Although DSHEA does not directly
apply to advertising, it has generated many questions about the FTC's 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 FTC's approach to supplement advertising is best
illustrated by its Enforcement Policy Statement
on Food Advertising (Food Policy Statement).3 Although
the Food Policy Statement does not specifically refer to supplements, the principles
underlying the FTC's regulation of health claims in food advertising are relevant to the
agency's 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.4
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.
II. APPLICATION OF FTC LAW TO
DIETARY SUPPLEMENT ADVERTISING
The FTC's 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.5 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 FTC's 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.6
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
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 product's 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 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.
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-the-counter 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 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.
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 FTC's 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.
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
health-related 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 competently-conducted 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.7
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 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.
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 substance's effect. The FTC considers studies conducted in foreign countries
as long as the design and implementation of the study are scientifically sound.8
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 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 anti-clotting 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 well-controlled, 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 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 advertiser's 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 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.
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.
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.
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 Experiences 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.9 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 product's effect,
based solely on the experiences of individual consumers, is generally insufficient to
substantiate a claim. Further, if the advertiser's substantiation does not demonstrate
that the results are representative, then a clear and 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 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 Uses
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.
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.
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.
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.
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 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.
III. CONCLUSION
Marketers of dietary supplements should be familiar with
the requirements under both DSHEA 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.
The FTC works for the consumer to
prevent fraudulent, deceptive and unfair business practices in the
marketplace and to provide information to help consumers spot, stop and
avoid them. To file a
complaint or to get free information
on consumer issues, visit
www.ftc.gov or
call toll-free, 1-877-FTC-HELP (1-877-382-4357); TTY: 1-866-653-4261. The
FTC enters Internet, telemarketing, identity theft and other fraud-related
complaints into
Consumer Sentinel, a
secure, online database available to hundreds of civil and criminal law
enforcement agencies in the U.S. and abroad.
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