American Journal of Law & Medicine

Dietary supplement labeling: cognitive biases, market manipulation & consumer choice.(The Dietary Supplement Health and Education Act: Regulation at a Crossroads)


There exists increasing concern that the Dietary Supplements Health and Education Act ("DSHEA") has proven ineffective and perhaps counterproductive. Most illustratively, consider a recent and remarkably candid remark from Tommy Thompson, then Secretary of Health and Human Services: "I really think Congress should take a look at the food supplement law again. It doesn't make any sense to me." (1)

A health law that makes no sense to the Secretary of Health of Health and Human Services should certainly draw the attention of academics and policy-makers alike. Much of the debate concerning DSHEA regards the disparity in legislative treatment between dietary supplements, foods, and pharmaceutical drugs. Specifically, while pharmaceutical drugs must undergo years of costly pre-market testing, most dietary supplements--like most foods--can immediately enter the market, and only after repeated instances of adverse reactions can the Food and Drug Administration ("FDA") remove them. Such a framework appears to belie both consumer expectations and marketing strategies, as dietary supplements tend to be most perceived for their apparent medicinal qualities. Similar then to a dangerous street intersection that awaits a tragic accident before town officials install a traffic light, an unsafe dietary supplement awaits a tragic consumer reaction before the FDA may respond. This philosophy of waiting for a foreseeable harm strikes many as unnecessary, inefficient, and perhaps immoral.

On the other hand, many dietary supplements have proven not only safe, but reasonably effective. While significant media attention has been directed toward the minority of instances where dietary supplements have caused harm, less attention has been paid to the more repeated occurrences of either benign or helpful supplements. Moreover, before policy-makers mandate extensive pre-market testing of all dietary supplements, consider the likely effect on production: a certain percentage of dietary supplement makers will find the economics of production too costly and will thus leave the market. Granted, foreign markets for supplements might still provide the requisite incentives for production, but a more costly entrance fee into the U.S. market would clearly deter some level of production and convince a number of makers to leave the market altogether. Equally troubling, companies which choose to remain in the market would presumably pass on a portion of the increased costs to consumers, who often bear the costs of heightened regulation. Consequently, many beneficial dietary supplements would be priced out of the reach of lower and middle income consumers who either have become users of those products or could become users.

The issue then is one of nuance. Rather than sweeping regulatory intervention, perhaps more carefully-tailored alterations would prove most desirable. This philosophy appears desirable given informational deficiencies among dietary supplement consumers, particularly those with cognitive biases that are easily exploited by supplement manufacturers. Promisingly, such deficiencies may be ameliorated through low-cost measures that promote enhanced communication of product characteristics.

For these reasons, this Article proposes a refined approach to dietary supplement labeling that would legally distinguish them on the basis of potential risk and anticipated benefit. Indeed, the existing legal construct of the phrase "dietary supplements" is both curious and overly simplistic. It includes minerals, vitamins, herbs, botanical extracts, and amino acids--in other words, items that are not only functionally different, but which might also present radically different risks and benefits. Along those lines, the very consumers of dietary supplements should be more carefully distinguished. For example, a person who digests Cortislim, a controversial weight-loss supplement containing a murky mixture of vanadium, chromium and botanical extracts, probably subscribes to a different risk and benefit calculation than one who fancies Ricola cough drops. A more calibrated legal framework would recognize those varying calculations.

How might such a revised communicatory model work without precipitating material price increases or deterring beneficial dietary supplement production? One method would entail more carefully-contemplated labeling requirements for dietary supplements. Such requirements should enhance consumer risk-assessment and reward reputable supplement manufacturers. To accomplish these goals, labels should reveal potential interactions with pharmaceutical drugs and other supplements, warnings of over-usage, predictable distinctions between "health" claims and "structure/function" claims, and a recommended intake range based on age and gender, among other personal characteristics. Of similar benefit would be assured ingredient content, as well as greater coordination between the FDA and the Federal Trade Commission ("FTC") in regulating false or misleading dietary supplement claims. Importantly, because such labeling requirements would merely require enhanced informational disclosure, they would impose only minimal cost increases to manufacturing research, development, and production.

A second method would require dietary supplement manufacturers to register ingredient contents with the FDA and to report adverse reactions to all products. These two concepts are related in practice and in form to enhanced labeling disclosure and would remedy a framework whereby the FDA fails to learn of over 99 percent of adverse consumer reactions and cannot determine the ingredients in nearly one third of those supplements that trigger adverse reactions. Requiring such registration and reporting appears consistent with efficient modeling, particularly given the FDA's limited resources; for the FDA to pursue information already possessed by manufacturers appears wasteful and unnecessary. In addition to providing consumers with more timely and crucial information to use when making consumption choices, such requirements would also enhance lines of communication between the FDA and manufacturers, as industry and governmental actors would share product information. This in turn would enhance the reliability of adverse event reporting and offer promise for greater industry-governmental relations. Moreover, like enhanced labeling, registration and reporting are low-cost, informational directives that preserve the production incentives and pricing schemes of dietary supplement manufacturers.

Imposing such informational duties on dietary supplement manufacturing would enhance consumer information, as well as the level of informed risk and assessable benefit. Moreover, by avoiding incentive-altering regulation, such as pre-market testing of dietary supplements, production incentives would remain intact, particularly for those who sell verifiable products. Prices for such products should also remain within reach of current and future clientele. In addition, by calibrating dietary supplement information, consumer confidence in the much-maligned dietary supplement industry should rise, thus offering a corresponding benefit to manufacturers. Better informed consumers and more legitimized products would also supply manufacturers with additional protection from product liability claims.

In exploring these ideas, this Article will canvass the dietary supplement industry and explore how consumers of dietary supplements often experience deleterious consequences of cognitive biases, particularly those manipulated by manufacturers. At the same time, this Article will identify consumer benefits derived from dietary supplement consumption, even when such benefits cannot be "clinically" validated. This Article will also examine the salience of legislative choice in promulgating dietary supplement laws, especially as it pertains to communication of risk and benefit. In doing so, this Article will incorporate a comparative approach, including a comparison to European models of consumerism in the dietary supplements context. Lastly, this Article will examine the prescription of new informational duties for dietary supplement manufacturers and how such duties might enhance consumer choice without deterring production.



The term "dietary supplement" comprises a strikingly large and diverse class of products under one convenient rubric. Consider a working list of dietary supplements compiled by the FDA: vitamins, essential minerals, protein, amino acids, herbs, animal and plant extracts (e.g., garlic extracts and inert glandulars), fats and lipid substances (e.g., fish oils, sterols, and essential fatty acids), dietary fibers, and chemical compounds that may have biological activity but that are generally not recognized as nutrients under the traditional definition of that term (e.g., bioflavonoids, enzymes, nucleic acids, para-aminobenzoic acid, and rutin). (2) Together, these and other substances comprise the nearly 29,000 dietary supplements available for sale in the United States. (3)

Dietary supplements are distributed in a variety of instruments, most often capsules, tablets, liquids, or powders. (4) For this reason, some resemble medicines, particularly when packaged in containers that indicate expiration dates or lot numbers or that utilize cotton fillers, tamper proof caps, and other suggestive characteristics. (5) Moreover, given the abundance of dietary supplement products, many appear similar in packaging but offer disparate functions, risks, and benefits. (6)

The dietary supplement industry has more than quadrupled in size since the passage of DSHEA in 1994. More specifically, the industry recorded $20.1 billion in sales in 2003, (7) up from $18.8 billion in 2002 (8) and $17.8 billion in 2001. (9) In fact, industry sales have appreciated over 400 percent from $4 billion in 1994. (10) Moreover, to place the $20.1 billion dietary supplement industry sales figure in perspective, consider the following industry sales figures, also from 2003: candy industry ($1.99 billion); (11) videogame industry ($10.0 billion); (12) organic food industry ($10.8 billion); (13) toy industry ($20.7 billion); (14) and the restaurant industry ($440.1 billion). (15) Absent significant regulatory changes, the dietary supplement industry anticipates continued, high-rate growth for an indefinite period of time. (16)

On the other hand, some external observers are skeptical of such anticipated growth, reasoning that recent litigation has irreparably damaged the industry's reputation. (17)

The proportion of Americans using dietary supplements has grown in tandem with surging sales. Indeed, approximately 60 percent of U.S. adults regularly use dietary supplements, a percentage which has escalated considerably since the passage of DSHEA. (18) Similar growth patterns have also emerged amongst children. (19)

Growing sales and the widening class of dietary supplement consumers have invited inquiry about these products' popularity. Dietary supplements appear attractive for several reasons. Many consumers gravitate to supplements that promise to help them lose weight or "regain lost vigor" without requiring physical exertion or dieting. (20) Certain supplements can also induce effects similar to prescription medicines but retail without required prescriptions and often at markedly lower prices. (21) Still other consumers take supplements as substitutes for indigestible foods flush in nutrients; this is especially apparent among persons who cannot digest dairy products. (22) Moreover, as many as two out of five consumers take vitamin supplements everyday. (23) There are also consumers who simply prefer holistic and natural products to traditional medicines. Such preferences often reflect individualistic predilections, such as distrust of modern medicine or appreciation of "wholesome" or "earthly" substances. (24) Similarly, some consumers use supplements for cultural and ethnic practices, (25) as well as for emotional and psychological needs. (26)


Compared to drugs, dietary supplements and their labels appear strikingly unregulated. Instead, dietary supplements are regulated more like food products. Specifically, under DSHEA, the controlling legislation, most dietary supplements become available to consumers without FDA review or approval, and in only limited instances do novel ingredients receive pre-market evaluation for safety and efficacy. (27) Though seemingly benign, this pre-market arrangement proves slightly more arduous than that imposed on food products, which may enter the stream of commerce without FDA approval of specific ingredients, ingredient quantities, or interactions between ingredients. Like food labels, however, dietary supplement labels must list ingredients and levels of vitamins and minerals in a standardized "Supplement Facts" panel. Manufacturers are afforded wide latitude in product labeling and in product promotion; short of egregious misrepresentation or explicit promise to cure disease, supplement manufacturers possess broad autonomy in how they shepherd their product through the American economy. (28)

For those who regard dietary supplements more like drugs than food products, this absence of pre-market testing and stringent labeling requirements reflects a peculiar deviation from norms within the medical and regulatory communities. Indeed, compare dietary supplement regulation to that of pharmaceutical drugs. (29) Since passage of the Kefauver-Harris Amendment (30) in 1962, drugs must undergo carefully designed clinical tests before becoming available to American consumers. (31) Clinical drug testing has been deemed essential to prevent dangerous and inefficacious practices. (32) The "New Drug Application" ("NDA") process is often arduous and costly. Drug manufacturers may wait as long as thirteen years before receiving FDA approval, during which time they may invest as much as $1.7 billion in researching and testing. (33) Even after such investment and wait, an application may be denied for insufficient safety, inadequate testing, poor packaging, deficient manufacturing, and lack of evidence that the drug will achieve its intended effect. (34) In short, while dietary supplement manufacturers encounter a nearly unfettered path to American consumers, drug manufacturers often travel a lengthy, costly, and uncertain road to reach those same consumers.

A further variance concerns labels. Unlike largely unregulated supplement labels, which often express unrealistic claims and inaccurate content, drug labels are highly scrutinized and thus carefully tailored, resulting in cautions and measured claims. (35) Indeed, since passage of the Federal Food, Drug and Cosmetic Act of 1938 (36) ("FDCA") and subsequent regulations, drug manufacturers must label their products with unambiguous directions and all-inclusive lists of warnings while avoiding promotional language. (37) The FDCA also requires that the sponsor of a drug verify the safety and efficacy of each claim made in its labeling. (38) Moreover, drug manufacturers may only market their products for FDA approved uses; (39) any marketing beyond such uses comprises "off-label" marketing, which the FDCA prohibits. (40)


The existing regulatory treatment of dietary supplements has concerned policymakers in recent times, particularly as data has revealed that dietary supplement consumers often perceive their consumption choice as one in lieu of drugs or other medicines. Indeed, a recent study revealed that approximately 80 percent of consumers who use dietary supplements purchase them instead of prescription drugs or over-the-counter drugs. In another study, the two most cited consumer reasons for taking supplements were "to feel better" (72 percent) and "to help prevent getting sick" (67 percent). (41) Most consumers also assume that dietary supplements are qualitatively better than drugs: According to a third study, 56 percent of consumers believe that supplements offer benefits comparable to those of drugs but with fewer side effects, and 53 percent maintain that supplements often offer benefits that conventional drugs cannot. (42) Such data comports with the general impression among clinicians that patients increasingly bypass consultations in favor of self-medication through dietary supplements, (43) as well as with long-standing historical and global patterns of supplement use, particularly of herbs as medicines. (44) Therefore, extensive regulatory variances between dietary supplements and drugs appear disconsonant with consumer expectations. (45)

Moreover, dietary supplements are often marketed as medicinal products rather than as food products. (46) Likewise, supplement manufacturers sometimes obscure distinction between their products and medicines through misleading product names, such as the recently enjoined "Herbrozac," which, like the drug Prozac, claimed to treat clinical depression among children. (47) Similar concerns have been raised of the supplement "herbal fen-phen," which sounds uncannily similar to the diet drug combination fenfluramine and phentermine, commonly called "fen-phen." (48)

These consumer purchasing patterns and advertising schemes appear even more meaningful when considering that while many of the ingredients in dietary supplements would prove safe in isolated form, certain ingredients may present enhanced danger when offered in high concentrations or in chemical form. (49) Complicating matters, these ingredients are typically displayed on labels in promotional ways that distort risk. (50)

Promotional concerns appear especially salient for consumers prone to discounting product risk, such as economically-disadvantaged persons and children. These are especially impressionable groups, and thus vulnerable to "myth-making" among dietary supplements, whereby value is ascribed to reputational, rather than scientific qualities. (51) Indeed, despite the lack of clinical validation, many consumers believe that certain supplements are "proven." (52) For instance, garlic pills are said to lower cholesterol; ginkgo allegedly helps one's memory; and Echinacea may effectively treat flu symptoms. (53) To date, however, independent research has failed to confirm any of these claims. (54) Thus, much like superstitions and folklore, dietary supplements often enjoy more salience than objective data would suggest.

Optimism bias, or consumers' tendency to assume that general risks posed by products do not apply with equal force to themselves, (55) may offer a useful corollary to myth-making. This is especially true since optimism bias tends to flourish when risks are long-term or are presumed modifiable through behavior. (56) Along those lines, when consumers assume that signs of toxicity will appear early in product usage, they tend to assume that an absence of such early signs foretells exemption from future risk. (57) For instance, smokers tend to perceive smoking as significantly less risky for themselves than for other smokers. (58) These effects are most pronounced among children smokers, who often rate their own chances of contracting lung disease as nearly identical to those of non-smokers. (59)

Myth-making and optimism bias among consumers are especially exploitable characteristics. Indeed, when consumers systematically underestimate risk, manufacturers may more readily conceal risk information. (60) Conversely, when positive images of product use repeatedly appear--such as an often-aired infomercial of a slim man and woman consuming a particular diet pill--consumers tend to surmise unrealistically favorable expectations. (61) This is especially true when short-term product use seldom results in injury, at least to consumers' physical appearance. (62)

Moreover, in the midst of the ephedra fallout, some dietary supplement manufacturers have adroitly utilized the "irrelevant third option effect," whereby they market their products as "ephedra free" and thus of apparent less-risk. (63) When any seller introduces irrelevant options, a consumer typically becomes biased in favor of options that he originally disfavored. (64) Indeed, by framing the choice between something dangerous, something much less risky, and no action at all, supplement manufacturers may encourage new or continued use of supplements, much like the option of "unfiltered" or "light" cigarettes encourages would-be quitters to continue smoking. (65)

Individuals who lack significant resources are particularly vulnerable to choice distortions among dietary supplements. Indeed, those without access to health care often become heavy dietary supplement users. According to a December 2004 study released by the non-profit, non-partisan Center for Studying Health System Change, consumers who select supplements because they regard conventional treatments as expensive are almost twice as likely to earn incomes below the poverty line, significantly more likely to report poorer health status, and four times more likely to be uninsured. (66) Equally troubling, the most popular supplements among low-income persons are those known to cause serious side effects, such as St. John's Wort and Kava. (67) These consumption patterns are especially apparent among elderly persons who cannot afford prescription drugs, as they have increasingly turned to less expensive, but potentially dangerous, dietary supplements. (68) For instance, many seniors purchase anti-oxidants, such as vitamin E and beta-carotene, largely based on the word-of-mouth belief that they prevent cancer. (69) Available data, however, indicates no such discernable benefit; in stark contrast, those particular anti-oxidants have been associated with increased risk of lung cancer among smokers. (70)

Adolescents are likewise malleable consumers of dietary supplements. This malleability partly relates to general characteristics of persons in that age group, as they have a greater tendency than adults to take dangerous risks, weigh short-term consequences more heavily than long-term consequences, and act impulsively. (71) Such phenomena are especially evident among older adolescents, who tend to engage in risky and experimental behavior "as part of the process of separating from family and becoming autonomous." (72) Moreover, adolescents often struggle with discriminating fact from fiction (73) and are more likely than adults to uncritically ascribe to advice or suggestion. (74) Dietary supplement companies are also presumably aware that young persons represent the most lucrative purchasing cohort of any age group (75) and that their buying power has accelerated faster than that of any other age group in recent years. (76)

Data concerning dietary supplements use by student athletes uniquely illuminates the adolescent tendency to discount risk. For instance, most college athletes who use ephedra products became habitual users while playing sports in high school. (77) It is thought that ephedra and similar stimulants offer the "extra edge" to perform, improve skill level, or help one become more athletic; (78) correspondingly, many younger users are motivated by peer pressure (79) or quixotic sports aspirations. (80) Direct observations of supplement usage by role models only reinforce the availability and desirability of these stimulants. Children and adolescents may readily watch coaches, trainers, and teammates, as well as professional sports stars, use and promote dietary supplements. (81) By forecasting unrealistic benefits and depreciating risks, these impressions and exigencies merely exacerbate myth-believing and optimism bias among a particularly vulnerable group.

Of similar concern, adolescents and young adults appear increasingly interested in creatine monohydrate supplements. These supplements elevate the body's supply of a compound found in the liver, pancreas, and kidneys, which ultimately becomes phosphocreatine, a source of energy for weight-lifting. (82) According to the American Academy of Pediatrics, nearly 30 percent of college athletes use creatine, as do nearly 20 percent of high school juniors and seniors. (83) More recently, non-athlete students have become frequent creatine customers, apparently motivated by a desire to look stronger and more attractive. (84) However, neither the safety nor efficacy of creatine has been clinically determined, though commonly observed side effects include cramping and gastrointestinal upset; less often, kidney dysfunction has been reported. (85)

Perhaps more disturbing, use of creatine and similar products may encourage the subsequent use of toxic and illegal substances, such as anabolic steroids. (86) Indeed, the availability of such substances may endorse a socially-permissive attitude towards external enhancements, which might encourage a more lenient attitude toward steroid use. (87) Separately, consider the salience of the irrelevant third option effect in the creatine consumer model: by framing the choice between a steroid, creatine, and no enhancement, manufacturers of creatine products likely encourage would-be non-purchasers of steroids to purchase creatine. (88)

Of course, distorted perceptions are not apparent solely among those of economic disadvantage or those in their childhood and adolescent years. Rather, consumers tend to assume a product's safety merely by virtue of the product's placement on a store shelf, particularly at established retail chains. Other consumers presumptively equate "natural" products with "harmless" products. (89) Moreover, because dietary supplement manufacturers may readily advance disingenuous claims, they are able to utilize context-distortions to more generally mislead consumers. For instance, supplements which claim to "boost metabolism" and thereby facilitate bodybuilding often neglect to mention that only professional bodybuilders enjoy meaningful benefit. (90)

Similarly, consider the very real effect of celebrity product endorsements on consumer evaluation of dietary supplements. Although celebrities usually lack the requisite qualifications to knowledgeably dispense health-related advice, they are nevertheless employed with great alacrity by dietary supplement manufacturers. For instance, Phillip C. McGraw, Ph.D. (a.k.a. "Dr. Phil"), a trained psychologist but not a medical doctor, endorses energy bars and multivitamin supplements. (91) Less credibly, self-help guru Anthony Robbins likewise endorses a brand of nutritional supplements. (92) Similarly, actor James Brolin, who once starred as a physician in the television series "Marcus Welby, M.D.," now stars in promotions for a dietary supplement claiming to mitigate arthritis. (93) Even unintentional endorsements have proven salient: sales of Zantrex-3--a diet pill containing high doses of caffeine, green tea, and three South American herbs--soared after pop star Brittany Spears spilled a bottle of the product with photographers nearby. (94) Significantly, because consumers tend to regard the dietary supplement market as confusing and daunting, market experts find consumers are more likely to trust celebrity opinions of dietary supplements than of more familiar products. (95)


The preceding sections paint an admittedly dim view of dietary supplements and their interaction with consumer choice. However, many dietary supplements have proven effective, and, even without clinical validation, have achieved support within the American medical community. (96) This section will describe some of the more favorable aspects of dietary supplements, and why efforts to curtail their sale must be carefully tailored.

Proof of safety and effectiveness, at least in a clinical sense, is often hard to establish for dietary supplements. Without requisite assurances of product safety or stringent labeling guidelines, dietary supplement manufacturers lack the incentive to conduct exhaustive testing. This is particularly true given fierce industry competition and the resulting "rush" to deliver products onto the market. (97) Although independent supplement watchdog groups, such as, regularly test dietary supplements for ingredient integrity and claim accuracy, such testing typically occurs well after a product's introduction into the stream of commerce. (98)

Predictably, the lack of uniform supplement testing often draws stern rebuke from traditional medical providers, who employ clinical testing to distinguish not only helpful from harmful products, but also modern from primitive medicines. (99) Clinical testing measures biological plausibility, consistency and reproducibility of research, dose-response effects, strength of causal association, and correct temporality between cause and effect. (100) Accordingly, without clinical testing, there exists considerable opportunity for unrealistic and deleterious practices, as well as misinterpreted results. For instance, in some primitive tribal communities, medical healers still treat AIDS with herbs. (101) Despite using different herbs and dissimilar methods of preparation, they nevertheless believe their methodologies are effective. (102) Similarly, without rigorous testing, contaminants and adulterants within supplements may pose unexpected danger. To illustrate, a recent seizure of 260 imported Chinese supplements by the California Department of Public Health revealed that over half of the supplements contained high levels of lead and arsenic. (103)

Despite the absence of methodologically-deduced "proof," certain dietary supplements have been heralded by consumers. The herb ginseng, for instance, has been used for centuries by Tibetan people to improve endurance and memory; its relatively recent introduction into the United States market has evinced similar claims. (104) Likewise, many consumers of elderberry extract insist that it alleviates flu symptoms. (105) Although these findings represent anecdotal and unscientific evidence, they intimate that widespread clinical benefits may be associated with certain supplements.

Consumer impressions are also significant because certain supplements may subsequently receive clinical validation. For instance, scientists find that green tea extract and Chinese Red Yeast Rice feature anticancer effects. (106) Perhaps most dramatically, consider artemisinin, an ancient Chinese herbal compound based on qinghasuu (sweet wormwood). Decades ago, Chinese doctors found that artemisinin significantly reduced the death rate of malaria patients without imposing serious side-effects. (107) For years, westernized medical communities dismissed artemisinin's alleged prowess as mere mysticism. (108) However, as malaria evolved into resistant strains against the drug Chloroquine, world health agencies reluctantly turned to the herbal compound. (109) Later clinical studies have not only confirmed artemisinin's effectiveness, but now generally regard it as superior to Chloroquine. (110)

Along these lines, anthropological research may illuminate effective treatments among traditional medicines where clinical testing does not. (111) Put differently, the clinical value of historical, albeit circumstantial findings can reveal unique and valuable information. For instance, consider the long-standing Laotian tradition of incorporating herbs into meals. (112) Intriguingly, anthropologists find uncanny and detailed knowledge among Laotians about the ways in which each herb benefits the body, even though many Laotians lack formal education and even though such conclusions were originally drawn centuries ago, long before westernized testing of herbal efficacy. (113)

Furthermore, even when supplements lack measurable efficacy, they may nevertheless help persons cope with illness, particularly when compared to more stigmatizing modes of modern medical delivery. (114) For instance, the steroid dehydroepiandrosterone (a.k.a. "DHEA") has been identified as improving mental well-being and reducing stress. (115) Many consumers prefer its over the counter availability to stigmatizing or even embarrassing requests for prescription mental health medicines. (116) Such subjective value comports with the modern description of "holistic medicine": care of the whole patient (body, mind, relationships, emotions, and spirit) in the context of the patient's values, culture, and community. …

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