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Claire Kennedy

Instructor: Malcolm Campbell

English 1104

November 8, 2017

Death by Dietary Supplement

Dietary supplements such as calcium, vitamin D, fish oil and St. Johns Wort are taken by

millions of people every day (FDA 101: Dietary Supplements). Yet millions of people have no Deleted: e

idea what is truly in these supplements. Due to advertising and lack of regulation, dietary

supplement manufacturers can make false claims and sell inadequate products to the public. The Deleted: a

public is guinea pigs in the eyes of the law. The Food and Drug Administration (FDA) has no Deleted: a

legal control over dietary supplements until the product is sold for consumption. This can result Deleted: ,
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in unnecessary harm to the public. A study done by the U.S Drug- Induced Liver Injury Deleted: d

Network, found that daily use of bodybuilding herbal supplements can lead to prolonged

jaundice in the liver (Dietary Supplements: What You Need to Know). If dietary supplement Deleted: s

manufacturers were mandated to perform clinical trials and prove their products did what they Deleted: a

claim, the consumer would no longer be in danger of liver damage due to the improper Deleted:
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regulation of dietary supplements.

Supplements should be obligated to the same laws and regulation as prescription drugs.

No one would ever consider taking a prescription drug unless it had undergone countless clinical Deleted: s

trials to determine all the risks and side effects. Why is the public so eager to take unregulated Deleted: a
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supplements? Dietary supplement companies market products as wholesome and all natural Deleted:

and consumers instinctively believe this is true because the FDA oversees these products. Deleted: c
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Dietary supplements are a billion-dollar industry and some manufacturers do whatever it takes to Deleted: b
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keep the money flowing, even if it means putting innocent Americans at risk. Deleted: .

What are Dietary Supplements?

Dietary supplements may be one or a combination of, vitamins, minerals, herbs, amino

acids, concentrates, metabolites, constituents or extracts. These can be found in various forms

such as tablets, capsules, soft gels, gel caps, liquids or powders. Supplements are intended to

improve the quality of someones health and diet by filling in the gaps in their diet (Wein).

How the FDA is failing America Deleted:

The Dietary Supplement Health and Education Act of 1994 (DSHEA) placed dietary Deleted:

supplements under the control of the FDA. Supplements then became classified as a food instead Deleted:

of a drug. Many believed this would put an end to the false advertising in the industry. Instead,

this law did the complete opposite. DSHEA stated that manufactures are not required to prove Deleted: M

that a supplement is safe, nor are they required to put supplements through any clinical trials to Deleted:
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prove the product is effective (FDA 101: Dietary Supplements). Unfortunately, the FDA can Deleted: d
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only investigate and evaluate the safety of a dietary supplement after people become seriously ill Deleted:

or die!

Harvard Health editor, Patrick J. Skerrett, notes individuals often take dietary

supplements for weight loss and enhanced athletic performance. Ephedra is a supplement that

can improve performance and weight loss. Ephedra also can cause a dangerously high heart rate

and blood pressure. In spite of these problems, it took the FDA seven years to gather enough

evidence to take Ephedra off the market. During those seven years there were 16,000 reports of

injuries, 62,000 complaints and 155 deaths related to ephedra (Harvard Health). Consumers
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are at the mercy of manufacturers. Although some manufacturers can be trusted, many cannot,

and at this point there is no way to tell one from another.

There are over 4,000 manufacturers in the U.S and the consumers demand for dietary Deleted: T
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supplements is skyrocketing. Dr. Stephen Ostrof, former commissioner of the U.S Food and

Drug Administration, shared that the FDA does not know the exact number of manufacturers that

are needed for inspection because there is no formal registration process that is required

(Docherty).

Americans are completely unaware of possible hazards associated with dietary

supplements. People are assuming that the dietary supplement manufacturer labels and claims Deleted: s

are tested and proven. Millions of Americans are vulnerable because of the lack of oversight in Deleted: h
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this billion-dollar industry. A study done by Dr. Lla Harris in the journal Regulatory and Ethical Deleted:
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Issues in Dietary Supplements, found that 260 Asian supplements that were sold in California Deleted: p

contained very harmful and potentially deadly compounds, such as 14% arsenic, 14% mercury Deleted:
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and 10% lead (Harris). There is zero regulation on dietary supplements in China, one of the Deleted:
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largest distributors of dietary supplements. Yet, the FDA has not questioned the validity of these Deleted: H
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products.

Whos at risk?

One hundred and seventy million Americans take dietary supplements daily. Many Deleted: 1
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believe that dietary supplements contain all natural ingredients and nothing harmful can come

from them. However, dietary supplement overdose is real and far too common (Hamblin). The Deleted: .

most common supplements that consumers overdose on are fat burners and vitamin C. Fat

burners are notorious for being laced with chemicals and dangerous additives. Vitamin C is

known as a great immune booster, so when people are feeling sick they may take more than the
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suggested daily dosage. Taking too much of a supplement can cause toxicity. Toxicity can cause Deleted: H
other "all
supplemen
fatigue, headaches, abdominal pain and liver damage (DiLascio). Since most consumers believe serious sid
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the products they are ingesting are wholesome and natural they tend to take up to seven Deleted: T
sometimes
supplements daily. Mixing various supplements together can be a deadly combination. When Deleted:
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multiple supplements are taken together it tends to magnify the side effects or cause new ones Deleted:
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(Harvard Health). Without clinical trials, consumers and healthcare providers do not know
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which supplements can be taken together and if supplements are safe to take with prescription
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drugs. This problem could be avoided if supplements were under the same regulation as Deleted: .

prescription drugs. Interactions would be discovered during the clinical trial process.

Dr. Andrew Geller, from the Federal Center for Disease and Control Prevention,

concluded that supplement complications can lead to heart problems such as irregular heart beat Deleted: r

or chest pains. Using data form sixty-three emergency rooms he discovered that 23,005
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emergency room visits occur each year due to dietary supplements and 2,154 of those patients
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required hospitalization for further treatment (Stein). Deleted: s
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There is a lack of clarity in the medical community regarding appropriate dosing for Deleted:
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supplements like vitamin D. Doctors often fail to treat vitamin D deficiency adequately because patients w
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being caus
the data is extremely unreliable. At the beginning of this year I began to feel very fatigued even
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though I was sleeping well and exercising regularly. I was told I had vitamin D deficiency. My Deleted:
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primary physician recommended I take 2,000U daily, while the nutritionist I saw recommended Deleted: T
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5,000- 10,000U daily. This is a good example of the inconsistencies of dietary supplement use. Deleted:
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No one truly knows the proper dosage for many supplements, and they are also naive to the regulation
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negative effects. The FDAs website does discuss the dangers of dietary supplements, but this is Deleted: s
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not common knowledge. No one is working to make the public aware of these issues (FDA 101: Deleted: m
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one would
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Dietary Supplements). The most certain way to regulate dietary supplements efficiently is to Deleted: .

classify them as prescription drugs Deleted: T

dietary sup
Exposing the frauds

The worlds leading supplement advocacy group, The Natural Products Association,

fights to keep the regulations as they are. Advocates claim that the products are what they claim Deleted: M
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and there is no danger. Then why do manufacturers fight so hard against stricter regulation? Deleted: i
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There is a reason. They know they are lying. When PBS, Frontline began interviewing for their Deleted: s
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documentary Supplements and Safety, many large chain pharmaceutical companies expressed
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their concerns regarding the consistency of the supplements. The pharmaceutical companies
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finally took matters into their own hands and started testing the supplements themselves. They
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began requiring that any supplement filled must at least meet the labeling standard. Ninety Deleted: s
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percent of the companies did not respond to this request and the ten percent that did, did not met Deleted:
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the labeling standard by any means (Docherty). These results are alarming. If the majority of Deleted:
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manufacturers are not even following the labeling standard then it is likely other standards are

being disregarded as well.

In a specific case, Purity First owner, Candice Tripp, was selling every dietary Deleted:
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supplement imaginable. She distributed these supplements from her kitchen with zero education Deleted:
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in the medical field! Consumers loved her product and the message it stood for. Purity first. Deleted: p
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Cases of erratic behavior and health issues began to occur in Purity First customers. After tests Deleted:
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were done on the products, it was found that Purity First manufactures had been contaminating
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the supplements with steroids. To make matters worse, the FDA could not remove the product
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from the market for six months due to a lengthy legal process. This problem was undetected Deleted: e
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because the FDA does not have the power to access or regulate manufacturing plants and their Deleted: s
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processes (Docherty). Deleted: o

Daniel Fabricant, CEO of Natural Products Association, fights for a free market

healthcare system relating to dietary supplements. Fabricantss line of reasoning for fewer

regulations is that if consumers find issues with a supplement they will simply stop using it. This

is flawed reasoning. Consumers cannot tell if a product is bad until adverse effects occur.

Fabricant notes that pharmaceutical companies spend millions of dollars on clinical trials and

tests. He believes this would be an unnecessary burden on the supplement industry. Essentially,

Fabricant is saying that it would cost too much money for dietary supplement companies to put

their supplements through clinical trials (Hamblin). He suggests that financial gain is more

important than the safety of millions of Americans.

How to save your life

Dietary supplements are routinely self-prescribed, but this is not a safe practice. Deleted: I
educate th
Supplement manufacturers have an interest in making as much profit as possible. Unfortunately, Deleted:
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some manufacturers have no problem falsifying ingredient labels or making inaccurate claims to Deleted: ,
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sell their products. Consumers do not know which products are being marketed based on facts. Deleted:
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There is no clear way to tell what companies are being honest and which are not. It cost the Deleted:
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companies who follow the suggested FDA regulation more money and time to verify and factual or

produce a quality product (The Arguments against Dietary Supplements). Allowing

manufacturers to produce inadequate products without consequences discourages the production

of quality products.

Multiple supplements, such as Oxy Elite Pro have been taken off the market due to Formatte
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harmful effects (Harris). There were reports of liver damage resulting in liver failure and even Deleted: s
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death. Supplements similar to Oxy Elite Pro are still on the market today! With the current Deleted: t
individual
regulations, someone must die before any action is taken. To ensure the publics safety, Deleted: l
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consumers need to educate themselves and seek the advice of a healthcare professional before Deleted: h
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beginning treatment. It is never appropriate to self-diagnose (FDA 101: Dietary Supplements). Deleted:
dangers of
consumer
The supplement St. Johns Wort has been used for centuries to treat mental illnesses such precaution
of dietary
as depression. St. Johns Wort affects the levels of serotonin in the brain and is similar to Deleted: e
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prescription antidepressants like Zoloft and Prozac. Combining St. Johns Wort with an Deleted:

antidepressant can lead to an elevation in serotonin that can cause serotonin syndrome. Serotonin

syndrome is a medical emergency. If left untreated it can lead to death (St. John's Wort and Deleted:
antidepres
serotonin
Depression). Recently, I went to a GNC store and told them I was on Prozac, but still felt stiffness, d
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depressed. I asked if St. Johns Wort was safe to take along with Prozac. They explained that Deleted:
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since St. Johns Wort is a natural substance it is safe to take with other antidepressants. They had
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no idea that the combination could be a formula for disaster. completel
when take
They arent all bad Deleted: .
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Not all dietary supplement manufacturers are falsifying ingredient labels and misleading Formatte

the public. Dietary supplements can be safe, healthy and effective. Supplements are extremely Formatte
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helpful when someone has a deficiency. Anemia, which is commonly a cause of low energy and Formatte
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fatigue, can greatly improve and even resolved with an iron supplement. Low iron can only be

diagnosed with a blood test and iron should not be taken without a proper diagnosis (Wein).

What needs to be done

Drugs are considered unsafe until proven safe. Dietary supplements are assumed to be Deleted: ,

safe. However, dietary supplements can be just as dangerous as prescription drugs (DiLascio). Deleted: t
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There is no explanation for this discrepancy other than greed. Allowing dietary supplements to Deleted: d
products
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be considered food rather than a drug invites misrepresentation. No consumer can realistically Deleted: s
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make an informed decision on what supplements are best for their lifestyle and health, because of inaccurate
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the lack of regulation. Society wants products that are safe and labeled correctly. If dietary

supplements were regulated as drugs, the public would be fully aware of any possible side effects Deleted: ,

and they would know the correct dosages. The risk of death and harm would decrease

significantly (DiLascio). Healthcare professionals would be aware of issues with prescribing Deleted: a
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certain medication with supplements. Also, medical professionals would be able to monitor Deleted: ,
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supplement intake more efficiently because self-prescribing supplements would no longer be an Deleted:
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option.

The regulation of dietary supplements is in chaos. The FDA cannot keep up with the Deleted:
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unregulated supplement industry. The lack of regulation is affecting peoples lives by leaving Deleted: g
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them vulnerable to adverse health effects. In order to stop further damage, supplements must be supplemen
health effe

considered drugs. The best way to create change is to hold the industry accountable. Consumers Deleted: .
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who take dietary supplements care about their bodies and what they are putting in it. When Deleted: s
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people are aware that a healthy product is doing nothing to help them and could be hurting Deleted:
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them, they certainly will not continue to take the product. I believe it would help the industry if Deleted: I
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dietary supplements were regulated as drugs because then everyone could trust the content and Deleted: t
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validity of a product.
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help them
Reflection Deleted:

Currently, approximately sixty-eight percent of Americans take daily dietary

supplements. (Dietary Supplements: What You Need to Know). The demand for dietary

supplements will continue to increase so prompt action is required. The current laws and

regulations are failing the public and need to be changed. Now is the time to act. Consult a Deleted:
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healthcare provider before taking any dietary supplement and inform yourself, friends and family

of the possible dangers surrounding dietary supplements. No industry should have the power to Deleted: .
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blatantly harm its consumers with zero consequences. The public has the right to know the true supplemen
supplemen
industry d
ingredients of a product and its effects. If action is not taken soon, corruption and lies will regulate m
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undermine this industry. We live in such a highly regulated society; it is odd that this one Deleted: i
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industry has so much power and freedom. Manufacturers have proven time after time that they Deleted: c
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cannot be trusted with this amount of power. To keep the public safe it is crucial that dietary Deleted: p
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supplements be regulated as drugs. Deaths and serious illnesses have been over looked for far too Deleted: I
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long. It will be an injustice to society if the supplement industry is not held accountable for their
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actions.

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Work Cited Deleted: i

Consumer Updates - FDA 101: Dietary Supplements. U S Food and Drug Administration Deleted
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Home Page, Office of the Commissioner, 15 July 2015, Formatte

www.fda.gov/ForConsumers/ConsumerUpdates/ucm050803.htm. Accessed. 07 Oct Deleted

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2017.

Dietary Supplements: What You Need to Know. NIH Office of Dietary Supplements, U.S.

Department of Health and Human Services, 7 June 2011, ods.od.nih.gov/

HealthInformation/DS_WhatYouNeedToKnow.aspx. Accessed. 07 Oct 2017.

DiLascio, Tracey M. "Point: Dietary Supplements Should Face the Same Approval Process as

Prescription Drugs." Points of View: Dietary Supplement Safety, June 2015, p. 2.

EBSCOhost, librarylink.uncc.edu/login?url=http://search.ebscohost.com/login.aspx?

Accessed. 07 Oct 2017. Formatte

Docherty, Neil. Supplements and Safety. PBS, Public Broadcasting Service, 19 Jan. 2016,

www.pbs.org/wgbh/frontline/film/supplements-and-safety/. Accessed. 07 Oct 2017. Deleted: W

Hamblin, James. Vitamins and the Failure of Free-Market Health. The Atlantic, Atlantic Media

Company, 10 Apr. 2017, www.theatlantic.com/health/archive/2017/04/food-as-

medicine/521955/. Accessed. 22 Nov 2017.

Harris, Ila. "Regulatory and Ethical Issues with Dietary Supplements." Pharmacotherapy. 20.11. Formatte
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(2000): 1295-302. Print. Formatte

St. John's Wort and Depression: In Depth. National Center for Complementary and Integrative

Health, U.S. Department of Health and Human Services, 5 May 2016, nccih.nih.gov/ Deleted:

health/stjohnswort/sjw-and-depression.htm. Accessed. 07 Oct 2017.

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Stein, Rob. Dietary Supplements Send Thousands to ERs Yearly. NPR, NPR, 14 Oct. 2015,

http://www.npr.org/sections/health-shots/2015/10/14/448322590/dietary-supplements-.

Accessed. 07 Oct 2017. Deleted: W

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The Arguments against Dietary Supplements. Harvard Health, 7 June 2017, Formatte

www.health.harvard.edu/alternative-and-complementary-medicine/the-arguments-against- Formatte

dietary-supplements. Accessed. 22 Nov 2017.

Wein, Harrison. Should You Take Dietary Supplements? National Institutes of Health, U.S. Formatte

Department of Health and Human Services, 13 July 2017, Formatte

newsinhealth.nih.gov/2013/08/should-you-take-dietary-supplements. Accessed. 22 Nov

2017.

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