NURS 6050 GCU Nursing in Florida Presentation.docx
FTCGuidelinesMemo
1. Memorandum
To:
Cc:
From: Jerry Woods
Date: May 1, 2014
Re: FTC Advertising Guidelines for Dietary Supplements
Questions Presented
1. What guidelines must a dietary supplement advertiser follow to be compliant with FTC law?
2. Are the guidelines different for internet advertisers than for other advertisers?
3. Are the guidelines different for affiliate advertisers?
Brief Answers
1. Advertisements must be truthful and not mislead the consumer into buying a product that may
have health consequences. A deceptive ad contains misrepresentations or omissions that are likely
to “trick” consumers into using a product that does not work as the advertisement claims.
Advertisers must be able to adequately substantiate all objective product claims to ensure
compliance with FTC law. Additionally, they must make sure that all claims expressly stated in an
ad are correct.1
2. No. The same truth-in-advertising guidelines apply, whether the advertisement appears on a
billboard, on television, is heard on the radio, seen on the internet, or anywhere else an
advertisement can be viewed, heard, or otherwise displayed for public dissemination.2
1
Dietary Supplements: An Advertising Guide for Industry. Federal Trade Commission, Bureau of
Consumer Protection. (April, 2001), 3.
2
Bureau of Consumer Protection Business Center, http://business.ftc.gov/advertising-and-marketing,
2. 3. Yes. In addition to the standard truth-in-lending principles established by the FTC, affiliate
advertisers must disclose to the consumer their relationship with the respective primary online
business.3
Discussion
Under FTC law, advertisers are held accountable for the accuracy of a product claim, whether stated
or implied, in the ad. When creating the ad, advertisers must consider the overall impression that the
ad makes on the consumer. If an ad can be reasonably interpreted more than one way, the advertiser
must substantiate each interpretation.4
Implied Claims
Depending on phrasing, or presentation context, a statement about the product’s impact on the
body’s normal “structure or function” may also imply a claim to consumers that the product is
effective in preventing or treating a disease. If the ad implies in any way that product use provides a
disease remedy, the advertiser must be able to substantiate these claims, even if the ad makes no
specific reference to the disease itself.5
If an advertisement fails to disclose certain information, it can also be deceptive. The FTC Act, § 15
states that advertisers must disclose any information relevant to representations made or implied by
the ad, or relevant when considering how a consumer would normally use the product. Therefore, if
any ad is misleading, absent qualifying information, that information must be included in the ad. If
there are any safety risks connected to a consumer’s product use, advertisers must inform consumers
of these possible risks.6
Clear and Conspicuous Placement
When information disclosure is necessary to prevent the ad from being deceptive, the information
must be conspicuously placed where a consumer would normally, and easily, be able to see and read
the information. The language used should be clear and small type should be avoided. No distracting
3
The FTC Revised Endorsement Guides: What People Are Asking, 5,
http://www.business.ftc.gov/documents/bus71-ftcs-revised-endorsement-guideswhat-people-are-asking,
4
Dietary Supplements: An Advertising Guide for Industry. Federal Trade Commission, Bureau of
Consumer Protection. (April, 2001), 3.
5
Id. at 4.
6
Id. at 5.
3. elements that could hide or contradict the disclosure should be incorporated in the ad. The
disclosure must be unambiguous and consistent with all other statements made about the product.7
A brief video superscript in a television ad, a disclaimer that is easily missed on an internet site
because it is located separately at the very bottom of a scroll down page, a disclaimer that’s buried in
text, or fine print located at the bottom of a print ad, are normally inadequate.8
Any qualifying information should be very easy to understand so that the ordinary consumer notices
it and also understands its importance. In situations where a body of science is emerging but still
insufficient to substantiate unqualified claims, advertisers should avoid using words like “helps” or
“may” in relation to achieving a claimed benefit because these terms are too vague. Additionally,
advertisers should not make any qualified claims where the studies they rely on completely
contradict a stronger body of evidence. In this case, even a qualified claim could be deceptive.9
Sufficient Scientific Evidence for Claims
When creating an ad, marketers must verify that there is sufficient evidence for their claims. What is
considered sufficient depends on the claim being made, how that claim is presented given the
substance of the entire ad, and how it’s qualified.10
The FTC requires that claims about dietary supplement product safety or efficacy are supported by
“competent and reliable scientific evidence,” defined by the FTC as “generally accepted in the
profession to yield accurate and reliable results.” The same standard is applied by the FTC to any
industry that makes health related claims. There is no precise formula for the number of studies or
the type conducted but there are many considerations to help an advertiser assess the adequacy of the
scientific evidence for a specific ad claim.11
If no specific claim is made about the level of support, the evidence required depends on the essence
of the claim. The FTC considers experts who conduct research in the relevant field of study those
who are qualified to provide sufficient evidence of a claim. Generally, the most reliable proof is that
7
Id. at 6 - 7,
8
Dietary Supplements: An Advertising Guide for Industry. Federal Trade Commission, Bureau of
Consumer Protection. (April, 2001), 7.
9
Id. at 7.
10
Id. at 8.
11
Id. at 9.
4. which is derived from well-controlled human clinical studies. Animal and in vitro study results will
be examined if they are, either acceptable substitutes for human trials or human trials are infeasible.12
Scientific Research
The FTC does not require a specific number of studies to establish a valid claim, but if results can be
replicated through many independent studies, this adds to the credibility of the evidence. Usually,
the quality of the studies is a higher priority than the quantity. In situations where a nutrient’s effect
on a physical condition may not reveal itself for decades, clinical trials may not be possible. In these
cases, epidemiologic evidence may be an adequate replacement for clinical data.13
The FTC also carefully examines whether the research was conducted in a highly organized,
competent, reliable fashion to yield a relevant outcome.14
The FTC has no set guidelines for how to conduct adequate research, however there are some
generally accepted principles that the scientific community relies on which enhance a study’s
validity. A carefully controlled group of blinded subjects and researchers will usually create a more
reliable outcome. Long-term studies are effective in determining product safety and effectiveness.
Other valuable research results include dose-response relationships and biological or chemical
mechanisms which explain a supplement’s effect. A study that successfully demonstrates a
statistically significant difference between a test and control group will go far in confirming the
effectiveness of a dietary supplement. The study results should not be so small as to have little benefit
to a consumer’s health.15
The FTC will consider both published and unpublished studies, although publication of a peer-
reviewed study in a respected journal suggests that the study has received some level of analysis.
However, advertisers should not rely on the fact that a study has been published as proof that a
dietary supplement is effective. The written report must be presented in an organized manner for the
research to be accurately evaluated. An informal or abstract summary is unacceptable. The FTC will
consider studies from foreign countries as long as the studies are conducted using scientifically sound
methods.16
Reconciling the Research
12
Id. at 10.
13
Id.
14
Id. at 12.
15
Id. at 12.
16
Id.
5. Advertisers must consider all relevant research when making any claims, regardless of whether the
research supports or refutes the supplement’s claimed benefit. Additionally, advertisers must carefully
consider how relevant any aspect of research is to the specific claim they intend to make. Conflicting,
inconsistent, or inconclusive results will call into doubt the sufficiency of an advertiser’s
substantiation. Where these discrepancies exist, it is critical to review the evidence for a plausible
explanation (e.g., differences in dosage amount, whether the dose is taken orally or intravenously, or
the population tested). If an array of different studies has been conducted with as many different
quality control methods, advertisers should first review those studies using the most reliable
methodologies.17
The surrounding body of evidence will significantly impact the type, amount, and quality of
evidence needed to validate a claim, as well as how that claim is qualified in the ad to correctly reflect
the evidence. If a stronger surrounding body of evidence contradicts the claimed effect, even a
carefully qualified claim can be deemed deceptive.18
A common substantiation issue that advertisers face is that an advertiser has valid research, but the
research does not support the claim the advertiser wants to make. Advertisers must ensure that the
studies they rely on are not merely internally valid, but also applicable to the specific product and
product benefit being advertised. Advertisers need to carefully evaluate whether the dosage and
formulation used in the study actually compare to that in the advertised product. Advertisers should
also consider whether their product contains any additional ingredients that may change the effect of
the ingredient used in the study and if their product is administered the same way as it was in the
study. Furthermore, advertisers should consider whether the test population adequately reflects the
lifestyle and characteristics of consumers being marketed to.19
Advertisers’ claims must match underlying evidence. If the claims do not match this evidence, the
claims will likely not be substantiated. An advertisement should not exaggerate the degree, quality, or
permanence of the effects produced in a study, and should not exaggerate the existence of scientific
certainty. The FTC recognizes that emerging science can sometimes provide the basis for a carefully
qualified claim. Despite this, advertisers must take precautions and educate consumers of any
important limitations or discrepancies in the studies being used. Therefore, a clear and conspicuous
17
Id. at 14.
18
Id.
19
Id. at 16.
6. disclaimer must be made as to the product’s effectiveness and the results that any consumer should
expect to achieve through product use. As of 2009, the disclaimer “Results not typical” is no longer
acceptable for FTC compliance. Additionally, the disclaimer “Results may vary” is likely to be
considered too vague and therefore unacceptable.20
Testimonials
A consumer’s experience with a dietary supplement is not acceptable as proof of a supplement’s
effects and cannot be used to replace scientific research. Even if the experience is real, it may be due
to factors unrelated to the dietary supplement. Because of this, advertisers should avoid consumer
and expert testimonials that cannot be substantiated with scientific evidence.21
Affiliate Advertisers
The FTC also strongly recommends full disclosure in a clear and conspicuous manner for affiliate
advertisers. In addition to the foregoing disclosure requirements, affiliate advertisers are responsible
for disclosing to consumers their relationship to those whose website the affiliate hosts.22
Bloggers
Bloggers who accept cash or in-kind payment to review a product are making an endorsement in the
eyes of the FTC. To be compliant, those who blog about a product under these circumstances must
make a full disclosure of the material connection they have with the product seller.23
Compliance Guidelines
Regardless of the advertising medium and regardless of whether the advertiser is primary or affiliate,
the same truth-in-advertising rules apply. The FTC has created guidelines to help online marketers
ensure compliance.
20
Id. at 16, 18; FTC Publishes Final Guides Governing Endorsements, Testimonials, (October 5, 2009),
www.ftc.gov
21
Dietary Supplements: An Advertising Guide for Industry. Federal Trade Commission, Bureau of
Consumer Protection. (April, 2001), 10, 16.
22
The FTC Revised Endorsement Guides: What People Are Asking,5,
http://www.business.ftc.gov/documents/bus71-ftcs-revised-endorsement-guideswhat-people-are-asking,
23
The FTC Revised Endorsement Guides, 16 CFR Part 255, Guides Concerning the Use of
Endorsements and Testimonials in Advertising, § 255.5.
7. The Ordinary Consumer’s Perspective
Advertisers should review their own ads, adopting the perspective of the ordinary consumer. The
ordinary consumer has a short attention span and wants relevant information immediately.
Therefore, disclosures should be visually placed as closely as possible to the ad body itself so that
attention is actually drawn to the disclosure. With that in mind, advertisers should research what
areas of any given device’s screen a consumer is most likely to look when viewing an advertisement.24
The Use of Hyperlinks
In situations where platforms offer extremely limited space for the ad, a disclosure may become
tedious, however it is necessary for compliance purposes. If health and safety concerns have been
completely addressed on the initial disclosure, a hyperlink from the initial disclosure may be used to
guide the consumer directly to additional information regarding cost if those details are far too
lengthy to be covered in the initial disclosure. However, advertisers must pay careful attention to the
number of possible online routes a consumer may use to get to the ad and ensure that consumers
can’t help but see the initial disclosure, regardless of the route taken. Further, if a hyperlink is used,
the presence of the hyperlink itself must be obvious and must have a consistent look throughout the
website.25
Content and Functionality
Advertisers should frequently review the content and functionality of their own websites to ensure
that their disclosures cannot be missed by the ordinary consumer. This includes reviewing their ads
on different devices to make sure that, in each case, the disclosure is placed clearly and
conspicuously. If, for example, the disclosure can be read on a pc or laptop but cannot be read on an
iphone or tablet for any reason, a modification must be made so that a consumer viewing the ad on
these smaller devices can clearly see the disclosure.26
Advertisers should be careful when using any design that incorporates a scroll because this feature
may cause the consumer to miss the disclosure. However with some platforms, especially those used
with iphones and tablets, a scroll may be inevitable. An excellent way to make sure that an
24
.com Disclosures: How to Make Effective Disclosures in Digital Advertising (March 2013), 8, ii,
http://business.ftc.gov/documents/bus41-dot-com-disclosures-information-about-online-advertising
25
Id. at 10-12, 19.
26
Id. at 8-9, 18.
8. advertiser’s website is designed so that the consumer can’t avoid seeing the disclosures is to
incorporate a frame within the body of the ad that remains constantly in view as the consumer is
scrolling through the ad.27
Disclosure of Products Available at Brick and Mortar and Other Online Locations
If an advertiser’s product is also available for sale at a brick and mortar store or through another
online merchant, the disclosure should be placed in the ad itself so that consumers are informed
immediately.28
Disclosure Repetition
Advertisers should make sure that their disclosures repeat as often as necessary to ensure that a
consumer will see and understand them. For audio disclosures, the disclosure must be made in a
cadence, volume, and pace that the ordinary consumer understands. Advertisers need to keep in
mind that not everyone will have audio capabilities when viewing the ad content. Therefore, they
should be careful not to leave anything out of a print or visual disclosure that can only be
disseminated through the audio portion of an advertiser’s disclosure.29
Negative Option Trial Disclosure
Disclosures for any negative option trials must also be clearly identified. Negative options are
transactions in which the buyer’s lack of an affirmative action to refuse certain goods or services is
interpreted by the seller as an agreement to accept and be charged for certain goods or services.30
Abbreviated Disclosures and the Use of Click-Through Pages
Rotating panels or scrolling text can be used in an ad to provide an abbreviated version of a
disclosure if the disclosure also indicates that there is more information available on the click-
through page. If a series of click-through pages which lead to a website is necessary to reveal a
product’s identity, the disclosure must be clearly and conspicuously displayed on the website.31
27
Id. at 9, 13.
28
Id. at iii
29
Id. at 19, 20.
30
Id. at 18-19, Negative Options: A Report by the staff of the FTC’s Division of Enforcement, (January
2009), 2.
31
.com Disclosures: How to Make Effective Disclosures in Digital Advertising (March 2013), 16, 17,
http://business.ftc.gov/documents/bus41-dot-com-disclosures-information-about-online-advertising
9. Advertisements on Twitter
Advertisements in the form of tweets must have a disclosure included in every single page of the ad
as if it were viewed as its own individual ad. Advertisers should never assume that any consumer will
see the entire sequence of tweets that make up an ad.32
Republication
If an advertisement is a short form message which may be republished by others, the best practice is
to place the disclosure at the very beginning or end of the ad so that the disclosure cannot be
removed from the rest of the ad.33
Conclusion
The FTC makes very clear their intent to ensure advertiser compliance with FTC law, regardless of
whether the advertiser is an affiliate or primary product advertiser for dietary supplements.
Advertisers should familiarize themselves with FTC labeling and marketing requirements to make
sure that claims are not misleading, but truthful and substantiated. Those who make endorsements
regarding a product’s efficacy, including bloggers, must disclose to consumers their relationship to a
product seller when receiving cash or in-kind payment. Advertisers would be well advised to have
someone on their staff dedicated to enforcing compliance of FTC guidelines.
Advertisers would benefit from creating a compliance department to ensure that the above described
guidelines and any additional guidelines that the FTC creates are enforced.
32
Id. at 16,
33
Id.