ari allen on spirituality and alternative medicine: snake oil or holy water?

7/25/2019 Ari Allen on Spirituality and Alternative Medicine: Snake Oil or Holy Water?

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SNAKE OIL OR HOLY WATER?

RECONCILING THE DIETARY SUPPLEMENT PARADOX

Ari Allen

January 2011


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I. Introduction

The purpose of this paper will be to explore the impact of the Dietary Supplement

Health and Education Act of 1994 (DSHEA), in a historical context. In other words,

how does the advent of dietary supplements fit in with the overall development of

allopathic medicine and its regulation? This issue has become of growing importance in

recent years. Indeed:

Dietary supplements--vitamins, minerals, herbs, aminoacids, and sundry other substances--have soared in

popularity over the past decade, resulting in a $20 billionindustry with more than a thousand manufacturersmarketing 29,000 products. A recent survey conducted bythe National Center for Complementary and AlternativeMedicine (NCCAM) found that approximately one-fifth ofAmericans use supplements.1

With the quick growth of the dietary supplement industry (and the alternative

medicine discipline as a whole), there have been myriad of criticisms of the way in which

these substances are regulated. However, it is clear that they must be regulated

somehow. Consumers must be protected from the dangers of ephedra,2and the tactics of

fraudulent and deceptive marketing (snake oil salesmen). This is not only important for

the safety of individuals, but for public health at large:

The use of CAM is impressive everywhere. For example,the World Health Organization estimates that 4 billion

1Lars Noah and Barbara Noah,A Drug By Any Other Name? Paradoxes in Dietary Supplement Risk

Regulation, Stanford Law and Policy Review, 165 (2006).2Gardiner Harris,Judges Decision Lifts Ban on Sale of Ephedra in Utah , New York Times (2005).


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people, or 80 percent of the world's population, presentlyuse herbal medicine.3

Generally, critics have tackled issues relating to misleading promotional

statements, unsubstantiated health claims, potency, contamination and other

manufacturing problems, but the greater question of when [] a supplement cross[es] the

line and become a drug for regulatory purposes, ties all of these other issues together.4

In this light, this paper sets out to explore the definition of dietary supplements, its

distinction as it relates to drugs, and how to ensure these dietary supplements are

regulated safely, without infringing on the free access bestowed upon it by DSHEA.

It will be argued that the implied purpose of DSHEA is to protect safety and

ensure accurate disclosures and full transparency without testing and invalidating

efficacy. The reasons and consequences of recognizing this purpose are important, and

will be explored later in Section IV.

However, dietary supplements and other alternative practices of medicine are

becoming subject to increasing demand not only by consumers, but by practitioners as

well. Recent surveys indicate 80 percent of medical students and 70 percent of family

physicians want training in alternative medicine.5 Practitioners are interested in the full

array of tools available to them: Western or Eastern. Furthermore, the possibility of

using Eastern medicine and herbal supplements as complementaryto Western allopathic

3Fred Frohock,Moving Lines and Variable Criteria: Differences/Connections between Allopathic and

Alternative Medicine, Annals of the American Academy of Political and Social Science 583: 214, 216

(2002).4Noah,supranote 1, at 165.5Frohock,supranote 3, at 220.


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medicine creates the integrated approach that is quickly growing among holistic

practices. Indeed, perhaps the Eastern focus on natural botanical medicine can

complement andsupplementthe Western focus on allopathic scientific procedures if

only they were delineated properly. This project of delineation is the aim of this paper.

II.

Background

In the 19thcentury, "the very idea of licensing health-care providers was

deemed unnecessary.6 Indeed, an 1850 report by the Sanitary Commission of

Massachusetts stated: [a]nyone, male or female, learned or ignorant, an honest man or a

knave, can assume the name of physician, and practice upon any one, to cure or to kill,

as either may happen, without accountability. It's a free country!"7

However, over time, the medical profession would eventually become the highly

regulated machine it is today. Specifically in regards to substances, medicine has

obtained an important role in ensuring that anything we consume is transparent, safe, and

effective. In 1906, Congress passed the original Pure Food and Drug Act (PFDA).8 In

the wake of Upton Sinclairs revealing novel, The Jungle, there was a public outcry to

ensure that food be processed under sanitary conditions. Once the production process

was placed in public view, it became necessary to regulate an industry that, like many

others, was hiding its profit-making process behind closed doors. Primarily targeting the

6John Dodes,Alternative Therapy: An Historical Perspective on Health Fraud, Quinnipiac Health Law

Journal (2000).7Id.8Ilyse Barkman,Industry invites regulation: the passage of the Pure Food and Drug Act of 1906,

American Journal of Public Health 75(1): 18-26 (1985).


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meat packing industry, Sinclair wrote of the piles of meat and the dried dung of rats,

and the great fraud and abuse perpetrated by the industry.9 The public was defrauded,

and the only way to protect the public health was to establish government oversight.

However, this initial impetus has grown into a powerful force not foreseen by its

authors. Sinclair would likely be pleasantly surprised by the industrys current

transparency whether in relation to the quality and sanitation of foods, or in relation to

the disclosures the industry must provide as required labeling. However, neither Sinclair

nor Congress likely foresaw the enormous bureaucracy that would later be established to

ensure not only transparency, but safety and, in the case of drugs, efficacy as well.

The PFDA established regulatory oversight over two abuses: adulteration and

misbranding.10 Preventing adulteration involves ensuring a standard of quality, and

ensuring that manufacturers do not allow foreign contaminants, nor use inferior or

extraneous ingredients. In other words, the product must be purely what it sets out to be.

Proper branding involvesstatingwhat the product sets out to be, and what it actually is.

In other words, the product must be properly labeled so that the consumer may be

properly informed. The idea being that an informed consumer allows a market to

function properly.

However, the PFDA also created another distinction: foods and drugs. The

relationship between foods and drugs is obvious, but often misunderstood. Both foods

and drugs are xenobiotics foreign substances introduced into the body that are not

9Upton Sinclair, The Lost First Edition of Upton Sinclairs The Jungle,121-2(Gene DeGruson ed.,

Peachtree Publishers 1988) (1906).10Barkman,supranote 8, at 20.


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normally produced or found in the body at such levels of concentration.11

A xenobiotic,

under the PFDA was a drug only if it was sold under or by a name recognized in the

United States Pharmacopoeia or Natural Formulary.12

Therefore, a substance could not

become a drug by default. Rather, drugs were predefined, and regulated accordingly.

Surprisingly (but understandable due to its reactionary origins), foods seem to

have been regulated morestrictly than drugs under the PFDA. While the criteria for

adulterated foods included a list of possible violations (six in total), the criteria for

adulterated drugs merely required that drugs not differ from the accepted standard of

strength, quality, or purity.13 In addition, the criteria specifically carved out an

exception, whereas even if the drug did differfrom the accepted standard, so long as it

was labeled properly, no violation would be deemed to have occurred. The PFDA clearly

stated: no drug shall be deemed to be adulterated under this provision if the standard

of strength, quality, or purity be plainly stated upon the bottle, box, or other container

thereof.14

In essence, adulterated foods were strictly forbidden, while adulterated drugs

could be sold so long as they were properly labeled. Foods could be in violation of the

PFDA under the adulteration or misbranding provisions, while drugs in violation would

likely be held under the misbranding standard. Indeed, cocaine, heroin, and cannabis

were all available without prescription, so long as they were accurately labeled with

contents and dosage.

11Noah,supranote 1, at 175.12Barkman,supranote 8, at 21.13Id.at 22.14Id.


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In an era when libertarian ideals were still strong, consumer sovereignty was of

prime importance. The role of the government on the other hand, was not to govern what

substances couldbe ingested, but rather to ensure that the consumer knew whatthey were

ingesting. Transparency was the mechanism that allowed consumers to make informed

decisions. After all, in a legal system where consent is the prerequisite for liberty,

information is crucial hence, today we have the common notion of informed consent.

This is an important concept in establishing libertarian policies, and it will arise again

later in this analysis.

However, in 1938, the PFDA was replaced by the Federal Food, Drug, and

Cosmetic Act (FFDCA).15 The FFDCA was much stricter when it came to the

regulation of drugs, in comparison with the PFDA. The reason for focusing on drugs was

again, of reactionary origins. In 1937, a batch of sulfanilamide was prepared improperly

and led to mass poisoning and over 100 deaths.16 The PFDA did not provide any

mechanism to hold the manufacturers responsible, and were only able to obtain a small

fine for merely misbranding the product as an elixir (because an elixir must contain

alcohol).17 In other words, the governments hands were tied.

However, the Harrison Narcotics Tax Act of 1914 (HNTA) paved the way for

stricter regulation of drugs in general by closely regulating the distribution of cocaine,

heroine and other narcotics.18

The modern war on drugs had begun in 1914, and in 1938,

15Noah,supranote 1, at 168.16Carol Ballentine, Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident, FDA

Consumer Magazine (1981).17Id.18Edward Marshall, Uncle Sam is the Worst Drug Fiend in the World, New York Times (1911).


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it was growing into what it has become today. In reaction to the 1937 incident, and with

the growing public acceptance of government regulation, the FFDCA established the

Food and Drug Administration (FDA), as we presently know it.

The FFDCA significantly augmented the federal authority over drugs. Firstly, it

mandated a pre-market review of thesafetyof all new drugs. Secondly, it banned false

therapeutic claims in labeling drugs (withoutthe need to prove fraudulent intent).19 In

other words, snake oil was no longer defined by its bad faith salesman, but was

rebranded as worthless products those without scientifically proven efficacy.20 In one

swoop, all holy water was turned to snake oil not by virtue of a bad actor intending to

defraud, but by virtue of a scientific declaration that holy water doesnt do what it

purports to. Transparency was no longer about contents, dosage and safety, but about

efficacy, results and scientific approval. As this paper will explore, this is a very

important changing of the tides in the history of regulating xenobiotics and one that

deserves a fundamental reexamination. The beginnings of this reexamination can be seen

in 1994 with the passing of DSHEA. While it is true that DSHEA was the result of

intense lobbying efforts by the manufacturers of dietary supplements, an underlying

theme of restored libertarianism often goes overlooked.

III. Current Law

19Noah,supranote 1, at 196.20Id.at 177.


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DSHEA established a new category of xenobiotics: dietary supplements.

However, dietary supplements have a unique place in the world of xenobiotics. On the

one hand, they are dietary, and thus food-like. On the other hand, they are supplements

intended to affect health. In a word, dietary supplements seem to straddle the boundary

between food and drug. However, in passing DSHEA, Congress reversed the tides once

again, taking a rather libertarian stance on dietary supplements. Whether the stance was a

result of lobbying has no impact on its libertarian nature. For regulatory purposes,

DSHEA essentially established dietary supplements as a food, rather than a drug:

The FDA supervises a wide range of products, includingbasic food stuffs, items that deliver more than a simplecaloric effect (such as caffeinated beverages), productsthought to have a quasi-therapeutic effect (such as dietarysupplements), and carefully designed and processedsubstances that are offered solely for therapeutic purposes(such as prescription and over-the-counter drugs). Indrafting DSHEA, Congress chose not to create an entirelynew category of products subject to agency controls;instead, it defined dietary supplements as a subcategory of

food.21

In making this decision, Congress explicitly rejected past FDA efforts to treat

these products as drugs or food additives. Additionally:

Congress also opted against treating dietary supplements asdrugs. In contrast to the regulatory scheme governing newdrugs, which requires substantial premarket evaluation ofsafety and efficacy before the granting of a license,

DSHEA allows dietary supplement manufacturers tomarket their products without receiving any advanceclearance from the FDA.22

21Noah,supranote 1, at 170.22Id.at 171.


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Also mirroring earlier libertarian approaches to xenobiotic regulation:

DSHEA also permits manufacturers to include so-called

structure or function claims in their product labeling, solong as the manufacturer has substantiation that suchstatement is truthful and not misleading, but it does notrequire preclearance of these claims by the agency Ifdietary supplement manufacturers wish to includepermitted structure-or-function claims on their productlabels, they need only add a disclaimer that the product hasnot been evaluated by the FDA and that the product is notintended to diagnose, treat, cure, or prevent any disease.23

Therefore, the DSHEA approach to regulating dietary supplements is reminiscent

of the early PFDA carve-out for drugs in general: no drug shall be deemed to be

adulterated under this provision if the standard of strength, quality, or purity be plainly

stated upon the bottle, box, or other container thereof.24 In other words, full disclosure

can keep untested products on the shelf. Disclosure allows for informed consent, and

therefore, from a libertarian standpoint, efficacy is unimportant, so long as the consumer

knows what it is that they are consuming. However, there is one distinction between the

PFDAs regulation of drugs and DSHEAs regulation of dietary supplements: safety.

Safety is the one paternalistic concern that has survived this revival of libertarian

xenobiotic regulation. Although the burden is on the state (because premarket testing is

not required), a product may be removed if it presents a significant unreasonable risk of

illness or injury under conditions recommended or suggested in the labeling or if it

poses an imminent hazard to public health or safety.25 Again, DSHEA reestablishes

23Noah,supranote 1, at 171.24Id.at 195.25Id.at 172.


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the intertwining of safety and disclosure seen in PFDA. Indeed, under libertarian ideals,

disclosure is the self-regulating mechanism that ensures safety in the absence of

government intervention. It is not beyond the imagination to envision a case in which the

labeling is revised in order to recommend avoidingconditions that present a significant

unreasonable risk. In this light, we have restored the snake oil salesman to his proper

place: snake oil is defined by its salesmans fraudulent intent and deceptive marketing,

not by the products lack of efficacy. In other words, in evaluating safety, the FDA

generally deems the potential benefits of a product to be irrelevant."26

However, when even the slightest risk arises, the FDA may deem the product to

pose an unreasonable risk because of the absence of a sufficient benefit.27 As such,

unreasonable risk is turned into a risk-benefit calculation in which the purported

benefits can be taken into account when determining what to do with products that pose a

risk. In a word, known risks can trigger analysis of benefits. However, many

commentators are calling for the converse known benefits should trigger risk analysis.

One scholar notes: the more pharmacologically active a supplement is, the greater the

risk of adverse effects associated with its ingestion.28 While this logic makes sense, it

creates a DSHEA paradox. The purpose of DSHEA was not to evaluate products based

on efficacy. However, DSHEA presupposes that some supplements may in fact be

effective. It then follows that if benefits trigger risk analysis, then the very efficacy of a

supplement leads to an FDA authority to regulate the supplement more similarly to a drug

26Noah,supranote 1, at 181.27Id.at 186.28Id. at 174.


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than as a food or dietary supplement. In this light, we have an entire category of

xenobiotics whereby the products that lackefficacy are least regulated. Furthermore, by

virtue of this categorization, dietary supplements not regulated are implicitly deemed

placebos, with no effect at all. This is problematic because it disturbs the underlying

purpose of DSHEA: transparency and safety are important, whereas efficacy is not

guaranteed.

IV. Proposed Definition: Reconciling Traditional and Modern Medicine

By statute, the term drug focuses on intended use rather than mere

pharmacological activity.29 While there are many critics of this definition, this paper

criticizes both the conventional definition and the alternative. Neither intended use nor

pharmacological activity differentiates a drug from a dietary supplement. Rather,

drugs are chemically designedfor an intended use. This is very different than naturally

occurring dietary supplements.

Under DSHEA, the definition of dietary supplement includes vitamins, minerals,

herbals, botanicals and amino acids.30 In other words, naturally occurring xenobiotics

(that are not mere foods) are considered dietary supplements so long as they are ingested

orally and not misrepresented. However, critics that focus on ample evidence of adverse

effects associated with a wide variety of dietary supplements, and, consequently, the

connection between pharmacological activity and risk of adverse events,31

miss the point

completely. If a dietary supplement is no longer treated as a dietary supplement by virtue

29Noah,supranote 1, at 176.30SeeJustin Gillis,Herbal Remedies Turn Deadly for Patients, Washington Post, A1 (2004).31Noah,supranote 1, at 175.


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of its efficacy, then the law has a serious bias againstdietary supplements. As the same

critic concedes:

Under this approach to risk identification, wheneversupplement manufacturers attempt to substantiate theirstructure-or-function claims with scientific evidence, theyunwittingly open the door to heightened regulatory scrutinyof potential health risks.32

The authors of DSHEA surely did not intend such counterintuitive results. If they

were concerned about the efficacy of supplements, they would have legislated

accordingly. To bring efficacy under the authority of the FDAs regulation of dietary

supplements is to effectively undo DSHEAs libertarian focus on safety and disclosure.

DSHEA has endowed dietary supplements with an element of consumer

sovereignty. While procedurally, this may be the result of extensive lobbying efforts by

the industry, substantively, it may reflect an effort to reconcile paternalistic science and

medicine with individualistic cultural and religious practices. For example, many dietary

supplements have their roots in the Chinese culture (e.g., ginseng, ginger, and astragalus).

However, the term snake oil is a derogatory reference to such cultural medicine

oil made from the Chinese Water Snake.33 This is just one example in which

conventional Western allopathic medicine attempts to frame the debate in its favor. The

libertarian view, on the other hand, would attempt to eliminate the debate entirely: so

long as the snake oil does not present safety concerns, and provides adequate warnings

disclosures, then it is not snake oil in the derogatory sense. Rather, from our

32Id.at 180.33R. A. Kunin, Snake Oil, West J Med., 151(2): 208 (1989).


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Westernized perspective, snake oil would better be analogized to holy water a

substance with no scientific proof of efficacy, but also no anecdotes of significant safety

concerns. As such, the libertarian view introduces a tolerance for such cultural

relativism.

However, derogatory classifications such as snake oil, is not unusual for the

church of science. The orthodoxy of science holds that efficacy can only be proven

through the scientific method of experimentation. However, the scientific method is

entrenched in its ability to eliminate the placebo effect.34 Yet, science never explains

why the placebo effect is not worthwhile in and of itself. If we spend billions of dollars

trying to control the placebo effect, then maybe placebo therapy35is a power worth

harnessing. From this perspective:

The celebrated controlled experiment is not what itpretends to be, a test of an internal theory against externalreality, but is a mere internal coherence test comparing twoconstructs that are produced according to different

procedural requirements: the logic of theoretical reasoningand the logic of the laboratory.36

In relation to the placebo effect, the science of controlled experiments cannot

carry the day completely for the simple reason that many therapies work because patients

believe they will work."37

Indeed:

Put in terms of the deeper issue, mind and body mayconstitute a complex framework, perhaps a kind of layered

34Frohock,supra note 3, at 221.35Dodes,supranote 6, at 37.36Gunther Teubner,How The Law Thinks: Toward a Constructivist Epistemology of the Law, Law and

Society Review, 743 (1989).37Frohock,supranote 3, at 221.


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unitary self, able to influence and undermine clinical trialswith findings in the larger world of human experiences.38

Thus, the goal for regulating supplements with an established cultural history is

very difficult to achieve: protect consumers whilepreserving the placebo effect. Once a

patient is aware that a placebo is merely a placebo, belief is taken away, as is the efficacy

of the placebo. This is the inherent dilemma at hand. Stated elegantly:

The deeper issue is that the binary self may be aninadequate model for the human person. Psychiatrists tellus that the therapeutic powers of beliefs are best triggered

by an authority figure: the shaman in traditional cultures,the health care people in modern societies, and maybe afew others.39

As such, when the health care people begin to question the shaman in

traditional cultures, the shamans healing powers disappear.40 The question then, is why

science feels it has the need, and the authorityto rain on faiths parade. Placebo

therapy is something to revel at and in our society, rampant with mental illness,

perhaps beliefcan heal our mindsso that our mindsmay heal our bodies. The church of

science however, has other plans inventing illnesses and becoming increasingly

invasive.

This begs the question: when was naturalhealing deemed alter-native? Why are

naturally occurring dietary supplements recommended by ancient wisdom alternativeto

conventional allopathic scientifically synthesized chemicals produced by for-profit

pharmaceuticals? Modern pharmaceuticals also depend on an element of faith. Many

38Id.at 223.39Frohock,supranote 3, at 222.40As one saying goes: a superstition is only a superstition if it isnt a superstition.


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commercials for pharmaceuticals explicitly state that the mechanism of action is

unknown, but that results are proven. In other cases, pharmaceutical companies invent

illnesses so that they may have a profitable product. Surely, in these cases, science is

manipulating the market for its own purposes. Science has successfully framed the

debate, and has deemed nature itselfas alter-native. Indeed, this circularity is clear:

Studies have shown that physicians tend to label as alternative that type of medicine in

which they have had the least amount of training.41

However, before returning to the question of how to define dietary supplements in

this light, it may serve useful to provide some evidence of the medical benefits of faith.

It has been shown that those with strong religious beliefs recover more rapidly from

severe burns.42 Furthermore:

Those who go to church have fewer heart attacks. In onestudy of 250 people monitored after open-heart surgery,those with religious convictions and social support weretwelve times less likely to die than those who had none. In

a meta-review, 76 percent of data based, peer-reviewedstudies documented positive benefits of religiouscommitments on alcohol and drug abuse, depression andanxiety, and a variety of illnesses and adjustmentchallenges. None of these findings is startling. They testifyto long-standing understandings that beliefs, and perhapscertain types of beliefs, can make one better (or worse) inand of themselves.

43

In one study, smelling a placebo helped asthmatic children increase their lung

function by 33 percent, and people exposed to fake poison ivy developed real rashes.44

41Id.at 216.42Id.at 222.43Frohock,supranote 3, at 228.44Id. at 222.


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In this light, the power of the placebo effect is unsurprising:

There is no mystery here. A century of psychotherapy(unfairly maligned in recent literatures) is based on getting

mental states right as a way to avoid and heal at least someafflictions of the body and generally enrich one's physicalstates. We know, for example, that group therapy canprolong life in breast cancer patients and that therapy formild depression can help postoperative heart patients. Theunconscious, notoriously receptive to suggestions intherapy, seems to contain a guidance system. A recentstudy has identified a part of the brain that draws onemotional memories and is activated to guide decisionsbefore awareness occurs the source of intuition, in short.These faculties are remarkably influential in fixing states of

health and in confusing the results of controlledexperiments on the efficacy of medical products.45

This analysis leaves us with two fundamental questions. Firstly, as mentioned

earlier: How can we protect the safety of consumers while preserving the power of the

placebo effect? Second, we have a new question: How can we define dietary

supplements to avoid the paradox that effective dietary supplements have

pharmacological effects that may also produce adverseeffects?

In answering these questions, two observations become clear. First, reclassifying

effectivedietary supplements as quasi-drugs is counterproductive because it removes the

protections for the most effective supplements. In other words, supplements should not

be penalized for being effective. Second, this same reclassification leaves the entire

dietary supplement classification empty of legitimacy because it is deemed to have no

pharmacological effect, and thus, destroys the power of the placebo. In essence, a

45Id.


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definition that allows efficacy-based scrutiny explodes the entire purpose of DSHEA, and

so, is not effective in implementing it. The purpose of DSHEA is to protect safety and

provide transparency for dietary supplements. The words efficacy and effectiveness

are not found anywhere in the text of DSHEA and so utilizing efficacy as a tool to

determine the presence of risks is disingenuous and self-defeating in both ways

elaborated above.

In sum, DSHEA must focus on its original purpose: allowing relatively

unfettered access to dietary supplements (including many cultural remedies) while

protecting consumers from safety, fraud and deception. The derogatory nature of the

term snake oil must be re-contextualized around the snake oil salesman rather than a

direct attack on snake oil itself. It is the intent to defraud, or the neglect of harm that

must be prevented not the autonomous decision of the consumer to determine what

constitutes snake oil.

In this light, it is time to turn to the first of three tasks of DSHEA: ensuring

consumer safety. A good example of DSHEA acting in the name of consumer safety is in

relation to the Chinese herb ephedra. Following many recorded adverse reactions, the

safety of ephedra was seriously called into question. Initially, the FDA proposed to

address these safety concerns with restrictions on dosage and recommended duration of

use.46

Later, the FDA implemented a complete ban. However, in 2005, a federal judge

in Utah struck down the ban by reasoning that the FDA had not proven that ephedra was

46Noah,supranote 1, at 182-3.


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unsafe at low doses.47

While the safety and pharmacological effects of ephedra is beyond

the scope of this paper, this Utah decision brings an interesting issue to the forefront.

Ephedra has its roots in Chinese medicine, but is also found in Native American and

Mormon traditions. In fact, ephedra is also called Mormon tea.48 It is curious that

Utah the state where Mormonism was founded was the state to strike down this ban.

Perhaps it is related to the notion that the supplement has a benefit that outweighs the

safety risks namely, if it is properly administered in a cultural or religious context, the

safety risks may be minimized and the benefits may become clearer.

While this is all mere speculation, it is interesting to consider this notion because

it raises a larger issue: how do we define health? Western medicine seems obsessed with

longevity and the quantityof life, while many alternatives focus on holistic wellbeing

(specifically, mental and spiritual wellbeing) and, consequently, the qualityof life.49

Questioning the ban on ephedra leads us to question the ban on many other herbal

supplements (e.g., cannabis and peyote) that have not been reasoned in the context of

DSHEA. Neither of these botanicals has been analyzed under DSHEA because they are

defined as drugs, rather than supplements. While the common ingestion of these

botanicals usually involves smoking, rather than oral ingestion, surely orally ingestible

forms are available and can be produced (although this requirement seems unimportant in

this context, and eliminates a certain natural element of these botanicals).

47Harris,supranote 2.48Stanley Kitchen,Ephedra nevadensis S. Wats., International Institute of Tropical Foresty (2008).49Frohock,supranote 3, at 224.


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This is not to say that DSHEA should allow free access to these botanicals, but

that they should at least be afforded an analysis under DSHEA before they are banned.

Interestingly, the safety implications of a drug such as cannabis are minimal in

comparison to ephedra not one death has been directly linked to the ingestion of

cannabis.50 Of course, there are adverse effects if the botanical is abused but the same

could be said of any vitamin or other supplement. Again, this is not a call to legalize

cannabis or peyote, but an attempt to bring this disingenuous ban to the forefront because

it contradicts the very definition of dietary supplements under DSHEA. In short, an

analysis of safety is important, but first this analysis must be allowed to take place.

Furthermore, it is the suggestion of this paper that adverse effects should not lead to

blanket bans. Rather, safety issues should lead to strong and clear dosage warnings and

disclosures. Again, abuse is always possible but we should be wary when concluding

that the possibility of abuse should preempt the possibility of anysafe use at all.

This brings us to our second task: accurate information and complete disclosure.

First, the requirement to state that the FDA has not evaluated the efficacy of the

supplement is an obvious and important disclosure requirement. Second, there is no

reason that the FDA cannot require specific warning disclosures for specific supplements.

The FDA could subject supplements to a separate approval process that makes dosage

recommendations not based on efficacy, but on safety. Therefore, the burden of proving

that a supplement is dangerous remains with the FDA, but the FDA is given a tool in

50C. H. Ashton,Pharmacology and effects of cannabis: a brief review, Br. J. Psychiatry, 178(2): 101-6

(2001).


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requiring more specific types of disclosure. Transparency is truly the key to the effective

implementation of DSHEA. It is both an end in itself and a means toward market self-

regulation. Regulation of disease claims is of crucial importance to ensuring this

transparency. The FDA considers a disease claim to mean an implicit or explicit claim

that the supplement:

(1) has an effect on a specific disease or class of diseases;(2) has an effect on the characteristic signs or symptoms ofa specific disease or class of diseases, using scientific or layterminology; (3) has an effect on an abnormal conditionassociated with a natural state or process, if the abnormal

condition is uncommon or can cause significant orpermanent harm; (4) belongs to a class of products that isintended to diagnose, mitigate, treat, cure, or prevent adisease; (5) is a substitute for a product that is a therapy fora disease; (6) augments a particular therapy or drug actionthat is intended to diagnose, mitigate, treat, cure, or preventa disease or class of diseases; (7) has a role in the body'sresponse to a disease or to a vector of disease; (8) treats,prevents, or mitigates adverse events associated with atherapy for a disease and manifested by a characteristic setof signs or symptoms; or (9) otherwise suggests an effect

on a disease or diseases.51

This brings us to our final task, which will tie together everything we have

already stated. How can we define dietary supplement so as to accomplish all of the

purposes stated above?

First, we should not take the stance that the most worrisome dietary supplements

are the ones that actually work exactly as promised.52

This would be a position that

corrupts the category of dietary supplements, as elaborated earlier. Rather, the definition

5121 C.F.R. 101.93(g)(2).52Noah,supranote 1, at 179.


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should remain as simple as it was legislated any further elaboration is a disingenuous

exclusion of certain supplements without a requirement of reasons. Most simply, the

many possible forms of supplements listed under DSHEA share a common trait: they are

naturally occurring substances. This trait is the very distinction between a supplement

and a drug. Drugs are chemically designed; supplements are natural, and almost always

have roots in a cultural or religious tradition.

In this way, the definition of DSHEA not only protects the integrity of the dietary

supplement category and the placebo effect, but also reconciles the regulation of

substances with the Free Exercise clause. Medicine is inherently intertwined with culture

and faith, as explored earlier. As such, any regulation of medicine inherently implicates

First Amendment issues. Defining supplements as naturally occurring, culturally rooted

substances can accomplish all of these tasks while also protecting the safety of consumers

through accurate and detailed disclosures. This definition is in direct opposition to the

recommendations of most critics of DSHEA:

Finally, if the FDA wants to make conscientious decisionsabout the utilization of its limited resources, it largelyshould ignore those products that are merely ineffectualbecause the risk of physical injury to consumers ofpharmacologically active dietary supplements faroutweighs the agency's more typical preoccupation withrooting out economic fraud.53

Rather, fraud and deception is inherently important to ensuring safety. In this

way, we can protect consumers against the snake oil salesman without insulting the snake

53Noah,supranote 1, at 196.


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oil itself.

V.

Conclusion

It is uncertain why dietary supplements and alternative medicine has surged in

recent decades. However, there is an apt quote that seems relevant in this regard: "As

medicine becomes increasingly technical, ingenious and more precise, the instinct of the

masses is aroused against it. This may be called the Brave New World effect a

desire to retreat to effective natural healing. It is worth noting that this surge in natural

alternative medicine is paralleled with a similar surge in the demand for organic foods.

There is something about scientific objectification that is impersonal and frightening.

Whether genetically engineered foods or chemically synthesized drugs, there is a growing

distrust of science in producing ingestible substances.

Perhaps we have reason to distrust conventional medicine. For example, Vioxx

remained on the market for five years before being recalled for unexpected adverse

effects. Indeed, recalls are not rare, and the mechanisms by which new pharmaceuticals

work are not always understood. Of course, the workings of natural alternatives are also

rarely understood. However, science generally purports to investigate how things work

not merely whetherthey work (in fact, that is how it distinguishes itself from the

alternative). Thus it is the duty of science to meet that standard. However, these failings

have led to a general distrust of these technical approaches. Natural health products are

easily trusted because they have been used for thousands of years and there is myriad of

anecdotal evidence to parse through in determining their efficacy and safety. Indeed:


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Our perception of what is acceptable treatment is coloredby our culture and society. Today a physician who bled apatient, or a dentist who said that decay is caused by toothworms, would be subjected to justifiable ridicule. But it is

only within the last hundred years or so that doctors andpatients have come to expect success from medicaltherapy.54

Given this history, it is only natural to be wary of new treatments because they are

so often overturned for safety reasons. Safety concerns of ancient supplements are well

documented and well understood anecdotally. Long-term safety implications of new

drugs are usually unknown for many years after the drug is approved. This perspective is

rarely elaborated, and so this paper has taken on the task of raising it to our awareness.

There are implicit contradictions in the current regulation of xenobiotics, and it is

inherently biased against Eastern medicine and natural supplements. It also serves as a

flashpoint between political conservatives, who prefer to allow market forces to curb

industry abuses, and liberals, who favor federal regulation in their zeal to

protect consumers from making poor decisions."55

Consider the following anecdotes:

A chiropractor manipulates the spinal alignment of apatient suffering lower back pain. A man swallows three900-mg capsules of glucosamine with chondroitin sulfateas part of his breakfast. A nurse moves her hands along theenergy field of a patient's body to remove blockages andrestore the natural flow of energy. A homeopathic

practitioner administers trace amounts of a medicationdiluted and succussed (struck or shaken) in water to apatient suffering from digestive problems. An

54Dodes,supra note 6, at 37.55Noah,supranote 1, at 194.


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acupuncturist inserts needles just below the epidermis of anelderly patient to help him cope with arthritic pain. A Reikimaster tries to combine a spiritual dimension and livingenergies to heal a woman suffering from asthma. A young

woman meditates in an effort to extinguish the virusinfection in her child's body. A man prays for his motherrecovering from burn injuries in a distant hospital.56

Given the history of medical successes and failings Eastern andWestern who

is to say that any of these approaches are more effective than another? Advocates of

Western allopathic medicine often point to a great increase in life expectancy, but as

explored earlier, this is just one definition of health. For example, the average life

expectancy of our citizens continues to grow, increasing by 3.8 years from 1970 to 1984

alone and now stands at almost seventy-six years.57 Yet, of the fifteen top causes of

death, ten have declined, and those which have not declined, such as alcoholic cirrhosis,

are most sensitive to social pathology.58 This data (presented by an advocate of

allopathic medicine) unwittingly reveals the incomplete nature of the allopathic approach:

it does not heal social pathology, and in fact, it may cause greater social pathology.

This is where the holistic, complementary approach can be harnessed. Eastern

and Western medicine have different risks and benefits but both are useful in their own

respect. Natural supplements cannot be subjected to the same testing as synthesized

drugs because Eastern medicine can only be analyzed in an Eastern context the

56Frohock,supranote 3, at 215.#$Dodes,supra note 6, at 38. It is also worth noting that the United States is falling behind the rest of the

world under its own measurement of health (life expectancy). The United States is now tied with Cuba

with the 36thhighest life expectancy certainly nothing to be proud of. World Health Organization, World

Health Statistics (2010).58Id.


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scientific method should be reserved for scientifically designed medicine. Indeed: the

operational problem is that it is very difficult to disentangle the placebo effect from the

medicinal effect when mind and body fold into each other."59

Thus, mind and body may

constitute a complex framework able to influence and undermine clinical trials with

findings in the larger world of human experiences."60

As such, the distinction between supplements and drugs must be clear and

decisive. This distinction requires a simple and accurate definition. Naturally occurring,

culturally rooted substances are supplements. Chemically synthesized, scientifically

studied substances are drugs. It is important that the FDA make this distinction clear and

known so as to allow for the effective implementation of the purposes of DSHEA.

59Frohock,supranote 3, at 222.60Id.at 223.

ari allen on spirituality and alternative medicine: snake oil or holy water?

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