DIETARY SUPPLEMENT

A Business Research Paper

Presented to

The Faculty of Adventist Medical Center College

San Miguel, Iligan City

In Partial Fulfilment

of the Requirements for the Subject

The Entrepreneurial Mind

By:

Malacaste, Alaine Vence R.

 Chapter 1

Introduction

Statement of the Problem

The fundamental challenge in any discussion about the regulation of dietary supplements is that

there is no global consensus on how the category of products known variously as dietary

supplements, natural health products (NHPs), complementary medicines or food supplements in

different countries is defined. For example, a product considered to be a dietary supplement and

regulated as a food in the USA, in another jurisdiction may be considered a food supplement or a

therapeutic good (complementary medicine) or a therapeutic good (prescription medicine) or

potentially even a controlled substance. The situation is even more complicated when countries

like China or India that have an existing regulatory framework for traditional medicine or

phytomedicine that includes crude botanicals are considered. To add further to the confusion,

many regulatory frameworks are changing.

 A final challenge is that “dietary supplement” health products are often very emotive and

polarizing topics, evoking a diverse range of opinions and viewpoints. While some observers

may contend that these products should be considered in a similar fashion to conventional drugs

and foods, others believe that a more tailored approach is necessary since there is often a

traditional or historical evidence base and products often contain multiple ingredients.

Increasingly, this situation has become even more complex because of the lucrative nature of the

global dietary supplement sector, increased involvement of a growing industry sector producing

them, and the introduction of many new and innovative products onto the market.

It was the Nobel-laureate Linus Pauling that made a public claim in the 70's that megadoses of at

least 10 times the recommended dietary allowance (RDA) of ascorbic acid could prevent/cure

the common cold, flu and cancer. This claim, according to Camire and Kantor, may have

stimulated the public interest in the use of vitamin supplements to enhance health.

In their historical overview of the use of dietary supplements, Camire and Kantor also noted that

the most common dietary supplements were multivitamin/mineral formulations containing

varying percentages of the RDAs for those nutrients until the mid-1990s.

The National Institute of Health's Offices of Dietary Supplements has defined dietary

supplements as products intended to supplement the diet and which contain one or more dietary

ingredients (including vitamins, minerals, herbs or other botanicals, amino acids and other

substances) or their constituents.

 Dietary supplements were defined in a law passed by Congress in 1994 called the Dietary

Supplement Health and Education Act (DSHEA). DSHEA defines supplements and outlines

quality, safety and efficacy regulations that are different from those for drugs. The U.S. Food and

Drug Administration do not review dietary supplements for safety or effectiveness before they

are sold. According to DSHEA, a dietary supplement is a product that is intended to supplement

the diet and it is labeled as being a dietary supplement.

Rationale of the Study

Nutritional supplements are preparations intended to supplement the diet and provide nutrients.

They include vitamins, minerals, fiber, fatty acids, or amino acids, that may be missing or may

not be consumed in sufficient quantities in a person's diet. Many health professionals including

dietitians, physicians and pharmacists are supplement users.

For over a century, standard reference databases for the composition of foods have been publicly

available in the United States to provide estimates of the content of nutrients and some other

bioactive ingredients in American diets (5, 6). However, although there may be as many as

85,000 DSs sold in the United States, until recently no such database existed for these

supplements. Little was known about their composition, other than the often-unverified content

claims made on product labels by manufacturers and distributors. Neither was this information

compiled in a form that was readily available and free of charge to consumers.
 The rationale for developing DS databases is to foster research on the associations of these

products with health outcomes, to provide tools for ascertaining the contribution of supplements

to total dietary intake of nutrients and other bioactive components, and to provide information

about their contents to researchers, consumers, industry, and other stakeholders.

Supplement users are exposed to many compounds that may affect their nutritional and health

status, including considerable amounts of nutrients, bioactive substances in botanicals, and other

nonvitamin, nonmineral ingredients. Congress recognized the need for better information on DSs

in DSHEA, and it included language in its 2003 appropriations directing the NIH Office of

Dietary Supplements (ODS) to develop a DS database.

However, the prevalence of supplement use has increased dramatically over the past 20 years [2],

and they have become a matter of consumer interest [3,4]. At the same time, the application of

state-of-the art scientific methods to explore issues involving dietary supplements has advanced

rapidly. The other invited articles in this special issue illustrate progress in our understanding of

supplement science as it applies to several nutrients, including vitamin D, iron, omega-3 fatty

acids, and iodine. Progress on botanicals and other non-nutrient ingredients (e.g., glucosamine,

methylsulfonylmethane (MSM), coenzyme Q10) has been more challenging [5]. There is no

global consensus in terminology for the category of products known variously as dietary

supplements, NHPs, and food supplements in different countries and while we recognize this
limitation, for the purpose of this article the term dietary supplement will be used to refer to such

products as nutritional supplements, herbal medicines and traditional medicines. This article

summarizes some of the scientific challenges in supplement research and some resources that

may be useful in studying them. 

 Theoretical Framework

Under the provisions of the Dietary Supplement Health and Education Act (DSHEA), dietary

supplements are to be considered as foods and assumed safe unless the Food and Drug

Administration (FDA) has evidence that the supplement or one of its ingredients presents “a

significant or unreasonable risk of illness or injury” when used as directed on the label or under

normal conditions of use. Since the FDA is not authorized to require or impose premarket safety

evaluations for dietary supplement ingredients marketed for use in the United States before

October 15, 1994, FDA itself must monitor safety data and gather and assess existing

information on safety to determine if a significant or unreasonable risk is present.

Thus the purpose of the Framework1 described in this chapter is to provide a process for FDA to

translate the results of their scientific review into a decision regarding regulatory action needed

to protect the health of the public.

S2 explores the influence of NPNG lay theory (which is an inference strategy employed by

consumers to judge products that possess negative or detrimental attributes) and the impact of

supplement form on perceptions of supplement side effect severity. Past research supports that

NPNG naïve beliefs cause consumers to accept some risks and side effects in hopes of enhanced

efficacy (e.g., Kramer et al., 2012). An NPNG attitude that muscle pain and physical discomfort

are necessary to attain bodybuilding physique or athletic performance goals is popular among

avid weight trainers and exercise buffs and has made its way into other domains (e.g., the finance
sector; Pain, 2009). Product disclaimers and other warning type interventions typically seek to

enhance the salience of risk, safety, and potential side effects. The Dietary Supplement Health

and Education Act (1994) requires that supplements making health or well‐being claims include

a disclaimer that the FDA has not evaluated the claim and the product is not intended to treat or

cure any disease. The placement of such disclaimers is not regulated, and, thus, they typically

appear in very small (almost unreadable) print on the back of affected supplement labels. S2 tests

the effectiveness of including a disclaimer about the lack of FDA oversight of supplements

vividly in a product promotion. An intervention that draws attention to the lack of government

regulation and testing of supplements should generate more thoughts about risks and potential

side effects, thereby motivating consumers to behave more cautiously when making supplement

decisions. At the same time and as noted above, NPNG naïve beliefs enhance acceptance of

product risks (e.g., Kramer et al., 2012). For example, one past study shows that government‐

mandated disclaimers did not impact beliefs about dietary supplement efficacy or safety (Mason

& Scammon, 2011). Thus, although a disclaimer may increase perceptions of side effect severity

without an NPNG prime, consumers with an NPNG mindset may not be impacted by such a

disclaimer.