Department of Health and Human Services 
OFFICE OF 
INSPECTOR GENERAL 
DIETARY SUPPLEMENT LABELS: 
KEY ELEMENTS 
JANET REHNQUIST 
INSPECTOR GENERAL 
MARCH 2003 
OEI-01-01-00120  O I G
FFICE OF  NSPECTOR  ENERAL

http://www.oig.hhs.gov/ 
The mission of the Office of Inspector General (OIG), as mandated by Public Law 95-452, as amended, 
is to protect the integrity of the Department of Health and Human Services (HHS) programs, as well as 
the health and welfare of beneficiaries served by those programs.  This statutory mission is carried out 
through a nationwide network of audits, investigations, and inspections conducted by the following 
operating components: 
Office of Audit Services 
The OIG's Office of Audit Services (OAS) provides all auditing services for HHS, either by conducting 
audits with its own audit resources or by overseeing audit work done by others.  Audits examine the 
performance of HHS programs and/or its grantees and contractors in carrying out their respective 
responsibilities and are intended to provide independent assessments of HHS programs and operations in 
order to reduce waste, abuse, and mismanagement and to promote economy and efficiency throughout the 
Department. 
Office of Evaluation and Inspections 
The OIG's Office of Evaluation and Inspections (OEI) conducts short-term management and program 
evaluations (called inspections) that focus on issues of concern to the Department, the Congress, and the 
public.  The findings and recommendations contained in the inspections reports generate rapid, accurate, 
and up-to-date information on the efficiency, vulnerability, and effectiveness of departmental programs. 
Office of Investigations 
The OIG's Office of Investigations (OI) conducts criminal, civil, and administrative investigations of 
allegations of wrongdoing in HHS programs or to HHS beneficiaries and of unjust enrichment by 
providers.  The investigative efforts of OI lead to criminal convictions, administrative sanctions, or civil 
monetary penalties.  The OI also oversees State Medicaid fraud control units which investigate and 
prosecute fraud and patient abuse in the Medicaid program. 
Office of Counsel to the Inspector General 
The Office of Counsel to the Inspector General (OCIG) provides general legal services to OIG, rendering 
advice and opinions on HHS programs and operations and providing all legal support in OIGs internal 
operations.  The OCIG imposes program exclusions and civil monetary penalties on health care providers 
and litigates those actions within the Department.  The OCIG also represents OIG in the global settlement 
of cases arising under the Civil False Claims Act, develops and monitors corporate integrity agreements, 
develops model compliance plans, renders advisory opinions on OIG sanctions to the health care 
community, and issues fraud alerts and other industry guidance.  E X E C U T I V E   S U M M A R Y  
OBJECTIVE 
To identify key elements that can increase the potential for dietary supplement labels to help 
consumers make informed and appropriate choices about supplement use. 
BACKGROUND 
In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA). 
DSHEA defined the term dietary supplement to include substances, such as vitamins, 
minerals, botanicals, and amino acids.  The Food and Drug Administration (FDA) has primary 
oversight responsibilities for dietary supplements and their labels. 
Widespread Use of Dietary Supplements.  An estimated 70 percent of the U.S. population, 
or 152 million people, tried at least one dietary supplement in 2001. Dietary supplements are 
nearly a $17 billion industry. 
Benefits and Risks of Dietary Supplements.  Dietary supplements have potential health 
benefits, but may also pose safety risks. For example, calcium and vitamin D supplementation 
can help to reduce bone loss in the elderly. Yet, FDA has also received reports of adverse 
events associating ephedra with heart attacks, strokes, seizures, and high blood pressure. 
Importance of Dietary Supplement Labels. In DSHEA, Congress recognized the 
importance of labels, calling for them to include information, such that consumers may make 
informed and appropriate health care choices for themselves and their families. Labels can be 
particularly significant, given that dietary supplements are often used as self-care products, and 
labels are an easily accessible source of information.  Furthermore, label oversight is a key 
regulatory tool for FDA to promote the safe use of dietary supplements among consumers. 
Concerns about Dietary Supplement Labels. Our 2001 report entitled Adverse Event 
Reporting for Dietary Supplements: An Inadequate Safety Valve (OEI-01-00-00180) 
highlighted the need for consumers to have more complete information about dietary 
supplements than is currently required.  In 2000, the General Accounting Office cited problems 
with label content for dietary supplements. 
Consumer Health Information for Better Nutrition Initiative. In December 2002, FDA 
announced the Consumer Health Information for Better Nutrition Initiative, which seeks to 
enhance the credibility of food and dietary supplement labels through the inclusion of more 
accurate, science-based information. This multi-part initiative includes the publication of 
guidance on qualified health claims for conventional foods and dietary 
i  supplements, strong enforcement of dietary supplement rules, and the establishment of an FDA 
task force on consumer health information for better nutrition. 
This Report. Given the limited requirements governing dietary supplement labels, FDA 
officials have expressed an interest in our presenting a vision for the kind of label that could 
better assist consumers in making informed and appropriate choices about supplement use. 
Thus, we consulted a wide variety of stakeholders, reviewed the pertinent literature, and then 
developed a template of key label elements. 
The template uses the existing requirements for dietary supplement labels as a starting 
framework (see the primer on page 4). We then incorporated the feedback we heard from 76 
interviews with key stakeholders, such as regulators, industry representatives, and consumer 
groups, and from 7 focus groups with consumers and health professionals.  We also took into 
account data from industry groups and independent research organizations, and conducted a 
comprehensive literature review on dietary supplement use and labels, including congressional 
testimony and national survey data. 
The template also serves as the framework for a companion report, Dietary Supplement 
Labels: An Assessment (OEI-01-01-00121). 
KEY ELEMENTS OF A DIETARY SUPPLEMENT LABEL 
Below, we present our template of key elements of a dietary supplement label that can help 
consumers make informed and appropriate choices about supplement use. 
Label Content: 
U  Ingredients.  It would fully and clearly disclose the ingredients contained in a supplement. 
The ingredient declaration would accurately reflect the amount of each dietary ingredient 
included in the supplement. 
U  Intended Use. It would provide consumers with sufficient information about the range of 
uses for a supplement.  All intended use claims would be based on accepted scientific evidence. 
U  Safety Information.  It would provide consumers with known safety information. This 
would include interactions, contraindications, and possible side effects and adverse reactions. 
U  Directions for Use. It would provide consumers with adequate directions for use. The 
directions would include guidance on proper doses, if the information is available. 
U  Product Information.  It would identify the manufacturer, production source and batch, 
and information about the net quantity of contents found in the supplement. 
Dietary Supplement Labels: Key Elements  ii  OEI-01-01-00120  Label Presentation: 
U  Standardized Format. It would present similar types of information in a similar order 
across supplements.  It would use widely accepted terminology and headings. 
U  Distinct Product Features. It would have a unique design, format, or specific language 
that assists consumers in distinguishing supplements from other self-care products. 
U Readability. It would contain language and visual cues that are easily understood by a 
broad group of consumers. 
U  Balance. It would present information in a balanced manner. It would give fair treatment 
to benefits and risks, to claims and disclaimers, and to factual and marketing information. 
U  Constructive Use of Space. It would seek to expand the limited label space through 
creative packaging and by pointing consumers to alternative sources of information. 
CONCLUSION 
This template sets forth a vision of key elements that can increase the potential of dietary 
supplement labels to help consumers make informed and appropriate choices about supplement 
use.  It is a vision that appears to have considerable support among the wide range of 
stakeholders whom we interviewed. We recognize that this template is general and that it 
leaves out many important details concerning specific expectations or requirements for 
supplement labels. It does, however, put forth a framework that government officials, 
consumer groups, industry representatives, academics, and others can use as they seek to find 
common ground on the specific content and presentation of labels. 
For an assessment of the extent to which existing dietary supplement labels reflect the elements 
identified in this template, see our companion report, Dietary Supplement Labels: An 
Assessment (OEI-01-01-00121). 
Dietary Supplement Labels: Key Elements  iii  OEI-01-01-00120  T A B L E   O F   C O N T E N T S  
PAGE

EXECUTIVE SUMMARY ...................................................... i

INTRODUCTION ............................................................ 1

PRIMER ON DIETARY SUPPLEMENT LABELS  ............................... 4

KEY ELEMENTS OF A DIETARY SUPPLEMENT LABEL  ........................ 5

Template ...............................................................7

Label content ...........................................................  7

Label presentation .......................................................12

CONCLUSION  ............................................................. 17

APPENDICES

A: Advertisements for dietary supplements  .....................................18

B: Methodology .........................................................19

C: Endnotes ............................................................21

ACKNOWLEDGMENTS ..................................................... 24

Dietary Supplement Labels: Key Elements  OEI-01-01-00120  I N T R O D U C T I O N  
OBJECTIVE 
To identify key elements that can increase the potential for dietary supplement labels to help 
consumers make informed and appropriate choices about supplement use. 
BACKGROUND 
In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA). 
DSHEA defined the term dietary supplement to include substances, such as vitamins, 
minerals, botanicals, and amino acids. It also created a new regulatory framework for dietary 
supplements and expanded the information that could be placed on labels. The Food and Drug 
Administration (FDA) has primary oversight responsibilities for dietary supplements and their 
labels. 
Widespread Use of Dietary Supplements 
An estimated 70 percent of the U.S. population, or 152 million people, tried at least one dietary 
supplement in 2001.1 Many consumers use supplements to enhance their nutritional intake or to 
maintain their health and well-being, while others hope to improve their energy levels and to 
prevent or treat common illnesses.  The dietary supplement industry has responded to consumer 
demand by marketing an increasing number and variety of supplements. FDA estimates that 
about 29,000 dietary supplements are on the market.2 Dietary supplements are nearly a $17 
billion industry.3 
Benefits and Risks of Dietary Supplements 
The growth of the dietary supplement market presents greater potential for consumers to 
experience the benefits of supplement use, and at the same time increases the chance that 
consumers will encounter safety risks. For example, the long-term consumption of vitamin C 
supplements may reduce the development of age-related lens opacities, and dietary calcium and 
vitamin D supplementation may help to reduce bone loss in the elderly.  Yet, FDA has also 
received reports of adverse events associating ephedra with heart attacks, strokes, seizures, 
and high blood pressure, and kava kava with liver damage. 
Importance of Dietary Supplement Labels 
In DSHEA, Congress recognized the importance of labels, calling for them to include 
information, such that consumers may make informed and appropriate health care choices for 
themselves and their families. Within FDA, the Center for Food Safety and Applied Nutrition 
(CFSAN) has the authority to regulate supplements by issuing labeling 
Dietary Supplement Labels: Key Elements  1  OEI-01-01-00120   rules and good manufacturing practice (GMP) regulations to the dietary supplement

industry and by monitoring adverse events related to supplement use. However, supplement-

specific GMP regulations have not been issued, and the adverse event reporting system is still

being enhanced. Therefore, label oversight can serve as a key regulatory tool for promoting the

informed and appropriate use of dietary supplements among consumers. 

It is especially important for labels to provide objective and accurate information on supplement

usage to balance the claims about supplements that consumers learn about through

advertisements.  In our brief review of advertisements, which are regulated by the Federal

Trade Commission (FTC), we found dietary supplements claiming to bring relief from crippling

pain within days and herbal weight loss formulas claiming to help individuals lose 70 pounds in 8

weeks with no calorie counting and no hunger (see Appendix A for a fuller description of the

advertisements). 

Concerns about Dietary Supplement Labels 
Our 2001 study entitled Adverse Event Reporting for Dietary Supplements: An Inadequate 
Safety Valve (OEI-01-00-00180) highlighted the need for consumers to have more complete 
information about dietary supplements than is currently required.  In 2000, the General 
Accounting Office (GAO) cited similar problems with dietary supplement labels.4 Concerns 
have also been raised by consumer and industry groups, federal and state regulators, and the 
media. 
Consumer Health Information for Better Nutrition Initiative 
In December 2002, FDA announced the Consumer Health Information for Better Nutrition 
Initiative, which seeks to enhance the credibility of food and dietary supplement labels through 
the inclusion of more accurate, science-based information. This multi-part initiative includes the 
publication of guidance on qualified health claims for conventional foods and dietary 
supplements, strong enforcement of dietary supplement rules, and the establishment of an FDA 
task force on consumer health information for better nutrition. In a report on dietary supplement 
enforcement, which accompanied the announcement of the initiative, FDA stated its intention to 
develop mechanisms to communicate critical information and useful strategies about dietary 
supplements to consumers.5 
Methodology 
Given the limited requirements governing dietary supplement labels, FDA officials have 
expressed an interest in our presenting a vision for the kind of label that could better assist 
consumers in making informed and appropriate choices about supplement use. Thus, we 
consulted a wide variety of stakeholders, reviewed the pertinent literature, and then developed 
a template of key label elements.  The template we developed can provide FDA with a starting 
point for a mechanism to communicate critical information and useful strategies about dietary 
supplements to consumers. 
Dietary Supplement Labels: Key Elements  2  OEI-01-01-00120  The template uses the existing requirements for dietary supplement labels as a starting 
framework (see the primer on page 4). We then incorporated the feedback we heard from 76 
interviews with key stakeholders, such as regulators, industry representatives, and consumer 
groups, and from 7 focus groups with consumers and health professionals.  We also took into 
account data from industry groups and independent research organizations, and conducted a 
comprehensive literature review on dietary supplement use and labels, including congressional 
testimony and national survey data. 
Throughout the course of our inquiry, we refined and adjusted the template to incorporate the 
diversity of perspectives that we encountered.  The template represents broad consensus 
among those we interviewed as to key label elements. 
This Report and its Companion Report 
This report identifies key elements that can increase the potential for dietary supplement labels 
to help consumers make informed and appropriate choices about supplement use, and 
organizes those elements into a template.  The template draws on existing requirements for 
dietary supplement labels, feedback from interviews and focus groups, industry data, and the 
professional literature. 
In our companion report, Dietary Supplement Labels: An Assessment (OEI-01-01-00121), 
we assess the extent to which current dietary supplement labels meet the potential expressed in 
the template outlined in this report. We also examine barriers that may prevent supplement 
manufacturers from developing labels that incorporate the elements of our template, and note 
potential consequences to consumers and health professionals of maintaining the current label 
requirements for dietary supplements. 
We conducted this inspection in accordance with the Quality Standards for Inspections 
issued by the Presidents Council on Integrity and Efficiency. 
Dietary Supplement Labels: Key Elements  3  OEI-01-01-00120  PRIMER ON DIETARY SUPPLEMENT LABELS 
What is a Dietary Supplement? 
The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines the term dietary supplement to mean 
a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following 
dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man 
to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or 
combination of any of the aforementioned ingredients. Furthermore, a dietary supplement must be labeled as a 
dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a 
sole item of a meal or of the diet. In addition, a dietary supplement cannot be approved or authorized for 
investigation as a new drug, antibiotic, or biologic, unless it was marketed as a food or a dietary supplement before 
such approval or authorization. Under DSHEA, dietary supplements are deemed to be food, except for purposes of 
the drug definition. 
What is a Dietary Supplement Label? 
Alabel is a display of written, printed, or graphic matter upon the immediate container of any article. In contrast, 
labeling is a more general term that includes the label and other written, printed, or graphic matter upon any article 
or any of its containers or wrappers, or accompanying the article. 
What is Required on a Dietary Supplement Label? 
DSHEA and other federal regulations require the following information to appear on dietary supplement labels: 
C	 a statement of identity that contains the words  C	 a complete list of ingredients by their common or 
dietary supplement. The word dietary may be  usual names, either in descending order of 
replaced by the name of the dietary ingredient (e.g.,  prominence or with the source of the dietary 
ginseng supplement);  ingredient in the Supplement Facts panel 
following the name of the dietary ingredient (e.g., 
C  net quantity of contents (e.g., 60 capsules);  calcium (from calcium carbonate)); 
C	 nutrition information in the form of a Supplement  C	 safety information that is considered material to 
Facts panel, including the product serving size, the  the consequences that may result from the use of 
amount, and percent daily value, if established, of  the supplement; 
each dietary ingredient; 
C	 the disclaimer This statement has not been 
C	 if a supplement contains a proprietary blend, the net  evaluated by the Food and Drug Administration. 
weight of the blend as well as a listing of each  This product is not intended to diagnose, treat, 
ingredient in descending order of weight must be  cure, or prevent any disease if the supplement 
identified;  bears a claim to affect the structure or function of 
the body (structure/function claim), a claim of 
C  the part of the plant used, if an herb or botanical;  general well-being, or a claim of a benefit related to a 
classical nutrient deficiency disease. 
C	 the name and place of business of the manufacturer, 
packer, or distributor; 
At their discretion, manufacturers may add additional information on labels (such as claims and statements of quality 
assurance), and may decide on the placement of that information on their labels. 
Who Oversees Dietary Supplement Labels? 
The Food and Drug Administration (FDA) is the federal agency primarily responsible for regulating dietary 
supplements and their labels. FDA regulates supplements in a post-market system, meaning manufacturers are 
allowed to market supplements without prior authorization. FDA has the burden of proof to show that a supplement 
presents a significant or unreasonable risk of illness or injury if taken as instructed on the label, or is otherwise 
adulterated. FDA also has the burden of proof to show that label information is misleading or not true. To establish 
proof, FDA conducts field exams, tests supplement ingredients, and reviews label claims. As necessary, FDA may 
take actions through courtesy letters, warning letters, recalls, seizures, and injunctions. 
Dietary Supplement Labels: Key Elements  4  OEI-01-01-00120  K E Y  E L E M E N T S  O F  A 
D I E T A R Y  S U P P L E M E N T  L A B E L  
We defined the key elements of a dietary supplement label to be those that can help consumers 
make informed and appropriate choices about supplement use.  This definition comes from 
DSHEA, in which Congress called for labels to contain information, such that consumers may 
make informed and appropriate health care choices for themselves and their families.  More 
recently, in announcing the FDAs Consumer Health Information for Better Nutrition Initiative, 
the FDA Commissioner and the Secretary of Health and Human Services have reinforced the 
important role that labels can play in helping consumers make informed choices about the 
products they buy. 
The label on a dietary supplement can fulfill this role by facilitating consumers choice of a 
supplement, guiding their use of it, and communicating any safety information associated with it. 
Consumers who have decided to purchase 
a supplement are often faced with a wide 
array of choices.  The label can play a role  Roles of the supplement label: 
in helping consumers to select an 
appropriate supplement by providing  U Facilitates product choice 
information about the purposes of the  U Guides use 
supplement, the conditions for which the  U Communicates safety information 
supplement should be taken, and factual 
information about the contents and 
manufacture of the supplement. 
Furthermore, by providing information on possible side effects and potential interactions, the 
label can play an important role in helping consumers to appreciate any risks associated with 
using the supplement. After a consumer selects an appropriate supplement, correct 
administration and dosing are essential. By providing such information, the label can guide 
consumers in the appropriate use of a supplement. Should a consumer experience adverse 
symptoms, the label can play an important advisory role by informing consumers when to stop 
taking a supplement and whom to contact. 
The notion that a label can help consumers make informed and appropriate choices takes on 
heightened significance, given that dietary supplements are self-care products. According to a 
recent national study, consumers would often rather treat their own health conditions than go to 
a doctor.6 While dietary supplements are not approved as a way to treat health conditions, 
close to one-quarter of the population (26 percent) say they have used dietary supplements for 
a health problem.7 According to another national study, 22 percent of adults report using 
vitamins and minerals to treat and prevent serious illnesses, and 14 percent report using herbal 
remedies for this reason.8 Some consumers even use supplements to treat life-threatening 
conditions, such as cancer.9 
Dietary Supplement Labels: Key Elements  5  OEI-01-01-00120  Given the limited requirements governing dietary supplement labels, FDA officials have 
expressed an interest in our presenting a vision for the kind of label that could better assist 
consumers in making informed and appropriate choices about supplement use. Thus, we 
consulted a wide variety of stakeholders, reviewed the pertinent literature, and then developed 
a template of key label elements. 
The template uses the existing requirements for dietary supplement labels as a starting 
framework (see the primer on page 4). We then incorporated the feedback we heard from 76 
interviews with key stakeholders, such as regulators, industry representatives, and consumer 
groups, and from 7 focus groups with consumers and health professionals.  We also took into 
account data from industry groups and independent research organizations, and conducted a 
comprehensive literature review on dietary supplement use and labels, including congressional 
testimony and national survey data. 
The template sets forth key elements of a dietary supplement label in terms of essential 
information and precepts for presenting that information (see page 7).  The template is meant to 
be a general framework that can apply to all types of supplements.  The template may serve as 
a mechanism to enhance the potential of the supplement label to communicate information and 
strategies about dietary supplements to consumers. 
Dietary Supplement Labels: Key Elements  6  OEI-01-01-00120  TEMPLATE OF THE KEY ELEMENTS FOR A DIETARY SUPPLEMENT LABEL 
Label Content: 
U Ingredients. It would fully and clearly disclose the ingredients contained in a supplement. The ingredient 
declaration would accurately reflect the amount of each dietary ingredient included in the supplement. 
U Intended Use. It would provide consumers with sufficient information about the range of uses for a 
supplement. All intended use claims would be based on accepted scientific evidence. 
U Safety Information. It would provide consumers with known safety information. This would include 
interactions, contraindications, and possible side effects and adverse reactions. 
U Directions for Use. It would provide consumers with adequate directions for use. The directions would 
include guidance on proper doses, if the information is available. 
U Product Information. It would identify the manufacturer, production source and batch, and information about 
the net quantity of contents found in the supplement. 
Label Presentation: 
U Standardized Format. It would present similar types of information in a similar order across supplements. It 
would use widely accepted terminology and headings. 
U Distinct Product Features. It would have a unique design, format, or specific language that assists 
consumers in distinguishing supplements from other self-care products. 
U Readability. It would contain language and visual cues that are easily understood by a broad group of 
consumers. 
U Balance. It would present information in a balanced manner. It would give fair treatment to benefits and risks, 
to claims and disclaimers, and to factual and marketing information. 
U Constructive Use of Space. It would seek to expand the limited label space through creative packaging and 
pointing consumers to alternative sources of information. 
Scope of the Template 
The template can serve as a general label framework that has applications to all types of dietary 
supplements, including vitamins and minerals, herbals and botanicals, and specialty 
supplements.  Where we determined that label information was relevant to only one type of 
dietary supplement, we note it in the text. 
LABEL CONTENT 
The first five elements of the template delineate the major categories of information that our 
analysis found to be key in a dietary supplement label.  A label may not be able to help 
consumers make informed and appropriate choices about supplement use, if it does not 
adequately address ingredients, intended use, safety information, directions for use, 
Dietary Supplement Labels: Key Elements  7  OEI-01-01-00120  and product information.  While the vast majority of stakeholders we spoke with agreed 
that these five categories of information are critical, there were differences of opinion in how 
best to incorporate each element into the label. The label is of limited size, and while all of 
these elements ought to be included on the label, we recognize that there may be trade-offs in 
terms of the extent of information that can presented about any single element. 
Ingredient Information 
The label would fully disclose the ingredients contained in a supplement.  The 
ingredient declaration would accurately reflect the amount of each ingredient 
included in the supplement. 
A dietary supplement label that meets our template would not only disclose the net quantity of 
ingredients, but would also provide information about the quantity and percent of each active 
ingredient.  This would be especially relevant to supplements containing multiple ingredients and 
to supplements that are available in different forms and from different sources. The active 
ingredients would have unique names so that consumers would be able to readily recognize 
them. Furthermore, the active ingredients would be easily distinguishable from the inactive 
ones.  If a supplements bioavailability (extent of absorption into the bloodstream) were known, 
this would be noted on the label. 
An accurate declaration of ingredients is key to maintaining consumer confidence in dietary 
supplements. Consumers would be made aware of any efforts toward standardizing, certifying, 
or producing a dietary supplement according to good manufacturing practices.  Because of the 
wide variety of standardization programs currently in use, information would be available to 
consumers about the methods used to standardize or certify a supplement.  This information 
need not be on the label itself, but would be available either in a package insert or through a 
toll-free number or website. 
Some stakeholders we interviewed, particularly herbalists and health care providers, stated that 
the labels of herbal supplements ought to contain additional information pertaining to ingredient 
origins and product preparation, because the growing conditions and production processes 
have a direct effect on the level of active ingredient(s) in a dietary supplement.  Herbs harvested 
in different parts of the world can contain disparate levels of active ingredients. In addition to 
stating the plant part and species of herb, they would like to see supplements state the country 
in which the ingredient was harvested.  Several interviewees told us that they would like 
tinctures to contain information about the extraction process, because the type of solvent used 
to extract an herb can have a substantial impact on the supplements potency. Others have 
cautioned, however, that while such information is important, it may be of limited use to the vast 
majority of consumers. 
Dietary Supplement Labels: Key Elements  8  OEI-01-01-00120  Intended Use 
The label would provide consumers with sufficient information about the range of 
uses for a supplement. All intended use claims would be based on accepted 
scientific evidence. 
To meet our template, statements about intended use would address the primary functions and 
purposes of the supplement, a description of how the supplement would result in a health 
benefit, and the conditions and symptoms for which the supplement is intended.  FDA currently 
requires benefit statements to be expressed as claims (such as structure/function claims or 
health claims), but that need not be the only format for expressing intended use. Whatever 
mechanism is used to convey intended use, the statements would be specific enough to be 
useful to consumers. 
Intended use statements could go further by helping consumers to understand the roles of key 
active ingredients.  Information on the supplements purposes could be presented in such a way 
that consumers could associate active ingredients with the primary purposes of the supplement. 
Other self-care products, such as over-the-counter drugs, are required by regulation to present 
active ingredients immediately adjacent and to the left of the purpose statement. 
Ideally, statements of intended use would be based upon accepted scientific evidence. 
Acceptable scientific evidence would be clearly defined, and this definition would be widely 
accepted and adhered to by manufacturers. The definition would delineate the extent and the 
conditions under which intended use claims could be extrapolated from existing research. 
Furthermore, equivalency would be required between the dose supporting an intended use 
claim and the dose administered during the clinical trial. The public would have access to the 
citations for any secondary research upon which the claims are based.  Such information could 
be made available though a package insert, website, or toll-free number. 
If labels could express intended use in more than one way, some delineation would exist, such 
that consumers would be able to understand the extent and nature of the federal oversight for 
each.  Furthermore, consumers would be able to distinguish among the various types of claims 
used on supplements. Should disclaimers be associated with statements of intended use, these 
disclaimers would be easily recognized and understood by consumers. 
Our stakeholders debated the appropriate place for intended use statements. Some industry 
representatives told us that the basic function of a dietary supplement and types of 
circumstances in which supplements should be consumed could not be conveyed on the label 
because of size limitations. They noted that, instead, such information ought to be conveyed 
through accompanying literature. Other interviewees, including consumers, health professionals, 
and herbal practitioners, believed that intended use statements were not only essential but also 
were feasible to include on supplement labels. 
Dietary Supplement Labels: Key Elements  9  OEI-01-01-00120  According to recent FDA focus groups, any mention of possible health benefits on a 
supplement label was considered desirable because it told consumers what the supplement was 
for.10 The American Association of Retired Persons (AARP) also found, in its recent survey, 
that information on the label about a supplements purposes is very important to consumers.11 
Safety Information 
The label would provide consumers with known safety information.  This would 
include interactions, contraindications, and possible side effects and adverse 
reactions. 
Safety information on a label that meets our template would include potentially harmful 
interactions between the supplement and prescription drugs, over-the-counter medicines, other 
supplements, and foods; contraindications for certain populations and medical conditions; 
possible side effects and adverse reactions; and a statement telling consumers to stop taking the 
supplement if they experience adverse symptoms. Focus groups conducted by FDA found that 
supplement users are keenly interested in safety information.12 A recent study by AARP 
confirmed this on a national scale.13 Other groups have also called for the inclusion of safety 
information on labels.14 
While most stakeholders we interviewed agreed on the concept of safety information and many 
of the particulars noted above, they disagreed over the extent of safety information necessary 
on a supplement label.  Some industry representatives believed that only in very specific 
circumstances should warnings appear on supplements (for example, on supplements containing 
Ephedra and St. Johns Wort, which have been associated with adverse reactions, or 
precautionary statements pertaining to pregnant or lactating women); otherwise it would be 
impractical to list all interactions. Their preferred approach would be to call upon doctors or 
pharmacists to alert consumers to potential interactions. Others believed that safety information 
ought not be included on the label, unless the risks were well-documented in research studies or 
through adverse events. 
Others, particularly consumer advocates, believed that labels ought to list all possible 
interactions. They expressed concerns that health professionals may lack sufficient knowledge 
about supplements to adequately inform consumers of potential interactions or adverse effects. 
Finally, some would like safety information to go even further by including information on 
adverse event reporting.  The State of Texas has begun requiring all Ephedra products to 
contain the toll-free number of the FDAs Medwatch medical product reporting program. 
Others, however, have raised concerns that by including the FDA Medwatch number on a 
supplement label, consumers may perceive it as an implied endorsement of the safety of the 
supplement and may assume an incorrect level of FDA oversight. 
The majority of consumers and health professionals in our focus groups told us that they were 
more comfortable with an explicit warning label, rather than a vague statement, such 
Dietary Supplement Labels: Key Elements  10  OEI-01-01-00120  as if you have a health condition, please discuss with your doctor. Our interviewees tended 
to prefer warnings that mentioned specific medical conditions and that were written in simple 
language. For example, most people liked the Ephedra warning because of its completeness. 
It addresses topics such as contraindications, interactions, maximum dosage, and adverse 
effects.15  A few people, however, told us that having too much information, or too many 
specific references, might either scare consumers or lead them to ignore the warning. 
Stakeholders were split over the need for labels to carry a statement calling for the consumer to 
consult with a health professional before using the supplement.  Since supplements are 
technically not considered drugs, some industry representatives believed that carrying a 
precautionary note to discuss usage with a health provider is unnecessary. Others, particularly 
consumer and health providers, believed that labels ought to encourage consumers to discuss 
supplement usage with their health providers, especially if they are taking other medications. A 
recent survey by Prevention Magazine found that 31 percent of consumers take dietary 
supplements in combination with a prescription medicine, and 30 percent of consumers take 
dietary supplements in combination with an over-the-counter product.16 
Despite disagreements about the level of information that ought to be included on supplements, 
all interviewees stated that there ought to be consistency among the warning labels for similar 
supplements. Warnings pertaining to supplement-drug interactions ought to convey similar 
information separately on the drug and the supplement.  Furthermore, stakeholders believed 
that requirements for warning statements ought to be harmonized across federal and state 
regulatory agencies. 
Directions for Use 
The label would provide consumers with adequate directions for use. The 
directions would include guidance on proper doses, if the information is available. 
Directions for use on a label that meets our template would cover a range of important 
information, including a recommended daily dose, minimum duration of time for which a 
supplement should be taken in order to see results, maximum dose or extent of time for which a 
supplement can be safely taken, and information about how to consume the supplement (e.g., 
with or without food and liquid). Some groups, including the Commission on Dietary 
Supplement Labels, would also like to see labels direct consumers to use the supplements only 
as recommended on the label. 
Consumer studies have shown that dosage information on labels is of the utmost importance to 
consumers.  For example, in a recent survey by Prevention Magazine, consumers reported 
that, of all the information on the label, they are most likely to look for information pertaining to 
recommended dose.17 Consumers in our focus groups told us that when they use a dietary 
supplement, the most important questions to which they 
Dietary Supplement Labels: Key Elements  11  OEI-01-01-00120  seek answers are: How much of the supplement do they need to take to get the result they are 
looking for?  How much is too much? 
Ideally, dose per use and duration of use would be based on the amount of supplement 
necessary to meet the label claims. Consumers would be able to achieve the benefits suggested 
on label claims based on the number of pills in the supplement; if this is not the case, the label 
would clearly indicate the amount of supplement needed to achieve that benefit.  Dosage 
information might vary depending on the condition or indication for which the supplement is 
being taken. It might also vary, based on the age of the consumer. Whatever dose is stated on 
the bottle would be clear to consumers; any distinctions between the recommended serving size 
and the recommended daily intake would be obvious.  Furthermore, dosage recommendations 
would be standardized across supplements so that identical supplements with similar claims 
would call for equivalent doses. 
To meet our template, the label would also contain any special storage instructions, including 
expiration dates for herbals and other supplements with a finite shelf life.  Such information can 
ensure that consumers do not attempt to ingest supplements whose ingredients can no longer 
deliver the desired benefit.  According to surveys by Prevention Magazine and AARP, 
consumers consider the expiration date to be a valuable component of the label.18 
Product Information 
The label would identify the manufacturer, production source and batch, and 
information about the net quantity of contents found in the supplement. 
Product information can assist consumers in identifying key attributes about the contents, 
production, and manufacture of a supplement.  A label that meets our template would contain 
the name, address, and contact information for the manufacturer.  Such information could be 
helpful to consumers, should they have a question about a supplement. Contact information is 
helpful to consumers when it contains a toll-free number or website address through which 
consumers can easily reach the manufacturer.  A second important piece of information is the 
net quantity of contents in the bottle or package, expressed in either weight, measure, or 
number. This type of information can help consumers comparison shop among supplement 
brands.  Finally, the label would contain a lot number to identify the production source and 
batch.  In the case of a product recall, lot numbers could help consumers and manufacturers 
easily identify and track those supplements. 
LABEL PRESENTATION 
The second five elements of the template deal with the way in which information is presented on 
a supplement label. While it is key for labels to adequately address ingredient information, 
intended use, safety information, directions for use, and product 
Dietary Supplement Labels: Key Elements  12  OEI-01-01-00120  information, it is equally important that the information be presented to consumers in a clear and 
meaningful way.  In this section we address five general precepts that are key to label design. 
Standardized Format 
The label would present similar types of information across supplements in a 
similar order. The label would use widely accepted terminology, headings, and 
titles. 
A standardized label would serve as a system for consumers, helping them to interpret 
important information on the label and also assisting them in comparing that information across 
supplements.  Furthermore, a standardized label structure would improve consumers ability to 
process label information. In both the food and drug areas, stakeholders told us that the 
standardizing of labels has proven to be enormously helpful. 
A standardized dietary supplement label that meets our template would reflect several elements. 
First, it would require that all labels contain similar types of information.  Second, it would 
require that information be conveyed across supplements in a consistent manner. The order 
and flow of information, and the format in which that information is displayed, would be 
consistent across supplements. Finally, the language on supplements would also be 
standardized. Important terminology, such as the name of a supplement, would be similar 
across supplements.  Headings, which would alert consumers to information, such as product 
safety and recommended dose, would be uniform across supplements. 
The standardized format would need to be well understood by consumers.  Because there is a 
limit to how much information consumers can hold in their memory at one time, it is key that the 
amount of information required on labels be congruent with consumers ability to retrieve and 
process information.  Research suggests that consumers are most likely to engage in a behavior, 
such as reading a label, if they believe they can successfully complete the task.19 Thus, 
consumers would have to find the format easy to use, navigate, and comprehend. 
A standardized label need not mean that there is only one way of presenting information. 
Required information could be presented in one of several standardized formats, depending on 
the type and size of the supplement.  For example, FDAs Center for Drug Evaluation and 
Research has authorized a range of different formats for over-the-counter (OTC) labels, 
depending on the type and size of product. 
While the vast majority of stakeholders we spoke with liked the idea of a standardized label, a 
few dissented. Some pointed out that manufacturers are already hard-pressed to get 
information on labels, and raised concern that requiring yet more information could lead to 
overcrowding on the label. Others pointed out that a standardized format might 
Dietary Supplement Labels: Key Elements  13  OEI-01-01-00120  encroach upon a manufacturers ability to use the label as a marketing tool, because it would 
greatly limit the discretionary space on labels. 
Distinct Product Features 
The label would have a unique design, format, or specific language that would 
assist consumers in distinguishing supplements from other self-care products. 
A label that meets our template would contain distinct product features so that consumers could 
distinguish dietary supplements from other types of self-care products.  The ability to distinguish 
one type of product from another is key to a consumers ability to select appropriate 
supplements. To achieve such a distinction, the dietary supplement label would need to look 
significantly different from other self-care products, such as over-the-counter drugs and 
homeopathic products. For example, supplement labels could have a unique design, shape, 
language, color, or product feature, such as a symbol on the bottle cap.  An important factor in 
choosing a distinct product feature for a dietary supplement is that it be one that consumers 
would readily associate with supplements. 
In distinguishing a supplement from other types of products, the label would also carry language 
that clearly communicates to consumers important features about supplement regulation. For 
example, the label could make clear through a disclaimer or some other mechanism that 
supplements are not subject to premarket approval or that FDA has not evaluated their safety 
and effectiveness. We recognize that such statements could call for trade-offs in label 
information. Such a statement, which would need to be in a large enough font and in simple 
language, may come at the expense of other critical information, such as safety information. 
Readability 
The label would contain language that is easily understood by a broad group of 
consumers. 
A label that meets our template would be easily understood by consumers.  To that end, the 
language must be clear and concise, with a reading level that is suitable for a broad group of 
consumers. The language must be simple enough that it could be understood by lay persons. 
An important component of readability is font size, which needs to be sufficient for a broad 
group of consumers. To increase readability, labels could contain symbols or other visual cues 
to focus the consumers attention to important information. Some of our interviewees believed 
that symbols or visual cues, such as a danger sign or red box, could effectively alert consumers 
to safety information. However, others believed that symbols could be problematic, pointing 
out that cues can have different meanings to different people. Thus, were symbols to be 
incorporated into labels, the label redesign would have to be accompanied by public education. 
Dietary Supplement Labels: Key Elements  14  OEI-01-01-00120  Changes in consumer information needs must be taken into account in assessing how best to 
ensure that labels are read and understood by a broad group of consumers.  With continued 
advances in nutrition, medicine, and the study of herbal medicine, labels will have to 
communicate increasingly sophisticated messages on topics, such as directions for use and 
safety information.  Changes in American demographics will also have an impact on consumer 
information needs.  The elderly, who are large users of supplements, are becoming a larger 
proportion of the population.20 They may have greater difficulty reading a label because of 
poor vision. Finally, as the number and percentage of United States residents, who do not 
speak English as their primary language, increases, labels that can be understood by a wide 
variety of language speakers will become increasingly important.21 
Balance 
The label would present information in a balanced manner. It would give fair 
treatment to benefits and risks, to claims and disclaimers, and to factual and 
marketing information. 
A label that meets our template would present a balance between competing types of 
information.  For example, the label would give fair treatment to information about a 
supplements benefits as well as its risks. The label would include an appropriate balance 
between factual information, as required by FDA label regulations, and marketing information, 
which could include claims, company logo, designs, and images. Finally, space would be 
balanced between claims and disclaimers. This balance would need to be determined on a 
case-by-case basis.  In some instances, balance would entail equal space being devoted to both 
kinds of information. In other cases, the amount of space would depend on the level of science 
and knowledge in a particular area. Finally, the placement of information on a label may have 
implications for the extent to which labels accomplish balance.  The balance of information is 
key to the informed and appropriate use of any self-care product, and is required in the 
advertising for OTC drugs. 
Constructive Use of Label Space 
The label would seek to expand the limited label space through creative packaging 
and pointing consumers to alternative sources of information. 
While the size of a label is an inherently limiting factor to the amount of information that can be 
placed on the label, the placement of that information need not be limited to the primary display 
panel. A label that meets our template would seek to expand the limited space through creative 
packaging. 
Expanded labels hold particular promise for information that is important but not so critical that 
it needs to be on the package label. For example, the following types of information could be 
effectively placed on an expanded label: information about the 
Dietary Supplement Labels: Key Elements  15  OEI-01-01-00120  scientific legacy of the supplement, including information about the clinical trials; key mechanism 
of action for the active ingredients; additional information about the processing and manufacture 
of a supplement; and the full text of a disclaimer, should a truncated version be used on the 
label.22 In our review of labels, we identified four options for expanding the information 
contained on a dietary supplement label. Below we discuss the options, identifying both 
benefits and potential concerns. 
<	 Innovations to existing label space. Label space can be expanded through innovations, 
such as a twist-n-turn label, in which the outer part of the label twists around an inner 
band of information; an accordian label, in which the label folds out to be several times its 
size; and a neck strap label, in which a tag is attached to the bottle neck.  However, these 
labels may get torn off, lost, or malfunction. Consumers may also be overwhelmed by the 
different label forms, resulting in increased confusion and a decreased ability to compare 
supplement labels. 
<	 Inclusion of a package insert. By physically increasing the size of the label or adding a 
package insert, more space can be made available.  Yet, in some cases a larger label may 
be impossible, especially for small packages. Some interviewees also cautioned that 
consumers and health providers might not read package inserts. 
<	 Use of outer packaging.  By enclosing supplements in boxes or another type of outer 
package, manufacturers can greatly enhance the label space available because the outer 
package becomes an extension of the label.  Yet, a large box, which might be necessary to 
carry all the necessary label information, could mislead consumers into thinking that the 
quantity contained in the accompanying bottle is greater than in fact it is.  Manufacturers 
also told us that the use of boxes could lead to increased production costs. 
<	 Alternative sources of information. Alternative sources of information could include a 
toll-free number or website. These would be listed on the label and would essentially serve 
as a continuation of the label.  Both options hold great promise because they allow for 
potentially unlimited space where manufacturers could disclose pertinent information, such 
as safety precautions.  However, consumers must take an additional step on their own 
initiative to get further information.  Not all consumers have access to the Internet.  Even for 
those who have access to a telephone, some concern exists about bias, because company 
employees would be fielding the calls.  Consumers and health professionals told us that it 
would be most helpful for labels to point consumers to a toll-free number staffed by a 
neutral party, such as the National Institutes of Health.  Finally, including a website or toll-
free number on the label raises a host of regulatory oversight issues, as it potentially 
expands the definition of a label. 
Dietary Supplement Labels: Key Elements  16  OEI-01-01-00120  C O N C L U S I O N  
This template sets forth a vision of key elements that can increase the potential of dietary 
supplement labels to help consumers make informed and appropriate choices about supplement 
use.  It is a vision that appears to have considerable support among the wide range of 
stakeholders whom we interviewed. We recognize that this template is general and leaves out 
many important details concerning specific expectations or requirements for supplement labels. 
It does, however, put forth a framework that government officials, consumer groups, industry 
representatives, academics, and others can use as they seek to find common ground on the 
specific content and presentation of labels. 
For an assessment of the extent to which existing dietary supplement labels reflect the elements 
identified in this template, see our companion report, Dietary Supplement Labels: An 
Assessment (OEI-01-01-00121). 
Dietary Supplement Labels: Key Elements  17  OEI-01-01-00120  APPENDIX A 
ADVERTISEMENTS FOR DIETARY SUPPLEMENTS

We discovered these advertisements, which are regulated by the Federal Trade Commission, 
during our review of magazines and newspapers. Supplement A is for a joint health product 
and Supplement B is for a weight loss product. In each case, we were struck by the messages 
and claims conveyed to consumers.  We do not disclose the names of the supplements, or the 
individuals who endorse them. Each of the following boxes highlights excerpts from the 
advertisements: 
Supplement A 
...For 20 years, severe bone/joint problems put Celebrity #1 through 
living hell.  But three days after he discovered a new breakthrough in 
natural relief from joint problems, the crippling pain was gone. Not 
diminished - gone! 
What was this miracle that finally got rid of Celebrity #1s bone/joint 
agony after 20 years of trying countless medications and treatments? 
Supplement A 
Supplement B 
...Teacher loses 70 pounds in only 8 weeks easily ... without being 
hungry... after everything else fails her! 
This has become the #1 choice of famous TV and movie stars to lose 
weight ... and the public ... with over 1 million people using it to lose 10 
million pounds. 
Supplement B includes 100 percent natural fat-busting, energizing natural 
nutrients that give your body no choice but to make fat and inches 
disappear like magic. 
Dietary Supplement Labels: Key Elements  18  OEI-01-01-00120  APPENDIX B 
METHODOLOGY

Development of the Template 
Our template represents a synthesis of the feedback we heard during 76 interviews, 7 focus 
groups, and a review of literature pertaining to important characteristics of supplement labels. 
We continuously added to and refined the elements of the template to reflect the diversity of 
perspectives, which we encountered, and particularly notable areas of agreement or 
disagreement. We also shared the template with key stakeholders at various stages of its 
evolution to confirm that it could be a useful and useable construct for them. 
Interviews and Focus Groups 
We conducted 76 interviews with key stakeholders. We spoke with each of the supplement 
industry trade groups, consumer advocacy groups, private quality oversight organizations, 
professional nutrition associations, academic researchers, marketers, and practicing herbalists. 
With each group, we discussed the role of a supplement label in the ideal and current label 
shortcomings, and solicited their recommendations for reform. 
We conducted focus groups with consumers and with health care professionals, and reviewed 
the findings of other focus groups.  In cooperation with the Administration on Aging, we led five 
focus groups of elderly consumers who represented a diversity of cultural backgrounds, 
socioeconomic status, health condition, use of supplements, and use of prescription drugs. 
These focus groups took place in Massachusetts, Colorado, and California.  We also, in 
partnership with the American Pharmaceutical Association and the American Geriatrics 
Society, conducted two focus groups of geriatricians and gerontologists and two groups of 
pharmacists with diverse geographic locations, practice settings, reliance on labels, and 
experience in advising patients.  Finally, we reviewed the findings from 1999 of FDAs 
consumer focus groups on dietary supplement labels. 
Literature Review 
We reviewed relevant federal legislation, regulation, and program priority documents; position 
papers from consumer and industry groups; articles in peer-reviewed journals and trade press; 
transcripts from congressional hearings and FDA town meetings; and reports from Presidential 
commissions, federal evaluators, and government-sponsored colloquia on dietary supplements. 
We also reviewed consumer-oriented newsletters, books, advertisements, and websites on 
supplement use. 
Dietary Supplement Labels: Key Elements  19  OEI-01-01-00120  APPENDIX B 
We obtained existing data from nationwide surveys on consumer use of dietary supplements 
and supplement labels. We looked at both the raw data and the findings from Prevention 
Magazines 1999 and 2000 surveys on dietary supplements, which were based on random 
samples of 2,000 people. In addition, we reviewed the findings of recent surveys from diverse 
federal, professional, academic, and private organizations. 
We also reviewed existing data on the economic characteristics of the supplement industry. 
We obtained statistics from FDA-commissioned research reports and the Nutrition Business 
Journal. 
Dietary Supplement Labels: Key Elements  20  OEI-01-01-00120  APPENDIX C 
ENDNOTES

1. Courtesy of Nutrition Business Journal. About 40 percent of the population uses supplements 
often, and 30 percent takes them infrequently. Nutrition Business Journal obtained these figures from 
a compilation of 13 consumer surveys.  Individual consumer surveys, by groups such as the Kaiser 
Family Foundation, Yankelovich Partners, the Dietary Supplement Education Alliance, and Prevention 
magazine, have found similar patterns in use over the past several years. 
2. FDA estimated that the number of supplements on the market may range from 25,000 to 33,000 
(29,000 is the midpoint of this range).  (Memorandum re: questions concerning dietary supplement 
labeling, June 13, 2001) 
3. NBJs Annual Overview of the Nutrition Industry VI, Nutrition Business Journal (2001), 7 
4. General Accounting Office, Food Safety: Improvements Needed in Overseeing the Safety of 
Dietary Supplements and 'Functional Foods', GAO/RCED-00-156, July 11, 2000. 
5. Food and Drug Administration, Dietary Supplement Enforcement Report. Retrieved from 
http://www.fda.gov/oc/nutritioninitiative/report.html, December 27, 2002. 
6. Roper Starch Worldwide, Self-Care in the New Millennium, 2001,10. According to this study, 73 
percent of people prefer to treat conditions themselves, rather than go to a doctor; furthermore, 59 
percent say that they are more likely to treat their own conditions than 12 months ago. In other cases, 
consumers are seeing a health care practitioner but not reporting their use of dietary supplements.  For 
example, another survey revealed that 30 percent of those who reported taking supplements regularly 
had not shared this information with their physician.  Robert Blendon et al, Americans Views on the 
Use and Regulation of Dietary Supplements, Archives of Internal Medicine (March 26, 2001), 161: 
805-810. 
7. Roper Starch Worldwide, Self-Care in the New Millennium, 2001,19. 
8. Prevention Magazine, National Survey of Consumer Use of Dietary Supplements, Rodale, Inc., 
1999, 32. 
9. Ibid., 35-37. 
10. Alan Levy and Brenda Derby, Consumer Studies Team. FDA Report on Dietary Supplement 
Labeling Focus Groups, September 30, 1999. 
11. Seventy-six percent of consumers thought it would be very important for information to appear on a 
supplement label about what a supplement does, for example, helps you sleep, boosts the immune 
system. AARP Public Policy Institute, Dietary Supplements and Older Consumers, Data Digest 66, 
Dietary Supplement Labels: Key Elements  21  OEI-01-01-00120  APPENDIX C 
7. 
12. Alan Levy and Brenda Derby, Consumer Studies Team. FDA Report on Dietary Supplement 
Labeling Focus Groups, September 30, 1999. 
13. Respondents thought it would be important to have the following information appear on dietary 
supplement labels: information on possible side effects or adverse reactions (82 percent); information 
on interactions with prescription and over-the-counter medicines (80 percent); the maximum amount 
that is safe to take (81 percent); expiration date (82 percent); and information on whom to contact in 
case of an adverse reaction (76 percent). AARP Public Policy Institute, Dietary Supplements and 
Older Consumers, Data Digest 66, 3. 
14. The Food Committee of the Association of Food and Drug Officials has called for the mandatory 
label disclosure of the following items: information regarding any side effects or adverse reactions; 
contraindications to warn those consumers who may be adversely affected because of their age, 
existing health problems, and risks posed, if pregnant or nursing; if there is a risk of adverse drug and 
dietary supplement interaction; and cautionary language to seek health practitioner guidance, if there are 
health concerns present. Association of Food and Drug Officials, Resolution Concerning: Safety and 
Marketing of Dietary Supplements. June 17, 2001. 
The Commission on Dietary Supplement labels recommended that, Ensuring the safety of supplements 
includes the need to provide adequate information and warnings to consumers. The Commission 
strongly suggests that dietary supplement manufacturers include appropriate warnings in product 
information, where necessary, as specifically permitted by DSHEA.  In addition, manufacturers should 
recognize the need to advise women who are pregnant or breast-feeding to consult a health 
professional about supplement use during pre-and postnatal periods.  Commission on Dietary 
Supplement Labels, Report of the Commission on Dietary Supplement Labels, November 1997, vii. 
15. The warning on the Ephedra supplement we used during our focus groups contained the following 
language: Not for use by or sale to persons under age 18.  Do not use if pregnant or nursing.  Consult 
a physician or licensed qualified health care professional (physician) before product use if you have, 
or have a family history of, heart or thyroid disease, diabetes, high blood pressure, recurrent headaches, 
depression, any psychiatric condition, glaucoma, difficulty urinating, enlarged prostate, seizure disorder, 
if you are using a monoamine oxidase inhibitor (MOAI) or any other dietary supplement, prescription 
drug or over-the-counter drug containing ephedrine, pseudoephedrine or phenylpropanolamine 
(ingredients found in certain allergy, asthma, cough/cold, and weight control products), or if you intend 
on taking to reduce weight.  Under Ohio law, the maximum recommended dosage of ephedrine for a 
healthy adult is 100 mg in a 24-hour period for not more than 12 weeks. Exceeding recommended 
serving may cause serious adverse health effects including heart attack and stroke. Discontinue use and 
call a physician immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of 
breath or other similar symptoms. Individuals who consume caffeine with this product may experience 
Dietary Supplement Labels: Key Elements  22  OEI-01-01-00120  APPENDIX C 
serious adverse health effects. Keep out of reach of children. 
16. Prevention Magazine, National Survey of Consumer Use of Dietary Supplements, Rodale, Inc., 
1999, 37-39. 
17. Prevention Magazine, National Survey of Consumer Use of Dietary Supplements, Rodale, Inc., 
1999, 59-63.  The recommended dosage is the most widely read item on a supplement label. 
Consumers reported to Prevention Magazine that they look for recommended dosage always or most 
of the time for vitamins and mineral (89 percent), and for herbal remedies (90 percent). 
The AARP also found that the amount [one] should take is a very important element that should 
appear on dietary supplement labels. Eighty-one percent of their survey respondents stated that it 
would be very important to appear on the label.  AARP Public Policy Institute, Dietary Supplements 
and Older Consumers, Data Digest 66, 7. 
18. Prevention Magazine, National Survey of Consumer Use of Dietary Supplements, Rodale, Inc., 
1999, 59-63.  The expiration date is the second most widely read item on a supplement label. 
Consumers told Prevention Magazine that they look for expiration date always or most of the time for 
vitamins and mineral (74 percent), for herbal remedies (77 percent). 
The AARP also found that the expiration date, that is, the date after which a supplement is no longer 
effective is a very important element that should appear on dietary supplement labels. Eighty-two 
percent of their survey respondents stated that the expiration date would be very important to appear 
on the label. AARP Public Policy Institute, Dietary Supplements and Older Consumers, Data Digest 
66, 7. 
19. Center for Drug Evaluation and Research, FDA, Summary of Study A and B (untitled 
document). Provided to OIG by the Center for Drug Evaluation and Research in 2001. 
20. Department of Commerce, Census Bureau, National Population Projections (Population 
Pyramids). Retrieved from http://www.census.gov/population/www/projections/np_p5.gif, March 26, 
2002. 
21. The Census data from 2000 show that almost 45 million people speak a language other than English 
at home, and over 19 million of those speak English less than very well. By contrast, in 1990 almost 
32 million people spoke a language other than English at home, and 14 million of those spoke English 
less than very well. Census 2000 Supplementary Survey Summary Table QT-03: Profile of Selected 
Social Characteristics: 2000; 1990 Summary Tape File 3 (STF 3) - Sample data  Table DP-2: Social 
Characteristics: 1990. Retrieved from http://factfinder.census.gov, May 17, 2002. 
22. Alan Levy and Brenda Derby, Consumer Studies Team. FDA Report on Dietary Supplement 
Labeling Focus Groups, September 30, 1999. 
Dietary Supplement Labels: Key Elements  23  OEI-01-01-00120  A C K N O W L E D G M E N T S  
This report was prepared under the direction of Mark R. Yessian, Ph.D., Regional Inspector General 
for Evaluation and Inspections in Boston and Joyce M. Greenleaf, MBA, Assistant Regional Inspector 
General. Other principal Office of Evaluation and Inspections staff who contributed include: 
Elizabeth Robboy, Project Leader  Joseph Rutherford, Program Specialist 
Chaletta Clark, Program Analyst  Genevieve Nowolinski, Program Specialist 
Sara Schulman, Program Analyst 
For information or copies of this report, please contact

the Office of Inspector Generals

Public Affairs office at (202) 619-1343.

Reports are also available on the World Wide Web at our home page address:

http://www.oig.hhs.gov/ 
Dietary Supplement Labels: Key Elements  24  OEI-01-01-00120