Repeal the DSHEA

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Running head: DSHEA: AN EXAMINATION OF THE SCIENCE AND POLICY

DSHEA: An Examination of the Science and Policy

Andrew Leahey

Drexel University



DSHEA: AN EXAMINATION OF THE SCIENCE AND POLICY 2

Abstract

This article examines the science and policy debate between supporters of the Dietary

Supplement Health and Education Act of 1994, amending the existing Food, Drug and Cosmetic

Act, and its opponents. It is broken in to two subsections, one each for an examination of the

science, and a critique of the policy of the act itself. The examination of the science of

supplements turns on the concept of there being two distinct schools of thought amongst

proponents: the first calls for supplementation to offset nutrition deficiencies; the second

advocates ³megadosing´ of supplements for positive health benefits. The policy examination

evaluates the findings of Congress as the framing of the bill, and its intended economic and

public health outcomes.

Keywords: dshea, dietary supplements, food policy




DSHEA: An Examination of the Science and Policy

Prior to the Dietary Supplement Health and Education Act of 1994 (DSHEA), the term

³dietary supplement´ was not defined in American food and drug policy. The act was largely

championed and lobbied for by the manufacturers of dietary supplements (Nestle, 2002); broadly

seen as vitamins, minerals, herbal extracts, and any combination thereof. These lobbyists aimed

to restrict the Food and Drug Administration¶s (FDA) oversight over their products, with the

stipulation that their efficacy claims be restricted to ³structure/function´ claims

(Structure/Function Claims). These claims are limited to general statements as to the role a

nutrient or supplement plays in the human body. Therefore, the goal of DSHEA lobbyists was to

define an umbrella term, under which their products would be able to be marketed outside of

FDA regulatory practices.

The proponents of a scientific base to the DSHEA fall in to three distinct categories: first,

there are those who advocate for the supplementation of the American diet with nutritional

supplements in pill form. This school of thought generally points to an overall deficiency, or

historical decline in the quality of, the American diet. This framing of advocacy has unique

policy implications as proponents intend to utilize their claims to place dietary supplements far

towards the ³food´ end of the FDA regulatory spectrum, with ³drugs´ occupying the opposite

end. This framing¶s prevalence and success is evident in the naming of the DSHEA itself.

The second school of thought with regards to the proponent science is those that believe

so-called ³megadosing´ carries with it positive health benefits. Megadosing can be defined as the

overdosing with nutrient supplements in quantities larger than the recommended daily

allowances (RDA) set forth by the United States Department of Agriculture (USDA).




Both schools of thought rest upon the assumption that ³natural´ supplements are

inherently safer than ³synthetic´ drugs. These proponents place the origins of dietary

supplements, including but not limited to herbs, above their chemical composition. This article

intends to examine the claims made by these schools of thought, and attempt to draw a

conclusion as to the truth value of their claims to a scientific body of evidence.

Following the examination of the science of the DSHEA, this article will continue with a

look at the policy of the act itself; an examination of the framing of the bill, and a conclusion as

to the success of its predicted outcomes. Finally, an overall examination of the bill¶s role in

public health will conclude with future policy recommendations.




THE SCIENCE OF DIETARY SUPPLEMENTS

The proponents of a scientific base for dietary supplements and the DSHEA broadly fall

in to two categories: the first, the ³Dosers´, advocate for the supplementation of the American

diet due to nutritional deficiencies. The second, the ³Megadosers´, predominantly relies on the

claim that overdosing on supplements, especially vitamins, is safe and carries with it positive

health benefits. Each of these relies on the unstated premise that dietary supplements, deriving

from natural sources, are safe to be self-administered without the oversight of a doctor. This

inferred safety from nature, then, can be used as logic for removing FDA regulation of marketed

dietary supplements ± as the DSHEA did. This concept will be discussed further in the policy

section of this article.

Dosers

The science of Dosers typically revolve around claims regarding a perceived deficiency

in certain nutrient, and then attempt to point causal arrows in the direction of a specific disease,

or set of diseases, perceived to be increasing in prevalence. The most apparent of these claims at

the time of this publication were those of a Vitamin D deficiency in the American diet. The

implication, therefore, is that dietary supplementation, and the DSHEA, is the path to alleviating

these deficiencies.

The claim to vitamin D deficiency is made by Michael F. Holick in a 2007 article, where

he states: ³Once foods were fortified with vitamin D and rickets appeared to have been

conquered, many health professionals thought the health problems resulting from vitamin D

deficiency had been resolved. « In fact, vitamin D deficiency remains common in children and

adults « vitamin D deficiency can cause growth retardation and skeletal deformities and may




increase the risk of hip fracture later in life´ (Holick, 2007). In this article, widely reported on

and cited, Holick finds a strong correlation between a deficiency in vitamin D and bone

disorders, as well as associations with autoimmune diseases, diabetes, cardiovascular disease,

and even schizophrenia and depression in cases of D deficiency.

Vitamin D is produced by the human body, with a number of factors influencing levels.

The most apparent mitigating factor is sun exposure. With increased levels of sun exposure also

having links to skin cancer (Holick, 2007), he makes a recommendation of dietary

supplementation of vitamin D to counteract deficiency: ³ Excessive exposure to sunlight,

especially sunlight that causes sunburn, will increase the risk of skin cancer. Thus, sensible sun

exposure (or ultraviolet B irradiation) and the use of supplements are needed to fulfill the body's

vitamin D requirement´ (Holick, 2007). Holick does make mention of a weak correlation

between subjects that took vitamin D supplements and a reduction in the likelihood of presenting

with the aforementioned diseases.

Vitamin D supplement proponents argue that Vitamin D, specifically Vitamin D3, can be

safely administered because of the fact that it is produced by the human body. The vitamin ³is

naturally produced in humans and animals when sunlight hits the skin, fur, or feathers « vitamin

D3 is generally considered safer than vitamin D2, which has more reported cases of overdose or

toxicity´ (Khalsa, 2009). The unstated premise here is that vitamin D3 in supplement form,

assuming purity, interacts with the human body in exactly the same way the endogenously-

produced vitamin does. Furthermore, the claims of safety are made via claims to the vitamins

occurrence in nature.




This section has utilized research and statements made regarding a specific supplement,

vitamin D, for the sake of brevity; however, the overarching premises and implications can be

seen at work in virtually all of the dietary supplement proponent literature. From vitamins E and

C (Hathcock & Azzi, et. al, 2005), to valerian root extract supplementation for psychotherapy

(Fugh-Berman & Cott, 1999), proponents equate ³natural´ with ³safe´. Additionally, in the cases

involving vitamins the assumption is made that no distinction is necessary between endogenous

and exogenous forms. It is upon these premises, along with an American diet that is lacking in

necessary nutrients, that the case of the Dosers rests.

Criticism of Dosers

The most clear-cut criticism of Dosers is the body of evidence indicating their chief

precept, the lacking of key nutrients in the American diet, is itself flawed. This argument has

been put forth by mainstream science since well before the DSHEA was a point of contention

between science and CAM. This section will begin by looking at the difference between

individuals taking dietary supplements and those relying on their diet, in two polar opposite sets:

those individuals with illnesses supposed to be caused by deficiency, and those individuals

taking part in athletic competition. This choice reflects the position given by proponents of

dietary supplementation: that an ³ordinary´ American diet is lacking in the nutrition needed to

maintain health; with this assertion in mind, it would be pointless to include individuals not

partaking in an ordinary diet. For this reason, studies involving groups such as the substantially

infirm, geriatric nursing home patients, and individuals in abject poverty were intentionally not

included.




Fiber is, in some ways, the earliest of the advocated dietary supplements. Author Andrew

Lockie asserts: ³bowel problems such as diverticular disease « and some cancers of the bowel

may be caused by a lack of fiber´ (Lockie, 1993) in his book he advocated ³self-help´ in the

form of fiber supplementation. This is in spite of the fact that, as early as 1981, a study looking

for a correlation between increased fiber intake, in the form of isphagula, and alleviation of

diverticular disease of the colon found the treated individuals no better off than those taking a

placebo (Ornstein et al, 1981). The placebo group¶s comparable number of symptoms seems to

indicate that, even if the American diet is perceived to be lacking, the supplementation with

fiber, does nothing to counteract that fact.

Additional studies were conducted in to the supplementation of vitamins and minerals

with the aim of increased athletic performance. In a study by M.H. Williams, the attempt to pin

down a claimed ³racers edge´, in the form of dietary supplements, found no link between

performance and supplementation (Williams, 1984). Indeed, the Williams study urged further

investigation to the possible negative side-effects of overdosing on vitamin B and C, amongst

athletes. It seems the positive benefits to supplementation are not likely to be found in short-

term health maintenance or improvement.

If dietary supplements are not beneficial in the short-term, the only logical defense

proponents can mount is that they are beneficial to health from a longitudinal perspective. Here,

Dosers have made some headway. A notable study was conducted in 2004 that seemed to

indicate the usage of vitamin E and C supplements in combination was weakly inversely

correlated with Alzheimer Disease (AD) in elderly individuals (Zandhi & Anthony &

Khachaturian, 2004). While interesting, this study was relatively small (n = 4740), limited in

scope, and very limited in duration. Additionally, this being an observational study, there were




numerous factors not accounted for, long term dietary supplement use was ascertained by

interview, and a large percentage of the respondents were considered ³at-risk´ at the start of the

study. This study was comparable to a number of similarly conducted positive studies in both

methods and size.

A later study, concluded in 2007, sought to zero in on this proposed long-term benefit to

vitamin C and E supplementation. This study made only two key changes; the duration was

increased to 5.5 years, and the participants were selected on the basis of not presenting with AD

or dementia symptoms at the start of the study. When the study concluded, there was correlation

between supplement intake and AD diagnosis (Gray & Anderson et. al, 2007). This seems to

indicate the longitudinal effect of vitamin E and C supplementation on preventing AD is

exceedingly questionable.

The claims by the Dosers as to the safety of vitamin D3 due to its presence in the human

body have been proven unfounded. There have been a number of cases of overdoses, most

prominently the case of a 2 year old in New York suffering from hypercalcemia and

hypertension following supplementation of vitamin D3 by his mother (Barrueto & Wang-Flores,

et al, 2005). The child was administered an exceedingly large dose, but the effects were

nonetheless marked and life threatening. While the patient eventually recovered, his

hypercalcemia remained for a total of 14 days following his admittance to the hospital, rendering

the ³safety´ of vitamin D3 supplementation, despite its presence in the body, in question.

The chief criticism of the Dosers exists in the body of evidence indicating that the human

body makes no distinction between chemicals from natural sources and chemicals created

synthetically. That is to say, the body cannot tell the difference between the methyl salicylate in




the bark of the willow tree, or aspirin, which is a synthetic form of the compound. An instructive

study that undermines the position of the Dosers is a 1999 examination of the Chinese herbal

supplement Dong quai. Dong quai had been a popular herbal supplement, largely trading on the

argument that it had been known to the Chinese for thousands of years; an absurd argument from

antiquity. The phytochemical analysis of the compounds contained in the herb returned

compounds comparable to Coumadin, a potent blood thinner, various chemicals that influence

heart rate, and carcinogenics (Page & Lawrence, 1999). It would seem that simply deriving from

nature does not necessarily guarantee the safety of a chemical.

This assertion is backed up by the science surrounding ephedra, an extract from an herb

native to Asia. In 2003 it was found that ephedra usage correlated with a ³2- to 3-fold increases

in the odds of psychiatric symptoms, autonomic symptoms, upper gastrointestinal symptoms, and

heart palpitations´ (Fontanarosa & Rennie & DeAngelis et. al, 2003). Unfortunately, ephedra

went unregulated for nearly a decade, was implicated in several deaths (Knight, 2004), and even

now is only subject to extremely fine pointed regulation, with similarly derived supplements

freely available ± and presenting similar risks (Hess & Sullivan, 2005). This is largely due to a

naturalistic fallacy; when origins, rather than chemical composition, are the dominant classifying

condition for what constitutes an unregulated dietary supplement or a drug subject to oversight,

such outcomes are inevitable.

Megadosers

The preponderance of the existing research with regards to the claim to a scientific basis

for megadosing is found from journals associated with chiropractic, homeopathy, and the

complementary and alternative medicine movement (CAM). They are often marked by a claim to




commitment to the individual patient, juxtaposing science¶s generalizability, and viewing that

de-emphasis of individual¶s uniqueness as a negative. This makes alternative medicine avenues

such as homeopathy, sharing similar views of individualized treatments (Odes, 2006), and

chiropractic, eschewing the mainstream ³disease-treatment business´ (Rondberg, 2005) as

extremely attractive. This, coupled with the fact that the dietary supplement industry is a

comparatively recent arrival on the scene of CAM, may account for the fact that the vast

majority of published literature by proponents of megadosing and, to some extent the DSHEA,

are by journals of related CAM avenues.

Megadosers take the advocacy of dietary supplementation a step further than Dosers; they

typically understand the recommended daily allowance (RDA) of nutrients to be sub optimal.

Their argument, therefore, does not hinge on the quality of the American diet, but instead turns

on an entirely separate claim: that the existing RDAs of vitamins and minerals are too low. In the

Chiropractic Journal, Michael T. Murray critiques existing RDAs: ³RDAs for vitamins and

minerals have been prepared by the Food and Nutrition Board of the National Research Council

to reduce the rates of severe nutritional deficiencies - not to achieve optimal health´ [Murray,

1999]. The claim here is that the RDAs have been set at levels that are minimums, and not to be

considered optimal levels.

Furthermore, proponents of megadosing argue that environmental factors render a

universal recommended daily allowance impossible to ascertain; ³RDAs do not adequately take

into consideration environmental and lifestyle factors (smoking, alcohol consumption, food

additives, pesticides or chemical toxins, etc.) which can destroy vitamins and bind minerals´

(Murray, 1999). As such, the claim is that the actual function of the RDAs set forth by the USDA

was never to set a ceiling to nutrient intake, as the term ³allowance´ might indicate, but merely




to act as a floor or minimum. Therefore the USDAs perceived avoidance of making upper-limit

claims to nutrients can, in the view of megadosers, be taken as an implicit statement of there not

being a dosage at which supplements become dangerous.

Criticism of Megadosers

The chief criticism of Megadosers lies in the substantial body of evidence indicating that

toxicity levels of vitamins and minerals are reachable with the use of dietary supplementation.

The most visible recent publication has been a meta-analysis conducted in 2005 that indicated a

non-statistically significant increase in total mortality associated with megadosing vitamin E

(Miller & Barriuso et. al, 2005). The report, as a meta-analysis, had substantial shortcomings and

limitations; the individuals receiving exceedingly high dosages were relatively small, and thus

the ability to extrapolate out to the general population may be tenuous.

The assertion by Megadosers of the RDA being a floor rather than a ceiling has also been

roundly criticized. Marion Nestle finds that the RDA¶s ³population-based definition meant that

the RDA is higher ± sometimes significantly higher ± than the amount needed by 97% of the

individuals´ (Nestle, 2002). This assertion seems to be supported by the fact that the RDA for a

number of vitamins and minerals, notably vitamin C and calcium, has been increased since the

USDA¶s original publication. This fact, in the absence of widespread malnutrition or rampant

scurvy, seems to indicate that the USDA does view the RDA as a recommended dosage; a level

to be aimed for with as much concern for exceeding as for not meeting.

Megadoser¶s claim to nutritional relativity and variance amongst individuals is in some

ways a reflection of their emphasis on individuals, and simultaneously a manifestation of their

eschewing the generalizability of science. As such, there is no direct retort to their claims in the




scientific body of literature due to the fact that the underlying claim of megadosers is that the

entire system of science through extrapolation is flawed. While it is impossible to imagine a

condition wherein the studies conducted to ascertain RDAs did not take in to account such

obvious confounding factors as tobacco usage and alcohol consumption, as Murray has claimed;

this is an ancillary claim atop the megadosers chief position that there is nothing generalizable

about nutrition.

Science Conclusion

In conclusion, the premises upon which both the Dosers and Megadosers base their

positions on the safety of dietary supplements are flawed. They rely on what amounts to the

logical fallacy of the appeal to nature; that is, what is natural is good. Furthermore, a

misunderstanding of what constitutes a ³chemical´ allows them to underestimate the potency and

potential toxicity of compounds derived from natural sources. This fact alone undermines their

entire position: that dietary supplementation should be unregulated.

Furthermore, there is a substantial body of evidence contraindicating the need for

widespread dietary supplementation, regulated or otherwise. From the treatment and prevention

of conditions said to be brought on by nutritional deficiencies, such as diverticulitis; to dietary

supplements for the athlete, the range of applicability for supplements is growing ever smaller

with each published study. Their claims to efficacy are largely clustered around areas lacking

studies of quality or depth; their position has become a retreat to obscure corners of

pseudoscience.




The Policy of the DSHEA

In this section, this article will examine the text of the Dietary Supplement Health and

Education Act (DSHEA) of 1994. The intention is to examine the findings of Congress, and the

intended outcomes of the bills passage. These claims fall in to several categories, of which each

will make up a subsection of this article. The first of which will be an examination of the

economic claims made within the DSHEA; second, a look at the public health framing within the

bill; third, an examination of the claims to supplement prevalence and plea for freedom of

choice; and fourth and finally, an examination of the claims of safety.

Economic Frame

There are two competing avenues of economic claims being simultaneously put forth: the

first, is a claim for the individual citizen¶s reduction of healthcare costs; the second, is a claim to

the buoyant burgeoning supplement market, and its sales figures.

(B) clinical research has shown that several chronic diseases can be prevented simply

with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and

sodium, with a high proportion of plant-based foods;

(4) healthful diets may mitigate the need for expensive medical procedures, such as

coronary bypass surgery or angioplasty. (S.784, 1994)

The finding of Congress here, with respect to dietary supplements, is a non sequitur. The

conclusion of this argument, of course, is that the DSHEA should be passed and dietary

supplements should be unregulated. These findings, acting as premises, do not in any way

advance that argument. The implicit assumption when these two statements are read in the




context of the overall findings of Congress (Appendix A) is that a healthy diet is conducive to

overall health, and that dietary supplements help achieve a healthy diet. The conclusion, then,

would be that the DSHEA should unregulated only those compounds that would ordinarily be

found in a diet; perhaps, if we are to get greedy, the compounds should be unregulated only in

dosages comparable to what might be found in an ideal diet, as well. However, this is a

constraint that the DSHEA does not wish to impose on dietary supplement manufacturers.

(C) the estimated 600 dietary supplement manufacturers in the United States produce

approximately 4,000 products, with total annual sales of such products alone reaching at

least $4,000,000,000; (S.784, 1994)

This is perhaps getting closer to the meat of the argument surrounding the DSHEA¶s

passage. This too, however, is not a cogent argument for the bill¶s passage. This sales figure,

presented to be impressively high, does not provide a compelling argument for the deregulation

of dietary supplements. Indeed if the supplement industry is doing so well, how constraining can

the regulation of supplements truly be? The argument for a lifting of regulation would be that the

industry cannot survive, or individual dietary supplement companies cannot turn a profit, under

the existing oppressive oversights. Instead, the DSHEA utilizes a pseudo-argument from

popularity to substantiate its claims; if sales figures are so high and so many consumers are

choosing to use dietary supplements, it must be both safe and positive.

Furthermore, upon what precedence is the argument for deregulation, deriving from the

popularity of a product or type of products, built? This author can find no indication that there is

now, or ever has been, an economic argument for the deregulation of an industry based on its

popularity and widespread adoption. Indeed, there is substantial evidence of the opposite: we




need look no further than the FD&C to see this in effect. The original Federal Food, Drug, and

Cosmetic Act was passed substantially due to the increase usage of pharmacological substances,

and the need to insure regulation and safety after the release of a toxic drug killed more than 100

people. With increased adoption comes an increase in the stakes, the potential loss of life, when

things go wrong.

Public Health Frame

(5) preventive health measures, including education, good nutrition, and appropriate use

of safe nutritional supplements will limit the incidence of chronic diseases, and reduce

long-term health care expenditures; (S.784, 1994)

The DSHEA was passed in 1994, with national health care expenditures topping $912.5

billion annually in 1993, or 13.7% of the total GDP (Appendix B). In 2008, the figure was

$2,338.7 billion, just above 16% of GDP. The DSHEA is sufficiently vague, and hedges its

claims for dietary supplements against education, good nutrition, and the weasel-word

³including´ in such a way that drawing any clear claim correlating healthcare expenditures and

dietary supplements out of the text is difficult.

However, while the text may make claims towards the positive benefits that will come

with increased health education, it does nothing to further that goal. The clear intention of the

DSHEA is to increase the access to dietary supplements in the market, and therefore the claim

for ³appropriate use of safe nutritional supplements´ being linked to a decrease in the ³incidence

of chronic diseases, and reduce long-term health care expenditures´ is the salient portion. Here,

the only terms in question are what constitutes the ³limit[ing]´ of disease and how ³long-term´

the net expenditure benefit to the DSHEA¶s passage should be. In fourteen years, the health care




expenditure has more than doubled, helping us achieve the dubious distinction of second highest

per capita amongst United Nations countries, as of 2008 (WHO, 2008). If fourteen years is not

long-term enough, how long must we wait to see the positive benefits, amidst all of the negative

effects?

Freedom of Choice

(7) there is a growing need for emphasis on the dissemination of information linking

nutrition and long-term good health;

(8) consumers should be empowered to make choices about preventive health care

programs based on data from scientific studies of health benefits related to particular

dietary supplements. (S.784, 1994)

The text of the DSHEA frames the bill in terms of maintaining consumer choice. The

exact phrasing of the finding conveys the idea that consumers should be enabled to utilize

³scientific studies of health benefits´ to inform their choices. This phrasing is particularly

frustrating, as it leaves the door open to substantial amounts of interpretation.

First, an examination of what this portion of the Congress¶ findings is actually stating: An

argument can be made that it is as much arguing for open access to journals in which the results

of dietary supplement studies are published, as it is proclaiming the right to have access to the

supplements themselves. This change, in so much as this author can tell, has not been made. A

cursory glance at any of the studies cited in this article will find that they are not presented in any

way free of charge by the FDA.






Safety Frame

(13) although the Federal Government should take swift action against products that are

unsafe or adulterated, the Federal Government should not take any actions to impose

unreasonable regulatory barriers limiting or slowing the flow of safe products and

accurate information to consumers;

(14) dietary supplements are safe within a broad range of intake, and safety problems

with the supplements are relatively rare; (S.784, 1994)

This portion of the DSHEA has been largely found to be false, as has been discussed in

this article. Dietary supplements are simply not inherently safe. There is more rational of a basis

for making a sweeping claim to the safety of ³dietary supplements´ as there is to the safety of

³chemical compounds usually taken in small doses.´ It is akin to claiming any prescription drug

safe, if administered in a relatively low dosage; it is simply not true.

Furthermore, the claim that safety problems are ³relatively rare´ is entirely subjective. If

every FDA regulated drug with ³relatively rare´ side effects were left on the market, freely

available, the prescription Fen-Phen would continue to be sold as a weight loss drug. Indeed,

some studies claim only 37 (Avorn, 2004) of potentially millions of individuals had serious

medical issues following taking the drug. This, possibly ³relatively rare´, dangerous side effect

however was enough not only to get the drug banned, but to lead to more than a billion dollars in

legal settlements. Relative rarity for safety problems is not an argument for lack of regulation,

complete safety is, and dietary supplements are not completely safe.

In 2002 the FDA issued an advisory regarding the supplement kava. Kava had been

found to cause liver failure, with 11 documented cases (Foote, 2007). Due to the construction of




the DSHEA, no safety studies were required of any of these supplements. Due to a lack of FDA

enforcement ability, supplements containing kava, and bearing no warning, remain on the

market. This ³relatively rare´ number of 11 cases of liver failure is almost assuredly

proportionally much higher than the cases involving the aforementioned Fen-Phen, having the

marketing resources of a large pharmaceutical company.

Conclusion

In conclusion, the Dietary Supplement Health and Education Act of 1994 not only fails

due to its support of an unfounded pseudoscience relying on magical thinking and 19th century

woo, it fails in its stated policy objectives. It does nothing to advance the dietary education of

Americans, and is merely a thinly veiled absolution for an industry that could not shoulder the

slightest burden of proof. Its objectives, to reduce health care expenditures and promote well-

being, have simply not come to fruition. Thus, a reexamination of the role of the FDA in

regulating dietary supplements must be undertaken; with substantial oversight vested in some

regulatory body, if not the FDA.

In his ³Theories of Economic Regulation´ Richard Posner states that the ³public interest

theory [of economic regulation] « holds that regulation is supplied in response to the demand of

the public for the correction of inefficient or inequitable market practices´ (Posner, 1974). Even

if an argument can be made that at the time of the passing of the DSHEA, the dietary supplement

industry needed to be propped up; that it needed legislation removing oversight and sheltering it

from direct competition with the established pharmaceutical industry, that time has now passed.

It is no longer a burgeoning industry, lacking the marketing ability, or financial means to meet




standards. There is a substantially inefficient and inequitable market practice in place, and a

demand must be made for regulation.




Appendix A

The findings of Congress in bill S.784 (1993) or the Dietary Supplement Health and Education

Act:

§2. Findings.

Congress finds that -

y (1) improving the health status of United States citizens ranks at the top of the national

priorities of the Federal Government;

y (2) the importance of nutrition and the benefits of dietary supplements to health

promotion and disease prevention have been documented increasingly in scientific

studies;

y (3)(A) there is a link between the ingestion of certain nutrients or dietary supplements

and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis;

and

y (B) clinical research has shown that several chronic diseases can be prevented simply

with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and

sodium, with a high proportion of plant-based foods;

y (4) healthful diets may mitigate the need for expensive medical procedures, such as

coronary bypass surgery or angioplasty;




y (5) preventive health measures, including education, good nutrition, and appropriate use

of safe nutritional supplements will limit the incidence of chronic diseases, and reduce

long-term health care expenditures;

y (6)(A) promotion of good health and healthy lifestyles improves and extends lives while

reducing health care expenditures; and

y (B) reduction in health care expenditures is of paramount importance to the future of the

country and the economic well-being of the country;

y

(7) there is a growing need for emphasis on the dissemination of information linking

nutrition and long-term good health;

y (8) consumers should be empowered to make choices about preventive health care

programs based on data from scientific studies of health benefits related to particular

dietary supplements;

y (9) national surveys have revealed that almost 50 percent of the 260,000,000 Americans

regularly consume dietary supplements of vitamins, minerals, or herbs as a means of

improving their nutrition;

y (10) studies indicate that consumers are placing increased reliance on the use of

nontraditional health care providers to avoid the excessive costs of traditional medical

services and to obtain more holistic consideration of their needs;

y (11) the United States will spend over $1,000,000,000,000 on health care in 1994, which

is about 12 percent of the Gross National Product of the United States, and this amount




and percentage will continue to increase unless significant efforts are undertaken to

reverse the increase;

y (12)(A) the nutritional supplement industry is an integral part of the economy of the

United States;

y (B) the industry consistently projects a positive trade balance; and

y (C) the estimated 600 dietary supplement manufacturers in the United States produce

approximately 4,000 products, with total annual sales of such products alone reaching at

least $4,000,000,000;

y (13) although the Federal Government should take swift action against products that are

unsafe or adulterated, the Federal Government should not take any actions to impose

unreasonable regulatory barriers limiting or slowing the flow of safe products and

accurate information to consumers;

y (14) dietary supplements are safe within a broad range of intake, and safety problems

with the supplements are relatively rare; and

y (15)(A) legislative action that protects the right of access of consumers to safe dietary

supplements is necessary in order to promote wellness; and

y (B) a rational Federal framework must be established to supersede the current ad hoc,

patchwork regulatory policy on dietary supplements.




Appendix B

Table 1 of the National Health Expenditures by the Center for Medical Statistics (2008):




References

Avorn, J. (2004). P owerful Medicines: The Benefits, Risks, and Costs of P rescription Drugs.

New York: Knopf.

Barrueto, F., Wang-Flores, H., Howland, M., Hoffman, R., & Nelson, L. (2005). Acute Vitamin

D Intoxication in a Child. P ediatrics, 116 (3), e453-e456.

Cohen, P. (2005). Science, Politics, and the Regulation of Dietary Supplements: It's Time to

Repeal DSHEA. American Journal of Law and Medicine, 31(2), 175.

Dietary Supplement Health and Education Act of 1994, S. 784, 103d Cong. (1993).

Fontanarosa, P., Rennie, D., & DeAngelis, C. (2003). The Need for Regulation of Dietary

Supplements: Lessons From Ephedra´. Journal of the American Medical Association,

289(12), 1568-1570.

Foote, J. (2007). Protecting Consumers in the Wake of the U.S. Dietary Supplement Health and

Education Act. Journal of Allied Health, 36 (1), 57-61.

Fugh-Berman, A., & Cott, J. M. (1999). Dietary Supplements and Natural Products as

Psychotherapeutic Agents . P sychosomatic Medicine, 61, 712-728.

Grey, S., Anderson, M., Crane, P., Breitner, J., McCormick, W., Bowen, J., et al. (2008).

Antioxidant Vitamin Supplement Use and Risk of Dementia or Alzheimer's Disease in

Older Adults. Journal of the American Geriatric Society, 56 (2), 291-295.

Hathcock, J. N., Azzi, A., Blumberg, J., Bray, T., Dickinson, A., & Frei, B. (2005). Vitamins E

and C are Safe Across a Broad Range of Intakes. American Journal of Clinical

Nutrition, 81(4), 736-745.

Hess, A., & Sullivan, D. (2005). Potential for Toxicity With Use of Bitter Orange Extract and

Guarana For Weight Loss. The Annals of P harmacotherapy, 39(3), 574-575.




Holick, M. (2007). Vitamin D Deficiency. The New England Journal of Medicine, 357 (3), 266.

Khalsa, S. (2009). The Vitamin D Revolution: How the P ower of this Amazing Vitamin Can

Change Your Life. Carlsbad, Calif.: Hay House.

Page, R. L., & Lawrence, J. (1999). Potentiation of Warfarin by Dong Quai . P harmacotherapy,

19(7), 870-876.

Lockie, A. (1998). The Family Guide to Homeopathy (1 ed.). London: Hamish Hamilton.

Miller, E., Pastor-Barriuso, R., Dalal, D., Riemersma, R., Appel, L., & Guallar, E. (2005). Meta-

Analysis: High-Dosage Vitamin E Supplementation May Increase All-Cause Mortality.

Annals of Internal Medicine, 142(1), 37-46.

Murray, M. (1999). Nutritional Supplements. Chiropractic Journal , 16 (6), 24.

National Health Expenditures. (2008). CMS Health Statistics Historical 1960-2008. Retrieved

November 25, 2010, from www.cms.gov

Nestle, M. (2002). Food politics: how the food industry influences nutrition and health.

Berkeley: University of California Press.

Odes, S. (2006). Consider Homeopathy for Your Practice. Drug Topics, 150, 56.

Ornstein, M., Littlewood, E., Baird, I., Fowler, J., North, W., & Cox, A. (1981). Are Fibre

Supplements Really Necessary in Diverticular Disease of the Colon? A Controlled

Clinical Trial. British Medical Journal , 282, 1352-1356.

Posner, R. (1974). Theories of Economic Regulation. The Bell Journal of Economics and

Management Science, 5(2), 335-358.

Rondberg, T. (2005). The Need for Nutritional Supplements . Chiropractic Journal , 19(4), 26-

28.

Sobal, J., & Marquardt, L. (1994). Vitamin and Mineral Supplement Use Among High-School




Athletes. Adolescence, 29(116), 835-843.

Structure/Function Claims. (n.d.). U S Food and Drug Administration Home P age. Retrieved

November 20, 2010, from

http://www.fda.gov/Food/LabelingNutrition/LabelClaims/StructureFunctionClaims/defa

ult.htm

Williams, M. (1984). Vitamin and Mineral Supplements to Athletes: Do They Help? . Clinical

Sports Medicine, 3(3), 623-37.

Zandhi, P., Anthony, J., Khachaturian, A., Stone, S., Gustafson, D., Tschanz, J., et al. (2004).

Reduced Risk of Alzheimer Disease in Users of Antioxidant Vitamin Supplements.

Archives of Neurology, 61(1), 82-88.

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