Running head: CURRENT KNOWLEDGE ON SUPPLEMENT REGULATION

Current Knowledge on Supplement Regulation

Leigh Ehrhardt
University of Mississippi

CURRENT KNOWLEDGE ON SUPPLEMENT REGULATION

Abstract
A trend that has become prevalent within the United States is the use of dietary
supplements. There have been many studies that have tested the knowledge of consumers and
health care professionals on the regulation process of dietary supplements. The studies have
suggested that there is a widespread lack of knowledge, particularity concerning the U.S. Food
and Drug Administrations overall role. The research presented in this paper was completed to
compare with prior research outcomes. Using an online survey to test the knowledge of dietetic
students showed that fewer than 50% of the knowledge base questions on current regulation were
answered correctly. To add on to the study, a larger scale study would include an education
module to examine if test scores would improve. Retention rate would also be measured by
providing a follow-up test. The findings from the study suggested that the regulation process of
supplements is still a confusing topic for consumers in the United States and with the use of an
education course overall knowledge may improve.

CURRENT KNOWLEDGE ON SUPPLEMENT REGULATION

Introduction
Using dietary supplements has become a big trend in the United States. Since
supplements are readily available over the counter at most grocery stores, everyone at any age is
able to buy them. There are hundreds of different supplement products that have a variety of
ingredients depending on their intended use. While the products do not require a medical;
prescription to buy, they are still regulated by the U.S. Food Drug Administration (FDA) under
the Dietary Supplement Health and Education Act (DSHEA). The FDA does not evaluate the
safety and effectiveness of supplements because only the manufacturer is responsible for
assuring that their product meets the standards. The only role FDA has is to make sure the
labeling on the products are correct and to address reported health adverse reactions that are due
to possible supplement products. Research has concluded that consumer knowledge on the
regulation process of supplements is lacking and that consumers are confused on how
supplements are regulated. It is therefore important to research the possible factors that play a
role in the lack of knowledge consumers currently have on supplement regulation in the United
States.
Multiple studies have been conducted that illustrate the lack of understanding consumers
have on current regulation laws. Questionnaires provided by Dodge and Kaufman (2007),
focused on true/false knowledge base questions on FDAs role and on average only 50% of the
questions were answered correctly. Few years later another study by Dodge, Litt, and Kaufman
(2011), verified the prior findings by providing another questionnaire similar to Dodge and
Kaufman (2007) that revealed fewer than 50% of the knowledge base questions were answered
correctly. By examining these two studies does show that the lack of knowledge is not being
addressed and is only continuing among consumers.

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The most important factor that I would like to focus on is not only is it the consumers
responsibility to know the regulation laws thoroughly, but also health care professionals are
equality responsible. Health care workers are more likely to be the ones that clients talk to about
possible supplement use. It is therefore essential for them to be knowledgeable on current
regulations. A study by Asher, Rice and Sisson (2007) suggests that physicians are not
knowledgeable on current regulations based on an average pre-test score of a 59% out of 100 but
after completing an education module the post-score average was a 91%. Also, another study by
Timbo, Ross, McCarthy and Lin (2013) argued that 60% of physicians reported not knowing
how to report adverse health reactions to the FDA. The study also stated that 48% of consumers
who did report having a health adverse reaction went to their physician. These two studies
confirm that health care professionals may need further education on regulation laws to be able
to provide better patient-physician communication in the future regarding dietary supplement
regulation and safety.
For my research project I want to further validate that there is still a lack of knowledge
regarding the current dietary supplement regulations in the United States. The question I want to
address is, are dietetic students at the University of Mississippi knowledgeable of the current
dietary supplement regulations? By completing a small-scale study based on this question is very
important to me because I am a dietetic student. I want to know how well my fellow peers
understand the regulations, because we will one day be nutrition experts in the health field. As
nutrition experts, it is vital for dietitians to be aware of current regulations. The possible
consequence of a current lack of knowledge is that consumers do not know how to properly
assess dietary supplements prior to use, which can lead to the misuse of these products. I have

CURRENT KNOWLEDGE ON SUPPLEMENT REGULATION

confidence that through my research I can eliminate limitations that are currently present
concerning this topic.
Primary Research Project Methods and Findings
For my primary research I strictly focused on using a survey to collect my data as a way
to answer my question on the current knowledge dietetic students have regarding dietary
supplements. While using a survey does have limitations, there are also advantages to using this
method. I primarily used an online survey because it is a fast way to collect data within a couple
of days and does not require in person communication. The survey provided me with a good deal
of information that can be used to answer my research question.
I was not sure at the start on how to create my survey. The two options were either a
paper based survey I would hand out during my dietetic classes or create an online survey to
email dietetic students who are registered within the dietetics and nutrition program at the
University of Mississippi. A fellow dietetic student in one of my classes suggested for me to talk
to Ms. Parkes, who is an instructor within the nutrition and hospitality management at the
university. I talked to her about my research question and she advised me to use
surveymonkey.com to create my survey. With her help, she emailed the entire dietetic department
the link to my survey. Within seconds of her email being posted, I was getting instant results. The
survey I created was based on Dodge and Kaufmans (2007) questionnaire knowledge based
true/false questions that test the knowledge of current dietary regulations. The survey also
included a general information section and post questions .The survey consisted of a total of 14
questions and can be found in Appendix A of this paper. I compiled response results from Nov.
12-16th 2014. I did not resend my survey link in email a second time, which caused response
rates to stop after a few days of the initial posting.

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Survey monkey automatically graphed all of my respondents answers to each question,

which made it very easy to analyze. There were a total of 49 responses but only 40 completed the
knowledge base questionnaire. Out of the 40 responses the average score out of 7 was a 3.75
which is a 53.57%. The average score in this survey does match similarly with the score found in
the Dodge and Kaufman (2007) questionnaire. Only 5 out of the 40 respondents got a perfect
score, which is 12.50% for the sample. The sample was mostly female being 40 out of the 49.
The most popular age range was from 18-24, 87.50%. Eighty-one percent of the sample was
white/Caucasian while the rest were, Black/African American 14.89%, Hispanic 2.13%, and
American Indian 2.13%. Regarding supplement use, 51.02% of the sample stated that they did
take nutritional supplements. After completing the knowledge base portion of the survey,
respondents were asked if they were satisfied with their answers, and 52.50% stated somewhat
while, 26.50% stated yes, and 20% stated no. The last question asked if respondents were
interested in furthering their knowledge on dietary supplements after completing the survey.
Seventy percent said yes and thirty percent said no. Additional comments on why the
respondents want further education include, it is important that the public gets an accurate
representation of what they are consuming, To be knowledgeable on the products being sold to
consumers and how they could affect me personally if I chose to take them, and its good to
know.
The results from the survey were eye-opening to me. By having an average score that
matched with prior studies does show to me that this problem has still not been addressed. I did
suspect at the start that the average score would be low but actually validating it in the end makes
me more dedicated to finding a solution to this current lack of knowledge. The most important
feedback that I did get out of this survey is that the majority of respondents (70%) would like to

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further their knowledge on supplement regulations. Since the respondents did not get to see their
results at the end, does show that they are interested in this topic even though they were unaware
of their overall score. I feel like I have helped spread awareness on this topic to my fellow peers
and I hope that they go in research the current regulations. While the survey did give me great
results there are still limitations to this research. The limitations include possible errors due to
being a custom survey and incomplete responses due to respondents not answering all the
questions.
Proposed Research Methods
For the large-scale study I will create an education module to test and educate dietetics
students on supplement regulation. The research question for this study is similar to my primary
research which is, are dietetic students at multiple universities knowledgeable of the current
dietary supplement regulations and if not, will education courses help resolve the issue? I
strictly want to focus on dietetic students because it is my major and there have not been any
prior studies that have focused on this discipline. By creating an education module that includes
a pre-test and post-test similar to Asher, Rice and Sisson (2007) study that educated physicians,
could lead to dietetic students mastering the regulation laws. One of the limitations in the study
mentioned above is that long-term retention rate was not tested among the physicians who
completed the module. For my research I want to take long-term retention rate into consideration
as a way to see if the education module makes a lasting impression on dietetic students.
The large-scale study will take at minimum of three years to plan and complete. The
universities that I have selected are the University of Mississippi, University of Alabama and
University of Kentucky. I have chosen these universities because they all provide a didactic
program in dietetics (DPD) and a coordinated Program (CP). The two programs allow for

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bachelors/masters degree (DPD) and supervised practical experience (CP) to become a

registered dietitian nutritionist. To reconnect with my small-scale study, I want to continue to use
the University of Mississippi as my central location between the other two universities. Since,
the university is moderately close to the University of Alabama and University of Kentucky it
will make traveling easier and cost lower.
To begin my research I will need to be granted permission to carry out my study by
contacting IRB and receiving approval. Before even creating an education module, I will need to
contact each universitys dietetic department. The contact information is found online. I will call
and make an in-person appointment to deliver my research proposal. Once my research proposal
is accepted at every location, I will need volunteers to help recruit dietetic students at the
universities by the use of email and displaying information at every dietetic building. The
recruitment process may take several months, to allow time to gather as many potential
participants as possible.
For the methods, I will travel to each university during two, three week periods (initial
and follow-up). I will administer the education module during three days for each university. The
module will include a pre-test and post-test. The questions will be similar to the small-scale
knowledge base questions and more in-depth information that is found directly from the U.S.
Food and Drug Administration government website. The module will be online based, which will
allow the results to be gathered and calculated automatically. Before the participants can
complete the study they will need to give written consent and agree to an initial meeting that
requires a follow up meeting a year later. The follow up test is necessary to measure the longterm retention rate of the participants. While the initial meeting will include the education
module course, the follow-up will only consist of completing a knowledge base test.

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Funding will be necessary to be able to use an online training/education program such as

Mindflash that costs $500/month to use. The program includes unlimited courses, quiz questions
and powerful reporting. Providing advertisement (posters, hand-outs) for my study is important
and may cost up to $500 dollars. I have estimated traveling to cost around $420 by car. Lodging
will cost around 3,000-4,000 and food cost around 2,000 between the two universities (my home
is in Oxford, MS). If I require an assistant, it will be an additional $800.
After the initial and follow-up meeting, it will take me a minimum of several weeks to
examine the results. By observing the results, I hope to have positive outcomes such as having
high scores on the follow-up that will suggest that participants have succeeded in knowing the
regulation process of dietary supplements. In particular, a high outcome will indicate that
providing education courses to health care professionals can help improve communication
regarding the safety of dietary supplements between health care workers and patients.
Conclusion
By testing the knowledge of dietetic students on the current dietary regulations in the
United States indicated that there is still a lack of knowledge. It is important to address this issue
because supplements can be misused and cause adverse health events. That being said, it is
critical for health care workers to be knowledgeable on the regulation and safety of supplement
products. A large-scale study that provides an education module for dietetic students to complete
could result in positive outcomes. A positive result would be if dietetic students were to retain
the information and to be able to properly educate their future clients to self-assess dietary
supplements prior to use. It is therefore important for the proposed large-scale study to begin as a
way to stop the wide-spread confusion on the regulation process of supplements

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References
Ashar, B., Rice, T., & Sisson, S. (2007). Physicians' understanding of the regulation of dietary
supplements. Archives of internal medicine, 167(9), 966-969.
Dodge, T., Litt, D., & Kaufman, A. (2011). Influence of the dietary supplement health and
education act on consumer beliefs about the safety and effectiveness of dietary
supplements. Journal of Health Communication, 16(3), 230-244
Dodge, T., & Kaufman, A. (2007). What makes consumers think dietary supplements are safe
and effective? The role of disclaimers and FDA approval. Health Psychology, 26(4), 513Timbo, B. B., Ross, M. P., McCarthy, P. V., & Lin, C. J. (2006). Dietary supplements in a
national survey: Prevalence of use and reports of adverse events. Journal of the American
Dietetic Association, 106(12), 1966-1974

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Appendix A
Knowledge Base Test Questions:
1. The Food and Drug Administration (FDA) must approve a dietary supplement
before it can be sold in nutrition stores. False
2. It is the FDA's responsibility to ensure that dietary supplements are safe before
they can be sold to consumers. False
3. Manufacturers must provide scientific evidence of product safety to the FDA
before it can be sold to consumers. False
4. There are no laws indicating that the FDA is to approve dietary supplements.
True
5. The FDA does not approve or disapprove dietary supplements. True
6. Manufacturers of dietary supplements are required by law to record, investigate,
or forward to the FDA any reports they receive of injuries or illnesses that may be
related to the use of their products. False
7. The FDA has to prove a dietary supplement is unsafe before it can be removed
from the marketplace. True