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Chris Silva
5 April 2016
ENGL 102
Chris Padgett
Regulating Supplements
Introduction
Every day millions of Americans take a dietary supplement. Whether this supplement is
for weight loss, the improvement of health or a way to improve athletic performance, millions of
people, from high school to retired individuals, take a supplement for any number of reasons.
However, these supplements, unlike other foods and medicines, are unregulated, meaning that
the U.S. government does not put requirements on these supplements regulating their ingredients
or their safety. The research question will be how can a supplement be sold without regulation or
verification that the supplement does what it claims and why are there no laws that regulate
supplements in the United States?
When this research is considered, there are many challenges that come with this type of
research because conducting it can be challenging given the many areas that the research can go.
Some of the challenges in trying to do this research can be finding enough evidence of the
supplement causing harm; people that might have been affected by taking supplements; and
possibly research that is too broad as well as too specific that could make writing this paper
difficult. Much research has been done in these areas, but the call for more regulation and
changes to the system of supplements has yet to happen. There many reasons that this research
should be done, because like any type of food or medicine, when a person takes a pill or a
powder, he or she should feel that it is safe for consumption. Since supplement use is so
widespread, most people would feel that it is safe, since it is rare that cases of death or sickness
are reported. However, just because these incidents are not reported does not mean that issues are

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not happening that is caused by the deregulation of supplements and there are many cases where
people are being harmed and even killed because of supplement use. The deregulation of
supplements and the loose policies that maintain the safety of these supplements poise a huge
threat to the ordinary people who take them every day. Deregulation of supplements may help
the supplement industry, but it puts unsuspecting people who want nothing more than to be
healthy, to be in danger of becoming seriously ill and possibly even dying from repeated use of
certain supplements.
Literature Review
There has been much research conducted on the issue of supplement regulation, but
many people who use supplements do not know the dangers because they are not educated
enough to know what is safe and what is not, plus many people think that if the product is being
sold is safe because there would be no reason for a product to be on the shelves. The reason
many people do not know the danger is because of what is on the label. Since supplements are
unregulated, the people and companies that made these supplements do not have to be truthful.
Any information, whether true or not can be put on the label to get people to buy the product.
The reason this is a problem is because if the person does not know the ingredients then he or she
is in danger of becoming sick, physically harmed or even dying.
Regulation of Supplements
Most people think that supplements like food and medicine are controlled and regulated
by the Food and Drug Administration (FDA). However, as pointed out by the researcher
Fontonarosa et al. the non-regulation of dietary supplements, especially those that have a certain
drug known as Ephedra shows that unregulated supplements lead to serious health problems
(Fontonarosa, 1568). The article points out that the drug Ephedra was marketed as a dietary
supplements to help people lose weight as well as regulate their health. The problem is that the

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research found by Fontonarosa is that this drug leads to other problems such as heart attacks. The
researchers argue that the supplement needs to be looked at further, especially the ingredients in
these supplements which need to be made known to the people using them as well as letting
people know what the possible side effects could be to using such supplements that are designed
for weight loss.
Another article titled, Too Little, Too Late: Ineffective Regulation of Dietary
Supplements in The United States by Starr and Ranjani looks at regulation of supplements and
discusses the number of the people taking dietary supplements daily, which reveals equal risk
both good and bad of health issues that might impact the lives of people taking supplements.
While a lot of people depend on supplements, some supplements as argued by Starr and Ranjani
could help individuals by improving their internal abilities, prevent them from getting sick and
the most popular among people is the ability to achieve weight loss (Starr and Ranjani 479). But
on the other hand taking these supplement could hurt someones metabolism, caused by the
misuse of the ingredients, the dosage, as well as the interaction with other drugs that might cause
a negative reaction to the substance. Starr and Ranjani argues that there needs to be more
regulation to protect the user from physical harm
An additional article titled, Rapid Onset Of Argyria Induced By A Silver-Containing
Dietary Supplement by Bowden et al, published in the Journal of Cutaneous Pathology,
describes a cases study where a 53 year old man developed Agraria due to the taking of a
supplement that contained silver (Bowden et al 834). Argyria is process by which a person gets a
change in their skin pigmentation, due to the high level of silver in the body. The value of this
article is that it demonstrates how there needs to be more regulation of dietary supplements
because this man received high doses of silver and did not know it because of the ingredients of

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the supplements were not checked or regulated. The article points out the need for more
regulation and also shows that more studies need to be done on this problem.
Danger in Supplement Use
Much of the research that has been done in this area is on the impacts of supplement use
and the physical problems that come from supplements that are unregulated. According to the
article, Dietary and Sports Supplements: The Need For A Systematic Tracking System by
Housamn et al the last research done concerning the dietary and the sport supplements among
teenagers has been far too long ago to test any major changes (Housamn et al 39). The impact of
supplements is often confusing, so this paper brings out facts and aims to clarify the confusion
and to measure the real impact. For the athlete using supplements as well the average person
there can be dangerous consequences in the misuse of such substances. This article shows the
possibility of setting up a system allowing for the consumption rates of those supplements to be
followed. Also discussed are the health factors of this process as well as benefits. According to
this article, The purpose of this paper is examine factors associated with adolescent
consumption of dietary and sport supplements, to suggest the need to establish a system to track
consumption rate, and to discuss the role of health educator in the process (Housamn 35). The
authors suggest major changes to be implemented in order to improve the impact that supplement
use has on adolescents. According to the article, Health professional need to develop programs
and specifically at reducing supplement consumption rates among adolescents (Housamn 38).
The impact of unregulated supplement even affect those who work for the foverment.
According to the article titled, Case Reports: Death Of Active Duty Soldiers Following
Ingestion Of Dietary Supplements Containing 1,3-Dimethylamylamine (DMAA) Eliason et al
demonstrated the idea that dietary supplements are dangerous, when they are misused by any

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individual or even an organization like the military (Eliason et al 1457). The fact that the army
itself had some issues with the supplement proves that the issue is not only toward a certain
group of individuals but also organization that can be affected. The reaction to this supplement
could affect any part of the body especially the brain. The argument of the author is that because
two people did die because of this supplement use, the author questions the reliability of this
product, and that some measures should be taken for the safety of each human being who uses
this supplement.
The issue of safety also extends into the general population since this is the largest group
using unregulated supplements. According to Miller, any drug supplement that is supposed to
help people lose weight should be regulated. According to the article titled, Safety Concerns
Regarding Ephedrine-Type Alkaloid-Containing Dietary Supplements certain herbs such as
guarana and mante when combined with caffeine can cause strokes and heart attack. People do
not know the risk and therefore should be informed and protected by the government against that
regulate food and drugs. According to Marcus et al the safety concerns regarding the use of the
Ephedrine-type Alkaloid-containing dietary supplements is the focus of the article (Marcus et al
1669). The article is explaining the good effects of using the Ephedrine-type Alkaloid concerning
weight lost and improvement of the athletes performance. This supplement can make the person
feel better in terms of these conditions, but like any other supplement, this one has two sides too,
the bad side is that cardiovascular, neurological, psychiatric, illness are injuries are associated
with more than 100 different Ephedra-type Alkaloid. The good effects meaning losing weight
and improving athlete or any human performance is the main reason for people risk taking it and
consume the product despite of the danger.

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Additionally, Garg and Roth point out that the effectiveness of testing for more accurate
and precise results when it comes to the accuracy of supplement testing needs to be improved
(Garg, S424; Roth et al., 13). DNA is the main testing mentioned in the article and according to
the author is non affective and reliable. The use of any other testing method such as ingredient
testing, is seen as more reliable because DNA testing has a tendency to destroy compounds that
is located in the supplement, often leaving the researcher or scientist confused about the findings,
which are usually inaccurate. The use of inaccurate testing is leading some vitamins to be
overlooked like Vitamin D. The use of supplements, especially Vitamin D for pregnant women,
are and have been evaluated as dangerous because of the regulation of bone minerals and
skeleton development produced by the use of the following supplements. This article shows that
because supplements are dangerous, to certain people who use them, at this point such vitamins
like Vitamin D should have regulation to its use and the known impacts should be made clear to
those that are planning on taking the supplement.
Keum and E Giovannucci presents the dangerous aspects of Vitamin D, which is
mentioned by the researchers to be toxic (Keum and E Giovannucci 977). The product creates
deficiency to the heart, which could be fatal overtime when not regulated properly and not used
in such a way to protect the person. The use of Vitamin D according to the article could also
generate many other diseases like Hypercalcemia, and heart blockages, all dangerous to the
human survival, and the continued use of this vitamin could disturb the functionality of other
vitamins in the body. The misuse of vitamin D supplements could be fatal for the user. As this
research shows, that certain effects of vitamin D when used for certain people and in
combination with other supplements could lead to cancer. Such impacts do not happen randomly,

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but the misuse of the following vitamin is the main cause of the tragedy and therefore needs to be
regulated since it is a vitamin that is seen to be harmless.
Current Challenge
Millions of people take a vitamin or a supplement every day most believing that what is
on the ingredient label is safe and effective. However, according to various researchers, this is
not happening since supplements are unregulated by the Food and Drug Administration (FDA).
According to Patrick J. Skerrett of Harvard Health Publications of Harvard Medical School,
Under the terms of the Dietary Supplement Health and Education Act of 1994 (DSHEA),
supplements with established ingredients (meaning those that had been sold in the United States
before 1994) can be marketed without any evidence that they are effective or safe (Skerrett 1).
The deregulation of vitamins and dietary supplements poses enormous dangers to the general
public. Currently under the current rules of DSHEA, those that produce the supplements and
vitamins consumed every day, are not required to prove that what is promised on the label of the
item, actually does what the product claims, nor do the ingredients have to be accurate as well.
This poses several problems meaning that a certain product can advertise certain health benefits
and ingredients and may not contain any of what is on the label.
This is not a new problem, but one that researchers are now seeing more widespread.
According to Starr and Ranjani, the regulation of supplements has been so ignored that the
problem is only growing more and more serious (Starr and Ranjani 481). Since the deregulation
of dietary supplements in 1994, many companies have become involved in the selling of
supplements without any proof that what they are selling is true or effective. The research of
Starr and Ranjani explains why many supplements are fraudulent; containing only a small
amount of the ingredients listed on the label, with some not containing a single element of what

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is listed. Since companies that manufacture these supplements are not required by the FDA to
include information that is true or even proven to work, manufacturers can put literally anything
within these vitamins and pills without fear of any regulation or even punishment if the
supplement is proven to be ineffective.
Suggestions for Reform
The calls for reform have been consistent since the passage of DSHEA in 1994, when the
United States Congress passed a law that deregulated the production of supplements, virtually
allowing manufacturers to not follow any manufacturing codes that other food and medicine
manufactures are required to follow by law. Prescription drugs are regulated by the FDA but
because of DSHEA, supplements are treated like a special food, one that is out of the regulation
of the government. It is important to know that the FDA considers a drug to be unsafe until it is
proven safe. But a supplement is seen as different; a supplement is seen as safe until it is proven
to be unsafe. Medicine has to be tested and studied before it can be given to patients. These
regulations are standardized by the rules that are in place based on the history and experience of
medicines that have been used in the past. There is a long history of the public being mistrustful
of those individuals selling medicines and potions claiming to cure illnesses and other health
related problems. The snake-oil salesman as they would come to be known, peddled products
that were not regulated and largely unproven to cure the illness that it claimed to treat. In the 20th
century regulations were eventually past that mandated that anything claimed as medicine had to
be regulated in such a way that the product had to be tested for its safety and it had to perform
the act of the claim as advertised. If not, the approval for sale was not given and the
manufacturer or creator of the product was not allowed to sell. The same changes need to happen

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currently with supplements, as all supplements should be regulated like medicine with the
product tested for safety and tested to see if the product actually performs what it claims
Conclusion
By the facts and evidence provided in this paper, people should see the truth about the
danger of taking supplements and awake an awareness regarding the required quantity prescribed
for to not pay attention risks great danger to health and well-being of those people who think
they are taking a supplement safely. The Food and Drug Administration should take a stand and
battle for a new law that will require all supplements to be regulated for all consumers. DSHEA
should be amended to regulate all supplements to ensure the safety of all users. The research and
facts shows how important the regulation of supplements is to the health of the population
because there is far too much risk in terms of complications and death from taking supplements
that are improperly regulated and improper information being given to consumers.

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Works Cited
Bowden, Lynden P., et al. Rapid Onset of Argyria Induced By a Silver-Containing Dietary
Supplement. Journal of Cutaneous Pathology 38.10 (2011): 832-835. Academic Search
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Eliason, Michael J., et al. Case Reports: Death Of Active Duty Soldiers Following Ingestion of
Dietary Supplements Containing 1,3-Dimethylamylamine (DMAA). Military
Medicine 177.12 (2012): 1455-1459. Academic Search Complete. Web. 31 Jan. 2016.
Fontanarosa, Phil B., Drummond Rennie, and Catherine D. DeAngelis. The Need for
Regulation of Dietary SupplementsLessons From Ephedra. JAMA: Journal of the
American Medical Association 26 Mar. 2003: 1568. Academic Search Complete. Web. 4
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G., Garg, et al. Vitamin D Toxicity Presenting As Hypercalcemia And Complete Heart Block:
An Interesting Case Report. Indian Journal of Endocrinology & Metabolism 16. (2012):
S423-S426.Academic Search Complete. Web. 28 Feb. 2016.
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Marcus, Donald M., Arthur P. Grollman, and Sidney M. Wolfe. Ephedra-Free Is Not DangerFree. Science 301.5640 (2003): 1669-1671. Academic Search Complete. Web. 27 Jan.
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Miller, Shannon Corey. Safety Concerns Regarding Ephedrine-Type Alkaloid-Containing


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Roth, Daniel E., et al. Maternal Vitamin D Supplementation During Pregnancy And Lactation
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