Department of Health and Human Services 
OFFICE OF 
INSPECTOR GENERAL 
DIETARY SUPPLEMENT LABELS: 
AN ASSESSMENT 
JANET REHNQUIST 
INSPECTOR GENERAL 
MARCH 2003 
OEI-01-01-00121  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 assess the extent to which existing dietary supplement labels reflect the key elements 
identified in our dietary supplement label template. 
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 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 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  supplements, strong enforcement of dietary supplement rules, and the establishment of an FDA 
task force on consumer health information for better nutrition. 
This Report. We performed an original analysis of the labels of 100 dietary supplements that 
consumers commonly use in order to examine the current state of labels in relation to our 
template of key label elements. That template, which was designed to identify key elements 
that can increase the potential for dietary supplement labels to help consumers make informed 
and appropriate choices about supplement use, is described in detail in our companion report, 
Dietary Supplement Labels: Key Elements (OEI-01-01-00120). 
We supported the observations from our label analysis by interviewing 76 key stakeholders, 
such as regulators, industry representatives, and consumer groups, and 7 focus groups with 
consumers and health professionals. We also integrated data from industry groups and 
independent research organizations, and conducted a comprehensive literature review on 
supplement use and labels, including congressional testimony and national survey data on 
supplement use. 
FINDINGS 
Our analysis suggests that dietary supplement labels fail to adhere to the key elements in our 
template.  We found that the labels are limited in their ability to guide the informed and 
appropriate use of supplements among consumers and often do not present information in a 
manner that facilitates consumer understanding. 
In part, the current state of labels is due to the absence of a standardized format for the 
presentation and type of information given on the label.  Moreover, FDA lacks clearly defined 
standards for disclosing safety information and for ensuring product authenticity. 
In their current state, dietary supplement labels could potentially lead consumers to use 
supplements inappropriately. In fact, consumers and health professionals in our focus groups 
expressed that labels were often not a useful source of information and noted that they may 
disregard them or to turn to alternative sources of information about supplement use. 
Dietary Supplement Labels Fail to Adhere to the Key Elements in Our Template. 
Our sample of 100 labels did not meet nine of the ten elements in our template.  For a full 
description of the template, which was designed to identify key elements that can increase the 
potential for dietary supplement labels to help consumers make informed and appropriate 
choices about supplement use, see our companion report, Dietary Supplement Labels: Key 
Elements (OEI-01-01-00120). 
ii 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  Labels often fail to provide sufficient information to guide the informed and 
appropriate use of supplements. 
<	 Ingredient information is often difficult to interpret. Supplement labels often fail to 
provide enough detail about supplement composition for users to understand exactly about 
what they are taking.  Of the 100 labels we reviewed, 93 did not make clear which 
ingredients were active and 94 did not make clear the extent to which ingredients were 
bioavailable (absorbed in the body); all of the 15 privately-held formulations (proprietary 
blends) lacked information on the amount of individual ingredients. 
<	 Statements of intended use often provide limited information.  Supplement claims we 
examined are often confusing to consumers because they do not adequately convey the 
intended use of the supplement. Consumers and health professionals in our focus groups 
could not distinguish between types of claims. 
<	 Safety information is often incomplete. From our sample of 100 labels, 89 lacked 
information about adverse reactions or side effects, 87 about interactions, 85 about 
maximum dose, 61 about contraindications, and 25 about expiration. Even when labels did 
include these types of information, we found that warning statements varied in detail. 
<	 Directions for use are often insufficient.  Supplement labels are required to list a 
serving size, but not necessarily recommended daily dose.  When that information is listed, it 
can be difficult to interpret. For example, dose information may be described in relation to 
a symptom, but the boundaries of that symptom may not be clear. 
Labels often fail to present information in a manner that facilitates consumer 
understanding. 
<	 No standardized format exists. There is little consistency in how important categories of 
information are referenced on labels. For example, of the 66 supplements in our sample 
packaged in bottles, 13 had safety information to the right of the front panel, 14 had the 
information to the left, and 39 did not have that information at all. 
<	 Supplement labels have few distinguishing features.  Some of the supplement labels 
in our sample were suggestive of pharmaceutical products. We found examples of 
supplements that contained pictures of people wearing physician lab coats and stethoscopes 
and that had product names like Prescribed Choice. 
<	 Complex language and small font size inhibit readability.  This prevents a broad 
range of consumers from easily reading and understanding label information. A number of 
elderly consumers in our focus groups and some health professionals had a  difficult time 
reading supplement labels and understanding the terminology used. 
iii 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  <	 Information on benefits and risks is often imbalanced.  Unequal space is often given 
to product benefits compared to risks. For example, 69 of the labels in our sample 
contained statements about a supplements potential benefits, but 38 of those did not 
disclose any safety information. 
Several Factors Inhibit Supplement Labels From Adhering to Our Template. 
Lack of clearly defined FDA standards. No uniform standards exist to guide manufacturers 
in determining what constitutes a material fact requiring safety information to be placed on 
supplement labels.  Furthermore, FDA has not defined standards for the amount and kinds of 
evidence necessary to substantiate claims.  Without clearly defined standards, manufacturers 
find it is difficult to achieve a level playing field. 
Few measures for ensuring product authenticity. Neither an official monograph system nor 
validated testing methods for supplements exist, making it difficult for manufacturers to ensure 
ingredient quality and potency.  The lack of such measures contributes to inconsistent 
supplement preparations and label declarations. 
Limited wording of claims.  Manufacturers have difficulty in clearly expressing the benefits of 
dietary supplements on labels because of restrictions in how claims may be worded. 
Evidence Suggests that Consumers and Health Professionals Find Supplement 
Labels of Limited Use. 
Our focus groups pointed to mistrust of the label as one of the main reasons why consumers 
turn to other sources of information, such as health professionals.  However, health 
professionals limited knowledge about supplements and difficulty in interpreting labels inhibit 
many of them from serving as a resource for supplement users.  According to a recent survey, 
only a third of consumers were very confident in the accuracy of information found on 
supplement labels. 
CONCLUSION 
Our analysis of 100 dietary supplement labels found that few reflected the label elements that 
our template identified as key to guiding the informed and appropriate use of supplements 
among consumers. These findings were confirmed by our interviews and focus groups, as well 
as by independent data analyses and professional literature. Our analysis also found that 
several barriers may prevent manufacturers from developing labels that can adhere to our 
template, and that the current state of supplement labels may limit the extent to which 
consumers and health professionals use labels. 
iv 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  We recognize that FDA has numerous efforts underway to address the current state of dietary 
supplement labels, and that limited resources, limited scientific evidence about the safety and 
efficacy of supplements, and competing priorities inhibit FDAs capacity to make timely 
progress.  Our analysis is designed to assist FDA as it addresses the legal framework related to 
dietary supplement labels, and as it reviews its standards for disclosing safety risks on labels, 
substantiating evidence related to label claims, and developing analytical methods and reference 
materials for testing supplements. 
v 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  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

FINDINGS

Dietary supplement labels fail to adhere to the key elements in our template .............. 5

Several factors inhibit supplement labels from adhering to our template.  ............... 19

Consumers and health professionals find labels of limited use ........................23

CONCLUSION  ............................................................. 26

APPENDICES

A: Template of key elements for dietary supplement labels .......................... 27

B: Information included on supplement labels  ...................................28

C: FDA initiatives related to dietary supplements ................................. 29

D: Methodology ......................................................... 31

E: Endnotes ............................................................33

ACKNOWLEDGMENTS ..................................................... 38

Dietary Supplement Labels: An Assessment  OEI-01-01-00121  I N T R O D U C T I O N  
OBJECTIVE 
To assess the extent to which existing dietary supplement labels reflect the key elements 
identified in our dietary supplement label template. 
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 legal framework for dietary 
supplements and expanded the information that could be placed on 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.  The Food and Drug 
Administration (FDA) estimates that about 29,000 dietary supplements are on the market.2 
Dietary supplements are now 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 rules and good 
manufacturing practice (GMP) regulations to the dietary supplement 
1 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  industry and by monitoring adverse events related to supplement use. However, supplement-
specific GMP regulations have not been issued, and the adverse event 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. 
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.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 
Our analysis of dietary supplement labels was based on our template of the key elements of a 
label as described in our companion report Dietary Supplement Labels: Key Elements (OEI-
01-01-00120).  The template was developed in response to FDAs request that we present a 
vision of the kind of label that could serve to better assist consumers in making informed and 
appropriate choices about supplement use. 
We performed an original analysis of the labels of 100 products that consumers recognize as 
dietary supplements and commonly use.  For a summary of our label analysis, see Appendix B. 
We obtained the products from supermarkets, pharmacies, and natural food stores in the 
greater Boston area and from samples distributed at industry conferences. 
2 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  Our diverse sample, which represents 36 manufacturers and 36 distributers, was a judgmental 
one.  Without the existence of an official registry of the number and types of supplements on the 
market, we could not conduct probability sampling. 
We also conducted 76 interviews with federal and state regulators, each of the major 
supplement industry trade groups, consumer advocacy groups, private quality oversight 
organizations, professional nutrition associations, academic researchers, marketers, and 
practicing herbalists.  To learn more about specific concerns facing particular groups of 
supplement users, we conducted 7 focus groups with consumers and with health care 
professionals, and reviewed the findings of other focus groups. 
We reviewed relevant federal legislation and regulation, as well as other materials prepared by 
government agencies, trade organizations, and consumer groups related to dietary supplements 
and supplement use.  As part of our literature search, we reviewed existing data from national 
surveys on consumer use of dietary supplements and their labels, as well as data on the 
economic characteristics of the supplement industry. 
For a more detailed description of our methods, see Appendix D. 
This Report and its Companion Report 
This report assesses the extent to which existing dietary supplement labels reflect the key 
elements identified in our dietary supplement label template. Our findings are based on an 
original analysis of the labels of 100 dietary supplements that consumers commonly use and 
supported by interviews, focus groups, independent data analyses, and professional literature. 
Our companion report, Dietary Supplement Labels: Key Elements (OEI-01-01-00120) 
provides more detail on the template. At the request of FDA, we designed a template to 
identify key elements that can increase the potential for dietary supplement labels to help 
consumers make informed and appropriate choices about supplement use. The template 
represents common ideas from a broad group of stakeholders and is intended to be 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. 
. 
We conducted this inspection in accordance with the Quality Standards for Inspections 
issued by the Presidents Council on Integrity and Efficiency. 
3 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  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 Currently 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 prominence 
replaced by the name of the dietary ingredient (e.g.,  or with the source of the dietary ingredient in the 
ginseng supplement);  Supplement Facts panel following the name of the 
dietary ingredient (e.g., calcium (from calcium 
C  net quantity of contents (e.g., 60 capsules);  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 the 
amount, and percent daily value, if established, of  supplement; and 
each dietary ingredient; 
C  the disclaimer This statement has not been 
C  if a supplement contains a proprietary blend, the  evaluated by the Food and Drug Administration. This 
net weight of the blend as well as a listing of each  product is not intended to diagnose, treat, cure, or 
ingredient in descending order of weight must be  prevent any disease if the supplement bears a claim 
identified;  to affect the structure or function of the body 
(structure/function claim), a claim of general well-
C  the part of the plant used, if an herb or botanical; 
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. 
4 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121 F I N D I N G S  
We found that few dietary supplement labels in our sample met the elements identified in our 
template, which was designed to help consumers make informed and appropriate choices about 
supplement use. Important information related to ingredients, intended use, safety, and 
directions for use was often incomplete, inconsistent, or missing for supplement labels in our 
sample. Labels also often failed to present information in a manner that facilitates understanding 
among consumers. No standardized format exists for labels, and labels have few distinguishing 
features to help consumers differentiate supplements from other self-care products. 
We drew on several sources of data for this analysis.  To assess the extent to which existing 
labels adhere to the elements identified in our template, we performed an original analysis of 
100 products that consumers recognize as dietary supplements and commonly use. The 
template is detailed in our companion report Dietary Supplement Labels: Key Elements 
(OEI-01-01-00120). We supported those findings with 76 stakeholder interviews with 
regulators, industry representatives, and consumer groups, as well as 7 focus groups with 
consumers and health professionals.  We also reviewed relevant literature, laws, and 
regulations, including congressional testimony, FDA consumer studies, and national survey data 
on supplement use. 
Dietary Supplement Labels Fail to Adhere to the Key Elements in 
Our Template. 
Consumers need accurate and sufficient information on labels to make informed and 
appropriate choices about supplement use. This is particularly important, given the widespread 
use of dietary supplements as self-care products, and the relative lack of other reliable sources 
of information. 
In our companion report entitled Dietary Supplement Labels: Key Elements 
(OEI-01-01-00120), we 
presented the template of the key 
Template of Key Label Elements 
elements of a label that can help 
consumers make informed and 
Content  Presentation 
appropriate choices about 
U Ingredients  U Standardized format 
supplement use.  (see box for a list 
of those elements.) We used the  U Intended use  U Distinct product features 
current federal requirements for 
U Safety information  U Readability 
supplement labels as a starting 
framework. We then incorporated  U Directions for use  U Balance 
the feedback from our interviews, 
U Product information  U Constructive use of space 
focus groups, and literature 
reviews.  The template sets forth a 
framework for key 
5 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  label elements in terms of essential information and precepts for presenting that information. In 
this report, we assess the extent to which existing dietary supplement labels reflect the key 
elements identified in our dietary supplement label template. When our assessment applies 
primarily to one type of supplement, we note it in the text. We organize our review by template 
element (see Appendix A for a complete description of the template). 
Labels Often Fail to Provide Sufficient Information to Guide the Informed and 
Appropriate Use of Supplements. 
We found that supplement labels routinely lack information or contain confusing information in 
four areas of our template: ingredient composition, intended use, directions for use, and safety 
information. Our label review, focus groups, and interviews with key stakeholders raised few 
concerns related to a fifth element: product information. 
Ingredient information is often difficult to interpret. 
Supplement labels ought to provide accurate and sufficient detail about supplement composition

for users to understand exactly what they are taking. Without such information, consumers may

be putting their health at risk by overdosing on certain ingredients, or they may be spending

money on supplements that are not formulated to meet their needs.

Labels with testing guarantees often give misleading assurances of ingredient quality.

In our review of 100 labels, we found several labels containing their own symbols and

statements guaranteeing ingredient

testing and quality.  These guarantees

Potentially misleading symbols related 
often appear to be misleading,  to the testing of ingredient quality:
indicating no clear basis of what 
supports them (see box for 
examples). One health provider told 
us that when she called a company to 
determine their standardization 
criteria, a company representative 
told her the company standardizes 
its products to excellence.  A 
number of the regulators and health professionals we spoke with raised concerns that such 
statements and symbols can mislead consumers. 
Labels often do not clearly distinguish active ingredients from inactive ones. Ninety-
three out of the 100 labels we reviewed did not make clear which ingredients were active. 
Some of the labels contained discussion about active properties, but it was difficult to determine 
whether this was marketing hype or factual information. DSHEA does not require dietary 
supplement labels to make clear which ingredients are active. Without being able to distinguish 
the active ingredients from the nonactive ones, it can be difficult 
6 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  for consumers to assess products content and to compare supplements in an informed manner. 
Furthermore, 94 of the labels we reviewed did not make clear the extent to which ingredients 
could be absorbed into the bloodstream (bioavailability).  A few labels alluded to 
bioavailability, disintegration, or time release, but did make not clear to what extent the 
ingredients were available for absorption. DSHEA does not require dietary supplement labels 
to make clear the extent of bioavailability of ingredients. Without this information, consumers 
and health care professionals cannot readily assess product efficacy or the potential for adverse 
reactions. The bioavailability of a supplement may depend on the form in which a supplement is 
taken. For example, the bioavailability of an ephedrine extract is far greater than the 
bioavailability of the unprocessed herb. 
Ingredient names may be inconsistent across supplement labels. This is particularly 
problematic for botanical supplements, which account for a quarter of dietary supplement 
sales.6 FDA labeling regulations for herbal supplements require that ingredients be listed under 
their Latin binomial names, except when they are listed in the Herbs of Commerce.7 However, 
even the Herbs of Commerce contains multiple common names in some instances. One 
commonly cited example relates to products containing ephedra. The species Ephedra 
equisetina may be called Chinese joinfir, ma huang, ephedra, or Chinese ephedra. A second 
species, Ephedra nevadensis, may be referred to as Mormon tea, Brigham-tea, or desert tea. 
Similarly, Echinacea angustifolia may be listed as echinacea, narrow-leaved echinacea, 
Kansas snakeroot, or narrow-leaved purple coneflower. Consumers may be unaware of the 
existence of multiple common names, and may end up purchasing several products containing 
the same ingredients. In fact, one of the health professionals in our focus groups shared a story 
of a patient who was taking three different weight loss supplements without realizing that all 
three contained Ephedra, thus putting herself at a potential risk for overdose. 
Supplement Facts panel may be of limited usefulness to consumers. The Supplement 
Facts panel provides important ingredient information, including the recommended serving size 
and the corresponding percent daily value. Many of the regulators, consumers, and health 
professionals we interviewed told us that the uniform format of the Supplement Facts panel has 
been very effective as a means of standardizing information 
7 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  consumers to more easily find and  The Percent Daily Value column makes little 
compare ingredient information.  sense for botanical supplements: 
However, many of these same 
interviewees raised concerns about the 
usefulness of the Supplement Facts panel. 
They pointed out that the format of the 
panel makes little sense for botanical and 
specialty substances, which do not have 
established Referenced Daily Intakes 
(RDI) or Daily Reference Values (RDV) 
(see box to right). Moreover, some 
nutritionists and health care professionals 
we spoke with questioned the current RDI 
for vitamins and suggested that quantities greater than the 100 percent of the RDI may be 
beneficial when these products are taken for therapeutic purposes. 
Labels often do not provide information about the quantity of individual ingredients 
in proprietary blends.  DSHEA requires that proprietary blends (in which the supplement 
formulation is privately-held) declare on the label the net weight of the blend and list the 
ingredients in descending order of weight. The labels are not required, however, to list the 
specific quantities of each individual ingredient. None of the 15 supplements containing 
proprietary blends that we reviewed during our inquiry disclosed any information about the 
amount of individual ingredients. 
Limited disclosure of ingredient 
Yet, information about the quantity of specific 
information in proprietary blends: 
ingredients can be important for supplements that 
contain pharmacologically active substances, such as 
St. Johns Wort or Ephedra. As blended products 
become an increasing segment of the herbal market, 
concerns about the lack of disclosure for the amount 
of individual ingredients becomes more pressing (see 
box to left). The propriety blend provision was 
initially written into FDA label regulations to protect 
proprietary recipes in an environment in which there is 
no patent protection.  However, several interviewees 
raised concern that the proprietary blend provision is 
specifically being used by some manufacturers to 
avoid full disclosure of ingredients. 
8 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  Statements of intended use often provide limited information. 
FDA label regulations do not require that supplement labels contain information about the 
intended use of the supplement, although they do allow manufacturers to make certain types of 
claims about the supplements benefits. Many manufacturers use structure/function claims, 
health claims, or qualified health claims to communicate to consumers the intended use(s) of 
their supplements. 
Structure/function claims are statements that a 
supplement will affect the bodys structure  The disclaimer required to accompany 
(such as the skeletal system) or one of its  structure/function claims: 
functions (such as circulation).  These claims 
This statement has not been evaluated by 
were first permitted on dietary supplements for 
the Food and Drug Administration. This 
non-nutritive purposes by DSHEA. These  product is not intended to diagnose, treat, 
claims must be accompanied by a disclaimer  cure, or prevent any disease. 
(see box to right). 
A health claim is a statement that expressly or by implication characterizes the relationship of a 
nutrient in a supplement to a disease or health-related condition. These claims were permitted 
on dietary supplements under the Nutrition Labeling and Education Act of 1990. No disclaimer 
is required to accompany a health claim. 
A qualified health claim is similar to a health claim in the statements it can make, but is more 
tentative in its tone and may be required to be accompanied by a disclaimer.  Qualified claims 
have only recently been permitted on dietary supplements as result of court cases. 
Structure/function claims often do not clearly communicate intended use. 
Structure/function claims constitute the vast majority of all claims on supplements, with as many 
as 12,000 supplements making a structure/function statement (see box to left for examples). A 
number of our interviewees, including 
health professionals, consumer groups, 
Typical structure/function claims 
found on dietary supplements:  and industry representatives, raised 
concerns that structure/function claims
Promotes well-being 
are often worded in a confusing way, and
Cerebral circulation

in many cases are too general to be

Supports joint function 
Promotes fast and accurate thinking  meaningful. They highlighted the fact that

For bone health  vague wording could lead to

May support womens needs 
inappropriate use of the supplements. 

9 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  During our review of supplement labels we found the claim of promotes well-being on 
Ginseng, Echinacea, SAMe, and St. Johns Wort supplements.  This statement, which is 
characteristic of the way in which structure/function claims are worded, does not disclose the 
ways in which the supplements promote well-being, the aspects of well-being targeted by the 
supplements, or the conditions under which the supplements should be taken.  Furthermore, 
consumers may mistakenly think that St. Johns Wort, Echinacea, SAMe, and Ginseng 
supplements with the same claim are interchangeable, when in fact they are not. 
Health claims and qualified health claims may also be of limited value to consumers. 
Currently, there are 19 authorized health claims for dietary supplements.  Although the 
consumers and health professionals in our focus groups liked the specificity of health claims and 
qualified claims, they did not find them to be user-friendly.  The length of the claims and 
complexity of the language made it difficult for them to understand the underlying message. The 
tentative tone of the claims further obscured the underlying message. Consumers in our focus 
groups expressed more confidence in the 
shorter, more direct statements in 
structure/function claims, and stated that 
Authorized Health Claim Found on Calcium 
they were likely to ignore health claims and  Products: 
qualified health claims. 
Regular exercise and a healthy diet with enough 
calcium helps teen and young adult Caucasian 
Our focus group participants raised two  women maintain good bone health and may reduce 
their risk of osteoporosis later in life. 
major concerns about the authorized 
health claim for calcium and osteoporosis  Recently Authorized Qualified Health Claim for 
(see box). First, they were confused as to  Omega-3 Fatty Acids: 
why the claim singled out benefits to  It is known that diets low in saturated fat and 
certain groups (i.e., teens and young adult  cholesterol may reduce the risk of heart disease. 
The scientific evidence about whether omega-3 
Caucasian women) and not others.  It was 
fatty acids may reduce the risk of coronary heart 
not clear to them whether products 
disease (CHD) is suggestive, but not conclusive. 
carrying this claim would be beneficial to  Studies in the general population have looked at 
consumers of other ages and races.  diets containing fish and it is not known whether 
diets or omega-3 fatty acids in fish may have a 
Second, many of consumers and health 
possible effect on a reduced risk of CHD. It is not 
professionals in our focus groups were 
known what effect omega-3 fatty acids may or may 
concerned by the word may, because  not have on risk of CHD in the general population. 
they believed that it detracted from the 
certitude of the statement. 
Currently, there are three authorized qualified health claims.  Our focus group participants 
primary concerns about the qualified claim for omega-3 fatty acids and coronary heart disease 
(see box) centered on the seemingly contradictory language of the claim.  For example, the 
health professionals were concerned that a long statement of potential evidence followed by a 
statement beginning It is not known would seem contradictory to consumers.  They also 
believed that terms, such as suggestive but not conclusive, might confuse consumers. 
10 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  Consumers and health professionals often have difficulty differentiating between 
health claims and structure/function claims. We found that none of the consumers and 
health professionals in our focus groups were able to distinguish between health claims and 
structure/function claims. FDA found similar results in the nine consumer focus groups it 
conducted.8 The presence of the FDA disclaimer may help consumers distinguish between 
structure/function claims and health claims because a health claim does not require a disclaimer. 
However, neither the consumers nor the health professionals in our focus groups could make 
the link between the disclaimer and the presence of a structure/function claim. 
Moreover, in its review of dietary supplement claims, the General Accounting Office suggested 
that consumers may incorrectly equate products claiming to maintain health (structure/function 
claims) with products claiming to reduce the risk of disease (health claims), and thus may 
attempt to treat a disease with a product not capable of producing that benefit.  If consumers 
do not appreciate the difference in the amount of regulatory oversight for each type of claim, 
they cannot factor information about the credibility of a products claim into their purchasing 
decision. 
Auxiliary statements on labels may lead to false expectations about the purposes or 
efficacy of supplements. In our review of 100 supplement labels, we found 12 that claimed 
to be scientifically tested. While clinically tested or scientifically proven may be a valid 
claim, it also has the potential to mislead consumers into thinking that a supplement has been 
tested in a pre-market fashion akin to prescription drugs, and thus may create a false perception 
of proven safety and efficacy.  FDAs focus group research found that some consumers believe 
that supplement manufacturers conduct controlled clinical trials to test the efficacy of specific 
supplements, when in fact few do.  Many of the health professionals and consumer advocacy 
groups we spoke with believed that, if manufacturers were going to put such statements on their 
labels, they should include information on the type of trial conducted and the dose used during 
the clinical trial.  However, of the 12 labels, which claimed to be clinically tested or scientifically 
proven, 9 did not provide a reference for the research claimed. 
Many supplements lack any type of claim, and thus provided no information to 
consumers on the purposes of the supplement.  FDA estimates that there are 29,000 
supplements on the market. Yet, FDA has authorized only 19 health claims, and received 
notification letters for almost 12,000 structure/function claims since the passage of DSHEA. 
Based on these numbers, it appears that many labels contain no claims.  In fact, in our sample 
of 100 supplements, 31 did not provide any information to the consumer on the purpose of the 
supplement. Since there are no approved mechanisms for communicating intended use on a 
label other than claims, this suggests that a large number of supplements may not communicate 
the supplements purpose(s).  Such information may be particularly important for those 
supplements that have no clear nutritive value. 
11 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  Safety information is often incomplete. 
While the vast majority of supplements appears to be safe within a broad range of intake, some 
supplements can have adverse effects. Because consumers are typically taking supplements on 
their own initiative and often in combination with other products, it is essential that they have 
enough safety information to take supplements in an informed and appropriate manner.9 
Many labels provide insufficient information on maximum doses. Eighty-five of the 100 
labels we reviewed did not contain a clear statement about maximum dose.  Such information is 
critical for supplements which, if taken in large doses, could have harmful effects.  For example, 
research studies have shown that doses greater than 10,000 IU of vitamin A are associated 
with birth defects;10 yet few bottles containing a supplement with vitamin A provide information 
on maximum dose. 
Exceeding the recommended dose could potentially present a significant public health problem. 
Prevention magazine extrapolated from the results of a recent survey and estimated that about 
7.3 million consumers of vitamins and minerals, 4.5 million consumers of herbal remedies, and 
3.8 million consumers of specialty products take more than the amount recommended on the 
label.11 Overdosing is of particular concern for consumers who are taking supplements to treat 
or prevent medical conditions. 
Many labels provide insufficient information about the medical conditions or 
populations for which the supplement may be contraindicated.  Sixty-one of the 100 
labels we reviewed did not mention specific contraindications. The cautions for particular 
populations on the remaining products greatly varied in the scope and specificity of the 
information they conveyed. We found this variability even among supplements containing 
identical ingredients in identical doses, which clearly have equivalent safety risks (see box). 
Many of our interviewees, especially 
Precautionary Information on 60 mg Gingko Biloba  the health professionals and consumer 
Supplements:  advocates, were particularly concerned 
about the lack of warnings on 
Supplement 1: If you are taking a prescription 
supplements for women who are 
medicine, such as an anticoagulant agent, are 
pregnant or are lactating, please contact your doctor  pregnant or nursing. They believed 
before taking this product.  that, unless studies have proven 
supplements to be safe for women who 
Supplement 2: If you are taking medication, facing 
surgery or have bleeding problems, consult your  are pregnant or nursing, labels should 
physician before taking this product.  automatically contain a precautionary 
statement. Seventy-one of the 100 
Supplement 3: No information given. 
labels we reviewed did not have such a 
statement.  Others expressed concern 
about the lack of specific 
12 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  warnings for the elderly, who metabolize chemical substances more slowly, and for children, 
who may need to take smaller doses or should avoid use of supplements completely. None of 
the supplement labels we reviewed contained cautions for the elderly and only 13 mentioned 
special considerations for children.  FDA has recently declared its intent to propose a rule 
requiring the inclusion of warning statements for women who are or may become pregnant. 
Many labels provide insufficient information on potential interactions with other 
supplements, over-the-counter drugs, or prescription drugs. Eighty-seven of the 100 
labels we reviewed did not list interactions 
with other products. When they did, we 
Precautionary Information on SAMe 200 mg 
found great variability in the information 
Supplements: 
provided about interactions. For example, 
the SAMe products we reviewed, all  Supplement 1: If you are pregnant, 
containing 200 milligrams, contained various  breastfeeding or are taking antidepressant 
medication, consult your physician before using 
levels of detail about interactions (see box). 
this product. Take this product under medical 
Given the wide variability in information 
supervision if you have a bipolar disorder. 
provided and terminology used, it is not 
surprising that consumers have difficulty  Supplement 2: Persons who have a health 
finding information on interactions.12  condition should consult with a health care 
professional before using this product. 
According to Prevention magazine, nearly a 
third of consumers report taking supplements 
Supplement 3: No information given. 
in combination with prescription drugs or 
with over-the-counter (OTC) medicines, 
which suggest an important place for information on interactions on the label.13 
Many labels provide insufficient information on potential adverse reactions or side 
effects that consumers may experience.  Eighty-nine of the 100 labels we reviewed did not 
list possible adverse reactions or side effects.  Yet, the Dietary Supplement Education Alliance 
states that side effects are possible with any dietary supplement.14 This lack of information on 
the label means that consumers may not know if a symptom they are experiencing should be 
anticipated, or whether it is one that should alert them to discontinue use and seek care from a 
qualified health professional. This may compromise consumers ability to make an informed 
choice about what supplements are appropriate for them. 
In the 11 cases where the labels did contain information on potential adverse reactions or side 
effects, they often failed to provide information on whom to contact in case of an adverse event. 
Seven of those 11 labels did not carry language calling for consumers to contact a health 
professional in case of accidental ingestion/overdose. None of the 11 supplements carried 
FDAs Medwatch phone number for consumers to alert FDA of any serious reactions or 
problems they may experience in taking a supplement. Yet, according to Prevention 
magazine, 12 percent of herbal consumers (about 11.9 million people) and 13 percent of 
specialty product users (about 6.5 million people) say they have experienced a side effect or 
adverse reaction.15 
13 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  Many labels lack information on supplement expiration. Twenty-five of the 100 labels 
we reviewed did not have an expiration date.  Of the 75 labels that did include expiration dates, 
15 were smudged, faint, or otherwise hard-to-read, making it difficult for consumers to find and 
to read this information. 
There was some disagreement among the stakeholders that we interviewed about the 
significance of the lack of expiration dates on supplements. Some pointed out that an expiration 
date can provide important information about the extent to which a supplement maintains its 
labeled potency, purity, and physical characteristics.  Without an expiration date, it would be 
impossible for consumers to determine whether a supplement is still potent.  Others believed 
that while an expiration date is theoretically important, it is of limited value on supplements 
because no uniform method exists for determining the expiration date.  In fact, one FDA official 
told us that some manufacturers put expiration dates on supplements for marketing purposes, to 
give supplements an aura of respectability. In such a case, the existence of an expiration date 
is not only misleading to consumers, but may also be meaningless. 
Directions for use are often insufficient. 
While DSHEA allows for supplement labels to contain information about the directions or 
conditions of use, this information is not required.  The only information that must be present 
on labels is a recommended serving size, which is defined as the amount recommended for 
consumption per an eating occasion. There is no requirement that labels disclose the number 
of servings necessary to achieve the claimed benefit, or under what conditions those servings 
should be taken to achieve maximum effectiveness.  As a result, labels often lack sufficient 
information about how and when consumers should take supplements to achieve the benefits 
claimed on the supplement label. 
Dosage information is often unclear.  There is great variability in the directions for use, and 
how that information is communicated on supplement labels. Several factors account for the 
confusion.  First, the serving size and recommended daily dose need not be the same.  Labels 
are not required to make clear the number of servings necessary to consume an effective daily 
dose. Second, locating information about the directions of use can be difficult. While the 
serving size is prominently displayed as part of the Supplement Facts panel, information on 
additional directions for use is usually buried in the label. While 99 of the 100 supplement 
labels that we reviewed did contain a section on directions for use, in many cases it was difficult 
to find. 
Variability in the disclosure of dosage information has a number of implications for the informed 
and appropriate use of supplements by consumers.  It makes comparison shopping for 
supplements difficult, as it requires consumers to multiply (or divide, depending on the 
instruction) the serving size by the recommended number of occasions for supplement intake in 
order to understand the total daily dose that they are consuming.  It can also contribute to 
noncompliance.  Consumers may not understand that they have to take multiple pills to get the 
desired effect. Furthermore, if consumers switch supplement brands, they may not be aware of 
a change in dose or intake pattern. 
14 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  Finally, sometimes dose information is 
Dose Information Can Be Confusing: 
described in relation to an effect on the 
structure or function of the body, but the  Supplement A (Memory Enhancing Supplement)* 
boundaries of that symptom may not be 
C  To maintain memory function, take 1 or 2 
clear. In our review of directions for use 
capsules daily. 
for 100 labels, we found 8 products in 
C  To enhance memory function, intake can vary 
which the dosage depended on the 
depending on individual needs and may be 
severity of the condition. Yet we could 
increased up to 6 capsules daily. 
not find definitions for the terms used on 
C  For severe memory loss, consult your 
the label, such as severe memory loss, 
physician. 
individual needs and intensive use, to 
differentiate between doses (see box).  Supplement B (for Improving Mental Sharpness) 
C  Take one tablet twice daily. 
Many labels do not specify a minimum 
amount of time for which the product  C  For intensive use, take up to two tablets 
should be taken before consumers can  twice daily. 
expect to see an effect.  Ninety-five of 
* The following information was listed on the package 
the 100 labels we reviewed did not list the  insert; the label referenced this insert. 
minimum duration of use.  Furthermore, 
the 8 mini-packages in our collection 
(which contained only one serving each) did not make clear to consumers that multiple servings 
of the supplement would be necessary to achieve the label claims. Unlike most over-the-
counter drugs, which start working in a matter of minutes, dietary supplements such as St. 
Johns Wort or Saw Palmetto may take up to 6 weeks. 
However, many consumers do not understand that supplements often take longer than 
prescription and OTC drugs to take effect, and may stop supplement use within a month of 
taking a supplement if they do not see results.16 In fact, a recent study by the Dietary 
Supplement Education Alliance found that one in five consumers erroneously believes 
supplements produce a benefit within a week.17 
Labels Often Fail to Present Information in a Manner that Facilitates Consumer 
Understanding. 
To help consumers make informed and appropriate choices about supplement use, a dietary 
supplement label should not only have adequate information but also present that information in 
a way that facilitates consumer understanding of the supplement. FDA recognized the 
importance of label presentation when it revised food labels in 1993 and OTC labels in 1999. 
However, neither DSHEA nor other federal regulations address label presentation for dietary 
supplements, except in requiring a Supplement Facts panel and the word supplement on the 
front panel of the label.  With few federal guidelines on label presentation, manufacturers print 
and organize label information in a variety of ways.  This can lead to great innovation on the 
part of manufacturers, but it can also add to consumer confusion and difficulty in finding 
important label information. 
15 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  No standardized format exists. 
In designing supplement labels, manufacturers may follow many different formats, use varying 
terminology, and sometimes even provide inconsistent information, even across similar 
substances. The lack of a logical and systematic framework for presenting label information 
may make it difficult for consumers and health professionals to locate and read important 
information and to select the most appropriate supplement.18 
Information placement often varies. In our review of 100 supplement labels, we found that 
safety information did not have a consistent position in relation to the front panel.  Of the 26 
supplements sold in boxes, 9 had safety information on the back panel, 3 on side panels, and 
14 did not have the information at all.  Of the 66 supplements sold in bottles, 13 had safety 
information to the right of the front panel, while 14 had the information to the left.  We found 
similar inconsistencies in the placement of directions for use information: 32 had the information 
listed above the Supplement Facts panel, 17 below, 17 to the right, 5 to the left, and 28 on the 
opposite side. With such inconsistent placement of information, consumers may find it difficult 
to locate the information they need. For example, when asked to identify and read aloud 
claims, safety information, and standardization symbols and statements, participants in our focus 
groups spent several minutes looking at the label, often needing assistance finding the 
information or having to read through the entire label first. 
Headings for identifying information are often inconsistent.  Headings can provide 
important visual clues to help consumers quickly distinguish between different types of 
information.  In its proposed OTC label 
revisions, FDA identified uniform headings 
Directions for use and safety information can 
and subheadings as one of three  have many different headings on supplements 
contributing factors to the readability and  labels: 
understanding of labels. However, in our  Directions for use:  Safety: 
review of 100 supplement labels, we 
1.  Recommendation(s)  1.  Warning(s) 
found several different headings that 
2.  Recommended Dose(age)  2.  Note 
referred to similar information (see box).  3. Recommended Adult Intake  3.  Caution 
Of the 44 labels that disclosed safety  4. Suggested Use  4.  Precaution 
5. Directions for Adult Use
information, 9 did not have a heading to 
draw attention to that information, and 4 
included that information in the section on 
directions for use. 
Supplement labels had few distinguishing features. 
In its 1997 label regulations, FDA aimed to distinguish supplements from other products 
through requiring the title Supplement Facts for the nutrition panel and the word supplement 
on the front panel.  However, these measures may be insufficient in distinguishing supplements 
from other self-care products, given the proximity of supplements to other types of self-care 
products.  First, supplements are often placed near 
16 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  OTC drugs, homeopathic products, and functional foods in stores. Second, some supplements 
share similar ingredients with these products; for example, both senna and cascara can be sold 
as an herbal supplement and as an OTC drug. 
Supplement claims are often indistinguishable from OTC claims.  In its final rule for 
structure/function claims, FDA allowed supplement labels to contain claims previously 
authorized for OTC drugs as long as the labels carried the mandatory FDA disclaimer and 
otherwise met the requirements set forth in DSHEA. For example, supplements for motion-
sickness can carry a structure/function claim for the prevention and treatment of nausea, 
vomiting, or dizziness associated with motion, and supplements to promote sleep can carry a 
structure/function claim for the relief of occasional sleeplessness. However, as discussed 
earlier in the report, the FDA disclaimer does little to alert consumers to the presence of a 
structure/function claim. Unable to distinguish between supplement structure/function claims 
and OTC claims, consumers may believe that OTC drugs and supplements are interchangeable. 
Language and illustrations on supplement labels may be suggestive of pharmaceutical 
products.  In our review of 100 supplement labels, we found statements that the supplement is 
sold through physicians offices and pharmacies, or is doctor recommended. Some 
supplement labels contained pictures of people 
wearing physician lab coats and stethoscopes. 
A Supplement or a Medicine? 
Some supplements also had company names 
Prescribed Choice  and trademarks that sound like they could be 
pharmaceutical products (see box). We also 
Natural Medicine	
found a few supplements made by well-known 
pharmaceutical companies, which might lead 
consumers to believe that supplements are the 
same as pharmaceutical products.  While such practices may be technically allowed under FDA 
regulation, our interviewees raised concerns that they may lead to false expectations. 
Supplements bearing structure/function claims are expressly not intended to diagnose, treat, 
cure, or prevent any disease. 
Complex language and small font size inhibit readability. 
Certain users of supplements may benefit from visual cues that highlight important information 
and from simple language that increases readability. This may be particularly true for elderly 
consumers and nonnative English speakers.  However, we found that many supplement labels 
lacked visual cues and used complex language, preventing a broad range of consumers from 
easily reading and understanding label information. 
Font size is often inadequate for many consumers. Federal regulations allow 
manufacturers to use a minimum 4.5-point type size on supplement labels.  By contrast, FDA 
determined that a 4.5-point type size for OTC drugs was too hard to read by consumers, 
especially those over 51 years old, and thereby mandated a minimum 6-point 
17 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  type size. Many of the elderly consumers in our focus groups complained that they had 
difficulty reading supplement labels due to their small font size; some participants recounted 
bringing a magnifying glass to the store to ensure that they could adequately read the label. 
When asked to read supplement labels, several health professionals in our focus groups also 
had difficulty. 
Some supplement labels use complex language.  We found that some consumers in our 
focus groups were unable to pronounce and understand safety information printed on 
supplement labels. These consumers expressed confusion over medical terminology such as 
anticoagulant, and preferred safety information to be in simple language.  One participant said 
that claims, like the FDA-approved qualified claim for omega-3 fatty acids, are too wordy, 
discouraging consumers like him from reading the label. A few pharmacists in our focus groups 
also told us about patients asking them to translate the label information into more readable 
language. 
Information on benefits and risks is often imbalanced. 
Federal laws and regulations do not formally require a supplement label to balance negative and 
positive messages. However, FDA does require supplement manufacturers to print certain 
factual information and to disclose material facts.  But, because FDA has yet to define the 
material facts provision, industry representatives told us that supplement manufacturers have 
varying criteria for disclosing safety information, contributing to the imbalance of label 
information. 
Limited space given to risks.  Thirty-eight of the 69 supplement labels in our sample had 
statements about a supplements potential benefits but did not disclose any safety information. 
Of the supplements that provided safety information, most used fewer lines for the safety 
information than for the products benefits, and a few used smaller fonts.  Industry 
representatives we interviewed said that supplement labels play a major role in marketing, and 
raised concerns that without federal standards for required safety information manufacturers 
may inconsistently highlight the value and benefits of supplements over risks or special 
considerations. 
Websites referenced on labels may not provide consumers with accurate information. 
Given the limited space on supplement labels, many manufacturers reference Internet websites 
on their labels as a source for additional information. In our review of 100 supplement labels, 
we found that 45 labels contained website references.  The Internet is an emerging source of 
health information, with potential to provide more information about supplements beyond the 
label. Many of the consumers and health professionals in our focus groups told us that they 
perceived website references as useful ways to get additional information. 
18 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  Some websites contain inaccurate and misleading information.  The Federal Trade 
Commission, in partnership with FDA and other government agencies, has found that 
examples of questionable products being peddled on the Web abound.19 These agencies 
discovered over 200 websites fraudulently claiming that dietary supplements and other products 
could treat illnesses like anthrax.20 Between October 1999 and August 2001, FTC received 
over 20,000 hits from consumers accessing its health-related teaser Websites that mimic sites 
that the agency has found to provide fraudulent information. A 2001 General Accounting 
Office report also highlighted how Websites that sell supplements geared to the elderly may use 
misleading and inaccurate claims.21 
Several Factors Inhibit Supplement Labels From Adhering to Our 
Template. 
Lack of clearly defined FDA standards. 
Supplement manufacturers conduct business in a highly competitive marketplace. Discount 
retailers, pharmacies, and grocery stores have begun to manufacture their own brands of 
dietary supplements, and to form partnerships with Internet companies to market supplements. 
Pharmaceutical companies have also entered the supplement industry, using their established 
brand names in prescription drugs as a marketing advantage in selling supplements. 
In this environment, uniform standards that delineate a baseline of acceptable label practices are 
vital in ensuring that both well-established and new manufacturers label their supplements 
accurately and consistently. Without such standards, manufacturers do not have the tools to 
create or sustain a level playing field. Below we identify three key areas where standards are 
lacking. 
No guidance on what constitutes a material fact. The federal Food, Drug, and Cosmetic 
Act requires manufacturers to disclose on the label facts material...to consequences that may 
result from taking a supplement.  FDA stressed the importance of the material facts provision in 
its structure/function final rule, and listed clarification of the material facts provision as a B-list 
priority in the Center for Food Safety and Applied Nutritions (CFSAN) 2001 Program 
Priorities.  However, FDA has not taken steps to determine the level of evidence necessary for 
a safety risk to become a material fact, what supplements currently fall under the material fact 
provision, and what language may be used on the label to describe the material fact. 
Manufacturers acknowledge that FDA makes efforts to alert the public and industry of harmful 
products through its website and letters to industry and health professionals, but criticize these 
efforts as not being enough to ensure consistent labels. 
Without a publicly articulated policy by FDA, manufacturers do not operate on a level playing 
field.  Manufacturers told us that, without written guidelines, they have few ways to determine 
which products fall under the material facts provision. While a number of manufacturers put 
warning information on their labels in response to public concerns, 
19 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  they voiced concern that too many warning statements on labels would overwhelm consumers, 
causing them to ignore the safety information altogether. 
To further complicate matters, a number of states have begun to require warning statements for 
certain supplements. For example, Texas requires warning statements for supplements 
containing the stimulant ephedra, and California requires warning statements on supplements 
containing dieters teas. In recent months, a number of other states and localities have 
considered requiring warning statements for products containing ephedra.  Many interviewees, 
particularly industry representatives, raised a concern that variations in state warnings can cause 
confusion among consumers and frustration for manufacturers. For example, Texas requires 
specific warning language on ephedra supplements and requires that manufacturers list FDAs 
toll-free Medwatch telephone number on the label. By contrast, the State of Ohio does not 
have a required warning statement for ephedra supplements.  It does, however, require a 
number of other pieces of information to appear on the label, such as a maximum recommended 
dose. The Texas warning is silent on the issue of maximum dose for ephedra supplements. 
In 2001, the Federal Trade Commission (FTC) took six enforcement actions against individual 
companies making unfounded claims on the Internet.  As part of the settlement, the FTC 
required two companies promoting the herb St. Johns Wort and one manufacturer of ephedra 
to disclose warnings of potential interactions on their labels, advertisements, and promotional 
materials. It is significant to note that FTCs required warning statement for ephedra differs 
from the ones required by most states. For example, the FTC statement mentions risk of injury 
that may include heart attack, stroke, seizure, or death, whereas the warning in Texas only 
requires that the supplement may cause serious adverse health effects. Yet, a number of 
manufacturers told us they are concerned that FTCs actions may cause confusion, as some 
manufacturers may interpret FTCs actions as applying to entire categories of products, when in 
fact they only apply to the offending companies. 
Both industry and consumer groups have called for FDA to define material facts and to issue 
guidance or regulation accordingly. To fill this regulatory void, several of the larger trade 
associations have developed a list of ingredients that should carry safety information; all 
member companies manufacturing supplements containing these ingredients must carry the 
safety information on labels. While some non-member companies do adhere to these industry 
guidelines, others do not. The guidelines are voluntary and thus non-members have little 
incentive to follow them. 
No guidance on the evidence needed for substantiation files.  Manufacturers are required 
to have substantiation for each structure/function claim made on a label. However, FDA has yet 
to define what level or type of evidence manufacturers should have even though it identified 
substantiation as a priority in CFSANs Ten-Year Strategic Plan. In some cases, the 
substantiating evidence behind structure/function claims appears 
20 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  to be quite weak. For example, at a FDA Dietary Supplement Stakeholder Meeting in July 
1999, a participant noted that, when she asked manufacturers of chitin for documents 
substantiating their claims, 98% of [it] has nothing to do with the claim made. The other 2% 
has to do with animal research.22 
Given the variability in substantiation data, manufacturers told us it is difficult to achieve a level 
playing field. However, manufacturers also told us that they are reluctant to make 
substantiation data public because companies do not have patent protection for supplements. 
At the same time, manufacturers said that they would be more confident in the quality of the 
data if FDA reviewed substantiation files. 
No guidance on the use of terms and phrases of product quality. Neither FDA nor 
industry groups have defined what constitutes label claims, such as pure, natural, and 
standardized, and phrases, such as clinically proven and doctor recommended. 
Manufacturers are frequently printing these terms and phrases on supplement labels as a way to 
market their supplements. Often, symbols and stamps, such as a gold-colored emblem, 
accompany the terms and phrases to bring attention to the supplements quality claim.  Our 
focus groups confirmed that such terms and phrases appeal to them and elicit an additional level 
of trust in the product. But, without uniform standards established by FDA or by industry 
groups, manufacturers cannot compare the quality of their products or hold each other 
accountable. 
Few measures for ensuring product authenticity. 
No official monograph system for supplements. Monographs can synthesize authoritative 
traditional and scientific literature on supplement properties, production, and use.  Monographs 
may also provide information about health benefits and risk for individual ingredients as well as 
information on safe doses. Without official monographs for supplements, manufacturers lack 
uniform standards against which to produce and label supplements, resulting in a wide spectrum 
of supplement preparations and recommended uses. 
In the absence of federally sanctioned monographs, organizations, such as the American Herbal 
Pharmacopeia, United States Pharmacopeia, and American Botanical Council, have published 
monographs on their own and are in the process of developing more.  While these serve as 
important steps toward a more uniform standard of supplement production and use, a number 
of concerns are associated with these private efforts.  The monographs are voluntary, do not 
cover the same information, and do not represent the vast number of herbal products on the 
market.  The monographs are costly and resource-intensive to design and, without steady 
funding streams, it is difficult for any one organization to make significant progress. Further, 
manufacturers may find it difficult to follow monographs because their criteria may require 
special machinery and procedures, like meeting GMPs, that only a few manufacturers are able 
to afford. 
21 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  No validated testing methods.  According to DSHEA, FDA can test dietary supplements 
only using established and officially accepted testing methods.23 However, GMP regulations 
may not impose standards for which there is no current and available analytical methodology. 
As a result, neither FDA nor industry have adopted uniform methods of analysis for identifying 
and quantifying active constituents in botanicals and specialty supplements.  Several 
organizations are trying to develop validated testing methods, but a lack of funding and cohesion 
hinder this costly and resource-intensive process.  In part, efforts are slowed by the fact that 
many supplements work synergistically, and it is not clear what aspect of the supplements 
should be tested. A number of manufacturers have developed their own in-house validation 
procedures, yet there is little uniformity in how they test supplements.24 This may be one 
explanation for why independent laboratory analyses of supplement labels often reveal a 
different amount of active ingredient than the one disclosed by the manufacturer on the label.25 
Limited wording of claims. 
Claims may not allow for clear communication of a supplements intended use.  FDA 
regulations for structure/function claims, health claims, and qualified health claims make it 
difficult for manufacturers to clearly express the health benefits of supplements. 
Structure/function claims are limited because while they are allowed to describe health to the 
structure or function of the body, they cannot make references to any type of medical condition 
or illness.  Structure/function claims cannot suggest that a supplement in any way treats, 
prevents, mitigates, or cures a disease. This creates a disconnect with the way consumers are 
using supplements, which is often for therapeutic benefit.  A number of manufacturers we spoke 
with expressed frustration at having to use vague language so that their claim could meet the 
legal definition of structure/function claim. 
While health claims and qualified claims allow manufacturers to make explicit statements about 
reducing the risk of disease, they may also be of limited value in communicating intended use to 
consumers.  In an attempt to make the state of current knowledge about supplements clear, 
FDA may in fact further confuse consumers by authorizing statements that are too long and too 
complex to be useful.  Some of the manufacturers we spoke with stated that the language on 
health claims and qualified health claims was not user-friendly. FDA officials told us they do 
not test either health claims or qualified health claims on consumers prior to authorizing them. 
Little incentive exists for manufacturers to seek health claims.  Given the current claims 
structure, manufacturers are most likely to use structure/function claims to communicate a 
products intended use.  These are the easiest types of claims to make as they require no pre-
authorization from the agency. 
22 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  If a manufacturer sought to develop a new health claim for a supplement, it would need to 
conduct extensive research or gather secondary evidence in order to meet FDAs standard of 
significant scientific agreement.  One industry guidance estimated that manufacturers typically 
need to submit between 20 and 30 studies to FDA for review.26 Yet the manufacturer will not 
receive any reward for investing in that research.  Once FDA approves a health claim, any 
manufacturer may use it at no cost. 
Manufacturers have a similar disincentive from seeking qualified health claims. At this point, 
manufacturers cannot seek a qualified health claim unless they have submitted a health claim, 
and it has been rejected for not meeting the principle of significant scientific agreement. 
Getting a qualified health claim approved can take a long time, and may involve long legal 
battles with FDA over the acceptability of wording. FDA has not yet defined what constitutes 
an acceptable level of evidence to make a qualified health claim, and it is likely that further legal 
battles will ensue over this issue. As a result, many manufacturers are hesitant to seek qualified 
health claims. However, as these claims evolve, they may gain popularity in the future. 
Evidence Suggests that Consumers and Health Professionals Find 
Supplement Labels of Limited Use. 
Labels may be of limited use for consumers. 
Consumers look to labels for information 
about supplement safety and 
Illustrative statements from our focus groups of 
effectiveness, but often find labels of little 
older adults about the limited usefulness of labels: 
use. They are particularly likely to read 
a supplement label the first time they  Because they dont tell you anything about side 
reactions...I dont believe the label sometimes...Im 
purchase a supplement.27  They look to 
awfully timid about [trusting] it. 
the labels primarily for information on 
directions for use, intended use,  Labels dont say what they do for you. They just 
ingredients, and warnings, such as side  say that [the supplement] has this and that and the 
other. But I dont know what this that and the other 
effects, interactions, and 
are! Because of that, I have to ask my doctor or 
contraindications.28 But, as we indicated 
pharmacist. 
earlier, this important information is 
lacking or has shortcomings, which may  Its a major feat to look at most labels...the print is 
so small...I dont know how older people are suppose 
prevent consumers from using labels in 
to read them. I cant buy [supplements] unless I 
an informed and appropriate manner 
have my magnifying glass. 
(see box). 
We read the label...but we dont know enough to 
tell what is good or bad. We dont have the 
Even though consumers read labels, they 
background to tell the difference. 
appear to have limited 
23 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  confidence in the information that labels provide. According to a recent national survey by 
Prevention Magazine, the majority of consumers are not confident in the accuracy of 
information found on supplement labels. Only 32 percent of consumers who shop for herbal 
remedies reported that they were very confident in the accuracy of the labels, and only 34 
percent of those who shop for vitamins and minerals reported that they were very confident. 
Furthermore, nearly half of those surveyed by Prevention Magazine did not believe or did not 
know if dietary supplements provide the health benefits that they claim.29 Our focus groups 
pointed to mistrust of the label as one of the main reasons why consumers turn to other sources 
of information, such as newsletters, the Internet, and health professionals.  Many of our focus 
group participants who had pre-existing medical conditions, like diabetes, recounted 
experiencing side effects and interactions that were not indicated on the label, which led them to 
no longer use the label as a primary source of information. 
Labels may be of limited use for health professionals. 
Finding the label of limited usefulness, many consumers turn to other sources of information to 
decipher the label.  Some rely on health professionals, such as physicians, pharmacists, nurses, 
and dieticians, to provide information about supplements and to advise them in taking 
supplements safely.30 During focus groups, health professionals told us that they view labels as 
important, because they are one of the few easily accessible information sources that relate 
specifically to the supplements their 
patients take. They also told us that 
Illustrative statements from our focus groups of 
labels have the potential to be a key 
health professionals about the limited usefulness of 
source of information for detecting  labels: 
interactions that their patients may 
I dont use the label...labels are misleading...How am 
experience. 
I suppose to advise my patients if I cant believe 
whats on the label? These [supplement] products 
Like consumers, many health  are not standardized or validated...I think this is a 
professionals find labels of limited  tremendous problem...especially in terms of doing 
any reasonable counseling to patients. 
usefulness (see box).  During our focus 
groups, health professionals told us that 
I dont use labels because I find them pretty 
the information they most often look for  useless, but luckily, pharmacists have access to good 
on labels, such as active ingredient(s),  reference materials. 
substance preparation, dose, interactions 
Its difficult for us [physicians], much less 
and contraindications, is lacking or has 
consumers, to read the fine print. 
significant shortcomings. Moreover, 
many found labels hard to understand, 
because they did not have enough 
general knowledge about dietary supplements. Recent studies have pointed out the limited 
knowledge many health professionals have of supplements. For example, a recent study 
reported that pharmacists scored an average of less than 50 percent on tests 
24 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  measuring their knowledge of herbal medication.31 Similarly, a prior study found that nurse 
practitioners scored an average of 3.36 out of a possible 19 on a test measuring their 
knowledge of the use and contraindications of herbal medications.32  Focus group participants 
told us that they received little professional training in nutrition and herbal medicine while they 
were in school. The lack of training about dietary supplements makes health professionals all 
the more dependent on the label information provided by manufacturers. 
25 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  C O N C L U S I O N  
Our analysis of 100 dietary supplement labels found that few reflected the label elements 
contained in our template. These findings were confirmed by our interviews and focus groups as 
well as by independent data analyses and professional literature. Our analysis also found that 
several barriers may prevent manufacturers from developing labels that can adhere to our 
template, and that the current state of supplement labels may limit the extent to which 
consumers and health professionals use labels. 
We recognize that FDA has numerous efforts underway to address the current state of dietary 
supplement labels, and that limited resources, limited scientific evidence about the safety and 
efficacy of supplements, and competing priorities inhibit FDAs capacity to make timely 
progress (see Appendix C for a description of activities underway). Our analysis is designed to 
assist FDA as it addresses the legal framework related to dietary supplement labels, and as it 
reviews its standards for disclosing safety risks on labels, substantiating evidence related to 
label claims, and developing analytical methods and reference materials for testing supplements. 
26 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  APPENDIX A 
Template of Key Elements for Dietary Supplement Labels

According to DSHEA, a dietary supplement label should help consumers make informed and 
appropriate choices about supplement use.  For this inquiry, we developed a template of the key 
elements for a dietary supplement label.  This template is based on several sources, including a review 
of 100 dietary supplement labels; 76 interviews with key stakeholders; data from industry groups and 
independent research organizations; and a comprehensive literature review.  Our intention is to set forth 
a vision for supplement labels in terms of essential information and precepts for presenting information. 
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. The label would contain language that is 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. 
27 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  APPENDIX B 
Information Included on Supplement Labels 
Based on 76 interviews with consumers, health providers, industry representatives, and regulators, we 
generated a template of the key elements of a dietary supplement label that can help consumers make 
informed and appropriate choices about supplement use.  In this report, we reviewed 100 supplements 
to see how many of them adhered to our template.  The table below summarizes our findings. 
For the label analysis, we selected supplements that consumers commonly use, including some of the 
vitamin, mineral, and herbal supplements that account for the greatest proportion of sales. Our sample 
attempted to reflect the variety in brands and in packaging currently on the market; our sample 
represents 36 manufacturers and 36 distributers. We obtained these supplements from retail stores in 
the greater Boston area and from samples distributed at industry conferences. For more information on 
our methodology, see Appendix D. 
Types of Information on Supplement Labels  Number without that 
Information (n=100) 
Minimum duration of use
 95 
Bioavailability of ingredients
 94 
Active ingredients 
 93 
Possible adverse reactions or side effects
 89 
Possible interactions
 87 
Maximum dose
 85 
Specific contraindications
 61 
Purpose of the supplement
 31 
Expiration date
 25 
Amount of individual ingredients in proprietary blends
 15* 
* Only 15 products in our sample of 100 were proprietary blends. 
28 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  APPENDIX C 
FDA Initiatives Related to Dietary Supplements

Below we highlight several initiatives that FDA has recently initiated or completed: 
Supplement Safety 
<	 Contract to Develop Safety Framework. FDA has contracted with the Institute of 
Medicine and the National Academy of Sciences to develop a framework for categorizing and 
prioritizing supplement ingredients based on safety. FDA expects the final report to be 
completed by September 2003. 
<	 Warning Statement for Pregnancy.  In May 2001, FDA declared its intent to issue a 
proposed rule requiring warning statements for women, who are or may be pregnant, on all 
products making structure/function claims, unless they can prove that the products are safe for 
pregnant women. 
Accuracy of Label Declarations 
<	 Consumer Health Information for Better Nutrition Initiative.  In December 2002, FDA 
announced that it 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. 
<	 Contract to Develop Reference Materials. FDA has an interagency agreement with the 
National Institutes of Health (NIH) and the Department of Commerces National Institute of 
Standards and Technology to develop reference materials from which to develop validated 
analytical methods for botanicals. Ephedra and kava kava are the first botanicals to be tested. 
<	 Contract to Develop Validated Analytical Methods. FDA has contracted with the 
Association of Analytical Chemists International and the NIH to produce analytical methods for 
ephedrine alkaloids and aristolochic acid. 
Understanding of Consumer Needs 
<	 Health and Diet Survey.  FDA issued a Federal Register notice in August 2001 for 
comment on its plans for conducting a survey to determine consumer opinion on uses and 
usefulness of labels. 
29 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  APPENDIX C 
Public Information and Outreach 
<	 Enhanced Website. FDA has recently redesigned and reorganized its dietary supplement 
website to make searches more intuitive and information more current and transparent, and has 
developed new information to fill in identified gaps.  The website includes a number of key 
sections, including: Warning and Safety Information, Adverse Event Reporting, Industry 
Information and Regulations, Announcements and Meetings, and Questions and Answers. 
<	 On-line Publications. FDA has issued a document entitled Tips for the Savvy Supplement 
User: Making Informed Decisions and Evaluating Information,  which is available in both 
English and Spanish.  It has also developed an electronic newsletter that gives interested parties 
access to key information and updates on dietary supplements, food labeling, and nutrition 
issues.  Moreover, FDA has joined with the Federal Trade Commission (FTC) to publish 
Miracle Health Claims: Add a Dose of Skepticism to help consumers assess claims. 
<	 Stakeholder Email List.  In 2001, FDA developed a list of key stakeholders to which it can 
quickly send out electronic notices about issues, such as safety alerts. This system replaces its 
fax-on-demand system. 
<	 Websites intended to Alert Consumers of Internet Health Fraud.  As part of Operation 
Cure.All, FDA has joined with FTC to simulate websites that make misleading and false 
claims.  Upon attempting to buy dietary supplements through these teaser websites, 
consumers are alerted about the purpose of the websites and are informed about ways to avoid 
becoming future victims of Internet health fraud. 
Industry Guidance 
<	 Small Entity Compliance Guide for Structure/Function Claims. FDA issued guidance in 
January 2002 to clarify its January 2000 rule on structure/function claims for small businesses 
and consumers. 
<	 Regulatory Guidebook for Industry.  The regulatory guidebook is being developed to 
provide manufacturers and distributors of dietary supplements a very basic introduction to the 
legal and regulatory requirements that must be met in order to market dietary supplements in the 
United States. 
30 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  APPENDIX D 
Methodology

Label Analysis 
We performed an original analysis of 100 labels of products that consumers would recognize as 
dietary supplements.  We obtained these supplements from supermarkets, pharmacies, and 
natural foods stores in the greater Boston area and from samples distributed at industry 
conferences. Our sample was judgmental. Without the existence of an official registry of the 
number and types of supplements on the market, we could not conduct probability sampling. 
We selected supplements that consumers commonly use, including some of the vitamin, mineral, 
and herbal supplements that account for the greatest proportion of sales (for example, vitamin 
C, calcium, ginseng, and soy).33 Our sample attempted to reflect the variety in brands and in 
packaging currently on the market; our sample represents 36 manufacturers and 36 distributers. 
We also sought to select supplements that could serve as effective visual aids in our consumer 
focus groups and that could provide examples of the perspectives we heard during our 
interviews. 
We tallied the number of labels that did not adhere to each of the key elements of our template. 
Two analysts independently reviewed the labels according to a detailed protocol reflecting the 
templates elements and recorded their observations in an Access database; a third analyst 
made final determinations. See Appendix A for the template and Appendix B for a summary of 
the findings of our analysis. 
Interviews and Focus Groups 
We conducted 76 interviews with key stakeholders. We spoke with each of the major 
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 also conducted interviews with federal and state regulators. We spoke with FDA officials 
at the Center for Food Safety and Applied Nutrition, the Center for Drug Evaluation and 
Research, and the Office of Regulatory Affairs, and National Institutes of Health officials in the 
Office of Dietary Supplements. In addition, we spoke with several state regulators who 
oversee food or supplement safety. 
To learn more about specific concerns facing particular groups of supplement users, we 
conducted our own focus groups with consumers and with health care professionals, and 
31 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  APPENDIX D 
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 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. 
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. 
32 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  APPENDIX E 
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. The Center for Disease 
Control and Preventions (CDC) third National Health and Nutrition Examination Survey (NHANES 
III), conducted between 1988 and 1994, found that 40 percent of the Americans surveyed had taken a 
dietary supplement in the month prior to the survey. 
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). Food and Drug Administration, Memorandum Re: Questions 
Concerning Dietary Supplement Labeling, June 13, 2001. 
3. NBJs Annual Overview of the Nutrition Industry VI, Nutrition Business Journal (2001) 5/6: 3, 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. Herbals/botanicals accounted for $4,120,000 or 25 percent of supplement sales in 2000.  NBJs 
Annual Overview of the Nutrition Industry VI, Nutrition Business Journal (2001) 5/6: 7. 
7. 21 C.F.R. sec. 104(h). 
8. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Consumer Studies 
Team, Dietary Supplement Labeling Focus Groups, September 30, 1999. 
9. Prevention Magazine, National Survey of Consumer Use of Dietary Supplements, Rodale, Inc., 
1999, 75.  According to this study, 12 percent of consumers have experienced a side effect from taking 
an herbal product. 
During the course of our research, we found examples of case reports, journal articles, and news 
stories documenting side effects and adverse reactions associated with supplements.  Many of these 
articles also highlighted the importance of having adequate warnings on supplement labels: 
<	 Victoria Stagg Elliott, Code Green: Seeing the Side Effects of Alternative Supplements, 
American Medical News, March 5, 2001. 
33 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  APPENDIX E 
<	 Evenson, Supplements Pose Danger in Combination with Heart Drugs, National 
Post/Chicago Sun-Times, March 21, 2002. 
<	 Jacqueline Stenson (2001) The Herbal Frontier: The Promise and Peril of Supplements, 
MSNBC, Retrieved from wysiwyg://64/http://www.msnbc.com/news/522365, June 12, 2001 . 
<	 Michael Ang-Lee et al., Herbal Medicines and Perioperative Care, Journal of American 
Medical Association 286 (July 11, 2001) 2: 208-216. 
<	 Lisa Chavis, Pharmacy-Based Consulting on Dietary Supplements, Journal of the American 
Pharmaceutical Association, 41 (March/April 2001) 2: 186-187. 
10. K.J. Rothman et al., Teratogenicity of High Vitamin A Intake, New England Journal of 
Medicine. 333 (November 1995) 21: 1369-73. 
11. Prevention Magazine, National Survey of Consumer Use of Dietary Supplements, Rodale, Inc., 
1999, 67. The survey found that 5 percent of users of vitamins and minerals, 5 percent of users of 
herbal remedies, and 9 percent of users of specialty products take more than the amount recommended 
on the label.  The authors of the study then calculated the number of people in the U.S. population that 
these percentages represent.  Twenty-eight percent of consumers who took vitamins and minerals to 
prevent a specific disease and 21 percent of consumers who took herbal remedies to treat a specific 
disease have taken more than the recommended dose in order to more effectively treat symptoms. 
12. Prevention Magazine, National Survey of Consumer Use of Dietary Supplements, Rodale, Inc., 
1999, 61-65. The survey indicated that 23 percent of consumers taking herbal products had difficulty 
finding information about possible interactions with prescription medicines; 20 percent had difficulty 
finding information about warnings about possible interactions with over-the-counter (OTC) products; 
and 21 percent had difficulty finding information on possible interactions with other supplements. 
Furthermore, 16 percent of consumers taking vitamins and minerals found it difficult to find warnings 
about possible interactions with prescription medicines, OTC medications, or herbal products. 
13. Prevention Magazine, National Survey of Consumer Use of Dietary Supplements, Rodale, Inc., 
1999, 37-39.  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 OTC drug. 
14. This quotation pertains to many of the supplements listed on the Dietary Supplement Information 
Bureau Website at www.supplementinfo.org. For example, we found this statement in the side effects 
section of the page pertaining to the supplement kava. Retrieved from 
http://content.intramedicine.com/dse/consumer/monoAll-style.asp?objID=100070&ctype=ds&mtyp=1, 
May 10, 2002. 
34 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  APPENDIX E 
15. Prevention Magazine, National Survey of Consumer Use of Dietary Supplements, Rodale, Inc., 
1999, 74-77. 
16. Prevention Magazine, National Survey of Consumer Use of Dietary Supplements, Rodale, Inc., 
1999, 29. Prevention data shows that 66 percent of users of herbal supplements and 61 percent of 
users of specialty supplements will use these supplements for up to a month without results. 
17. Dietary Supplement Education Alliance, The Key to Consumer Confidence in Dietary 
Supplements, FDLI Update (2001) 6: 14. 
18. Food and Drug Administration, Center for Drug Evaluation and Research, Consumer 
Comprehension and Preference for Variations in the Proposed Over-The-Counter Drug Labeling 
Format, December 3, 1998, 2. 
19. The FTC found these fraudulent websites through Operation Cure.All, a coordinated law 
enforcement and consumer education campaign between federal and state agencies. It targets Internet 
scams for herbal products, other supplements and devices that purport to cure diseases.  For more 
detail on this effort, see: Federal Trade Commission, Operation Cure.All Wages New Battle in 
Ongoing War Against Internet Health Fraud, released June 14, 2001. Retrieved from 
http://www.ftc.gov/opa/2001/06/cureall.com, November 6, 2001. 
20. Federal Trade Commission, FTC Cracks Down on Marketers of Bogus Bioterrorism Defense 
Products, released November 19, 2001. Retrieved from 
http://www.ftc.gov/opa/2001/11/webwarn.htm, January 30, 2002. 
21. Swindlers, Hucksters, and Snake Oil Salesmen: The Hype and Hope of Marketing Anti-Aging 
Products to Seniors Before the Senate Special Comm. on Aging, 107th Cong., 1st Sess. 2 
(September 10, 2001) (statement of Senators John Breaux and Larry Craig). 
Also, in the spring of 1997, pharmacy students evaluated Internet information about 11 popular herbal 
products. They found that 45 percent of the claims were true, 6 percent were false, 2 percent were 
meaningless, and 47 percent undetermined when compared to peer-reviewed journals. When 
evaluated for substantiation, only 36 percent of the Internet claims were substantiated, of which only 40 
percent were found to be true.  See Deanne Nowak and Thomas Zlatic, Herbal Products and the 
Internet: A Marriage of Convenience, Journal of the American Pharmaceutical Association, 
Retrieved from http://www.aphanet.org/PInfo/JaPha_Mar-Apr_99_Article.htm, February 13, 2001. 
22. The American Dietetic Association has cited examples of companies that present unpublished 
studies, animal data, and consumer testimonials as substantiating evidence for their claim. The State of 
Texas, which requests substantiation files for about 50 percent of the supplements that they regulate as 
drugs, has found that, in almost all cases, the manufacturer was not able to provide adequate 
35 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  APPENDIX E 
substantiation data. 
23. 21 C.F.R, sec. 101 requires FDA to use the Association of Analytical Communities Internationals 
(AOAC) methods of analysis when available and applicable.  AOAC has a compendium for vitamins 
and minerals based on validated methods, and FDA uses these methods in testing products.  However, 
AOAC is still in the process of developing such methods for botanicals and other dietary supplements. 
24. Judy Foreman, St. Johns Wort: Less than Meets the Eye.  Globe Analysis Shows Popular Herbal 
Antidepressant Varies Widely in Content, Quality, Boston Globe, January 10, 2000, C1. 
25. Joseph M. Betz, Responsible Commerce and Self-Regulatory Initiatives, American Herbal 
Products Association Report, Spring 2001. 
26. I. Scott Bass and Charles J. Raubicheck, Marketing Dietary Supplements (Washington, DC: 
FDLI, 2000), IV-19. 
27. Prevention Magazine, National Survey of Consumer Use of Dietary Supplements, Rodale, Inc., 
1999, 57-58. Seventy-six percent of consumers taking vitamin and mineral supplements, and 79 
percent of consumers taking herbal supplements always read the label the first time they buy 
supplements. 
28. Prevention Magazine, National Survey of Consumer Use of Dietary Supplements, Rodale, Inc., 
1999, 59.  The consumers in our focus groups listed these same components when we asked them 
what they consider the most important information on supplement labels. 
29. Ibid., 13 and 71. 
30. Ibid., 15.  According to the Prevention Magazine survey, 26 percent of consumers turn to health 
professionals for information about dietary supplements.  Moreover, a number of our focus group 
participants told us that they rely directly on the advice of physicians and pharmacists, and others said 
that they subscribe to newsletters and buy books on supplements, because they are written by people 
we can trust...like physicians and pharmacists. 
Also see, Sandra Levy, Healthcare 2000 Reveals Consumer View on R.Ph.s, Drug Topics, October 
4, 1999. Retrieved from http://dt.pdr.net/be_core/d/index.jsp, April 12, 2001. 
31. Ziba Chang et al., Pharmacists Knowledge and Attitudes Toward Herbal Medicine, The Annals 
of Pharmacotherapy, 34 (June 2000): 710-715. 
32. Ibid., 711. 
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Dietary Supplement Labels: An Assessment  OEI-01-01-00121  APPENDIX E 
33. Dietary Supplement Education Alliance, The Market for Dietary Supplements.  Retrieved from 
http://www.supplementinfo.org/industry/marketplace.htm, November 19, 2001 Also see NBJs Annual 
Overview of the Nutrition Industry VI, Nutrition Business Journal (2001) 5/6. 
37 
Dietary Supplement Labels: An Assessment  OEI-01-01-00121  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/ 
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Dietary Supplement Labels: An Assessment  OEI-01-01-00121