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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. For this paper, 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 United States?
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. 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 not happening that is caused by the deregulation of
supplements. 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. 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 Fontonarosa (2003)
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. 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 research found by Fontonarosa (2003) 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 (2015) 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 (2015) 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. 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 (2015) 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 (2011), 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. 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 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 the supplement
use. According to the article, Dietary and Sports Supplements: The Need For A Systematic
Tracking System by Housamn (2008) the last research done concerning the dietary and the sport
supplements among teenagers has been far too long ago to test any major changes. 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 (pg. 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 (pg. 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
(2012) demonstrated the idea that dietary supplements are dangerous, when they are misused by
any individual or even an organization like the military. 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 (2004) a drug supplement that is supposed
to help people lose weight; should be banned. 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 (2003) the safety concerns regarding the use of the
Ephedrine-type Alkaloid-containing dietary supplements is the focus of the article. 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.
Additionally, Garg (2015) and Roth (2012) 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. 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 much of the matter 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 (2014) presents the dangerous aspects of Vitamin D, which is mentioned by the
researchers to be toxic. 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, 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,
2012). 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 (2015) the regulation of supplements has been so ignored that the problem is
only growing more and more serious. 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. Based on the research of Starr (2015) 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 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. 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 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.

Chris,
Youve done a really great job here. You present some fascinating research, and your writing is
clear and you do a good job bringing a sense of exigency, but maintaining an academic tone here.
Also, it looks like your sources are really solid. This paper does feel a bit like an annotated
bibliography as opposed to an essay. Ive commented on this in the margins, but you should
really be synthesizing these voices with your own. Try started paragraphs with topic sentences.
That might help you engage more conversationally. As the paper is, it seems as if you are
running through the sources and offering annotations. Also, check your in-text citation.
Otherwise, good work here.

Works Cited
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