Kennedy 1

Claire Kennedy

Instructor: Malcolm Campbell

English 1104

November 8, 2017

Death by Dietary Supplement

Dietary supplements are taken by millions of people everyday. Yet millions of people

have no idea what is truly in these supplements. Due to advertising and lack of regulation,

dietary supplement manufacturers are able to make false claims and sell inadequate products to

the public. The public are guinea pigs in the eyes of the law. The Food and Drug Administration

(FDA) has no legal control over dietary supplements until the product is sold for consumption,

resulting in unnecessary death and harm to the public. A study done by the U.S Drug- Induced

Liver Injury Network found that herbal supplements used primarily for bodybuilding taken on a

daily basis led to prolonged jaundice in the liver. (Dietary Supplements: What You Need to

Know). If dietary supplements manufacturers were mandated to perform clinical trials and

prove their products did what they claim the consumer would no longer be in danger due to the

improper regulation of dietary supplements.

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

No one would ever consider taking prescription drugs unless it had undergone countless clinical

trials to determine all the risks and side effects. So why is the public so eager to take unregulated

supplements? One reason. Dietary supplement companies market products as wholesome and

all natural causing consumers instinctively to believe that it must be true because the FDA
 Kennedy 2

oversees them. Dietary supplements are a billion dollar industry and manufacturers do whatever

it takes to keep the money flowing. Even if it means putting innocent Americans at risk.

How the FDA is failing America

The Dietary Supplement Health and Education Act of 1994 placed dietary supplements

under the control of the FDA. This resulted in supplements being classified as food instead of a

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

law did the complete opposite. This law allowed manufactures are not required to prove that a

supplement is safe, nor are they required to put the supplement through any clinical trails to

prove the product does what the companies are claiming (FDA 101: Dietary Supplements).The

FDA can investigate and evaluate the safety of a dietary supplement only after people become

seriously ill or die!

The industry is only growing. There are over 4,000 manufacturers in the U.S and the

consumers demand for dietary 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 manufacturers labels and claims

have been proven and tested. Millions of Americans are vulnerable because of the lack of

oversight in this billion dollar industry. A study done by Dr. Lla Harris in the journal Regulatory

and Ethical Issues in Dietary Supplements, found that 260 Asian patent medicines that were sold
 Kennedy 3

in California contained very harmful and potentially deadly compounds, such as 14% containing

arsenic, 14% containing mercury and 10% containing lead (Harris). There is zero regulation on

these products in China, one of the largest distributors of dietary supplements. However the FDA

has yet to look into the validity of these products.

Whos at risk?

170 million Americans take dietary supplements on a daily basis. Many 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. Harvard Health editor Patrick

J. Skerrett notes that other "all natural" supplements, such as the weight-loss supplement

ephedra, have been linked to deaths and other serious side effects. Taking too much of a

supplement can cause dangerous levels of toxicity. This can be seen through many different

effects, sometimes it might be fatigue and headaches, or in some cases liver damage and

abdominal pain (DiLascio). Since most consumers of dietary supplements believe the products

they are ingesting are wholesome and natural they tend to take up to three or seven supplements

daily. Mixing various supplements together can be a deadly combination. When multiple

supplements are taken together it tends to magnify the side effects or cause new ones.

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

that supplement complications resulted in heart problems such as irregular heart beat or chest

pains. Using data form sixty-three emergency rooms he discovered that 23,005 emergency room

visits occur each year due to dietary supplements and 2,154 of those patients required

hospitalization for further treatment (Stein).

 Kennedy 4

There is a lack of clarity in the medical world of what is a safe amount for various

supplements like vitamin D. Doctors have been held liable for inadequately treating patients with

vitamin D because the data is extremely unreliable and they do not even recognized the problems

being caused by vitamin D to their patients. Beginning of this year I began to feel very fatigued

even though I would get plenty of sleep and was exercising regularly. I was told I had vitamin D

deficiency. My primary physician recommended I take 2,000U daily while the nutritionist I saw

recommended 5,000- 10,000U daily. There is no consistency with dietary supplements. No one

truly understands or knows what is the proper dosage or the effects from certain supplements

because no regulation is enforced. The FDA does state and elaborate on the dangers of dietary

supplements, but this is not common knowledge. No one is making the public aware of these

issues, and without personal experience or curiosity no one would know (FDA 101: Dietary

Supplements). The only way to fix this dyer problem is to have dietary supplements regulated

as prescription drugs.

Exposing the frauds

Many advocates for keeping the regulation as it is claim that the products are what they

say they are and there is nothing to worry about. Then why do they fight so hard against stricter

regulation? Theres a reason. They are lying. When PBS, Frontline began interviewing for their

documentary Supplements and Safety many large chain pharmaceutical companies shared their

concerns and constraints with the consistency of the supplements. The pharmacies took matters

into their own hands and started testing the supplement products since the manufacturing

companies do not have to. They began requiring that any supplement filled must at least meet the
 Kennedy 5

labeling standard. Ninety percent of the companies did not respond to this request and the ten

percent that did, did not met the labeling standard by any means (Docherty).

In a specific case, Purity First owner Candice Tripp was selling every dietary

supplement imaginable. She produced these supplements in her kitchen at home with zero

education in the medical field! Consumers loved her product and the message it stood for. Purity

first. Cases of erratic behavior and health issues began to stem from Purity First users. After tests

were done on her products it was found that Purity First manufactures had been contaminating

the supplements with steroids. To make matters worse, the FDA could not remove the product

from the market for six months due to lengthy legal processes. This was undetected because the

FDA does not have the power to assess or regulate manufacturing plants or their processes

(Docherty).

How to save your life

In order to be a safe consumer one must always educate themselves and seek help if

needed. Dietary supplements are far too often self prescribed, and it needs to be stopped.

Supplement manufactures have an invested interest in making as much profit as possible off its

consumers, so they have no problem falsifying ingredient labels or making inaccurate claims. It

is hard as a consumer to be fully aware of whats factual or not. Various supplements have been

taken off the market due to harmful effects such as Oxy Elite Pro (Harris). There were various

reported accounts of liver damage to the point of needing a transplant, and one individual died.

Supplements like Oxy Elite Pro are still on the market today! With the regulation today someone

has to die before any action will be taken. The only way to reduce ones risk to the possible

dangers of dietary supplements is to be an informed consumer and never self-diagnose. However,

 Kennedy 6

even if all precautionary steps are taken one is still at risk to the dangers of dietary supplements

(FDA 101: Dietary Supplements).

The supplement St. Johns Wort has been used for centuries to treat mental illnesses such

as depression. St. Johns Wort effects serotonin levels similarly to antidepressants like Prozac

and Zoloft. When taking St. Johns Wort with an antidepressant can cause serotonin syndrome.

Symptoms of serotonin syndrome include: tremors, diarrhea, muscle stiffness, drop in body

temperature, and death (St. John's Wort and Depression). A few years ago as an experiment I

went to a GNC store and told them I was on Prozac and asked if St. Johns Wort was safe to take

as well. They informed me that is was all natural and it is completely safe. Supplements are

dangerous, and deadly when taken with out input from a healthcare provider.

What needs to be done

Drugs are considered unsafe until proven safe, while dietary supplements are the

complete opposite. Dietary supplements can be just as dangerous as prescription drugs

(DiLascio). There is no explanation for the different treatment and regulation for these two

products other than greed. By continuing to allow dietary supplements to be considered food

rather than drugs will increase the marketing of misleading and inaccurate claims of supplements

contents. No consumer can realistically make an informed decision on what supplements are best

for their lifestyle and health because of 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, and they would know the correct dosages. The risk of

death and harm would decrease significantly (DiLascio). Healthcare professionals would be

aware of any issues with prescribing certain medication with supplements, making for a safer
 Kennedy 7

consumer and healthcare system. Also, medical professionals would be able to monitor

supplement intake much more efficiently because self prescribing supplements would no longer

be an option.

The regulation of dietary supplements is in chaos. The FDA can not keep up with the

exponentially growing industry and this is effecting peoples lives. Dietary supplements are

putting people everyday at risk for adverse health effects. In order to stop further damage

supplements must be considered drugs. The only way to see change is if people begin to speak

up and hold the industry accountable for its action. Consumers who take dietary supplements

usually care about their bodies and what they are putting in it. If the majority of people were

aware that these healthy products could be hurting them or simply doing nothing to help them I

am certain no one would continue to take them. I believe it would eventually help the industry if

dietary supplements were regulated as drugs because then everyone could trust the content and

validity of a product.

Reflection

The current laws and regulations are failing the public and need to be changed. Now is

the time to take action. The dietary supplement industry is producing more supplements than

ever before and people are consuming supplements more than ever before regulators of this

industry do not have the resources or knowledge to properly regulate manufactures (Dietary

Supplements: What You Need to Know). No industry should have the power to blatantly harm its

consumers with zero consequences. The public has the right to know the true ingredients of a

product and its effects. If action is not taken soon more corruption and lies will continue in this

industry. We live in such a highly regulated society it is odd that this one particular industry has
 Kennedy 8

so much power and freedom. Manufacturers have proven time after time that they can not be

trusted with this amount of power. In order to keep the public safe it is a necessity that dietary

supplements be regulated as drugs. Deaths and serious illnesses have been over looked for far too

long now. It will be an injustice to society if the supplement industry is not held accountable for

their actions.

Peer Review: I think you should give more in detail and specific ways that the FDA is failing

Americans. I see that youve pointed out how certain medicines have been overseen and that

Americans are vulnerable but maybe add in some cases from different articles in which this has

actually occurred. Your second section about whos at risk is very long and I think you could

possibly break that up into different sections and stay clear and concise when talking about whos

at risk. In exposing the frauds theres a part when you say Theres a reason. Theyre lying.

Instead of coming up so blatant saying that I think you could ease into it a little differently. I

think you should proofread and look at singular vs. plural issues. One vs. themselves. Would the

solution to this problem be costly? Maybe you can include something about the cost

effectiveness. Do you think that this topic needs more international coverage? If you think

Americans are not aware enough then maybe you could include something about that in your

section about what needs to be done. Look at your spelling, trial is spelled wrong several times.

Do you think that if consumers do realize whats really up with their drugs, that itll make a

difference in their intake? Maybe you could mention the time it would take and make it more

specific when mentioning the solution to this topic. Looks pretty clean though content and

structure wise youve organized it well with the sections. You dont seem to have a
 Kennedy 9

counterargument or another point that you really bring up. Maybe add in something about

another perspective and that counter argue that. If you did that already it wasnt emphasised

much. Really good paper. Love your passion.

 Kennedy 10

Work Citied

Commissioner, Office of the. Consumer Updates - FDA 101: Dietary Supplements. U S Food

and Drug Administration Home Page, Office of the Commissioner, 15 July 2015,

www.fda.gov/ForConsumers/ConsumerUpdates/ucm050803.htm. Web. 07 Oct 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.

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?

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

www.pbs.org/wgbh/frontline/film/supplements-and-safety/. Web. 07 Oct 2017.

Harris, Ila. "Regulatory and Ethical Issues with Dietary Supplements." Pharmacotherapy. 20.11.

(2000): 1295-302. Print.

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/

health/stjohnswort/sjw-and-depression.htm.

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-.

Web. 07 Oct 2017.