Professional Documents
Culture Documents
ROBERT KENAGY
robkenag@iusb.edu
School of Business & Economics
Indiana University South Bend
DAVID VOLLRATH
vollrath@iusb.edu
School of Business & Economics
Indiana University South Bend
MARK FOX
mfox1@iusb.edu
School of Business & Economics
Indiana University South Bend
ABSTRACT. We outline the tests used by the Federal Trade Commission (FTC) to
determine whether advertising is unfair or deceptive. Our focus is on how the FTC
views non-traditional health-related products and treatments. To help illustrate the
application of the FTC advertising tests, we show how they can be used to assess
claims made by some Community Acupuncture clinics that patients treated in a group
setting gain treatment benefits from group energy (“communal qi”).
1. Introduction
12
2. Advertising Law and Health-related Claims
13
immunize it from responsibility for its misrepresentations; intent to deceive
is not a required element for a section 5 violation.”19
The first prong of the test for deceptiveness is that there must have been
either an express or implied claim being made in the advertising. The FTC
will evaluate individual phrases or statements in an ad and also will con-
sider the overall “impression conveyed by all elements of the ad, including
the text, product name, and depictions.”20 If there is more than one reason-
able interpretation with respect to the wording, the advertiser is required to
substantiate each individual claim.21 The following FTC example illustrates
this concept:
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.22
The FTC recognizes that subjective claims about a product, such as state-
ments about a product’s smell, taste, feel, or appearance (e.g. “this cookie
tastes great”), are recognized by consumers as opinion and these types of
statements are generally not considered deceptive by the FTC.23 The FTC’s
focus is on the truthfulness and substantiation of a claim for any product, and
(as the FTC observes within the context of advertising for dietary supple-
ments):
Depending on how it is phrased, or the context in which it is
presented, a statement about a product’s effect on a normal ‘struc-
ture 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.24
The second prong of the FTC test is that the claim must be misleading to a
consumer acting reasonably in the circumstances, and reliance on the claim
must be to the consumer’s detriment. The FTC will look to the specific
audience of the advertisement, such as children, the elderly, or the terminally
ill, and the evaluation of whether or not the claim is misleading will be based
on the perspective of how the claim affects ordinary individuals in that group.25
The FTC will consider an advertisement to be misleading if a significant
minority of reasonable consumers is likely to be misled to their detriment.26
14
An advertisement can be found to be misleading even if the ad can be in-
terpreted several ways and only one of those is misleading.27
The third aspect of the FTC test for deceptiveness is that the claim must
be material, meaning that it must be likely to affect a consumer’s decision
about whether to buy or use the product.28 In light of the importance that
consumers place on health and safety for themselves and their families, ad-
vertising claims about the health benefits or safety of a product are presumed
to be material to consumers.29
To avoid a charge by the FTC of deceptiveness, an advertiser must have
substantiation for all objective claims made in the advertisement before the
ad is run.30 While the FTC has the burden of proving that the statements in
an advertisement are false or misleading,31 the FTC does not use different
standards for food, drugs, medical devices, and other health-related products.32
An advertiser making an express claim about the scientific basis for its state-
ments should have substantiation for the claim. This substantiation needs to
be based on tests conducted using accepted scientific methodology with results
that are statistically significant.33 If the advertisement does not make an express
statement in the ad regarding the scientific data supporting a claim, the FTC
evaluates the level of substantiation based on six factors: the type of product;
the type of claim; the consequences of a false claim; the benefits of a truth-
ful claim; the cost of substantiating the claim; and the level of substantiation
considered reasonable by experts in the field.34 The FTC considers reliable
scientific evidence to mean:
tests, analyses, research, studies, or other evidence based on the
expertise of professionals in the relevant area, that has been con-
ducted 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.35
Statements made by individual users of a product in advertisements are not
sufficient to substantiate advertising claims.36 If an ad contains a consumer
testimonial about the benefits or safety of a product, the claim should be
supported “by adequate substantiation that the testimonial experience is rep-
resentative of what consumers will generally achieve when using the product.”37
To address concerns that bloggers may be endorsing products for cash without
disclosing this to consumers the FTC has classified bloggers on the internet as
potential endorsers.38 Endorsers may be liable for endorsements containing
false or deceptive claims.39
However, not all claims must be substantiated by clinical tests. The level
of substantiation required is a function of the nature of the claim.40 The FTC
gives the following example to illustrate this principle:
A supplement manufacturer wants to market an herbal product
that has been used in the same formulation in China as a tonic
15
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 Thou-
sands 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 tra-
ditional 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.41
The FTC relies heavily on the last of the six factors (the level of substan-
tiation considered reasonable by experts in the field) and generally takes the
position that clinical studies are the most reliable way to substantiate health
claims.42
For claims relating to health or the prevention or treatment of medical
conditions, the FTC generally requires claims to be supported by the results
of “two adequate and well-controlled, double-blinded clinical studies which
conform to acceptable designs and protocols and are conducted by different
persons, each of whom is qualified by training and experience to conduct
such studies independently of each other.”43
In FTC v. QT, Inc., the Seventh Circuit Court of Appeals reviewed a dis-
trict court’s finding that advertisements promoting the Q-Ray Ionized Bracelet
as a cure for chronic pain were false.44 In affirming the lower court decision,
the court of appeals agreed that the advertisement was completely false and
highlighted some of the key district court findings:
• Defendants promoted the bracelet as a miraculous cure for chronic pain,
but it has no therapeutic effect.
• Defendants told consumers that claims of “immediate, significant or com-
plete pain relief” had been “test-proven”; they hadn’t.
• The bracelet does not emit “Q-Rays” (there are no such things) and is not
ionized (the bracelet is an electric conductor, and any net charge dissipates
swiftly).
• The bracelet is touted as “enhancing the flow of bio-energy” or “balancing
the flow of positive and negative energies”; these empty phrases have no
connection to any medical or scientific effect.
• Defendants represented that the therapeutic effect wears off in a year or
two, despite knowing that the bracelet’s properties do not change. This assertion
is designed to lead customers to purchase new bracelets. Likewise the false
statement that the bracelet has a “memory cycle specific to each individual
wearer” so that only the bracelet’s original wearer can experience pain relief
is designed to increase sales by eliminating the second-hand market and
“explaining” the otherwise-embarrassing fact that the buyer’s friends and
neighbors can’t perceive any effect.45
16
On appeal, the defendants in QT, Inc. asserted that the trial judge had erred by
subjecting their statements “to an excessively rigorous standard of proof” by
implying that any statement not supported by a placebo-controlled, double-
blind study must be deemed false.46 While noting that the FTC Act does not
require placebo-controlled, double-blind testing to substantiate claims, the
appeals court found that there was no error at trial because the defendants had
offered no valid proof that the Q-Ray Bracelet had any effect on pain.47 The
court rejected the defendants’ argument that the health claims were substan-
tiated by a study that showed “active” and “inactive” Q-Ray Bracelets had the
same effect on patients’ reported levels of pain. The court noted that the
results of the test were the product of the placebo effect.48 After rejecting the
defendant’s study, the court observed:
What remain are testimonials, which are not a form of proof
because most testimonials represent a logical fallacy: post hoc
ergo propter hoc, (A person who experiences a reduction in pain
after donning the bracelet may have enjoyed the same reduction
without it. That’s why the ‘testimonial’ of someone who keeps
elephants off the streets of a large city by snapping his fingers
is the basis of a joke rather than proof of cause and effect.)49
In Novartis Corp. v. FTC, the Court of Appeals for the District of Columbia
Circuit affirmed an FTC finding that advertisements for Doan’s pain reliever
pills were deceptive because they contained an unsubstantiated implied claim
of superiority in relieving back pain.50 The ads characterized Doan’s as a
remedy especially effective for back pain and containing a special ingredient
not found in other pain relievers such as aspirin or Tylenol. The FTC had
determined that these advertisement statements combined to create an implied
claim that Doan’s pills were superior to other analgesics in relieving back
pain and that there was no substantiation for this implied claim.51
On September 29, 2011, Reebok International and the FTC settled
charges brought by the FTC that Reebok had engaged in deceptive adver-
tising with respect to its Reebok Toning Footwear.52 Under the terms of the
settlement, Reebok agreed to end such advertising and pay $25 million for
customer refunds.53 According to the FTC complaint, Reebok had made
unsupported claims that its walking footwear would lead to 28 percent more
strength and tone in the buttock muscles, 11 percent more strength and tone
in the hamstring muscles, and 11 percent more strength and tone in the calf
muscles than regular walking shoes.54 A typical Reebok ad stated:
Reebok EasyTone shoes not only look fantastic, they’ll help
make your legs and butt look great, too. It’s the shoe proven [on
screen: camera zooms to woman’s backside] – dude – [camera
moves back to woman’s face and upper body] to work your
hamstrings and calves up to 11% harder and tones your butt up
to 28% more than regular sneakers.55
17
Coming back to our example of communal qi, it is clear from the law that
Community Acupuncture (CA) clinics that wish to make such claims should
base them on documented clinical evidence. We now turn our attention to
illustrating some of these considerations when conducting a clinical assess-
ment of the effectiveness of communal qi.
18
The question arises as to how to determine the effectiveness of acupuncture
treatment in a group setting that would be acceptable to the FTC. In the
absence of detailed explanations of group acupuncture treatments in TCM or
in the claims of CA clinics, it is reasonable to study medical conditions for
which individual acupuncture already has the strongest documented effects.
The World Health Organization and/or the National Institutes of Health
literature surveys of acupuncture effectiveness are useful in this regard. If
individual acupuncture has been demonstrated to be effective in treating these
conditions, then they may also be the conditions for which group acupuncture
is efficacious, too. Samuels observes that, unlike traditional medical practice –
where treatment options are more clearly defined across practitioners, acu-
puncturists themselves may approach diagnosis and treatment in different
ways depending upon their background, training and experience.58 Samuels
also notes that variations within different schools of practice may exist. To
resolve such issues Samuels proposes that, ideally, “study protocols should
entail a single, concise list of [acupuncture] points.”59 Further, so as to
maximize credibility, any study of the effects of communal qi should follow
standards and protocols for acupuncture research.60
Another issue that needs consideration when designing a clinical trial is
deciding which comparisons to make. In the case of demonstrating whether
communal qi exists, it would make the most sense to compare the effective-
ness of individual (one acupuncturist, one client, in a private setting) with
group treatment (ideally in one acupuncturist, group treatment settings). As
the World Health Organization notes:
Unlike the evaluation of a new drug, controlled clinical trials of
acupuncture are extremely difficult to conduct, particularly if they
have to be blind in design and the acupuncture has to be com-
pared with a placebo. Various ‘sham’ or ‘placebo’ acupuncture
procedures have been designed, but they are not easy to perform
in countries such as China where acupuncture is widely used. In
these countries, most patients know a great deal about acupuncture,
including the special sensation that should be felt after insertion
or during manipulation of the needle. Moreover, acupuncturists
consider these procedures unethical because they are already con-
vinced that acupuncture is effective. In fact, most of the placebo-
controlled clinical trials have been undertaken in countries where
there is skepticism about acupuncture, as well as considerable
interest.61
However, contrasting the effects of group versus individual treatment on con-
ditions that are already documented to be treatable with acupuncture would
likely also dispense with the need to contrast treatment effects by introducing
a placebo control group.
19
When conducting a clinical study that examines whether or not communal
qi exists, a treatment variable of chief interest is the number of clients simul-
taneously undergoing acupuncture treatment. At a minimum, the clinical trial
should compare treatment of a single client to treatment of multiple clients
at once. To gain more information about the form of the relationship, if any,
between number of clients and effectiveness, numbers of clients undergoing
treatment should vary, for example 1, 2, 3, 4, 5, or 6. If communal qi does
indeed exist, the concept itself implies that the larger the group within which
treatment is occurring the stronger the communal qi that is generated by the
group.
Clinical studies of communal qi should also take into account that “A
course of acupuncture treatment varies due to a number of factors: the chron-
icity of a condition, person’s general constitution, and their body’s response
to acupuncture.”62 The number of visits required to treat various conditions
also affects treatment. For example, Povolny notes that a patient seeking
treatment for a pain-related condition should generally see results within six
to eight visits.63 Taken together, these observations suggest that a research
design should include measures of effectiveness that are assessed immediately
after the first treatment, and thereafter at various times up to the sixth to
eighth visit.
Further, VanderPloeg and Yi note that acupuncture effects with delayed
onset and long duration are inconsistent with placebo explanations.64 To address
possible placebo effects, measures (e.g., of nausea, vomiting, pain or general
well-being) should be taken immediately after treatment, 1–2 hours after
treatment, and at longer intervals up to two weeks after treatment. The external
validity of results could be increased by designing the study to match fea-
tures of typical acupuncture clinics themselves. Issues of interest here include:
the gender of the acupuncturist; whether treatment is on a table, chair, or
recliner; and the presence or nature of any music being played during treat-
ment.
Effectiveness might also be defined in terms of general well-being, which
is the leading reason cited for use of alternative or complementary medicine
(Vos & Brennan, 2009). This measure of effectiveness seems applicable to
a wide range of clients (Note that from a legal point of view, “general well-
being” also implies a health benefit and would likely be viewed as a health-
related claim requiring either a disclaimer that it is not supported by scien-
tific fact or substantiation by clinical studies).
The World Health Organization also notes that:
While effectiveness is doubtless of the utmost importance, other
factors, including safety, cost, availability and the condition of local
health services must also be considered. Given the same effective-
ness, these other factors may lead to different evaluations of acu-
puncture in different countries and areas.65
20
These considerations are important with regards to Community Acupuncture
clinics as they seek to make acupuncture more affordable to the working class.
4. Conclusions
We have shown how the Federal Trade Commission evaluates whether or not
advertising is unfair or deceptive. One key element of the FTC’s six-prong
test is evaluating whether or not claims made in advertising would be deemed
credible by knowledgeable experts. Community Acupuncture clinics thus face
two significant hurdles in laying any foundation for advertising any express
or implied health-related claims for communal qi. First, these clinics will need
to develop testing that establishes evidence of some type of health benefit of
communal qi. Second, assuming that traditional Western scientific testing is
unable to establish this evidence, these clinics will have to resort to testing
approaches other than those recognized by traditional Western medical research
to establish such evidence. Even if this effort is successful, the CA clinics
must then persuade the FTC that such evidence suffices for any claims made.
At this point in time, the hurdles would seem to be beyond the realistic
financial resources available to most, if not all, CA clinics. Given this state
of affairs, the outlook for advertising communal qi may be bleak.
Based on the current state of the law and science, group acupuncture
practitioners face a difficult challenge in attempting to convey any health
benefits of communal qi to consumers in advertisements. Moreover, if the
context of the ad would suggest that communal qi positively affects treat-
ment outcomes, then the advertiser is under a duty to include a clear and
prominent disclaimer that there is no evidence to support that suggestion.66
While advertisers can refer to the traditional use of acupuncture, the ad must
not leave the impression that this use substitutes for scientifically established
results, and the FTC will in all likelihood find the ad deceptive unless there
is a clear disclaimer to alert the consumer.67
Group acupuncture practitioners are probably limited to the following types
of ad statements if they want to avoid a charge of deceptive advertising. First,
statements could be used that consumers find a group setting for acupuncture
to be a relaxing and friendly environment in which to experience acupuncture.
Second, statements that group acupuncture treatment is based on traditional
Chinese acupuncture, which has been practiced for centuries, would be accep-
table if there is no implication through the context in which the statement is
made that there is scientific evidence supporting the concept of communal
qi as enhancing treatment or otherwise creating a health benefit.
Advertisers who decide to include mention of the concept of communal
qi should be very clear in explaining that there is no scientific evidence to
support the concept. However, prominent inclusion of disclaimer language
21
in all likelihood undercuts any positive aspect of including the concept of
communal qi in the advertisement. Finally, testimonials cannot be used to
support a claim of the existence of communal qi. At most, a testimonial by a
consumer could state that group acupuncture “made me feel great” or “more
comfortable.” Statements such as these reflect a personal impression, not
scientific fact.
Given that there is currently no scientific evidence to support any health
benefit claim for communal qi, group acupuncture advertisers would need
to avoid making any direct or indirect claims that communal qi will improve
a health condition or enhance a treatment. In the final analysis, there does
not seem to be a legal foundation upon which the concept of communal qi
as an enhancement to treatment can be used in an advertisement.
1. Federal Trade Commission Act (15 U.S.C. §§ 41–58, as amended). Under this
Act, the Commission is empowered, among other things, to (a) prevent unfair methods
of competition, and unfair or deceptive acts or practices in or affecting commerce; (b)
seek monetary redress and other relief for conduct injurious to consumers; (c) pre-
scribe trade regulation rules defining with specificity acts or practices that are unfair
or deceptive, and establishing requirements designed to prevent such acts or practices;
(d) conduct investigations relating to the organization, business, practices, and man-
agement of entities engaged in commerce; and (e) make reports and legislative rec-
ommendations to Congress.
2. 15 U.S.C. §45(a)(1).
3. FTC Dietary Supplements at 1.
4. See FTC Advertising and Marketing on the Internet (2000), available at http://
business.ftc.gov/documents/bus28-advertising-and-marketing-internet-rules-road.pdf
5. 15 U.S.C. §45(a)(1).
6. 15 U.S.C. §52(a).
7. Examples of claims made by clinics include: “… we treat in a community
setting. Many people find it comforting. It is more effective because of the healing
energy as a group.”; “The group treatment setting not only makes acupuncture
affordable but creates a ‘community Qi.’ We have found that the energy in the room
amplifies individual healing.”; “We love community acupuncture because it makes it
easy for people to get treatments whenever they want, to be treated with their
families and friends, to feel comfortable rather than isolated, and to create together a
collective energetic field which makes the individual treatments more powerful and
clinically effective; community Qi.”
8. FTC Dietary Supplements: An Advertising Guide for Industry (1998) at 9,
available at http://business.ftc.gov/documents/bus09-dietary-supplements-advertising-
guide-industry (“FTC Dietary Supplements”).
9. The phenomena that can occur when an individual perceives improvement in
a medical condition when given an inert treatment.
10. Ibid., 8.
22
11. 15 U.S.C. §45(n).
12. 104 F.T.C. 949 (1984).
13. Ibid., 1052.
14. Ibid., 1053.
15. Ibid., 1065.
16. Anne V. Maher, and Lesley Fair (2010), “The FTC’s Regulation of Adver-
tising,” 65 Food Drug L.J. 589, 601 (2010).
17. Ibid.
18. Kraft, Inc., 114 F.T.C. 40, 121 (1991).
19. Chrysler Corp. v. FTC 561 F.2d 357, n.5 at 363 (D.C. Cir. 1977).
20. FTC Dietary Supplements at 3–4.
21. Ibid., 4.
22. Ibid., 4–5.
23. Deception Policy Statement, 103 F.T.C. at 181.
24. FTC Dietary Supplements at 4.
25. FTC Policy Statement on Deception, appended to Cliffdale Associates, Inc.,
103 F.T.C. 110, 174 (1984); available at http://business.ftc.gov/search/apachesolr_
search/Deception%20Policy%20Statement (“Deception Policy Statement”).
26. Telebrands Corp., 140 F.T.C. at 291.
27. Sear, Roebuck & Co., 95 F.T.C. 406, 511 (1980), aff’d, 676 F.2d 385 (9th
Cir. 1982).
28. Ibid.
29. Ibid., 182–183.
30. FTC Policy Statement Regarding Advertising Substantiation, appended to
Thompson Medical Co., Inc., 104 F.T.C. at 839, available at http://business.ftc.gov/
search/apachesolr_search/Policy%20Statement%20Regarding%20Advertising%20S
ubstantiation (“Statement Regarding Advertising Substantiation”).
31. Federal Trade Commission v. QT, Inc., 512 F.2d 858, 861 (7th Cir. 2008).
32. Maher & Fair, supra note 17, at 605.
33. See FTC Dietary Supplements.
34. Statement Regarding Advertising Substantiation, 104 F.T.C. at 840.
35. FTC Dietary Supplements at 10; See e.g., KFC Corp., 138 F.T.C. 422 (2004).
36. FTC Dietary Supplements at 10, 18.
37. See FTC Guides Concerning Use of Endorsements and Testimonials in Ad-
vertising, available at http://business.ftc.gov/documents/bus71-ftcs-revised-endorsement-
guideswhat-people-are-asking.pdf (“FTC Guides Concerning Endorsements”). See also
Note and Recent Development: “How New FTC Guidelines on Endorsement and
Testimonials Will Affect Traditional and New Media,” 28 Cardozo Arts & Ent. L.J.
609 (2011).
38. FTC Guides Concerning Endorsements at 4.
39. Ibid., 3.
40. FTC Dietary Supplements at 10.
41. Ibid., 22.
42. Ibid.
43. Novartis, 127 F.T.C. at 726.
44. 512 F.3d 858 (7th Cir. 2008).
45. Ibid., 860–861.
23
46. Ibid., 861.
47. Ibid., 862.
48. Ibid.
49. Ibid.
50. 223 F.3d 783, 785 (D.C. Cir. 2000), aff’g 127 F.T.C.
51. Ibid., 786.
52. FTC v. Reebok International Ltd. No. 1:11-cv-02046 (N.D. Ohio Sept. 29, 2011).
53. Ibid., 7.
54. Complaint at 4, FTC v. Reebok International Ltd. No. 1:11-cv-02046 (N.D.
Ohio Sept. 29, 2011).
55. Ibid., 5.
56. Lee M. S., Lee Y. H., Shin B. C., Jeong D. M., Kim M. K., Eo Y. G., Ko S.
B. (2005), “Is There Any Energy Transfer during Acupuncture?” American Journal
of Chinese Medicine 33(3): 507–512, at 508.
57. “NIH Consensus Development Panel on Acupuncture” (1998), Journal of the
American Medical Association 280(17): 1518–1524, at 1518.
58. Samuels, N. (2009), “Acupuncture Research: Getting to the Point,” Interna-
tional Journal of Clinical Practice 63(11): 1553–1555.
59. Ibid.
60. Morris, William R. (2011) “Standards for Reporting Acupuncture Research,”
American Acupuncturist Summer, 26–29; Altman D. G., Moher D., Egger M.,
Davidoff, F., Elbourne D., Gøtzsche P. C., Lang T. (2001), “The Revised CONSORT
Statement for Reporting Randomized Trials: Explanation and Elaboration,” Ann.
Intern. Med. 134(8): 663–9; Hugh MacPherson et al., for the STRICTA Group (2002),
“Standards for Reporting Interventions in Controlled Trials of Acupuncture: The
STRICTA Recommendations,” Acupuncture in Medicine 20(1): 22–25.
61. World Health Organization (2003), “Acupuncture: Review and Analysis of
Reports on Controlled Clinical Trials,” http://apps.who.int/medicinedocs/en/d/Js49
26e/3.3.html, at 2–3.
62. Povolny, Bonnie (2008), “Acupuncture and Traditional Chinese Medicine: An
Overview,” Techniques in Regional Anesthesia and Pain Management 12: 109–110,
at 110.
63. Ibid.
64. VanderPloeg, Kristin and Yi, Xiaobin (2009), “Acupuncture in Modern
Society,” Journal of Acupuncture Meridian Studies 2(1): 25–33.
65. Supra note 61.
66. See FTC Dietary Supplements, at 20–21.
67. Ibid.
24