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Recommendation Report:
PUSH FOR REGULATED DIETARY SUPPLEMENTS IN THE UNITED STATES

ABSTRACT

The purpose of this report is to recommend regulations for dietary supplements as well as

enact bans for supplements that have been shown to cause harm and serious side effects for

users. I argue that using these products can pose fatal for users as they aren’t guaranteed to be

safe, nor are they backed by any significant data that would allow for the FDA to be allowed

interference. My methodology consisted of referencing case studies as well as journals and

articles from academics who have researched this topic in intensity so as to find a definitive. I

also made reference to a book on marketing strategies that would better explain the principles the

products are by law supposed to follow and how they can use it to push their own marketing

strategies so as to gain consumer support. After conducting my own research and examining all

findings, I have found that nationwide, supplements have been found to be inconsistent in quality

and efficiency as there are no standard guidelines or code of ethics set in place by the FDA.

Many scientists have conflicting results of varying magnitudes which makes deciphering

between “good” and “bad” a matter of opinion rather than fact. In offering a solution to this, my

recommendations were as follows: 1. To have FDA mandated regulations for all products labeled

as “dietary supplements” or products claiming to work in place of actual diet and exercise, 2.

Have the FDA collect and review all supplements currently on the market, 3. Mandate that

companies be more transparent in product display and marketing and in order to prevent legal

disputes, work with them to create a better compromise than just taking over completely, 4. Have

the FDA work with a team of scientists to conduct their own case studies focusing on the effects

of dietary supplements so as to determine the efficacy of them and become better educated on
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how they work so s to assign safety and warning labels accordingly. In presenting these

recommendations, they will act as the most promising and efficient way to prevent health

problems posed by supplements manufactured in the years to come as the data and scientists

point to the health problems being prevented in the first place if the proper research is conducted

beforehand.

INTRODUCTION

In the United States, the problem of obesity has risen to significant levels as processed

food has become a staple to the culture's cuisine and it is often times the go-to for many who

cannot afford fresh food, do not have time to cook, or have become accustomed to eating such

unhealthy foods that transitioning to a healthy way of eating is difficult and in extreme cases,

impossible. This leads to many turning to easier solutions of losing the unhealthy weight such as

buying into weight loss teas, appetite suppressing lollipops, and diet pills among other products

that fall into the “miracle-working” category as they market on the fact that users won’t have to

change their diet, exercise, or wait for a significant amount of time for results to start showing.
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Figure 1. “​Combining data from 2015 through 2017, non-Hispanic blacks had the
highest prevalence of self-reported obesity (38.4%), followed by Hispanics (32.6%) and
non-Hispanic whites (28.6%)” (CDC).

The United States has already issued warnings to people of the dangers of supplements in

the past continuing to today as more and more are turning to them in times of desperation or

laziness. The FDA contributes to this process by working “with industry and our state partners to

publish press releases and other public notices about recalls that may potentially present a

significant or serious risk to the consumer or user of the product” (FDA) but this only goes so far

as the products are still, in the end, marketed for profit. In their consumer section specifically,

they even address this by mentioning that while they create a framework for safety and labeling,

they are not authorized to actually review the supplements before they are put into the market

(FDA). This lack of authority cements the need to initiate safety protocol and regulatory

measures so as to prevent the next violation and recall from happening and will serve as a point

of topic further down in the “Discussion” section of the report.

BACKGROUND

Supplements, while newly popular, have roots dating as far back to ancient times where

herbal medicine was a source of healing and remediation for many ailments. Many of these herbs

used historically are actually still in use today with some of the most common being aloe vera for

burns, echinacea tinctures or tea for flu-like symptoms and most especially mint for things like

flavorings, medicine, tea, and even skincare (Barrington). It should also be noted that these

medicinal practices weren’t limited to one specific country either as many cultures developed

their own methods of healing that best suited the needs of the patient. In focusing on more
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modern applications, the United States has had a long history with supplements as was most

prominantly seen among Native American pueblos and European settlers.

In 1958, things became commercially cemented as the Food Additive Amendment was

enacted making any product intended for premarket exposure need approval from the FDA

which would determine it as GRAS (“generally recognized as safe”) or not (NIH Office of

Dietary Supplements). However, should companies choose to not run their product by the FDA,

they can still test for GRAS by checking it against “scientific data, methods, or principles” along

with having a consensus being reached among experts about the safety of the product for its

intended use (NIH). This became problematic as companies were basically given the approval to

make any claims they wanted for their product and the amounts of vitamins allowed in each

supplement went unchecked leading to many becoming ill from hypervitaminosis. The FDA, in

realizing their mistake with this, then set about tightening regulations again in 1962 by

introducing the Recommended Daily Allowance (RAD) and also attempted to set disclaimers for

vitamins that cautioned the use of supplements unless you had “special medical needs” (Pray).

This caused controversy and tensions grew between the FDA and companies, however, it wasn’t

until 1973 that the FDA finally lost its battle with regulations. Due to regulatory establishment

taking over the industry, dietary supplement manufacturers sought for mobilization with

congressional support with the goal of invalidating the regulations completely. Eventually,

manufacturers won out and the previously held regulations were overturned for revisions that

allowed significantly more freedoms for dietary supplements and the companies making them

and would go on to be known as the Proxmire Amendments (Pray).


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After its compliance in relinquishing the control it once had, the FDA had another major

dispute with manufacturers. In 1989, a recall for Tryptophan, which was never approved, was

issued as it caused 1,510 cases and 38 deaths, associated with “eosinophilia with sharp muscular

pain, fatigue, fever, and rashes” (Pray) and led the FDA to examine the entire dietary supplement

industry. Following this, on July 29, 1993, the Commissioner for the FDA, David Kessler,

presented a report to the House of Representatives detailing the agency's findings.

“About 80% of the dietary supplement industry (at that time) consisted of

vitamins and minerals that made no unsubstantiated claims, but the balance

consisted of products that presented safety concerns (some serious and

life-threatening) or made thousands of unsubstantiated claims in catalogs,

brochures, and sales pitches” (Pray).

The conclusion was that, should the trend continue, the U.S. would be reverted to times

when medicine was experimental, at best, and medicine shows were widely used to sell products

to unsuspecting and desperate people who were drawn in by the mystery and newness of it all.

When The FDA's investigators were tasked with visiting health food stores incognito to ask if

anything was available for cancer, they were sold “antioxidant vitamins, germanium, ginseng,

shark cartilage, red clover, Venus flytrap, bee pollen, herbal teas, lion's tooth, saw palmetto,

honeysuckle, aloe vera, pancreatic enzymes, and colonic rinses” (Pray). However, even with

such substantial evidence and documentation of how devastating these products could be, the

FDA’s report was brutally attacked by the President of the National Foods Association whose

opposition was a source of strife in the FDA’s fight for safety regulations.
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Then came the Dietary Supplement Health and Education Act (DSHEA) of 1994 which

was the final step needed to truly keep the FDA out of matters pertaining to dietary and other

supplements that were constantly under scrutiny by the few regulations left. This made

supplements like vitamins which were once required to adhere to NLEA regulations, now free to

be marketed without having to provide any sort of information to the FDA before sending it to

market. Products that were once prescribed like vitamins, minerals, botanicals, herbs, and even

amino acids, now were no longer under the FDA’s jurisdiction and manufacturers could once

again make unproven and unrealistic claims about the effects that their products could have on

users.

METHODOLOGY

In order to synthesize on the idea of regulations and more FDA control over dietary

supplements, I drew from a variety of perspectives so as to make my recommendation

multiperspectived which would offer my stance on the sucject and also those of professionals

with more knowledge than I. In researching about this topic, my methodology consisted of

gathering information from scholarly sources, online databases, government articles, aand

various health websites. The scholarly sources consisted of journals and atricles written by

scientists, medical professionals, and health professionals who had conducted their own research

and experiments to test the efficiency of supplements and come up with scientific results of

substance. The online data bases were used to pull graphs and statistical data that would present

numerical information I could refer to in support of my findings, similarly in how I used the

health websites as sources for specific products, laws, and bills that were nixed or passed and

revolved around supplements. I also found it prudent to refer to a printed text as it was helpful in
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prividing information on how dietary supplements are by law allowed to label and market their

products. This allowed for me to gain insight to the labeling process, as a whole, and provided

more information on how manufacuters can and have used it to find loopholes so as to make

ill-advised and unsupported claims for their products.

Some cases I decided to study had to do with the few products that were actually banned

by the FDA such as Tryptophan, and the Fen-Phen concoction, both of which caused deaths and

serious harm to users who were taking them in the 90s both before and after the regulations were

lifted and how control was made almost nonexistant for the FDA. Further, I considered the

products that have become widely popular today as they have made headway in television

coverage, social media, and celebrety endorsement which has made them even harder to disprove

the efficacy of and remain a part of the United States dietary culture.

LITERATURE REVIEW

The sources listed below in the citations section all contribute to the main argument that

centered around the topic of providing safety for users by giving the FDA control over

supplements through regulations. For example the article “The FDA, Vitamins, and the Dietary

Supplement Industry” by W. Steven Pray, which was published in the U.S. Pharmacist Journal of

Clinical Excellence proved to be informative in finding the history and major events pertaining

to the FDA and its relationship with dieatary supplements. Other sources that also provided

historical context include “Dietary Supplements: A Framework for Evaluating Safety” (NCBI),

“DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994” (NIH), “HISTORY

OF DIETARY SUPPLEMENTS” (Kimpal), and “Dietary Supplements: Nutritional and Legal

Considerations” published in the Institute of Food Technologists official website.


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Information drawn from the FDA and CDC websites, as well as the book ​Dietary

Supplements: Safety, Efficacy and Quality ​was useful in that it delved into the legality of

supplements and how that contributed to furthering them from the reach of the FDA. The insight

it gave into the marketing process, or rather lack thereof, was better exposed as, while

manufacurers are under obligation to at least know what they legally can and cannot do,

consumers are most of the times impartial to this information and in reading these documents,

they can inform themselves and better make the decision for or against dietary supplements.

For referrence in experiments of products proven to be harmful, I looked to scientific and

medical journals as the results would be the most informative and accurate. For example, the

Cleveland State University Journal of Law and Health’s article was informative on proving that

misconceptions and misleading information was heavily prevelant in the before the 1994

ammendment and was causing a spike in harm to users by people misdosing themselves and

making supplemental concoctions that were proven to cause pulmonary valve problems and in

extreme cases, death. Similarly, “Hepatoxicity associated with weight-loss supplements: A case

for better post-marketing surveillance” made the case against Hydroxycut which contained

Garcinia cambogia​ that was proven to cause hepatoxicity in patients.

Lastly, the articles “​10 Ancient Medicinal Herbal Remedies That Actually Work” by

Mitch Barrington and “The three types of supplements you should never buy” by Kendra

Pierre-Louis were helpful in providing information on the many different types of supplements.

They also talked about what they have typically been used for and in the case of Pierre-Louis,

she delves into why they can be harmful when, in theory, they were created to be medicinal in

the first place.


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RESULTS

In the experiment conducted by Ano Lobb, the results concluded that the supplement

Hydroxycut does in fact cause hepatoxicity in patients. Hepatoxicity, being liver damage by

chemicals in the body, caused many types of side effects among users with the most common

being nausea, vomiting, and fatigue. Users should be cautious when presented with supplements

containing ​Garcinia cambogia a​ s it contains hepatoxic hydroxycitric acid making it the active

ingrediant, and the root of the symptoms as found in this study.

Figure 2. ​“​Table 1​ ​Patients, symptoms and laboratory values reported with hydroxycut

associated hepatoxicity.” (Lobbs)

Also, my findings concluded that while labeling is more informative on what should be

the recommended dose per supplement, companies can make claim to any type of outcome they

want to attract consumer attention, even though this is illegal. They can get away with this by
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ensuring their claims are listed in the Annex of Regulation provided that they are within the set

condition of use. This means that while a company cannot outright say, for example, that their

product can cure cancer, they can say that it can help in improving overall health and nutrition.

Graphs provided by Katja Berginc and Samo Kreft exemplify the gudlines specifically and give

suggestions that most manufacturers use to advertise their products uses on the market.

Figure 3. ​Table of examples of nutritional claims that manufacturers can make when

advertiseing their products.


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Figure 4. ​Types of health claims according to the EC regulations. Manufacturers cannot

make claims that products will cure cancer, for example, are not acceptable.

Lastly, my findings show that any sort of FDA control and regulating has proven to be a

great source for outrage and congressional disput. When the FDA oversaw to much of the

process products were required to undergo before proceeding to the marketplace, companies

were of the opinion that it was prohibiting their business and lobbied for more freedoms on

multiple occasions. Now that the FDA has such limited control and companies are allowed much

more freedoms however, these supplements have significantly gone down in efficacy, safety, and

honesty. Thoriughout the years we can see this just by looking to the major ammendments and

acts listed above in the Background section as each time a new restriction was put against the

FDA, more health problems, risks, and even deaths occured.

DISCUSSION
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The results outlined above are indicative of the idea that FDA regulations have proven to

be successful in preventing harms and death to users and when taken away, the correlation

between problematic supplements and declining health is indefinitly apparent across many types

of supplements and many years. Since the commerce for supplements first really began in the

‘40s, the FDA has been working to make the market safe so that they could be sold. With every

act and ammendment against them, that safetly was compromised and the risks grew more

prominant yet companies and manufacturers could care less as they were making money

regardless.

The height of the FDA’s control in 1973 was also the height of the markets intolerance

for authority as they wanted to be allow to market whatever they pleased, even if it meant that

the supplement contained an ingrediant that was once proven problematic or banned altogether.

No matter the amount of case studies and experiments run, supplement manufacturers will not

listen to reason nor will they think to compromise when the FDA is concerned as any

interference with business is strongly abhorred.

Supplements like weight loss teas and ​Garcinea combogia a​ re most typical among

consumer use and are also most typical for having problematic side effects yet they still go

unmonitored and checked for any type of discrepencies. Regulations would solve this effectively

and quickly by demanding manufacturers run them by the FDA before even being sold in the

first place. Everything, ultimately, comes back to a lack of control for the FDA and marketers

isolating themselves within their selfgiven allowances.

RECOMMENDATIONS
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With the theortetical framwork established to resolve the issue of unregulated dietary

supplements, and through evidence afforded by scientists, academics, and the government, most

especially the FDA, I recommend the following strategies for implimenting regulation and safety

within the supplement market:

1. To have FDA mandated regulations for all products labeled as “dietary supplements” or

products claiming to work in place of actual diet and exercise.

2. Have the FDA collect and review all supplements currently on the market so as to reject

those that have been allowed sale to users when they are infact harmful.

3. Require that companies be completely transparent with product claims in order to prevent

legal disputes from users becoming ill or even dying over a product. In relation, the FDA

should work to compromise with companies so that they will be more inclined to adhere

to the regulations and safety protocols.

4. Have the FDA work with a team of scientists to conduct their own case studies focusing

on the effects of dietary supplements so as to determine the efficacy of them and become

better educated on how they work so as to assign safety and warning labels accordingly.

CONCLUSION

Despite the decades-long efforts to ensure the safety and regulations of supplements, the

FDA has always been met with opposition and dislike from manufacturers who feel that the FDA

is a source of restriciton and limitation. When the FDA had more control however, conditions

were significantly better as fewer people were falling victim to supplement induced illnesses and

the regulations ensured uniform protocal for all. The lack of consideration that companies have

toward their consumers is precisely why they must be regulated in the first place. They have
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gone for too long with the absence of authority that was meant to tell them that their products

cannot make false claims, nor can they use certain ingrediants that are proven to cause any sort

of negative effect to users.

Scientists, health professionals, and academics have been proving the dangers of these

products for years but their evidence goes ignored in the wake of catchy and attention drawing

advertisements companies know will divert away consumers. We must take action to ensure that

this no longer goes on if we are to better ourselves by not continuing to consume products that

can change our lives for the worst or end it completely. I stongly advise people concerned about

the dangers of supplements to advocate for FDA regualtion and help in holding manufacturers

accountable for their subpar products. By following the directions currently listed on their

website and reading up on which supplements are banned, we can then take the better initiative

to start petitioning for more authority on the FDA’s part, aside from issuing warnings after the

damage has already been done. Also, the FDA must become the front runner in this fight as the

only way this problem will be taken seriously is if they make their case as a governmental office.

The amount of support and advocacy they can gain by making clear the evidence from scholarly

opinions, experiment results, and science journals and articles is more then enough to get a foot

hold in the door.


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Citations

“Adult Obesity Prevalence Maps | Overweight & Obesity | CDC.” ​Centers for Disease Control

and Prevention​, Centers for Disease Control and Prevention,

www.cdc.gov/obesity/data/prevalence-maps.html​.

Barrington, Mitch. “10 Ancient Medicinal Herbal Remedies That Actually Work.” ​FOOD

MATTERS®,​ Food Matters, 11 Mar. 2019,

www.foodmatters.com/article/10-ancient-medicinal-herbal-remedies-that-actually-work​.

Center for Food Safety and Applied Nutrition. “Dietary Supplements - What's New in ​Dietary

Supplements.” ​US Food and Drug Administration Home Page,​ Center for Food Safety

and Applied Nutrition, ​www.fda.gov/Food/DietarySupplements/ucm478187.htm​.

Center for Food Safety and Applied Nutrition. “Information for Consumers on Using Dietary

Supplements.” ​US Food and Drug Administration Home Page,​ Center for Food Safety

and Applied Nutrition,

www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/default.htm​.

“Dietary Supplement Health and Education Act of 1994 Public Law 103-417 103rd Congress.”

NIH Office of Dietary Supplements,​ U.S. Department of Health and Human Services,

ods.od.nih.gov/About/DSHEA_Wording.aspx#sec4.
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“Dietary Supplements: Nutritional and Legal Considerations.” ​Dietary Supplements: Nutritional

and Legal Considerations - IFT.org,​

www.ift.org/knowledge-center/read-ift-publications/science-reports/scientific-status-sum

maries/dietary-supplements.aspx​.

"Dietary Supplements: Safety, Efficacy and Quality." ​ProtoView,​ May 2015. ​Academic

OneFile,​

http://link.galegroup.com/apps/doc/A412486132/AONE?u=albu78484&sid=AONE&xi

d=6cd4838d. Accessed 3 Mar. 2019.

Institute of Medicine (US) and National Research Council (US) Committee on the Framework

for Evaluating the Safety of Dietary Supplements. Dietary Supplements: A Framework

for Evaluating Safety. Washington (DC): National Academies Press (US); 2005.

Kimpel, Paul A. “HISTORY OF DIETARY SUPPLEMENTS.” ​DIETARY SUPPLEMENTS

HISTORY​, 2000, iml.jou.ufl.edu/projects/Spring2000/Kimpel/history.html.

Lobb A. Hepatoxicity associated with weight-loss supplements: A case for better post-marketing

surveillance. ​World J Gastroenterol​ 2009; 15(14): 1786-1787


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Note, Misconceptions and Misleading Information Prevail - Less Regulation Does Not Mean

Less Danger to Consumers: Dangerous Herbal Weight Loss Products, 14 J.L. & Health

107 (1999-2000)

Pierre-Louis, Kendra. “The Three Types of Supplements You Should Never Buy.” ​Popular

Science,​ 1 Aug. 2017, ​www.popsci.com/what-are-vitamins-supplements#page-2

Pray, W. Steven. “The FDA, Vitamins, and the Dietary Supplement Industry.” ​U.S. Pharmacist –

The Leading Journal in Pharmacy,​ Southwestern Oklahoma State University, 17 Oct.

2008,

www.uspharmacist.com/article/the-fda-vitamins-and-the-dietary-supplement-industry.