplement” pill or powder. There is no evidence of its efficacy.

Valerian is an herb touted as a sleep aid. Some studies show some efficacy, others do not. There are no serious toxicities or interactions, however, except cautions about using it with other depressants of the central nervous system, and concern about the quality and accuracy of the labeled ingredients.

DHA (docosahexaenoic acid), an unsaturated omega-3 fatty acid, is one of the fish oils. These are used in the body to synthesize prostaglandins and function as antioxidants. While they may help to lower levels of triglycerides in the blood, no human data show that DHA is effective in augmenting energy, concentration, or memory. Excessive amounts can cause bleeding, as can its possible interaction with anticoagulants.

Melatonin is a hormone secreted by the pineal gland that modulates the circadian sleep-wake cycle. It has helped relieve the effects of jet lag, but does not have any other brain-related activity. Side effects include headache and fatigue.

Vitamin E, an essential fat-soluble, antioxidant vitamin, in high doses may slow the progression of dementia in some Alzheimer’s patients. At those higher doses, however, it can interfere with platelet activity and thus cause bleeding.

I will spare you further analyses of the many combination products—each with gaudy promises of youthful vigor, elevated mood, enhanced concentration, or better memory—except to list some of their names:

Cognitive Factors
Recall Support
Cerephine (from Think!™)
MoodPlex and Memorall
Natrol DHA Neuromins Brain Pep

And let’s not forget the children:

Attention Focus
Focus Child
Pedi-Active ADD

When Do You Need Supplements?

Are there reliable ways for us to help maintain the integrity of our brains and nervous systems? “Use it or lose it” is probably the best advice. Keeping an active mind is associated with a lower risk of cognitive decline, as is keeping physically fit. Sorry, but no magic bullet.

Adhering to a sound, well-balanced diet, with adequate macronutrients (protein, fat, and carbohydrate) and micronutrients (vitamins, minerals) will also help, making vitamin and mineral supplementation in general unnecessary, with the follow exceptions:

  • Strict vegetarians will likely need Vitamin B12 supplements.
  • Women of childbearing age need a daily intake of at least 400 micrograms of folate to lower the risk of birth defects (specifically, neural tube defects) in their babies.
  • Older people usually need calcium and Vitamin D supplements, as do many women after menopause.
  • Some older individuals may need extra B12 to treat pernicious anemia, secondary to inadequate secretion of acid in the stomach (acid is necessary for absorption of B12).

Certain vitamin and nutrient deficiencies can cause mental disturbances, but thanks to modern nutrition, these ailments are rare in most countries. Niacin (Vitamin B3) deficiency causes pellagra, a disease of the skin and brain; thiamine (B1) deficiency causes the behavioral disorder Wernicke-Korsakoff syndrome, most commonly seen in alcoholics with poor diets. B12 deficiency, if severe enough, causes pernicious anemia, which is often associated with neurological damage; and iodine deficiency during gestation leads to cretinism in the newborn.

“Let the Buyer Beware”

At least as far back as Ponce de Leon, humans have been seeking to slow, halt, or reverse the process of aging. Despite what the ads for dietary and nutritional supplements claim, we have still not succeeded.

The U.S. Surgeon General recently estimated that about one in five Americans suffers from some “diagnosable mental disorder” during the course of a year. Given the strides made by neuroscience over the past 10 or 15 years in understanding and treating conditions such as schizophrenia, depression, and obsessive-compulsive disorder, it is understandable that so many yearn for a magical formula to make their lives easier, their minds stronger, and their health better. But where should we be looking for such a formula?

Orthodox medicine, also called biomedicine or Western allopathic medicine, proceeds slowly but surely toward its goal of improving health, alleviating suffering, and curing disease. To do so, it utilizes the scientific method: generate a hypothesis (theory), test it experimentally, observe the results, then repeat till confident that the results are reproducible, and therefore predictable.

Advocates of dietary/nutritional supplements to improve health or extend life belong to another category of caregivers: complementary/alternative medicine (CAM), also called “integrative medicine.” Their approach to health care claims to take into account “the whole person,” not just the disease (this is, of course, among the core values of orthodox medicine as well). CAM relies on ancient, traditional philosophies, and gives great credence to testimonials and anecdotal reports of efficacy relating to herbal and other nonpharmaceutical treatments. Some of these include homeopathy, naturopathy, chiropractic, ayurveda, acupuncture, herbalism, and holistic healing. CAM has become very popular over the past few years, as people seek to become more involved in their own health care. As a result of the demands of patients, orthodox medicine has had to deal with this movement in ways it never anticipated. Almost two-thirds of American medical schools surveyed in 1997 to 1998 offered courses in CAM. When I went to medical school 30 years ago, that number would certainly have been zero.

Why the change? Well, more and more people seem to distrust science and scientists, and doctors trained in years gone by certainly considered themselves scientists, although we tried to add a human face. Doctors are often no longer personal physicians but “providers,” and patients see them as part of the daunting process of access to health care. On the other hand, CAM and the opportunity to decide for oneself what remedy to try is empowering for the individual.

When is this a good thing? For example, people can get information easily and quickly, but information of what quality? Are they truly empowered if they cannot make informed decisions about their health? If they ask the clerk in a health food store to suggest ways to treat a condition or problem, they will get advice—but of what worth? A recent article in a pediatric journal reported that an amazing 84 percent of children attending a New York City hospital cancer clinic had tried an unconventional (usually herbal) treatment; for fully half of them, this treatment had not been reported to their physicians. Even acknowledging the great potential for adverse effects, not to mention actual negligence, when receiving treatment from a licensed physician, at least the prescriber is expected to be competent to discuss risks and benefits with the patient, who then knows whom to call with any question. To whom does a customer turn if a supplement fails to work?

There is no valid “alternative” to scientific medicine. There is either scientific, evidence-based medicine, or unproved treatments. Whether a treatment is old or new, of the East or the West, involves a holistic approach or a computerized algorithm, is not the issue. The only issue is: Has it been proven to work, with minimal risk to the patient? CAM therapies, including the DNS discussed here, have not been adequately evaluated. If they had been, they would be available as pharmaceuticals.

Offering courses on CAM in medical schools, establishing a National Center of CAM under the auspices of the National Institutes of Health, or even adding CAM coverage to health insurance policies will not turn this dross into gold. Medical scientists should protest the uncritical acceptance of unproved treatments, which of late has been driven by unsubstantiated advertising claims rather than science. Science, which has given us the best health and the best medical care system in human history, must continue to be our compass. Caveat emptor—“Let the buyer beware”—should not be allowed to replace the physician’s creed, “First, do no harm.”

Put the FDA Back in the Picture

What steps can we take to regain control from the modern snake-oil salesmen? The Dietary Supplement Health Education Act of 1994 should be repealed, and nutritional supplements restored to the same level of FDA supervision and regulation as they had before that law, when DNS were in the same category as food additives. Consumers who wish to do so should be able to get supplements, but marketers, advertising executives, and even pharmacy and health food employees would have to advise them of the risks and benefits of these drugs (yes, they are drugs). Why should they be less regulated than toasters, cough drops, or food additives?

True, the FDA is far from perfect, but it does its job better than most federal agencies—one indication being that it is often caught in a crossfire of abuse. Consumer groups attack it for being too cavalier with its approvals. Libertarians accuse it of over-regulating and thus preventing useful therapies from reaching those who could benefit from them.

The issue is not whether DNS have valid medical uses or can help our brains. Nor is it whether they should be available to those who want to use them. The question is whether it is in the public interest to exempt DNS from the strict quality controls that almost everything else that might be ingested is required to pass. As Dr. Marion Nestle, chairman of the department of food studies and nutrition at New York University, recently said, “Half the adult population of the United States is putting this stuff in their mouths. It really does present the biggest challenge we have had in years to the way medicine in this country is practiced.” Right now, consumers are left on their own to sort through an avalanche of conflicting and misleading claims.

Former FDA commissioner Kessler recently wrote in a New England Journal of Medicine editorial, “Congress has shown little interest in protecting consumers from the hazards of dietary supplements, let alone from the fraudulent claims that are made, [n]or does the public understand how potentially dangerous these products can be.” Closing the supplement loophole would save lives. Until this change occurs, uninformed, unsuspecting American consumers will continue to serve as the safety test for these supplements.