DIETARY SUPPLEMENTS:

AN ADVERTISING

GUIDE FOR

INDUSTRY

TABLE OF CONTENTS

I INTRODUCTION 1

II APPLICATION OF FTC LAW TO DIETARY SUPPLEMENT ADVERTISING 3

A. Identifying Claims and Interpreting Ad Meaning 3

1. Identifying Express and Implied Claims...............................................................................3

2. When to Disclose Qualifying Information ............................................................................5

3. Clear and Prominent Disclosure .........................................................................................6

B. Substantiating Claims 8

 Overview .......................................................................................................................8

1. Ads that Refer to a Specific Level of Support ......................................................................9

2. The Amount and Type of Evidence ................................................................................... 10

3. The Quality of the Evidence ............................................................................................ 12

4. The Totality of the Evidence ........................................................................................... 14

5. The Relevance to the Evidence to the Specific Claim........................................................... 16

C. Other Issues Relating to Dietary Supplement Advertising 18

1. Claims based on Consumer Testimonials and Expert Endorsements ......................................... 18

2. Claims based on Traditional Use ...................................................................................... 20

3. Use of the DSHEA Disclaimer in Advertising ...................................................................... 23

4. Third Party Literature .................................................................................................... 24

III CONCLUSION 25

 End Notes 26

I

1

Advertising for

ANY product

must be truthful,

not misleading,

and

substantiated.

INTRODUCTION

The dietary supplement industry is a dynamic one. Scientific research on the associations

between supplements and health is accumulating rapidly. The number of products  and

the variety of uses for which they are promoted  have increased significantly in the last few

years. The role of the Federal Trade Commission, which enforces laws outlawing unfair or

deceptive acts or practices, is to ensure that consumers get accurate information about dietary

supplements so that they can make informed decisions about these products.1

The Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) work

together under a long-standing liaison agreement governing the division of responsibilities

between the two agencies. As applied to dietary supplements, the FDA has primary

responsibility for claims on product labeling, including packaging, inserts, and other

promotional materials distributed at the point of sale. The FTC has primary responsibility for

claims in advertising, including print and broadcast ads, infomercials, catalogs, and similar

direct marketing materials. Marketing on the Internet is subject to regulation in the same

fashion as promotions through any other media. Because of their shared jurisdiction, the two

agencies work closely to ensure that their enforcement efforts are consistent to the fullest

extent feasible.

In 1994, the Dietary Supplements Health and Education Act (DSHEA) significantly changed

the FDAs role in regulating supplement labeling.2 These claims are commonly referred to as

structure/function claims.3 Although DSHEA does not directly apply to advertising, it has

generated many questions about the FTCs approach to

dietary supplement advertising. The answer to these

questions is that advertising for any product  including

dietary supplements  must be truthful, not misleading,

and substantiated. Given the dramatic increase in the

volume and variety of dietary supplement advertising in

recent years, FTC staff is issuing this guide to clarify how

long-standing FTC policies and enforcement practices relate to

dietary supplement advertising.

The FTCs approach to supplement advertising is best

illustrated by its Enforcement Policy Statement on Food

Advertising (Food Policy Statement). Although the Food

Policy Statement does not specifically refer to supplements, the

principles underlying the FTCs regulation of health claims in food advertising are relevant to

the agencys approach to health claims in supplement advertising. In general, the FTC gives

great deference to an FDA determination of whether there is adequate support for a health

claim. Furthermore, the FTC and the FDA will generally arrive at the same conclusion when

evaluating unqualified health claims. As the Food Policy Statement notes, however, there may
be certain limited instances when a carefully qualified health claim in advertising may be

permissible under FTC law, in circumstances where it has not been authorized for labeling.

However, supplement marketers are cautioned that the FTC will require both strong scientific

support and careful presentation for such claims.5

Supplement marketers should ensure that anyone involved in promoting products is familiar

with basic FTC advertising principles. The FTC has taken action not just against supplement

manufacturers, but also, in appropriate circumstances, against ad agencies, distributors,

retailers, catalog companies, infomercial producers and others involved in deceptive

promotions. Therefore, all parties who participate directly or indirectly in the marketing of

dietary supplements have an obligation to make sure that claims are presented truthfully and to

check the adequacy of the support behind those claims.

2
APPLICATION OF FTC LAW TO

DIETARY SUPPLEMENT ADVERTISING

The FTCs truth-in-advertising law can be boiled down to two common-sense propositions:

1) advertising must be truthful and not misleading; and

2) before disseminating an ad, advertisers must have

 adequate substantiation for all objective product claims.6

A deceptive ad is one that contains a misrepresentation or omission that is likely to mislead

consumers acting reasonably under the circumstances to their detriment. The FTCs

substantiation standard is a flexible one that depends on many factors. When evaluating claims

about the efficacy and safety of foods, dietary supplements and drugs, the FTC has typically

applied a substantiation standard of competent and reliable scientific evidence.

To determine whether an ad complies with FTC law, it is first necessary to identify all express

and implied claims that the ad conveys to consumers. Once the claims are identified, the

scientific evidence is assessed to determine whether there is adequate support for those claims.

The following sections describe this two-step process with examples illustrating how principles

of ad interpretation and substantiation apply in the context of dietary supplement advertising.

The examples have been simplified to illustrate one or two specific points. Therefore,

advertisers should use these examples as general guidance only.7

A. Identifying Claims and Interpreting Ad Meaning

1. Identifying Express and Implied Claims

The first step in evaluating the truthfulness and accuracy of advertising is to identify all

express and implied claims an ad conveys to consumers. Advertisers must make sure that

whatever they say expressly in an ad is accurate. Often, however, an ad conveys other claims

beyond those expressly stated. Under FTC law, an advertiser is equally responsible for the

accuracy of claims suggested or implied by the ad. Advertisers cannot suggest claims that they

could not make directly.

When identifying claims, advertisers should not focus just on individual phrases or statements,

but rather should consider the ad as a whole, assessing the net impression conveyed by all

elements of the ad, including the text, product name, and depictions. When an ad lends itself

to more than one reasonable interpretation, the advertiser is responsible for substantiating each

II

3
interpretation. Copy tests, or other evidence of how consumers actually interpret an ad, can

be valuable. In many cases, however, the implications of the ad are clear enough to determine

the existence of the claim by examining the ad alone, without extrinsic evidence.

Example 1

An advertisement claims that “university studies prove”

that a mineral supplement can improve athletic

performance. The advertiser has expressly stated the

level of support for the claimed benefit and is therefore

responsible for having “university studies” that

document the advertised benefit. Furthermore, the

implied reference to scientific evidence likely conveys to

consumers the implied claim that the studies are

methodologically sound.

Example 2

An advertisement for a vitamin supplement claims that

90% of cardiologists regularly take the product. In

addition to the literal claim about the percentage of

cardiologists who use the product, the ad likely conveys

an implied claim that the product offers some benefit for

the heart. Therefore, the advertiser must have adequate

support for both representations.

Depending on how it is phrased, or the context in which it is presented, a statement about a

products effect on a normal structure or function of the body may also convey to consumers

an implied claim that the product is beneficial for the treatment of a disease. If elements of

the ad imply that the product also provides a disease benefit, the advertiser must be able to

substantiate the implied disease claim even if the ad contains no express reference to disease.

Example 3

An ad for an herbal supplement makes the claim that the

product boosts the immune system to help maintain a

healthy nose and throat during the winter season. The

ad features the product name “Cold Away” and includes

images of people sneezing and coughing. The various

elements of the ad — the product name, the depictions

of cold sufferers, and the reference to nose and throat

health during the winter season — likely convey to

consumers that the product helps prevent colds.

Therefore, the advertiser must be able to substantiate

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that claim. Even without the product name and images,

the reference to nose and throat health during the

winter season may still convey a cold prevention claim.

Example 4

An ad for a dietary supplement called “Arthricure” claims

that the product maintains joint health and mobility

into old age. The “before” picture shows an elderly

women using a walker. The “after” picture shows her

dancing with her husband. The images and product

name likely convey implied claims that the product is

effective in the treatment of the symptoms of arthritis,

and may also imply that the product can cure or

mitigate the disease. The advertiser must be able to

substantiate these implied claims.

2. When to Disclose Qualifying Information

An advertisement can also be deceptive because of what it fails to say. Section 15 of the FTC

Act requires advertisers to disclose information if it is material in light of representations made

or suggested by the ad, or material considering how consumers would customarily use the

product. Thus, if an ad would be misleading without certain qualifying information, that

information must be disclosed. For example, advertisers should disclose information relevant

to the limited applicability of an advertised benefit. Similarly, advertising that makes either an

express or implied safety representation should include information about any significant safety

risks. Even in the absence of affirmative safety representations, advertisers may need to

inform consumers of significant safety concerns relating to the use of their product.

Example 5

An advertisement for a multi-vitamin/mineral

supplement claims that the product can eliminate a

specific mineral deficiency that results in

feelings of fatigue. In fact, less than 2% of

the general population to which the ad is

targeted suffers from this deficiency.

The advertiser should disclose this fact

so that consumers will understand that

only the small percentage of people who

suffer from the actual mineral deficiency are

likely to experience any reduction in fatigue

from using the product.

5
Example 6

An advertiser for a weight loss supplement cites a

placebo-controlled, double-blind clinical study as

demonstrating that the product resulted in an average

weight loss of fifteen pounds over an eight-week period.

The weight loss for the test group is, in fact,

significantly greater than for the control subjects.

However, both the control and test subjects engaged in

regular exercise and followed a restricted-calorie diet as

part of the study regimen. The advertisement should

make clear that users of the supplement must follow the

same diet and exercise regimen to achieve the claimed

weight loss results.

Example 7

An advertiser claims that its herbal product is a natural

pain reliever “without the side effects of over-thecounter pain relievers.” However, there is substantial

evidence that the product can cause nausea in some

consumers when taken regularly. Because of the

reference to the side effects of other pain relievers,

consumers would likely understand this ad to mean that

the herbal product posed no significant adverse effects.

Therefore, the advertiser should disclose information

about the adverse effects of the herbal product.

Example 8

An herbal weight loss product contains an ingredient

which, when consumed daily over an extended period,

can result in a significant increase in blood pressure.

Even in the absence of any representation about the

product’s safety, the advertiser should disclose this

potentially serious risk.

3. Clear and Prominent Disclosure

When the disclosure of qualifying information is necessary to prevent an ad from being

deceptive, that information should be presented clearly and prominently so that it is actually

noticed and understood by consumers. A fine-print disclosure at the bottom of a print ad, a

6
disclaimer buried in a body of text, a brief video superscript in a television ad, or a disclaimer

that is easily missed on an Internet web site, are not likely to be adequate. To ensure that

disclosures are effective, marketers should use clear language, avoid small type, place any

qualifying information close to the claim being qualified, and avoid making inconsistent

statements or distracting elements that could undercut or contradict the disclosure. Because

consumers are likely to be confused by ads that include inconsistent or contradictory

information, disclosures need to be both direct and unambiguous to be effective.

Example 9

A marketer promotes a supplement as a weight loss aid.

There is adequate substantiation to indicate that the

product can contribute to weight loss when used in

conjunction with a diet and exercise regimen. The

banner headline claims “LOSE 5 POUNDS IN 10 DAYS,”

the ad copy discusses how easy it is to lose weight by

simply taking the product 3 times a day, and the ad

includes dramatic before-and-after pictures. A fine print

disclosure at the bottom of the ad, “Restricted calorie

diet and regular exercise required,” would not be

sufficiently prominent to qualify the banner headline and

the overall impression that the product alone will cause

weight loss. The ad should be revised to remove any

implication that the weight loss can be achieved by use

of the product alone. This revision, combined with a

prominent indication of the need for diet and exercise,

may be sufficient to qualify the claim. However, if the

research does not show that the product contributes

anything to the weight loss effect caused by diet and

exercise, it would be deceptive, even with a disclosure,

to promote the product for weight loss.

Qualifying information should be sufficiently simple and clear that consumers not only notice

it, but also understand its significance. This can be a particular challenge when explaining

complicated scientific concepts to a general audience, for example, if an advertiser wants to

promote the effect of a supplement where there is an emerging body of science supporting that

effect, but the evidence is insufficient to substantiate an unqualified claim. The advertiser

should make sure consumers understand both the extent of scientific support and the existence

of any significant contrary evidence. Vague qualifying terms  for example, that the product

may have the claimed benefit or helps achieve the claimed benefit  are unlikely to be

adequate. Furthermore, advertisers should not make qualified claims where the studies they

rely on are contrary to a stronger body of evidence. In such instance, even a qualified claim

could mislead consumers.

7
Example 10

A company has results from two studies suggesting that

the main ingredient in its supplement helps to maintain

healthy cholesterol levels. There are, however,

significant limitations to each of the studies and a

better controlled study is necessary to confirm whether

the effect is genuine. The company makes a claim in

advertising that “scientific studies show that our

product may be effective in reducing cholesterol.” The

use of the word “may” is not likely to be a sufficient

disclaimer to convey the limitations of the science. A

disclosure that clearly describes the limitations of the

research, in language consumers can easily understand,

and states directly and unambiguously that additional

research is necessary to confirm the preliminary results

is more likely to be effective. As discussed in the

following section on substantiating claims, the extent to

which studies support an unqualified claim will depend

largely on what experts in the relevant field would

consider to be adequate support.

B. Substantiating Claims

In addition to conveying product claims clearly and accurately, marketers need to verify that

there is adequate support for their claims. Under FTC law, before disseminating an ad,

advertisers must have a reasonable basis for all express and implied product claims. What

constitutes a reasonable basis depends greatly on what claims are being made, how they are

presented in the context of the entire ad, and how they are qualified. The FTCs standard for

evaluating substantiation is sufficiently flexible to ensure that consumers have access to

information about emerging areas of science. At the same

time, it is sufficiently rigorous to ensure that consumers can

have confidence in the accuracy of information presented in

advertising. A number of factors determine the appropriate

amount and type of substantiation, including:

The Type of Product. Generally, products

related to consumer health or safety require a

relatively high level of substantiation.

The Type of Claim. Claims that are difficult for

consumers to assess on their own are held to a

more exacting standard. Examples include health

claims that may be subject to a placebo effect or

technical claims that consumers cannot readily verify for themselves.

8
9

The Benefits of a Truthful Claim and The Cost/Feasibility of Developing

Substantiation for the Claim. These factors are often weighed together to ensure

that valuable product information is not withheld from consumers because the cost

of developing substantiation is prohibitive. This does not mean, however, that an

advertiser can make any claim it wishes without substantiation, simply because the

cost of research is too high.

The Consequences of a False Claim. This includes physical injury, for example,

if a consumer relies on an unsubstantiated claim about the therapeutic benefit of a

product and foregoes a proven treatment. Economic injury is also considered.

The Amount of Substantiation that Experts in the Field Believe is Reasonable.

In making this determination, the FTC gives great weight to accepted norms in the

relevant fields of research and consults with experts from a wide variety of

disciplines, including those with experience in botanicals and traditional medicines.

Where there is an existing standard for substantiation developed by a government

agency or other authoritative body, the FTC accords great deference to that

standard.

The FTC typically requires claims about the efficacy or safety of dietary supplements to be

supported with competent and reliable scientific evidence, defined in FTC cases as tests,

analyses, research, studies, or other evidence based on the expertise of professionals in the

relevant area, that have been conducted and evaluated in an objective manner by persons

qualified to do so, using procedures generally accepted in the profession to yield accurate and

reliable results. This is the same standard the FTC applies to any industry making healthrelated claims. There is no fixed formula for the number or type of studies required or for

more specific parameters like sample size and study duration. There are, however, a number

of considerations to guide an advertiser in assessing the adequacy of the scientific support for a

specific advertising claim.

1. Ads that Refer to a Specific Level of Support

If an advertiser asserts that it has a certain level of support for an advertised claim, it must be

able to demonstrate that the assertion is accurate. Therefore, as a starting point, advertisers

must have the level of support that they claim, expressly or by implication, to have.

Example 11

An ad for a supplement includes the statement

“Scientists Now Agree!” in discussing the product’s

benefit. This statement likely conveys to consumers

that the state of science supporting the benefit has

reached the level of scientific consensus. Unless the

advertiser possesses this level of evidence, the claim is

not substantiated.
Example 12

An advertiser claims that its product has been “studied

for years abroad” and is now the “subject of U.S.

government-sponsored research.” In addition to the

explicit claim that the product has been studied, such

phrases likely convey to consumers an implied claim that

there exists a substantial body of competentlyconducted scientific research supporting the efficacy of

the product. The advertiser would be responsible for

substantiating both claims.

2. The Amount and Type of Evidence

When no specific claim about the level of support is made, the evidence needed depends on the

nature of the claim. A guiding principle for determining the amount and type of evidence that

will be sufficient is what experts in the relevant area of study would generally consider to be

adequate. The FTC will consider all forms of competent and reliable scientific research when

evaluating substantiation. As a general rule, well-controlled human clinical studies are the

most reliable form of evidence. Results obtained in animal and in vitro studies will also be

examined, particularly where they are widely considered to be acceptable substitutes for

human research or where human research is infeasible. Although there is no requirement that

a dietary supplement claim be supported by any specific number of studies, the replication of

research results in an independently-conducted study adds to the weight of the evidence. In

most situations, the quality of studies will be more important than quantity. When a clinical

trial is not possible (e.g., in the case of a relationship between a nutrient and a condition that

may take decades to develop), epidemiologic evidence may be an acceptable substitute for

clinical data, especially when supported by other evidence, such as research explaining the

biological mechanism underlying the claimed effect.

Anecdotal evidence about the individual experience of consumers is not sufficient to

substantiate claims about the effects of a supplement. Even if those experiences are genuine,

they may be attributable to a placebo effect or other factors unrelated to the supplement.

Individual experiences are not a substitute for scientific research.8

Example 13

An advertiser relies on animal and in vitro studies to

support a claim that its vitamin supplement is more

easily absorbed into the bloodstream than other forms of

the vitamin. However, the animal research uses a

species of animal that, unlike humans, is able to

synthesize the vitamin, and the in vitro study uses a

different formulation with a higher concentration of the

10
compound than the product being marketed. In

addition, human research is feasible and relatively

inexpensive to conduct in light of the potential sales of

the product and is the type of research generally

accepted in this particular field of study. The

substantiation is likely to be inadequate in this case,

both because there are significant methodological

problems and because, in this particular instance, human

research is both feasible and the accepted approach in

the field.

Example 14

A company wants to advertise its supplement as helpful

in maintaining good vision into old age. There have

been two long-term, large-scale epidemiologic studies

showing a strong association between life-long high

consumption of the principal ingredient in the

supplement and better vision in those over 70. Experts

have also discovered a plausible biological mechanism

that might explain the effect. A clinical intervention

trial would be very difficult and costly to conduct.

Assuming that experts in the field generally consider

epidemiological evidence to be adequate to support the

potential for a protective effect, and assuming the

absence of any stronger body of contrary evidence, a

claim that is qualified to accurately convey the nature

and extent of the evidence would be permitted.

Example 15

An advertisement for a supplement claims that the

product will cause dramatic improvements in memory

and describes the experiences of 10 people who obtained

these results. The descriptions of these anecdotal

experiences are truthful, but the advertiser has no

scientific substantiation for the effect of its product on

memory and cannot explain why the product might

produce such results. The individual experiences are not

adequate to substantiate the claim without confirming

scientific research.

11
3. The Quality of the Evidence

In addition to the amount and type of evidence, the FTC will also examine the internal validity

of each piece of evidence. Where the claim is one that would require scientific support, the

research should be conducted in a competent and reliable manner to yield meaningful results.

The design, implementation, and results of each piece of research are important to assessing

the adequacy of the substantiation.

There is no set protocol for how to conduct research that will be acceptable under the FTC

substantiation doctrine. There are, however, some principles generally accepted in the

scientific community to enhance the validity of test results. For example, a study that is

carefully controlled, with blinding of subjects and researchers, is likely to yield more reliable

results. A study of longer duration can provide better evidence that the claimed effect will

persist and resolve potential safety questions. Other aspects of the research results  such as

evidence of a dose-response relationship (i.e., the larger the dose, the greater the effect) or a

recognized biological or chemical mechanism to explain the effect  are examples of factors

that add weight to the findings. Statistical significance of findings is also important. A study

that fails to show a statistically significant difference between test and control group may

indicate that the measured effects are merely the result of placebo effect or chance. The

results should also translate into a meaningful benefit for consumers. Some results that are

statistically significant may still be so small that they would mean only a trivial effect on

consumer health.

The nature and quality of the written report of the research are also important. Research

cannot be evaluated accurately on the basis of an abstract or an informal summary. In

contrast, although the FTC does not require that studies be published and will consider

unpublished, proprietary research, the publication of a peer-reviewed study in a reputable

journal indicates that the research has received some measure of scrutiny. At the same time,

advertisers should not rely simply on the fact that research is published as proof of the efficacy

of a supplement. Research may yield results that are of sufficient interest to the scientific

community to warrant publication, but publication does not necessarily mean that such

research is conclusive evidence of a substances effect. The FTC considers studies conducted

in foreign countries as long as the design and implementation of the study are scientifically

sound.9

Example 16

An advertiser conducts a literature search and finds

several abstracts summarizing research about the

association between a nutrient and the ability to

perform better on memory tests. The advertiser relies on

these summaries to support a claim that its supplement,

which contains the same nutrient, aids memory.

However, without looking carefully at the specifics of

the study design, implementation, and results, there is

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no way for an advertiser to ascertain whether the

research substantiates the product claims. (For example,

did the research use a comparable formulation of the

ingredient? Was the study adequately controlled? Did

the study yield results that are statistically significant?)

The advertiser should carefully review the underlying

science, with the assistance of an expert if necessary,

before drafting advertising claims.

Example 17

An advertiser makes an unqualified claim about the anticlotting effect of a supplement that contains a

compound extracted from fruit. There are three studies

supporting the effect and no contrary evidence. One

study consists of subjects tested over a one-week

period, with no control group. The second study is wellcontrolled, of longer duration, but shows only a slight

effect that is not statistically significant. The third

study administers the compound through injection and

shows a significant anti-clotting effect, but there is

some question whether the compound would be

absorbed into the bloodstream if administered orally.

Because the studies all have significant limitations, it

would be difficult to draft even a carefully qualified

claim that would adequately convey to consumers the

limited nature of the evidence. The advertiser should

not base a claim on these studies.

Example 18

The marketer of an herbal supplement claims that its

product promotes healthy vision and is approved in

Germany for this purpose. The product has been used

extensively in Europe for years and has obtained

approval by the German governmental authorities,

through their monograph process, for use to improve

vision in healthy people. The company has two abstracts

of German trials that were the basis of the German

monograph, showing that the ingredient significantly

improved the vision of healthy individuals in the test

group over the placebo group. Animal trials done by the

company suggest a plausible mechanism to explain the

13
effect. Although approval of the supplement under the

German monograph suggests that the supplement is

effective, advertisers should still examine the underlying

research to confirm that it is relevant to the advertiser’s

product (for example, that the dosage and formulation

are comparable) and to evaluate whether the studies are

scientifically sound. Advertisers should also examine

any other research that exists, either supporting or

contradicting the monograph, especially if it is not

possible to identify and review the research on which

the monograph is based.

4. The Totality of the Evidence

Studies cannot be evaluated in isolation. The surrounding context of the scientific evidence is

just as important as the internal validity of individual studies. Advertisers should consider all

relevant research relating to the claimed benefit of their supplement and should not focus only

on research that supports the effect, while discounting research that does not. Ideally, the

studies relied on by an advertiser would be largely consistent with the surrounding body of

evidence. Wide variation in outcomes of studies and inconsistent or conflicting results will

raise serious questions about the adequacy of an advertisers substantiation. Where there are

inconsistencies in the evidence, it is important to examine whether there is a plausible

explanation for those inconsistencies. In some instances, for example, the differences in

results are attributable to differences in dosage, the form of administration (e.g., oral or

intravenous), the population tested, or other aspects of study methodology. Advertisers should

assess how relevant each piece of research is to the specific claim they wish to make, and also

consider the relative strengths and weaknesses of each. If a number of studies of different

quality have been conducted on a specific topic, advertisers should look first to the results of

the studies with more reliable methodologies.

The surrounding body of evidence will have a significant impact both on what type, amount

and quality of evidence is required to substantiate a claim and on how that claim is presented

 that is, how carefully the claim is qualified to reflect accurately the strength of the

evidence. If a stronger body of surrounding evidence runs contrary to a claimed effect, even a

qualified claim is likely to be deceptive.

Example 19

An advertiser wishes to make the claim that a

supplement product will substantially reduce body fat.

The advertiser has two controlled, double-blind studies

showing a modest but statistically significant loss of fat

at the end of a six-week period. However, there is an

equally well-controlled, blinded 12-week study showing

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no statistically significant difference between test and

control groups. Assuming other aspects of methodology

are similar, the studies taken together suggest that, if

the product has any effect on body fat, it would be very

small. Given the totality of the evidence on the subject,

the claim is likely to be unsubstantiated.

Example 20

Advertisements for a fiber supplement make the claim

that the product is “proven” to aid weight loss.

Although the company has two published, peer-reviewed

studies showing a relationship between fiber and weight

loss, neither of these studies used the same proportions

of soluble and insoluble fiber or the same total amount

of fiber as the supplement product. There are numerous

controlled, published human clinical studies, however,

using the amount and type of fiber in the supplement

product, that provide evidence that the product would

not result in measurable weight loss. The totality of the

evidence does not support the “proven” claim and, given

the stronger body of contrary evidence, even a qualified

claim is likely to be deceptive.

Example 21

An advertiser runs an ad in a magazine for retired

people, claiming that its supplement product has been

found effective in improving joint flexibility. The

company sponsored a 6-week study of its supplement,

involving 50 subjects over the age of 65, to test the

product’s effect on improving flexibility. The study was

double-blinded and placebo-controlled and has been

accepted for publication in a leading medical journal.

The study showed dramatic, statistically significant

increases in joint flexibility compared to placebo, based

on objective measurements. In addition, several large

trials have been conducted by European researchers

using a similar formulation and dose of the active

ingredient in the supplement. These trials also found

statistically significant results. The advertiser reviewed

the underlying European research and confirmed that it

meets accepted research standards. The evidence as a

whole likely substantiates the claim.

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5. The Relevance of the Evidence to the Specific Claim

A common problem in substantiation of advertising claims is that an advertiser has valid

studies, but the studies do not support the claim made in the ad. Advertisers should make sure

that the research on which they rely is not just internally valid, but also relevant to the specific

product being promoted and to the specific benefit being advertised. Therefore, advertisers

should ask questions such as: How does the dosage and formulation of the advertised product

compare to what was used in the study? Does the advertised product contain additional

ingredients that might alter the effect of the ingredient in the study? Is the advertised product

administered in the same manner as the ingredient used in the study? Does the study

population reflect the characteristics and lifestyle of the population targeted by the ad? If there

are significant discrepancies between the research conditions and the real life use being

promoted, advertisers need to evaluate whether it is appropriate to extrapolate from the

research to the claimed effect.

In drafting ad copy, the advertiser should take care to make sure that the claims match the

underlying support. Claims that do not match the science, no matter how sound that science

is, are likely to be unsubstantiated. Advertising should not exaggerate the extent, nature, or

permanence of the effects achieved in a study, and should not suggest greater scientific

certainty than actually exists. Although emerging science can sometimes be the basis for a

carefully qualified claim, advertisers must make consumers aware of any significant limitations

or inconsistencies in the scientific literature.

Example 22

An ad for a supplement claims that a particular nutrient

helps maintain healthy cholesterol levels. There is a

substantial body of epidemiologic evidence suggesting

that foods high in that nutrient are associated with

lower cholesterol levels. There is no science, however,

demonstrating a relationship between the specific

nutrient and cholesterol, although it would be feasible

to conduct such a study. If there is a basis for believing

that the health effect may be attributable to other

components of the food, or to a combination of various

components, a claim about the cholesterol maintenance

benefits of the supplement product is likely not

substantiated by this evidence.

16
Example 23

A number of well-controlled clinical studies have been

conducted to suggest that a mineral supplement can

improve mental alertness and memory in subjects with

significantly impaired blood circulation to the brain. A

claim suggesting that the supplement will improve

memory or mental alertness in healthy adults may not be

adequately substantiated by this evidence. Advertisers

should not rely on research based on a specific test

population for claims targeted at the general population

without first considering whether it is scientifically

sound to make such extrapolations.

Example 24

An advertiser wants to make claims that its combination

herbal product helps increase alertness and energy safely

and naturally. The product contains two herbs known to

have a central nervous system stimulant effect. The

advertiser compiles competent and reliable scientific

research demonstrating that each of the herbs,

individually, is safe and causes no significant side

effects in the recommended dose. This evidence may be

inadequate to substantiate an unqualified safety claim.

Where there is reason to suspect that the combination of

multiple ingredients might result in interactions that

would alter the effect or safety of the individual

ingredients, studies showing the effect of the individual

ingredients may be insufficient to substantiate the

safety of the multiple ingredient product. In this

example, the combination of two herbs with similar

stimulant properties could produce a stronger cumulative

stimulant effect that might present safety hazards. A

better approach would be to investigate the safety of

the specific combination of ingredients contained in the

product.

17
Example 25

Several clinical trials have been done on a specific

botanical extract showing consistently that the extract

is effective for supporting the immune system. The

studied extract is a complex combination of many

constituents and the active constituents that may

produce the benefit are still unknown. An advertiser

wishes to cite this research in its advertising, as proof

that its product will support the immune system. The

advertiser’s product is made using a different extraction

method of the same botanical. An analysis of the

extract reveals that it has a significantly different

chemical profile from the studied extract. The advertiser

should not rely on these clinical trials alone as

substantiation because the difference in extracts may

result in significant differences in the two products’

efficacy.

C. Other Issues Relating to Dietary Supplement Advertising

In addition to the basic principles of ad meaning and substantiation discussed above, a number

of other issues commonly arise in the context of dietary supplement advertising. The

following sections provide guidance on some of these issues including: the use of consumer or

expert endorsements in ads; advertising claims based on traditional uses of supplements; use of

the DSHEA disclaimer in advertising; and the application to advertising of the DSHEA

exemption for certain categories of publications, commonly referred to as third party

literature.

1. Claims Based on Consumer Testimonials or Expert Endorsements

An overall principle is that advertisers should not make claims either through consumer or

expert endorsements that would be deceptive or could not be substantiated if made directly.10

It is not enough that a testimonial represents the honest opinion of the endorser. Under FTC

law, advertisers must also have appropriate scientific evidence to back up the underlying

claim.

Consumer testimonials raise additional concerns about which advertisers need to be aware.

Ads that include consumer testimonials about the efficacy or safety of a supplement product

should be backed by adequate substantiation that the testimonial experience is representative of

what consumers will generally achieve when using the product. As discussed earlier,

anecdotal evidence of a products effect, based solely on the experiences of individual

consumers, is generally insufficient to substantiate a claim. Further, if the advertisers

substantiation does not demonstrate that the results are representative, then a clear and

18
conspicuous disclaimer is necessary. The advertiser should either state what the generally

expected results would be or indicate that the consumer should not expect to experience the

attested results. Vague disclaimers like results may vary are likely to be insufficient.

Example 26

An advertisement for a weight loss supplement features

a before-and-after photograph of a woman and quotes

her as saying that she lost 20 pounds in 8 weeks while

using the supplement. An asterisk next to the quotation

references a disclaimer in fine print at the bottom of the

ad that reads, “Results may vary.” The experience of the

woman is accurately represented, but the separate,

competent research demonstrating the efficacy of the

supplement showed an average weight loss of only 6

pounds in 8 weeks. Therefore, the disclosure does not

adequately convey to consumers that they would likely

see much less dramatic results. The placement and size

of the disclaimer is also insufficiently prominent to

qualify the claim effectively. One approach to adequate

qualification of this testimonial would be to include a

disclaimer immediately adjacent to the quote, in equal

print size that says, “These results are not typical.

Average weight loss achieved in clinical study was 6

pounds.”

When an advertiser uses an expert endorser, it should make sure that the endorser has

appropriate qualifications to be represented as an expert and has conducted an examination or

testing of the product that would be generally recognized in the field as sufficient to support

the endorsement. In addition, whenever an expert or consumer endorser is used, the

advertiser should disclose any material connection between the endorser and the advertiser of

the product. A material connection is one that would affect the weight or credibility of the

endorsement, or put another way, a personal, financial, or similar connection that consumers

would not reasonably expect.

Example 27

An infomercial for a dietary supplement features an

expert referred to as a “Doctor” and a “leading clinician

in joint health” discussing the effect of a supplement

product on the maintenance of healthy joints. The

expert is not licensed to practice medicine, but has a

graduate degree and is a trained physical therapist,

running a sports clinic. The expert has not conducted

19
any review of the scientific literature on the active

component of the supplement. In return for appearing

in the infomercial, she is given a paid position as an

officer the company. The ad is likely to be deceptive for

several reasons. First, her qualifications as an expert

have been overstated and she has not conducted

sufficient examination of the product to support the

endorsement. In addition, her connection to the

company is one that consumers might not expect and

may affect the weight and credibility of her

endorsement. Even if she is adequately qualified and

has conducted an adequate review of the product, her

position as an officer of the company should be clearly

disclosed.

Example 28

A best-selling book about the benefits of a supplement

product includes a footnote mentioning the most

effective brand of the supplement, by name. The

manufacturer of the brand cited in the book has an

exclusive promotional agreement with the author and

has paid him to reference the product by name. The

manufacturer’s ad touts the fact that its product is the

only brand recommended in this best-selling book. The

ad is deceptive since it suggests a neutral endorsement

when, in fact, the author has been paid by the

manufacturer to promote the product.

2. Claims Based on Traditional Use

Claims based on historical or traditional use should be substantiated by confirming scientific

evidence, or should be presented in such a way that consumers understand that the sole basis

for the claim is a history of use of the product for a particular purpose. A number of

supplements, particularly botanical products, have a long history of use as traditional

medicines in the United States or in other countries to treat certain conditions or symptoms.

Several European countries have a separate regulatory approach to these traditional medicines,

allowing manufacturers to make certain limited claims about their traditional use for treating

certain health conditions. Some countries also require accompanying disclosures about the fact

that the product has not been scientifically established to be effective, as well as disclosures

about potential adverse effects. At this time there is no separate regulatory process for

approval of claims for these traditional medicine products under DSHEA and FDA labeling

rules.

20
In assessing claims based on traditional use, the FTC will look closely at consumer perceptions

and specifically at whether consumers expect such claims to be backed by supporting scientific

evidence. Advertising claims based solely on traditional use should be presented carefully to

avoid the implication that the product has been scientifically evaluated for efficacy. The

degree of qualification necessary to communicate the absence of scientific

substantiation for a traditional use claim will depend in large part on

consumer understanding of this category of products. As consumer

awareness of and experience with traditional use supplements

evolve, the extent and type of qualification necessary is also

likely to change.

There are some situations, however, where traditional use evidence

alone will be inadequate to substantiate a claim, even if that claim is

carefully qualified to convey the limited nature of the support. In

determining the level of substantiation necessary to substantiate a claim, the

FTC assesses, among other things, the consequences of a false claim. Claims

that, if unfounded, could present a substantial risk of injury to consumer health or safety

will be held to a higher level of scientific proof. For that reason, an advertiser should not

suggest, either directly or indirectly, that a supplement product will provide a disease benefit

unless there is competent and reliable scientific evidence to substantiate that benefit. The FTC

will closely scrutinize the scientific support for such claims, particularly where the claim could

lead consumers to forego other treatments that have been validated by scientific evidence, or to

self-medicate for potentially serious conditions without medical supervision.

The advertiser should also make sure that it can document the extent and manner of historical

use and be careful not to overstate such use. As part of this inquiry, the advertiser should

make sure that the product it is marketing is consistent with the product as traditionally

administered. If there are significant differences between the traditional use product and the

marketed product, in the form of administration, the formulation of ingredients, or the dose, a

traditional use claim may not be appropriate.

Example 29

The advertiser of an herbal supplement makes the claim,

“Ancient folklore remedy used for centuries by Native

Americans to aid digestion.” The statement about

traditional use is accurate and the supplement product is

consistent with the formulation of the product as

traditionally used. However, if, in the context of the ad,

this statement suggests that there is scientific evidence

demonstrating that the product is effective for aiding

digestion, the advertiser would need to include a clear

and prominent disclaimer about the absence of such

evidence.

21
Example 30

A supplement manufacturer wants to market an herbal

product that has been used in the same formulation in

China as a tonic for improving mental functions. The

manufacturer prepares the product in a manner

consistent with Chinese preparation methods. The ad

claims, “Traditional Chinese Medicine — Used for

Thousands of Years to Bring Mental Clarity and Improve

Memory.” The ad also contains language that clearly

conveys that the efficacy of the product has not been

confirmed by research, and that traditional use does not

establish that the product will achieve the claimed

results. The ad is likely to adequately convey the

limited nature of support for the claim.

Example 31

A supplement manufacturer markets a capsule containing

a concentrated extract of a botanical product that has

been used in its raw form in China to brew teas for

increasing energy. The advertisement clearly conveys

that the energy benefit is based on traditional use and

has not been confirmed by scientific research. The ad

may still be deceptive, however, because the

concentrated extract is not consistent with the

traditional use of the botanical in raw form to brew teas

and may produce a significantly different effect.

Example 32

A supplement ad claims that a supplement liquid mineral

solution has been a popular American folk remedy since

early pioneer days for shrinking tumors. The ad is likely

to convey to consumers that the product is an effective

treatment for cancer. There is no scientific support for

this disease benefit. Because of the potential risks to

consumers of taking a product that may or may not be

effective to treat such a serious health condition,

possibly without medical supervision, the advertiser

should not make the claim.

22
3. Use of the DSHEA Disclaimer in Advertising

Under DSHEA, all statements of nutritional support for dietary supplements must be

accompanied by a two-part disclaimer on the product label: that the statement has not been

evaluated by FDA and that the product is not intended to diagnose, treat, cure or prevent any

disease. Although DSHEA does not apply to advertising, there are situations where such a

disclosure is desirable in advertising as well as in labeling to prevent consumers from being

misled about the nature of the product and the extent to which its efficacy and safety have been

reviewed by regulatory authorities. For example, a disclosure may be necessary if the text or

images in the ad lead consumers to believe that the product has undergone the kind of review

for safety and efficacy that the FDA conducts on new drugs and has been found to be

beneficial for the treatment of disease. Failure to correct those misperceptions may render the

advertising deceptive.

At the same time, the inclusion of a DSHEA disclaimer or similar disclosure will not cure an

otherwise deceptive ad, particularly where the deception concerns claims about the disease

benefits of a product. In making references to DSHEA and FDA review, advertisers should

also be careful not to mischaracterize the extent to which a product or claim has been reviewed

or approved by the FDA. Compliance with the notification and disclaimer provisions of

DSHEA does not constitute authorization of a claim by FDA and advertisers should not imply

that FDA has specifically approved any claim on that basis.

Example 33

A company markets a supplement for “maintaining joint

flexibility.” The product packaging is similar in color

and design to a nonprescription drug used to treat joint

pain associated with arthritis and the product name is

similar to the drug counterpart. The ad includes

statements urging consumers to “ask their pharmacist”

and “accept no generic substitute.” The various

elements of the ad may lead consumers to believe that

the supplement is, in fact, an approved drug, or may

give consumers more general expectations that the

product has been subjected to similar government review

for safety and efficacy. A clear and prominent disclaimer

may be necessary to indicate that the product has not

been evaluated by FDA and is not an approved drug

product.

23
Example 34

An advertisement for an herbal supplement includes

strong, unqualified claims that the product will

effectively treat or prevent diabetes, heart disease, and

various circulatory ailments. The advertiser does not

have adequate substantiation for this claim, but includes

the DSHEA disclaimer prominently in the ad. In face of

the strong contradictory message in the ad, the

inclusion of the DSHEA disclaimer is not likely to negate

the explicit disease claims made in the ad, and will not

cure the fact that the claims are not substantiated.

Example 35

 A dietary supplement advertisement makes a number of

claims about the benefits of its product for supporting

various body functions. The ad also includes the

statement, “Complies with FDA notification procedures

of the Dietary Supplement Health and Education Act.”

This statement may suggest to consumers that FDA has

authorized the claims made in the ad or that it has

reviewed the support for the claims and found the

product to be effective. Because there is no review and

authorization process for such claims under DSHEA, this

would be deceptive.

4. Third Party Literature

Dietary supplement advertisers should be aware that the use of newspaper articles, abstracts of

scientific studies, or other third party literature to promote a particular brand or product can

have an impact on how consumers interpret an advertisement and on what claims the advertiser

will be responsible for substantiating. For purposes of dietary supplement labeling, Section 5

of DSHEA provides an exemption from labeling requirements for scientific journal articles,

books and other publications used in the sale of dietary supplements, provided these materials

are reprinted in their entirety, are not false or misleading, do not promote a specific brand or

manufacturer, are presented with other materials to create a balanced view of the scientific

information, and are physically separate from the supplements being sold.

The FTC will generally follow an approach consistent with the labeling approach when

evaluating the use of such publications in other contexts, such as advertising. Although the

FTC does not regulate the content or accuracy of statements made in independently written and

published books, articles, or other non-commercial literature, FTC law does prohibit the

deceptive use of such materials in marketing products. The determination of whether the

24
materials will be subject to FTC jurisdiction turns largely on whether the materials have been

created or are being used by an advertiser specifically for the purpose of promoting

its product. As a practical matter, publications and other materials that comply with the

elements of the DSHEA provision, particularly with the requirement that such materials be

truthful, not misleading and balanced, are also likely to comply with FTC advertising law.

Example 36

An author publishes a book on the curative properties of

an herb. The book title is “The Miracle Cancer Cure.”

The book does not endorse or otherwise mention any

particular supplement brand. The author/publisher does

not sell the herbal supplement and does not have any

material connection to any marketers of the herb. As

non-commercial speech, the book itself would not be

subject to the FTC’s jurisdiction over advertising.

However, if a marketer of the herb referred to the book

in advertising materials (for instance, by quoting the

title and using excerpts to describe the anti-cancer

benefits of its product), such references would likely be

considered advertising. The advertiser would be

responsible for substantiating any claims about the

advertiser’s product that are conveyed by these

references.

CONCLUSION

Marketers of dietary supplements should be familiar with the requirements under bothDSHEA and the FTC Act that labeling and advertising claims be truthful, not misleading

and substantiated. The FTC approach generally requires that claims be backed by sound,

scientific evidence, but also provides flexibility in the precise amount and type of support

necessary. This flexibility allows advertisers to provide truthful information to consumers

about the benefits of supplement products, and at the same time, preserves consumer

confidence by curbing unsubstantiated, false, and misleading claims. To ensure compliance

with FTC law, supplement advertisers should follow two important steps: 1) careful drafting

of advertising claims with particular attention to how claims are qualified and what express and

implied messages are actually conveyed to consumers; and 2) careful review of the support for

a claim to make sure it is scientifically sound, adequate in the context of the surrounding body

of evidence, and relevant to the specific product and claim advertised.

25

III
26

Endnotes

1 The FTCs authority derives from Section 5 of the FTC Act. In addition, supplements have traditionally been regulated under Sections 12 and 15, which prohibit false advertisements, defined as those

that are misleading in a material respect, for foods, drugs, devices or cosmetics.

2 Under DSHEA, supplement marketers are allowed to make two kinds of claims on labeling: 1) health

claims specifically authorized by the FDA; and 2) statements of nutritional support. Health claims 

representations about the relationship between a nutrient and a disease or health-related condition 

are permitted only if they have been authorized by an FDA finding that there is significant scientific

agreement to support the claim. The Food and Drug Administration Modernization Act of 1997

(FDAMA) also now allows health claims that are based on authoritative statements from certain

federal scientific bodies, such as NIH and the National Academy of Sciences. Aside from these

authorized claims, supplement marketers are prohibited from making any labeling claim about the

diagnosis, mitigation, treatment or cure of a disease. In contrast to health claims, structure/function

claims, within the broader category of statements of nutritional support, refer to representations

about a dietary supplements effect on the structure or function of the body for maintenance of good

health and nutrition.

3 Structure/function claims are not subject to FDA pre-authorization. A marketer may make these

claims in labeling if it notifies FDA and includes a disclaimer that the claim has not been evaluated by

FDA and that the product is not intended to diagnose, mitigate, treat, cure, or prevent disease.

DSHEA also requires that structure/function claims in labeling be substantiated and be truthful and not

misleading. This requirement is fully consistent with the FTCs standard that advertising claims be

truthful, not misleading and substantiated.

4 FTC policy statements and other information for businesses and consumers are available on the FTCs

Internet home page, www.ftc.gov.

5 As indicated in the Food Policy Statement, the FTC will be especially vigilant in examining whether

qualified claims are presented in a manner that ensures that consumers understand both the extent of

the support for the claim and the existence of any significant contrary view within the scientific community. In the absence of adequate qualification the Commission will find such claims deceptive.

6 These principles are articulated in the FTCs Deception Policy Statement and Advertising Substantiation Policy Statement, available at www.ftc.gov. The FTC also has authority to challenge unfair trade

practices. An unfair practice is one that causes or is likely to cause substantial injury to consumers

which is not reasonably avoidable by consumers themselves and not outweighed by countervailing

benefits to consumers or competition. The majority of advertising cases are brought pursuant to the

FTCs deception authority.

7 Throughout these examples the terms advertiser, marketer, supplement manufacturer and

company are used interchangeably.

8 Additional guidance on the use of consumer testimonials is provided in Part C.1.

9 Any foreign research submitted to the FTC in the course of an investigation should be presented in

English translation and with sufficient detail to allow the agency to evaluate the study.

10 The FTC has provided detailed guidance on this subject in its Guides Concerning Use of Endorsements

and Testimonials in Advertising, available at www.ftc.gov.
Federal Trade Commission

Bureau of Consumer Protection

April 2001
FEDERAL TRADE COMMISSION

WWW.FTC.GOV

TOLL-FREE 1-877-FTC-HELP

FOR THE CONSUMER