Department of Health and Human Services 

OFFICE OF 

INSPECTOR GENERAL 

JANET REHNQUIST 

INSPECTOR GENERAL 

MARCH 2003 

OEI-01-01-00120 

DIETARY SUPPLEMENT LABELS: 

KEY ELEMENTS 
OFFICE OF INSPECTOR GENERAL

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 OIG’s 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. 
EXECUTIVE SUMMARY 

OBJECTIVE 

To identify key elements that can increase the potential for dietary supplement labels to help 

consumers make informed and appropriate choices about supplement use. 

BACKGROUND 

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA). 

DSHEA defined the term “dietary supplement” to include substances, such as vitamins, 

minerals, botanicals, and amino acids. The Food and Drug Administration (FDA) has primary 

oversight responsibilities for dietary supplements and their labels. 

Widespread Use of Dietary Supplements. An estimated 70 percent of the U.S. population, 

or 152 million people, tried at least one dietary supplement in 2001. Dietary supplements are 

nearly a $17 billion industry. 

Benefits and Risks of Dietary Supplements. Dietary supplements have potential health 

benefits, but may also pose safety risks. For example, calcium and vitamin D supplementation 

can help to reduce bone loss in the elderly. Yet, FDA has also received reports of adverse 

events associating ephedra with heart attacks, strokes, seizures, and high blood pressure. 

Importance of Dietary Supplement Labels. In DSHEA, Congress recognized the 

importance of labels, calling for them to include information, such that “consumers may make 

informed and appropriate health care choices for themselves and their families.” Labels can be 

particularly significant, given that dietary supplements are often used as self-care products, and 

labels are an easily accessible source of information. Furthermore, label oversight is a key 

regulatory tool for FDA to promote the safe use of dietary supplements among consumers. 

Concerns about Dietary Supplement Labels. Our 2001 report entitled Adverse Event 

Reporting for Dietary Supplements: An Inadequate Safety Valve (OEI-01-00-00180) 

highlighted the need for consumers to have more complete information about dietary 

supplements than is currently required. In 2000, the General Accounting Office cited problems 

with label content for dietary supplements. 

Consumer Health Information for Better Nutrition Initiative. In December 2002, FDA 

announced the Consumer Health Information for Better Nutrition Initiative, which seeks to 

enhance the credibility of food and dietary supplement labels through the inclusion of more 

accurate, science-based information. This multi-part initiative includes the publication of 

guidance on qualified health claims for conventional foods and dietary 

i 
supplements, strong enforcement of dietary supplement rules, and the establishment of an FDA 

task force on consumer health information for better nutrition. 

This Report. Given the limited requirements governing dietary supplement labels, FDA 

officials have expressed an interest in our presenting a vision for the kind of label that could 

better assist consumers in making informed and appropriate choices about supplement use. 

Thus, we consulted a wide variety of stakeholders, reviewed the pertinent literature, and then 

developed a template of key label elements. 

The template uses the existing requirements for dietary supplement labels as a starting 

framework (see the primer on page 4). We then incorporated the feedback we heard from 76 

interviews with key stakeholders, such as regulators, industry representatives, and consumer 

groups, and from 7 focus groups with consumers and health professionals. We also took into 

account data from industry groups and independent research organizations, and conducted a 

comprehensive literature review on dietary supplement use and labels, including congressional 

testimony and national survey data. 

The template also serves as the framework for a companion report, Dietary Supplement 

Labels: An Assessment (OEI-01-01-00121). 

KEY ELEMENTS OF A DIETARY SUPPLEMENT LABEL 

Below, we present our template of key elements of a dietary supplement label that can help 

consumers make informed and appropriate choices about supplement use. 

Label Content: 

U Ingredients. It would fully and clearly disclose the ingredients contained in a supplement. 

The ingredient declaration would accurately reflect the amount of each dietary ingredient 

included in the supplement. 

U Intended Use. It would provide consumers with sufficient information about the range of 

uses for a supplement. All intended use claims would be based on accepted scientific evidence. 

U Safety Information. It would provide consumers with known safety information. This 

would include interactions, contraindications, and possible side effects and adverse reactions. 

U Directions for Use. It would provide consumers with adequate directions for use. The 

directions would include guidance on proper doses, if the information is available. 

U Product Information. It would identify the manufacturer, production source and batch, 

and information about the net quantity of contents found in the supplement. 

Dietary Supplement Labels: Key Elements ii OEI-01-01-00120 
Label Presentation: 

U Standardized Format. It would present similar types of information in a similar order 

across supplements. It would use widely accepted terminology and headings. 

U Distinct Product Features. It would have a unique design, format, or specific language 

that assists consumers in distinguishing supplements from other self-care products. 

U Readability. It would contain language and visual cues that are easily understood by a 

broad group of consumers. 

U Balance. It would present information in a balanced manner. It would give fair treatment 

to benefits and risks, to claims and disclaimers, and to factual and marketing information. 

U Constructive Use of Space. It would seek to expand the limited label space through 

creative packaging and by pointing consumers to alternative sources of information. 

CONCLUSION 

This template sets forth a vision of key elements that can increase the potential of dietary 

supplement labels to help consumers make informed and appropriate choices about supplement 

use. It is a vision that appears to have considerable support among the wide range of 

stakeholders whom we interviewed. We recognize that this template is general and that it 

leaves out many important details concerning specific expectations or requirements for 

supplement labels. It does, however, put forth a framework that government officials, 

consumer groups, industry representatives, academics, and others can use as they seek to find 

common ground on the specific content and presentation of labels. 

For an assessment of the extent to which existing dietary supplement labels reflect the elements 

identified in this template, see our companion report, Dietary Supplement Labels: An 

Assessment (OEI-01-01-00121). 

Dietary Supplement Labels: Key Elements iii OEI-01-01-00120 
TABLE OF CONTENTS 

PAGE

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

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

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

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

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

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

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

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

APPENDICES

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

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

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

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

Dietary Supplement Labels: Key Elements OEI-01-01-00120 
INTRODUCTION 

OBJECTIVE 

To identify key elements that can increase the potential for dietary supplement labels to help 

consumers make informed and appropriate choices about supplement use. 

BACKGROUND 

In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA). 

DSHEA defined the term “dietary supplement” to include substances, such as vitamins, 

minerals, botanicals, and amino acids. It also created a new regulatory framework for dietary 

supplements and expanded the information that could be placed on labels. The Food and Drug 

Administration (FDA) has primary oversight responsibilities for dietary supplements and their 

labels. 

Widespread Use of Dietary Supplements 

An estimated 70 percent of the U.S. population, or 152 million people, tried at least one dietary 

supplement in 2001.1 Many consumers use supplements to enhance their nutritional intake or to 

maintain their health and well-being, while others hope to improve their energy levels and to 

prevent or treat common illnesses. The dietary supplement industry has responded to consumer 

demand by marketing an increasing number and variety of supplements. FDA estimates that 

about 29,000 dietary supplements are on the market.2 Dietary supplements are nearly a $17 

billion industry.3 

Benefits and Risks of Dietary Supplements 

The growth of the dietary supplement market presents greater potential for consumers to 

experience the benefits of supplement use, and at the same time increases the chance that 

consumers will encounter safety risks. For example, the long-term consumption of vitamin C 

supplements may reduce the development of age-related lens opacities, and dietary calcium and 

vitamin D supplementation may help to reduce bone loss in the elderly. Yet, FDA has also 

received reports of adverse events associating ephedra with heart attacks, strokes, seizures, 

and high blood pressure, and kava kava with liver damage. 

Importance of Dietary Supplement Labels 

In DSHEA, Congress recognized the importance of labels, calling for them to include 

information, such that “consumers may make informed and appropriate health care choices for 

themselves and their families.” Within FDA, the Center for Food Safety and Applied Nutrition 

(CFSAN) has the authority to regulate supplements by issuing labeling 

Dietary Supplement Labels: Key Elements 1 OEI-01-01-00120 
 rules and good manufacturing practice (GMP) regulations to the dietary supplement

industry and by monitoring adverse events related to supplement use. However, supplementspecific GMP regulations have not been issued, and the adverse event reporting system is still

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

informed and appropriate use of dietary supplements among consumers. 

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

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

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

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

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

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

advertisements). 

Concerns about Dietary Supplement Labels 

Our 2001 study entitled Adverse Event Reporting for Dietary Supplements: An Inadequate 

Safety Valve (OEI-01-00-00180) highlighted the need for consumers to have more complete 

information about dietary supplements than is currently required. In 2000, the General 

Accounting Office (GAO) cited similar problems with dietary supplement labels.4 Concerns 

have also been raised by consumer and industry groups, federal and state regulators, and the 

media. 

Consumer Health Information for Better Nutrition Initiative 

In December 2002, FDA announced the Consumer Health Information for Better Nutrition 

Initiative, which seeks to enhance the credibility of food and dietary supplement labels through 

the inclusion of more accurate, science-based information. This multi-part initiative includes the 

publication of guidance on qualified health claims for conventional foods and dietary 

supplements, strong enforcement of dietary supplement rules, and the establishment of an FDA 

task force on consumer health information for better nutrition. In a report on dietary supplement 

enforcement, which accompanied the announcement of the initiative, FDA stated its intention to 

develop mechanisms to communicate critical information and useful strategies about dietary 

supplements to consumers.5 

Methodology 

Given the limited requirements governing dietary supplement labels, FDA officials have 

expressed an interest in our presenting a vision for the kind of label that could better assist 

consumers in making informed and appropriate choices about supplement use. Thus, we 

consulted a wide variety of stakeholders, reviewed the pertinent literature, and then developed 

a template of key label elements. The template we developed can provide FDA with a starting 

point for a mechanism to communicate critical information and useful strategies about dietary 

supplements to consumers. 

Dietary Supplement Labels: Key Elements 2 OEI-01-01-00120 
The template uses the existing requirements for dietary supplement labels as a starting 

framework (see the primer on page 4). We then incorporated the feedback we heard from 76 

interviews with key stakeholders, such as regulators, industry representatives, and consumer 

groups, and from 7 focus groups with consumers and health professionals. We also took into 

account data from industry groups and independent research organizations, and conducted a 

comprehensive literature review on dietary supplement use and labels, including congressional 

testimony and national survey data. 

Throughout the course of our inquiry, we refined and adjusted the template to incorporate the 

diversity of perspectives that we encountered. The template represents broad consensus 

among those we interviewed as to key label elements. 

This Report and its Companion Report 

This report identifies key elements that can increase the potential for dietary supplement labels 

to help consumers make informed and appropriate choices about supplement use, and 

organizes those elements into a template. The template draws on existing requirements for 

dietary supplement labels, feedback from interviews and focus groups, industry data, and the 

professional literature. 

In our companion report, Dietary Supplement Labels: An Assessment (OEI-01-01-00121), 

we assess the extent to which current dietary supplement labels meet the potential expressed in 

the template outlined in this report. We also examine barriers that may prevent supplement 

manufacturers from developing labels that incorporate the elements of our template, and note 

potential consequences to consumers and health professionals of maintaining the current label 

requirements for dietary supplements. 

We conducted this inspection in accordance with the Quality Standards for Inspections 

issued by the President’s Council on Integrity and Efficiency. 

Dietary Supplement Labels: Key Elements 3 OEI-01-01-00120 
PRIMER ON DIETARY SUPPLEMENT LABELS 

What is a Dietary Supplement? 

The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines the term “dietary supplement” to mean 

a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following 

dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man 

to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or 

combination of any of the aforementioned ingredients. Furthermore, a dietary supplement must be labeled as a 

dietary supplement and be intended for ingestion and must not be represented for use as conventional food or as a 

sole item of a meal or of the diet. In addition, a dietary supplement cannot be approved or authorized for 

investigation as a new drug, antibiotic, or biologic, unless it was marketed as a food or a dietary supplement before 

such approval or authorization. Under DSHEA, dietary supplements are deemed to be food, except for purposes of 

the drug definition. 

What is a Dietary Supplement Label? 

A‘label’ is a display of written, printed, or graphic matter upon the immediate container of any article. In contrast, 

‘labeling’ is a more general term that includes the label and other written, printed, or graphic matter upon any article 

or any of its containers or wrappers, or accompanying the article. 

What is Required on a Dietary Supplement Label? 

DSHEA and other federal regulations require the following information to appear on dietary supplement labels: 

C a statement of identity that contains the words 

“dietary supplement.” The word “dietary” may be 

replaced by the name of the dietary ingredient (e.g., 

“ginseng supplement”); 

C net quantity of contents (e.g., “60 capsules”); 

C nutrition information in the form of a “Supplement 

Facts” panel, including the product serving size, the 

amount, and percent daily value, if established, of 

each dietary ingredient; 

C if a supplement contains a proprietary blend, the net 

weight of the blend as well as a listing of each 

ingredient in descending order of weight must be 

identified; 

C the part of the plant used, if an herb or botanical; 

C the name and place of business of the manufacturer, 

packer, or distributor; 

C a complete list of ingredients by their common or 

usual names, either in descending order of 

prominence or with the source of the dietary 

ingredient in the “Supplement Facts” panel 

following the name of the dietary ingredient (e.g., 

calcium (from calcium carbonate)); 

C safety information that is considered “material” to 

the consequences that may result from the use of 

the supplement; 

C the disclaimer “This statement has not been 

evaluated by the Food and Drug Administration. 

This product is not intended to diagnose, treat, 

cure, or prevent any disease” if the supplement 

bears a claim to affect the structure or function of 

the body (structure/function claim), a claim of 

general well-being, or a claim of a benefit related to a 

classical nutrient deficiency disease. 

At their discretion, manufacturers may add additional information on labels (such as claims and statements of quality 

assurance), and may decide on the placement of that information on their labels. 

Who Oversees Dietary Supplement Labels? 

The Food and Drug Administration (FDA) is the federal agency primarily responsible for regulating dietary 

supplements and their labels. FDA regulates supplements in a post-market system, meaning manufacturers are 

allowed to market supplements without prior authorization. FDA has the burden of proof to show that a supplement 

presents a significant or unreasonable risk of illness or injury if taken as instructed on the label, or is otherwise 

adulterated. FDA also has the burden of proof to show that label information is misleading or not true. To establish 

proof, FDA conducts field exams, tests supplement ingredients, and reviews label claims. As necessary, FDA may 

take actions through courtesy letters, warning letters, recalls, seizures, and injunctions. 

Dietary Supplement Labels: Key Elements 4 OEI-01-01-00120 
KEY ELEMENTS OF A 

DIETARY SUPPLEMENT LABEL 

We defined the key elements of a dietary supplement label to be those that can help consumers 

make informed and appropriate choices about supplement use. This definition comes from 

DSHEA, in which Congress called for labels to contain information, such that “consumers may 

make informed and appropriate health care choices for themselves and their families.” More 

recently, in announcing the FDA’s Consumer Health Information for Better Nutrition Initiative, 

the FDA Commissioner and the Secretary of Health and Human Services have reinforced the 

important role that labels can play in helping consumers make informed choices about the 

products they buy. 

The label on a dietary supplement can fulfill this role by facilitating consumers’ choice of a 

supplement, guiding their use of it, and communicating any safety information associated with it. 

Consumers who have decided to purchase 

a supplement are often faced with a wide 

array of choices. The label can play a role 

in helping consumers to select an 

appropriate supplement by providing 

information about the purposes of the 

supplement, the conditions for which the 

supplement should be taken, and factual 

information about the contents and 

manufacture of the supplement. 

Roles of the supplement label: 

U Facilitates product choice 

U Guides use 

U Communicates safety information 

Furthermore, by providing information on possible side effects and potential interactions, the 

label can play an important role in helping consumers to appreciate any risks associated with 

using the supplement. After a consumer selects an appropriate supplement, correct 

administration and dosing are essential. By providing such information, the label can guide 

consumers in the appropriate use of a supplement. Should a consumer experience adverse 

symptoms, the label can play an important advisory role by informing consumers when to stop 

taking a supplement and whom to contact. 

The notion that a label can help consumers make informed and appropriate choices takes on 

heightened significance, given that dietary supplements are self-care products. According to a 

recent national study, consumers would often rather treat their own health conditions than go to 

a doctor.6 While dietary supplements are not approved as a way to treat health conditions, 

close to one-quarter of the population (26 percent) say they have used dietary supplements for 

a health problem.7 According to another national study, 22 percent of adults report using 

vitamins and minerals to treat and prevent serious illnesses, and 14 percent report using herbal 

remedies for this reason.8 Some consumers even use supplements to treat life-threatening 

conditions, such as cancer.9 

Dietary Supplement Labels: Key Elements 5 OEI-01-01-00120 
Given the limited requirements governing dietary supplement labels, FDA officials have 

expressed an interest in our presenting a vision for the kind of label that could better assist 

consumers in making informed and appropriate choices about supplement use. Thus, we 

consulted a wide variety of stakeholders, reviewed the pertinent literature, and then developed 

a template of key label elements. 

The template uses the existing requirements for dietary supplement labels as a starting 

framework (see the primer on page 4). We then incorporated the feedback we heard from 76 

interviews with key stakeholders, such as regulators, industry representatives, and consumer 

groups, and from 7 focus groups with consumers and health professionals. We also took into 

account data from industry groups and independent research organizations, and conducted a 

comprehensive literature review on dietary supplement use and labels, including congressional 

testimony and national survey data. 

The template sets forth key elements of a dietary supplement label in terms of essential 

information and precepts for presenting that information (see page 7). The template is meant to 

be a general framework that can apply to all types of supplements. The template may serve as 

a mechanism to enhance the potential of the supplement label to communicate information and 

strategies about dietary supplements to consumers. 

Dietary Supplement Labels: Key Elements 6 OEI-01-01-00120 
TEMPLATE OF THE KEY ELEMENTS FOR A DIETARY SUPPLEMENT LABEL 

Label Content: 

U Ingredients. It would fully and clearly disclose the ingredients contained in a supplement. 

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. 

U Safety Information. It would provide consumers with known safety information. 

interactions, contraindications, and possible side effects and adverse reactions. 

U Directions for Use. It would provide consumers with adequate directions for use. 

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. 

would use widely accepted terminology and headings. 

U Distinct Product Features. It would have a unique design, format, or specific language that assists 

consumers in distinguishing supplements from other self-care products. 

U Readability. It would contain language and visual cues that are easily understood by a broad group of 

consumers. 

U Balance. It would present information in a balanced manner. 

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. 

The ingredient 

All intended use claims would be based on accepted scientific evidence. 

This would include 

The directions would 

It 

It would give fair treatment to benefits and risks, 

Scope of the Template 

The template can serve as a general label framework that has applications to all types of dietary 

supplements, including vitamins and minerals, herbals and botanicals, and specialty 

supplements. Where we determined that label information was relevant to only one type of 

dietary supplement, we note it in the text. 

LABEL CONTENT 

The first five elements of the template delineate the major categories of information that our 

analysis found to be key in a dietary supplement label. A label may not be able to help 

consumers make informed and appropriate choices about supplement use, if it does not 

adequately address ingredients, intended use, safety information, directions for use, 

Dietary Supplement Labels: Key Elements 7 OEI-01-01-00120 
and product information. While the vast majority of stakeholders we spoke with agreed 

that these five categories of information are critical, there were differences of opinion in how 

best to incorporate each element into the label. The label is of limited size, and while all of 

these elements ought to be included on the label, we recognize that there may be trade-offs in 

terms of the extent of information that can presented about any single element. 

Ingredient Information 

The label would fully disclose the ingredients contained in a supplement. The 

ingredient declaration would accurately reflect the amount of each ingredient 

included in the supplement. 

A dietary supplement label that meets our template would not only disclose the net quantity of 

ingredients, but would also provide information about the quantity and percent of each active 

ingredient. This would be especially relevant to supplements containing multiple ingredients and 

to supplements that are available in different forms and from different sources. The active 

ingredients would have unique names so that consumers would be able to readily recognize 

them. Furthermore, the active ingredients would be easily distinguishable from the inactive 

ones. If a supplement’s bioavailability (extent of absorption into the bloodstream) were known, 

this would be noted on the label. 

An accurate declaration of ingredients is key to maintaining consumer confidence in dietary 

supplements. Consumers would be made aware of any efforts toward standardizing, certifying, 

or producing a dietary supplement according to good manufacturing practices. Because of the 

wide variety of standardization programs currently in use, information would be available to 

consumers about the methods used to standardize or certify a supplement. This information 

need not be on the label itself, but would be available either in a package insert or through a 

toll-free number or website. 

Some stakeholders we interviewed, particularly herbalists and health care providers, stated that 

the labels of herbal supplements ought to contain additional information pertaining to ingredient 

origins and product preparation, because the growing conditions and production processes 

have a direct effect on the level of active ingredient(s) in a dietary supplement. Herbs harvested 

in different parts of the world can contain disparate levels of active ingredients. In addition to 

stating the plant part and species of herb, they would like to see supplements state the country 

in which the ingredient was harvested. Several interviewees told us that they would like 

tinctures to contain information about the extraction process, because the type of solvent used 

to extract an herb can have a substantial impact on the supplement’s potency. Others have 

cautioned, however, that while such information is important, it may be of limited use to the vast 

majority of consumers. 

Dietary Supplement Labels: Key Elements 8 OEI-01-01-00120 
Intended Use 

The label would provide consumers with sufficient information about the range of 

uses for a supplement. All intended use claims would be based on accepted 

scientific evidence. 

To meet our template, statements about intended use would address the primary functions and 

purposes of the supplement, a description of how the supplement would result in a health 

benefit, and the conditions and symptoms for which the supplement is intended. FDA currently 

requires benefit statements to be expressed as claims (such as structure/function claims or 

health claims), but that need not be the only format for expressing intended use. Whatever 

mechanism is used to convey intended use, the statements would be specific enough to be 

useful to consumers. 

Intended use statements could go further by helping consumers to understand the roles of key 

active ingredients. Information on the supplement’s purposes could be presented in such a way 

that consumers could associate active ingredients with the primary purposes of the supplement. 

Other self-care products, such as over-the-counter drugs, are required by regulation to present 

active ingredients immediately adjacent and to the left of the purpose statement. 

Ideally, statements of intended use would be based upon accepted scientific evidence. 

Acceptable scientific evidence would be clearly defined, and this definition would be widely 

accepted and adhered to by manufacturers. The definition would delineate the extent and the 

conditions under which intended use claims could be extrapolated from existing research. 

Furthermore, equivalency would be required between the dose supporting an intended use 

claim and the dose administered during the clinical trial. The public would have access to the 

citations for any secondary research upon which the claims are based. Such information could 

be made available though a package insert, website, or toll-free number. 

If labels could express intended use in more than one way, some delineation would exist, such 

that consumers would be able to understand the extent and nature of the federal oversight for 

each. Furthermore, consumers would be able to distinguish among the various types of claims 

used on supplements. Should disclaimers be associated with statements of intended use, these 

disclaimers would be easily recognized and understood by consumers. 

Our stakeholders debated the appropriate place for intended use statements. Some industry 

representatives told us that the basic function of a dietary supplement and types of 

circumstances in which supplements should be consumed could not be conveyed on the label 

because of size limitations. They noted that, instead, such information ought to be conveyed 

through accompanying literature. Other interviewees, including consumers, health professionals, 

and herbal practitioners, believed that intended use statements were not only essential but also 

were feasible to include on supplement labels. 

Dietary Supplement Labels: Key Elements 9 OEI-01-01-00120 
According to recent FDA focus groups, any mention of possible health benefits on a 

supplement label was considered desirable because it told consumers what the supplement was 

for.10 The American Association of Retired Persons (AARP) also found, in its recent survey, 

that information on the label about a supplement’s purposes is very important to consumers.11 

Safety Information 

The label would provide consumers with known safety information. This would 

include interactions, contraindications, and possible side effects and adverse 

reactions. 

Safety information on a label that meets our template would include potentially harmful 

interactions between the supplement and prescription drugs, over-the-counter medicines, other 

supplements, and foods; contraindications for certain populations and medical conditions; 

possible side effects and adverse reactions; and a statement telling consumers to stop taking the 

supplement if they experience adverse symptoms. Focus groups conducted by FDA found that 

supplement users are keenly interested in safety information.12 A recent study by AARP 

confirmed this on a national scale.13 Other groups have also called for the inclusion of safety 

information on labels.14 

While most stakeholders we interviewed agreed on the concept of safety information and many 

of the particulars noted above, they disagreed over the extent of safety information necessary 

on a supplement label. Some industry representatives believed that only in very specific 

circumstances should warnings appear on supplements (for example, on supplements containing 

Ephedra and St. John’s Wort, which have been associated with adverse reactions, or 

precautionary statements pertaining to pregnant or lactating women); otherwise it would be 

impractical to list all interactions. Their preferred approach would be to call upon doctors or 

pharmacists to alert consumers to potential interactions. Others believed that safety information 

ought not be included on the label, unless the risks were well-documented in research studies or 

through adverse events. 

Others, particularly consumer advocates, believed that labels ought to list all possible 

interactions. They expressed concerns that health professionals may lack sufficient knowledge 

about supplements to adequately inform consumers of potential interactions or adverse effects. 

Finally, some would like safety information to go even further by including information on 

adverse event reporting. The State of Texas has begun requiring all Ephedra products to 

contain the toll-free number of the FDA’s Medwatch medical product reporting program. 

Others, however, have raised concerns that by including the FDA Medwatch number on a 

supplement label, consumers may perceive it as an implied endorsement of the safety of the 

supplement and may assume an incorrect level of FDA oversight. 

The majority of consumers and health professionals in our focus groups told us that they were 

more comfortable with an explicit warning label, rather than a vague statement, such 

Dietary Supplement Labels: Key Elements 10 OEI-01-01-00120 
as “if you have a health condition, please discuss with your doctor.” Our interviewees tended 

to prefer warnings that mentioned specific medical conditions and that were written in simple 

language. For example, most people liked the Ephedra warning because of its completeness. 

It addresses topics such as contraindications, interactions, maximum dosage, and adverse 

effects.15 A few people, however, told us that having too much information, or too many 

specific references, might either scare consumers or lead them to ignore the warning. 

Stakeholders were split over the need for labels to carry a statement calling for the consumer to 

consult with a health professional before using the supplement. Since supplements are 

technically not considered drugs, some industry representatives believed that carrying a 

precautionary note to discuss usage with a health provider is unnecessary. Others, particularly 

consumer and health providers, believed that labels ought to encourage consumers to discuss 

supplement usage with their health providers, especially if they are taking other medications. A 

recent survey by Prevention Magazine found that 31 percent of consumers take dietary 

supplements in combination with a prescription medicine, and 30 percent of consumers take 

dietary supplements in combination with an over-the-counter product.16 

Despite disagreements about the level of information that ought to be included on supplements, 

all interviewees stated that there ought to be consistency among the warning labels for similar 

supplements. Warnings pertaining to supplement-drug interactions ought to convey similar 

information separately on the drug and the supplement. Furthermore, stakeholders believed 

that requirements for warning statements ought to be harmonized across federal and state 

regulatory agencies. 

Directions for Use 

The label would provide consumers with adequate directions for use. The 

directions would include guidance on proper doses, if the information is available. 

Directions for use on a label that meets our template would cover a range of important 

information, including a recommended daily dose, minimum duration of time for which a 

supplement should be taken in order to see results, maximum dose or extent of time for which a 

supplement can be safely taken, and information about how to consume the supplement (e.g., 

with or without food and liquid). Some groups, including the Commission on Dietary 

Supplement Labels, would also like to see labels direct consumers to use the supplements only 

as recommended on the label. 

Consumer studies have shown that dosage information on labels is of the utmost importance to 

consumers. For example, in a recent survey by Prevention Magazine, consumers reported 

that, of all the information on the label, they are most likely to look for information pertaining to 

recommended dose.17 Consumers in our focus groups told us that when they use a dietary 

supplement, the most important questions to which they 

Dietary Supplement Labels: Key Elements 11 OEI-01-01-00120 
seek answers are: How much of the supplement do they need to take to get the result they are 

looking for? How much is too much? 

Ideally, dose per use and duration of use would be based on the amount of supplement 

necessary to meet the label claims. Consumers would be able to achieve the benefits suggested 

on label claims based on the number of pills in the supplement; if this is not the case, the label 

would clearly indicate the amount of supplement needed to achieve that benefit. Dosage 

information might vary depending on the condition or indication for which the supplement is 

being taken. It might also vary, based on the age of the consumer. Whatever dose is stated on 

the bottle would be clear to consumers; any distinctions between the recommended serving size 

and the recommended daily intake would be obvious. Furthermore, dosage recommendations 

would be standardized across supplements so that identical supplements with similar claims 

would call for equivalent doses. 

To meet our template, the label would also contain any special storage instructions, including 

expiration dates for herbals and other supplements with a finite shelf life. Such information can 

ensure that consumers do not attempt to ingest supplements whose ingredients can no longer 

deliver the desired benefit. According to surveys by Prevention Magazine and AARP, 

consumers consider the expiration date to be a valuable component of the label.18 

Product Information 

The label would identify the manufacturer, production source and batch, and 

information about the net quantity of contents found in the supplement. 

Product information can assist consumers in identifying key attributes about the contents, 

production, and manufacture of a supplement. A label that meets our template would contain 

the name, address, and contact information for the manufacturer. Such information could be 

helpful to consumers, should they have a question about a supplement. Contact information is 

helpful to consumers when it contains a toll-free number or website address through which 

consumers can easily reach the manufacturer. A second important piece of information is the 

net quantity of contents in the bottle or package, expressed in either weight, measure, or 

number. This type of information can help consumers comparison shop among supplement 

brands. Finally, the label would contain a lot number to identify the production source and 

batch. In the case of a product recall, lot numbers could help consumers and manufacturers 

easily identify and track those supplements. 

LABEL PRESENTATION 

The second five elements of the template deal with the way in which information is presented on 

a supplement label. While it is key for labels to adequately address ingredient information, 

intended use, safety information, directions for use, and product 

Dietary Supplement Labels: Key Elements 12 OEI-01-01-00120 
information, it is equally important that the information be presented to consumers in a clear and 

meaningful way. In this section we address five general precepts that are key to label design. 

Standardized Format 

The label would present similar types of information across supplements in a 

similar order. The label would use widely accepted terminology, headings, and 

titles. 

A standardized label would serve as a “system” for consumers, helping them to interpret 

important information on the label and also assisting them in comparing that information across 

supplements. Furthermore, a standardized label structure would improve consumers’ ability to 

process label information. In both the food and drug areas, stakeholders told us that the 

standardizing of labels has proven to be enormously helpful. 

A standardized dietary supplement label that meets our template would reflect several elements. 

First, it would require that all labels contain similar types of information. Second, it would 

require that information be conveyed across supplements in a consistent manner. The order 

and flow of information, and the format in which that information is displayed, would be 

consistent across supplements. Finally, the language on supplements would also be 

standardized. Important terminology, such as the name of a supplement, would be similar 

across supplements. Headings, which would alert consumers to information, such as product 

safety and recommended dose, would be uniform across supplements. 

The standardized format would need to be well understood by consumers. Because there is a 

limit to how much information consumers can hold in their memory at one time, it is key that the 

amount of information required on labels be congruent with consumers’ ability to retrieve and 

process information. Research suggests that consumers are most likely to engage in a behavior, 

such as reading a label, if they believe they can successfully complete the task.19 Thus, 

consumers would have to find the format easy to use, navigate, and comprehend. 

A standardized label need not mean that there is only one way of presenting information. 

Required information could be presented in one of several standardized formats, depending on 

the type and size of the supplement. For example, FDA’s Center for Drug Evaluation and 

Research has authorized a range of different formats for over-the-counter (OTC) labels, 

depending on the type and size of product. 

While the vast majority of stakeholders we spoke with liked the idea of a standardized label, a 

few dissented. Some pointed out that manufacturers are already hard-pressed to get 

information on labels, and raised concern that requiring yet more information could lead to 

overcrowding on the label. Others pointed out that a standardized format might 

Dietary Supplement Labels: Key Elements 13 OEI-01-01-00120 
encroach upon a manufacturer’s ability to use the label as a marketing tool, because it would 

greatly limit the discretionary space on labels. 

Distinct Product Features 

The label would have a unique design, format, or specific language that would 

assist consumers in distinguishing supplements from other self-care products. 

A label that meets our template would contain distinct product features so that consumers could 

distinguish dietary supplements from other types of self-care products. The ability to distinguish 

one type of product from another is key to a consumer’s ability to select appropriate 

supplements. To achieve such a distinction, the dietary supplement label would need to look 

significantly different from other self-care products, such as over-the-counter drugs and 

homeopathic products. For example, supplement labels could have a unique design, shape, 

language, color, or product feature, such as a symbol on the bottle cap. An important factor in 

choosing a distinct product feature for a dietary supplement is that it be one that consumers 

would readily associate with supplements. 

In distinguishing a supplement from other types of products, the label would also carry language 

that clearly communicates to consumers important features about supplement regulation. For 

example, the label could make clear through a disclaimer or some other mechanism that 

supplements are not subject to premarket approval or that FDA has not evaluated their safety 

and effectiveness. We recognize that such statements could call for trade-offs in label 

information. Such a statement, which would need to be in a large enough font and in simple 

language, may come at the expense of other critical information, such as safety information. 

Readability 

The label would contain language that is easily understood by a broad group of 

consumers. 

A label that meets our template would be easily understood by consumers. To that end, the 

language must be clear and concise, with a reading level that is suitable for a broad group of 

consumers. The language must be simple enough that it could be understood by lay persons. 

An important component of readability is font size, which needs to be sufficient for a broad 

group of consumers. To increase readability, labels could contain symbols or other visual cues 

to focus the consumer’s attention to important information. Some of our interviewees believed 

that symbols or visual cues, such as a danger sign or red box, could effectively alert consumers 

to safety information. However, others believed that symbols could be problematic, pointing 

out that cues can have different meanings to different people. Thus, were symbols to be 

incorporated into labels, the label redesign would have to be accompanied by public education. 

Dietary Supplement Labels: Key Elements 14 OEI-01-01-00120 
Changes in consumer information needs must be taken into account in assessing how best to 

ensure that labels are read and understood by a broad group of consumers. With continued 

advances in nutrition, medicine, and the study of herbal medicine, labels will have to 

communicate increasingly sophisticated messages on topics, such as directions for use and 

safety information. Changes in American demographics will also have an impact on consumer 

information needs. The elderly, who are large users of supplements, are becoming a larger 

proportion of the population.20 They may have greater difficulty reading a label because of 

poor vision. Finally, as the number and percentage of United States residents, who do not 

speak English as their primary language, increases, labels that can be understood by a wide 

variety of language speakers will become increasingly important.21 

Balance 

The label would present information in a balanced manner. It would give fair 

treatment to benefits and risks, to claims and disclaimers, and to factual and 

marketing information. 

A label that meets our template would present a balance between competing types of 

information. For example, the label would give fair treatment to information about a 

supplement’s benefits as well as its risks. The label would include an appropriate balance 

between factual information, as required by FDA label regulations, and marketing information, 

which could include claims, company logo, designs, and images. Finally, space would be 

balanced between claims and disclaimers. This balance would need to be determined on a 

case-by-case basis. In some instances, balance would entail equal space being devoted to both 

kinds of information. In other cases, the amount of space would depend on the level of science 

and knowledge in a particular area. Finally, the placement of information on a label may have 

implications for the extent to which labels accomplish balance. The balance of information is 

key to the informed and appropriate use of any self-care product, and is required in the 

advertising for OTC drugs. 

Constructive Use of Label Space 

The label would seek to expand the limited label space through creative packaging 

and pointing consumers to alternative sources of information. 

While the size of a label is an inherently limiting factor to the amount of information that can be 

placed on the label, the placement of that information need not be limited to the primary display 

panel. A label that meets our template would seek to expand the limited space through creative 

packaging. 

Expanded labels hold particular promise for information that is important but not so critical that 

it needs to be on the package label. For example, the following types of information could be 

effectively placed on an expanded label: information about the 

Dietary Supplement Labels: Key Elements 15 OEI-01-01-00120 
scientific legacy of the supplement, including information about the clinical trials; key mechanism 

of action for the active ingredients; additional information about the processing and manufacture 

of a supplement; and the full text of a disclaimer, should a truncated version be used on the 

label.

22 In our review of labels, we identified four options for expanding the information 

contained on a dietary supplement label. Below we discuss the options, identifying both 

benefits and potential concerns. 

< Innovations to existing label space. Label space can be expanded through innovations, 

such as a “twist-n-turn” label, in which the outer part of the label twists around an inner 

band of information; an “accordian” label, in which the label folds out to be several times its 

size; and a “neck strap” label, in which a tag is attached to the bottle neck. However, these 

labels may get torn off, lost, or malfunction. Consumers may also be overwhelmed by the 

different label forms, resulting in increased confusion and a decreased ability to compare 

supplement labels. 

< Inclusion of a package insert. By physically increasing the size of the label or adding a 

package insert, more space can be made available. Yet, in some cases a larger label may 

be impossible, especially for small packages. Some interviewees also cautioned that 

consumers and health providers might not read package inserts. 

< Use of outer packaging. By enclosing supplements in boxes or another type of outer 

package, manufacturers can greatly enhance the label space available because the outer 

package becomes an extension of the label. Yet, a large box, which might be necessary to 

carry all the necessary label information, could mislead consumers into thinking that the 

quantity contained in the accompanying bottle is greater than in fact it is. Manufacturers 

also told us that the use of boxes could lead to increased production costs. 

< Alternative sources of information. Alternative sources of information could include a 

toll-free number or website. These would be listed on the label and would essentially serve 

as a continuation of the label. Both options hold great promise because they allow for 

potentially unlimited space where manufacturers could disclose pertinent information, such 

as safety precautions. However, consumers must take an additional step on their own 

initiative to get further information. Not all consumers have access to the Internet. Even for 

those who have access to a telephone, some concern exists about bias, because company 

employees would be fielding the calls. Consumers and health professionals told us that it 

would be most helpful for labels to point consumers to a toll-free number staffed by a 

neutral party, such as the National Institutes of Health. Finally, including a website or tollfree number on the label raises a host of regulatory oversight issues, as it potentially 

expands the definition of a label. 

Dietary Supplement Labels: Key Elements 16 OEI-01-01-00120 
CONCLUSION 

This template sets forth a vision of key elements that can increase the potential of dietary 

supplement labels to help consumers make informed and appropriate choices about supplement 

use. It is a vision that appears to have considerable support among the wide range of 

stakeholders whom we interviewed. We recognize that this template is general and leaves out 

many important details concerning specific expectations or requirements for supplement labels. 

It does, however, put forth a framework that government officials, consumer groups, industry 

representatives, academics, and others can use as they seek to find common ground on the 

specific content and presentation of labels. 

For an assessment of the extent to which existing dietary supplement labels reflect the elements 

identified in this template, see our companion report, Dietary Supplement Labels: An 

Assessment (OEI-01-01-00121). 

Dietary Supplement Labels: Key Elements 17 OEI-01-01-00120 
APPENDIX A 

ADVERTISEMENTS FOR DIETARY SUPPLEMENTS

We discovered these advertisements, which are regulated by the Federal Trade Commission, 

during our review of magazines and newspapers. Supplement A is for a joint health product 

and Supplement B is for a weight loss product. In each case, we were struck by the messages 

and claims conveyed to consumers. We do not disclose the names of the supplements, or the 

individuals who endorse them. Each of the following boxes highlights excerpts from the 

advertisements: 

Supplement A 

“...For 20 years, severe bone/joint problems put Celebrity #1 through 

living hell. But three days after he discovered a new breakthrough in 

natural relief from joint problems, the crippling pain was gone. Not 

diminished - gone! 

What was this ‘miracle’ that finally got rid of Celebrity #1’s bone/joint 

agony after 20 years of trying countless medications and treatments? 

Supplement A” 

Supplement B 

“...Teacher loses 70 pounds in only 8 weeks easily ... without being 

hungry... after everything else fails her! 

This has become the #1 choice of famous TV and movie stars to lose 

weight ... and the public ... with over 1 million people using it to lose 10 

million pounds. 

Supplement B includes 100 percent natural fat-busting, energizing natural 

nutrients that give your body no choice but to make fat and inches 

disappear like magic.” 

Dietary Supplement Labels: Key Elements 18 OEI-01-01-00120 
APPENDIX B 

METHODOLOGY

Development of the Template 

Our template represents a synthesis of the feedback we heard during 76 interviews, 7 focus 

groups, and a review of literature pertaining to important characteristics of supplement labels. 

We continuously added to and refined the elements of the template to reflect the diversity of 

perspectives, which we encountered, and particularly notable areas of agreement or 

disagreement. We also shared the template with key stakeholders at various stages of its 

evolution to confirm that it could be a useful and useable construct for them. 

Interviews and Focus Groups 

We conducted 76 interviews with key stakeholders. We spoke with each of the supplement 

industry trade groups, consumer advocacy groups, private quality oversight organizations, 

professional nutrition associations, academic researchers, marketers, and practicing herbalists. 

With each group, we discussed the role of a supplement label in the ideal and current label 

shortcomings, and solicited their recommendations for reform. 

We conducted focus groups with consumers and with health care professionals, and reviewed 

the findings of other focus groups. In cooperation with the Administration on Aging, we led five 

focus groups of elderly consumers who represented a diversity of cultural backgrounds, 

socioeconomic status, health condition, use of supplements, and use of prescription drugs. 

These focus groups took place in Massachusetts, Colorado, and California. We also, in 

partnership with the American Pharmaceutical Association and the American Geriatrics 

Society, conducted two focus groups of geriatricians and gerontologists and two groups of 

pharmacists with diverse geographic locations, practice settings, reliance on labels, and 

experience in advising patients. Finally, we reviewed the findings from 1999 of FDA’s 

consumer focus groups on dietary supplement labels. 

Literature Review 

We reviewed relevant federal legislation, regulation, and program priority documents; position 

papers from consumer and industry groups; articles in peer-reviewed journals and trade press; 

transcripts from congressional hearings and FDA town meetings; and reports from Presidential 

commissions, federal evaluators, and government-sponsored colloquia on dietary supplements. 

We also reviewed consumer-oriented newsletters, books, advertisements, and websites on 

supplement use. 

Dietary Supplement Labels: Key Elements 19 OEI-01-01-00120 
APPENDIX B 

We obtained existing data from nationwide surveys on consumer use of dietary supplements 

and supplement labels. We looked at both the raw data and the findings from Prevention 

Magazine’s 1999 and 2000 surveys on dietary supplements, which were based on random 

samples of 2,000 people. In addition, we reviewed the findings of recent surveys from diverse 

federal, professional, academic, and private organizations. 

We also reviewed existing data on the economic characteristics of the supplement industry. 

We obtained statistics from FDA-commissioned research reports and the Nutrition Business 

Journal. 

Dietary Supplement Labels: Key Elements 20 OEI-01-01-00120 
APPENDIX C 

ENDNOTES

1. Courtesy of Nutrition Business Journal. About 40 percent of the population uses supplements 

often, and 30 percent takes them infrequently. Nutrition Business Journal obtained these figures from 

a compilation of 13 consumer surveys. Individual consumer surveys, by groups such as the Kaiser 

Family Foundation, Yankelovich Partners, the Dietary Supplement Education Alliance, and Prevention 

magazine, have found similar patterns in use over the past several years. 

2. FDA estimated that the number of supplements on the market may range from 25,000 to 33,000 

(29,000 is the midpoint of this range). (Memorandum re: questions concerning dietary supplement 

labeling, June 13, 2001) 

3. NBJ’s Annual Overview of the Nutrition Industry VI, Nutrition Business Journal (2001), 7 

4. General Accounting Office, Food Safety: Improvements Needed in Overseeing the Safety of 

Dietary Supplements and 'Functional Foods', GAO/RCED-00-156, July 11, 2000. 

5. Food and Drug Administration, Dietary Supplement Enforcement Report. Retrieved from 

http://www.fda.gov/oc/nutritioninitiative/report.html, December 27, 2002. 

6. Roper Starch Worldwide, Self-Care in the New Millennium, 2001,10. According to this study, 73 

percent of people prefer to treat conditions themselves, rather than go to a doctor; furthermore, 59 

percent say that they are more likely to treat their own conditions than 12 months ago. In other cases, 

consumers are seeing a health care practitioner but not reporting their use of dietary supplements. For 

example, another survey revealed that 30 percent of those who reported taking supplements regularly 

had not shared this information with their physician. Robert Blendon et al, Americans’ Views on the 

Use and Regulation of Dietary Supplements, Archives of Internal Medicine (March 26, 2001), 161: 

805-810. 

7. Roper Starch Worldwide, Self-Care in the New Millennium, 2001,19. 

8. Prevention Magazine, “National Survey of Consumer Use of Dietary Supplements,” Rodale, Inc., 

1999, 32. 

9. Ibid., 35-37. 

10. Alan Levy and Brenda Derby, Consumer Studies Team. FDA Report on Dietary Supplement 

Labeling Focus Groups, September 30, 1999. 

11. Seventy-six percent of consumers thought it would be very important for information to appear on a 

supplement label about “what a supplement does, for example, helps you sleep, boosts the immune 

system.” AARP Public Policy Institute, Dietary Supplements and Older Consumers, Data Digest 66, 

Dietary Supplement Labels: Key Elements 21 OEI-01-01-00120 
APPENDIX C 

7. 

12. Alan Levy and Brenda Derby, Consumer Studies Team. FDA Report on Dietary Supplement 

Labeling Focus Groups, September 30, 1999. 

13. Respondents thought it would be important to have the following information appear on dietary 

supplement labels: information on possible side effects or adverse reactions (82 percent); information 

on interactions with prescription and over-the-counter medicines (80 percent); the maximum amount 

that is safe to take (81 percent); expiration date (82 percent); and information on whom to contact in 

case of an adverse reaction (76 percent). AARP Public Policy Institute, Dietary Supplements and 

Older Consumers, Data Digest 66, 3. 

14. The Food Committee of the Association of Food and Drug Officials has called for the mandatory 

label disclosure of the following items: information regarding any side effects or adverse reactions; 

contraindications to warn those consumers who may be adversely affected because of their age, 

existing health problems, and risks posed, if pregnant or nursing; if there is a risk of adverse drug and 

dietary supplement interaction; and cautionary language to seek health practitioner guidance, if there are 

health concerns present. Association of Food and Drug Officials, Resolution Concerning: Safety and 

Marketing of Dietary Supplements. June 17, 2001. 

The Commission on Dietary Supplement labels recommended that, “Ensuring the safety of supplements 

includes the need to provide adequate information and warnings to consumers. The Commission 

strongly suggests that dietary supplement manufacturers include appropriate warnings in product 

information, where necessary, as specifically permitted by DSHEA. In addition, manufacturers should 

recognize the need to advise women who are pregnant or breast-feeding to consult a health 

professional about supplement use during pre-and postnatal periods.” Commission on Dietary 

Supplement Labels, Report of the Commission on Dietary Supplement Labels, November 1997, vii. 

15. The warning on the Ephedra supplement we used during our focus groups contained the following 

language: “Not for use by or sale to persons under age 18. Do not use if pregnant or nursing. Consult 

a physician or licensed qualified health care professional (“physician”) before product use if you have, 

or have a family history of, heart or thyroid disease, diabetes, high blood pressure, recurrent headaches, 

depression, any psychiatric condition, glaucoma, difficulty urinating, enlarged prostate, seizure disorder, 

if you are using a monoamine oxidase inhibitor (MOAI) or any other dietary supplement, prescription 

drug or over-the-counter drug containing ephedrine, pseudoephedrine or phenylpropanolamine 

(ingredients found in certain allergy, asthma, cough/cold, and weight control products), or if you intend 

on taking to reduce weight. Under Ohio law, the maximum recommended dosage of ephedrine for a 

healthy adult is 100 mg in a 24-hour period for not more than 12 weeks. Exceeding recommended 

serving may cause serious adverse health effects including heart attack and stroke. Discontinue use and 

call a physician immediately if you experience rapid heartbeat, dizziness, severe headache, shortness of 

breath or other similar symptoms. Individuals who consume caffeine with this product may experience 

Dietary Supplement Labels: Key Elements 22 OEI-01-01-00120 
APPENDIX C 

serious adverse health effects. Keep out of reach of children.” 

16. Prevention Magazine, “National Survey of Consumer Use of Dietary Supplements,” Rodale, Inc., 

1999, 37-39. 

17. Prevention Magazine, “National Survey of Consumer Use of Dietary Supplements,” Rodale, Inc., 

1999, 59-63. The recommended dosage is the most widely read item on a supplement label. 

Consumers reported to Prevention Magazine that they look for recommended dosage “always or most 

of the time” for vitamins and mineral (89 percent), and for herbal remedies (90 percent). 

The AARP also found that “the amount [one] should take” is a very important element that should 

appear on dietary supplement labels. Eighty-one percent of their survey respondents stated that it 

would be very important to appear on the label. AARP Public Policy Institute, Dietary Supplements 

and Older Consumers, Data Digest 66, 7. 

18. Prevention Magazine, “National Survey of Consumer Use of Dietary Supplements,” Rodale, Inc., 

1999, 59-63. The expiration date is the second most widely read item on a supplement label. 

Consumers told Prevention Magazine that they look for expiration date “always or most of the time” for 

vitamins and mineral (74 percent), for herbal remedies (77 percent). 

The AARP also found that the “expiration date, that is, the date after which a supplement is no longer 

effective” is a very important element that should appear on dietary supplement labels. Eighty-two 

percent of their survey respondents stated that the expiration date would be very important to appear 

on the label. AARP Public Policy Institute, Dietary Supplements and Older Consumers, Data Digest 

66, 7. 

19. Center for Drug Evaluation and Research, FDA, Summary of Study A and B (untitled 

document). Provided to OIG by the Center for Drug Evaluation and Research in 2001. 

20. Department of Commerce, Census Bureau, National Population Projections (Population 

Pyramids). Retrieved from http://www.census.gov/population/www/projections/np_p5.gif, March 26, 

2002. 

21. The Census data from 2000 show that almost 45 million people speak a language other than English 

at home, and over 19 million of those speak English less than “very well.” By contrast, in 1990 almost 

32 million people spoke a language other than English at home, and 14 million of those spoke English 

less than “very well.” Census 2000 Supplementary Survey Summary Table QT-03: Profile of Selected 

Social Characteristics: 2000; 1990 Summary Tape File 3 (STF 3) - Sample data – Table DP-2: Social 

Characteristics: 1990. Retrieved from http://factfinder.census.gov, May 17, 2002. 

22. Alan Levy and Brenda Derby, Consumer Studies Team. FDA Report on Dietary Supplement 

Labeling Focus Groups, September 30, 1999. 

Dietary Supplement Labels: Key Elements 23 OEI-01-01-00120 
ACKNOWLEDGMENTS 

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 General’s

Public Affairs office at (202) 619-1343.

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

http://www.oig.hhs.gov/ 

Dietary Supplement Labels: Key Elements 24 OEI-01-01-00120