81_FR_90361 81 FR 90122 - Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs

81 FR 90122 - Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs

FEDERAL TRADE COMMISSION

Federal Register Volume 81, Issue 239 (December 13, 2016)

Page Range90122-90123
FR Document2016-29770

The Federal Trade Commission has issued an Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs. The Statement describes the level of substantiation that the Commission expects for marketing claims for over-the-counter (OTC) homeopathic drugs. It also recognizes that marketing claims for OTC homeopathic products for an unsubstantiated indication might be made non-deceptive by the inclusion of additional explanatory information that effectively communicates to consumers that there is no scientific evidence that the product works and that the product's claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.

Federal Register, Volume 81 Issue 239 (Tuesday, December 13, 2016)
[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 90122-90123]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-29770]



[[Page 90121]]

Vol. 81

Tuesday,

No. 239

December 13, 2016

Part III





 Federal Trade Commission





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 Enforcement Policy Statement on Marketing Claims for OTC Homeopathic 
Drugs; Notice

Federal Register / Vol. 81 , No. 239 / Tuesday, December 13, 2016 / 
Notices

[[Page 90122]]


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FEDERAL TRADE COMMISSION


Enforcement Policy Statement on Marketing Claims for OTC 
Homeopathic Drugs

AGENCY: Federal Trade Commission.

ACTION: Commission policy statement.

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SUMMARY: The Federal Trade Commission has issued an Enforcement Policy 
Statement on Marketing Claims for OTC Homeopathic Drugs. The Statement 
describes the level of substantiation that the Commission expects for 
marketing claims for over-the-counter (OTC) homeopathic drugs. It also 
recognizes that marketing claims for OTC homeopathic products for an 
unsubstantiated indication might be made non-deceptive by the inclusion 
of additional explanatory information that effectively communicates to 
consumers that there is no scientific evidence that the product works 
and that the product's claims are based only on theories of homeopathy 
from the 1700s that are not accepted by most modern medical experts.

DATES: The Commission announced the issuance of the Statement on 
November 15, 2016.

FOR FURTHER INFORMATION CONTACT: Michael Ostheimer (202-326-2699) or 
Richard Cleland (202-326-3088), Bureau of Consumer Protection, 600 
Pennsylvania Avenue NW., Washington, DC 20580.

SUPPLEMENTARY INFORMATION:

Enforcement Policy Statement on Marketing Claims for OTC Homeopathic 
Drugs

    The Federal Trade Commission (FTC) is issuing this Policy Statement 
to provide guidance regarding its enforcement policy with respect to 
marketing claims for over-the-counter (OTC) homeopathic drugs. It 
applies only to OTC products intended solely for self-limiting disease 
conditions \1\ amenable to self-diagnosis of symptoms and treatment.\2\ 
The Commission believes this Policy Statement is appropriate in light 
of the burgeoning mainstream marketing of OTC homeopathic products 
alongside other OTC drugs.
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    \1\ A self-limiting disease condition is one that resolves 
spontaneously with or without specific treatment.
    \2\ This Policy Statement does not apply to the practice of 
medicine.
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    The FTC's authority over disease and other health-related claims 
comes from Sections 5 and 12 of the FTC Act. Section 5, which applies 
to both advertising and labeling, prohibits unfair or deceptive acts or 
practices in or affecting commerce, such as the deceptive advertising 
or labeling of OTC drugs.\3\ Section 12 prohibits the dissemination of 
false advertisements in or affecting commerce of food, drugs, devices, 
services, or cosmetics.\4\ Under these provisions, companies must have 
a reasonable basis for making objective product claims, including 
claims that a product can treat specific conditions, before those 
claims are made.\5\
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    \3\ Federal Trade Commission Act, 15 U.S.C. 45(a)(2).
    \4\ Federal Trade Commission Act, 15 U.S.C. 52.
    \5\ See Advertising Substantiation Policy Statement, appended to 
Thompson Medical Co., 104 F.T.C. 648, 839 (1984), aff'd, 791 F.2d 
189 (D.C. Cir. 1986) (``Advertising Substantiation Policy 
Statement'').
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    Homeopathy, which dates back to the late-eighteenth century, is 
based on the view that disease symptoms can be treated by minute doses 
of substances that produce similar symptoms when provided in larger 
doses to healthy people. Many homeopathic products are diluted to such 
an extent that they no longer contain detectable levels of the initial 
substance. In general, homeopathic product claims are not based on 
modern scientific methods and are not accepted by modern medical 
experts, but homeopathy nevertheless has many adherents.\6\
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    \6\ FTC Staff Report on the Homeopathic Medicine & Advertising 
Workshop (Nov. 2016).
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    In 1988, the Food & Drug Administration (FDA) issued a Compliance 
Policy Guide (CPG) entitled ``Conditions Under Which Homeopathic Drugs 
May be Marketed,'' which permitted marketers to distribute OTC 
homeopathic products without demonstrating their efficacy.\7\ Under the 
CPG, only homeopathic products intended solely for self-limiting 
disease conditions amenable to self-diagnosis of symptoms and treatment 
may be marketed OTC. The CPG requires that OTC homeopathic drugs be 
labeled as homeopathic and that their labeling display at least one 
major OTC indication for use.
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    \7\ See CPG Sec. 400.400 Conditions Under Which Homeopathic 
Drugs May be Marketed (revised Mar. 1995), http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074360.htm.
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    The FTC Act does not exempt homeopathic products from the general 
requirement that objective product claims be truthful and 
substantiated.\8\ Nevertheless, in the decades since the Commission 
announced in 1972 that objective product claims must be 
substantiated,\9\ the FTC has rarely challenged misleading claims for 
products that were homeopathic or purportedly homeopathic.\10\
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    \8\ ``[A] product that contemporary technology does not 
understand must establish that this `magic' actually works. Proof is 
what separates an effect new to science from a swindle . . . . [I]f 
a condition responds to treatment, then selling a placebo as if it 
had therapeutic effect directly injures the consumer.'' FTC v. QT, 
Inc., 512 F.3d 858, 862-63 (7th Cir. 2008).
    \9\ See Pfizer, Inc., 81 F.T.C. 23, 62-64 (1972).
    \10\ See, e.g., Complaint, FTC v. HCG Diet Direct, LLC, No. 
2:14-cv-00015-NVW (D. Ariz. Jan. 7, 2014) (stipulated judgment) 
(challenging weight-loss claims for purported homeopathic products); 
Complaint, FTC v. Iovate Health Scis. USA, Inc., No. 10-CV-587 
(W.D.N.Y. July 14, 2010) (stipulated judgment) (challenging claims 
that purported allergy-relieving product was homeopathic and 
effective); Quigley Corp., No. C-3926, 2000 FTC LEXIS 24 (Feb. 10, 
2000) (consent order) (challenging cold treatment and prevention 
claims for homeopathic products); Levey, 116 F.T.C. 885 (1993) 
(consent order) (challenging weight-loss and impotency treatment 
claims for purported homeopathic products).
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    Efficacy and safety claims for homeopathic drugs are held to the 
same standards as similar claims for non-homeopathic drugs. As 
articulated in the Advertising Substantiation Policy Statement, 
advertisers must have ``at least the advertised level of 
substantiation.'' Absent express or implied reference to a particular 
level of support, the Commission, in evaluating the types of evidence 
necessary to substantiate a claim, considers ``the type of claim, the 
product, the consequences of a false claim, the benefits of a truthful 
claim, the cost of developing substantiation for the claim, and the 
amount of substantiation experts believe is reasonable.'' \11\ For 
health, safety, or efficacy claims, the FTC has generally required that 
advertisers possess ``competent and reliable scientific evidence,'' 
defined as ``tests, analyses, research, or studies that have been 
conducted and evaluated in an objective manner by qualified persons and 
[that] are generally accepted in the profession to yield accurate and 
reliable results.'' \12\ In general, for health benefit claims, 
particularly claims that a product can treat or prevent a disease or 
its symptoms, the substantiation required has been well-designed human 
clinical testing.\13\
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    \11\ Advertising Substantiation Policy Statement, 104 F.T.C. at 
840. These factors are known as the Pfizer factors, after the 1972 
case, supra note 9, in which they were first enunciated.
    \12\ See, e.g., POM Wonderful LLC, 155 F.T.C. 56, 193 (2013), 
aff'd in part, 777 F.3d 478, 504-05 (D.C. Cir. 2015), cert. denied, 
No. 15-525, 2016 U.S. LEXIS 2991 (May 2, 2016); Telebrands Corp., 
140 F.T.C. 278, 347 (2005), aff'd, 457 F.3d 354 (4th Cir. 2006); 
Novartis Corp., 127 F.T.C. 580, 725 (1999), aff'd, 223 F.3d 783 
(D.C. Cir. 2000); Brake Guard Prods., Inc., 125 F.T.C. 138, 256 
(1998).
    \13\ See, e.g., POM Wonderful LLC, 155 F.T.C. at 5-6 (requiring 
well-designed, well-conducted, double-blind, randomized controlled 
clinical testing to substantiate heart disease, prostate cancer, and 
erectile dysfunction prevention and treatment claims; also imposing 
such a requirement for all future disease claims), aff'd in part, 
777 F.3d at 504-05 (affirming Commission holding that competent and 
reliable scientific evidence consisting of randomized, well-
controlled human clinical testing is needed for disease-related 
claims but finding fencing-in order requirement of two such tests 
was not justified in this instance); see also FTC v. Nat'l 
Urological Group, Inc., 645 F. Supp. 2d 1167, 1202-03 (N.D. Ga. 
2008) (accepting undisputed expert testimony that erectile 
dysfunction claims require well-designed, placebo-controlled, 
randomized, double-blind clinical trials for substantiation); FTC v. 
Direct Mktg. Concepts, Inc., 569 F. Supp. 2d 285, 303 (D. Mass. 
2008), aff'd, 624 F.3d 1 (1st Cir. 2010) (``it seems well-accepted 
that double-blind, placebo-controlled studies are necessary to 
substantiate health-related efficacy claims''); Removatron Int'l 
Corp., 111 F.T.C. 206 (1988), aff'd, 884 F.2d 1489 (1st Cir. 1989) 
(requiring ``adequate and well-controlled clinical testing'' to 
substantiate claims for hair removal product); Thompson Med. Co., 
104 F.T.C. at 826 (requiring well-controlled clinical studies to 
substantiate certain analgesic drug claims). The Commission has also 
accepted numerous settlements that required randomized controlled 
clinical testing for disease treatment and prevention claims. See, 
e.g., Brown, 152 F.T.C. 466, 481-82 (2011) (consent order); 
Nestl[eacute] HealthCare Nutrition, Inc., 151 F.T.C. 1, 13 (2011) 
(consent order); Viral Response Sys., Inc., 115 F.T.C. 676, 691 
(1992) (consent order).

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[[Page 90123]]

    For the vast majority of OTC homeopathic drugs, the case for 
efficacy is based solely on traditional homeopathic theories and there 
are no valid studies using current scientific methods showing the 
product's efficacy. Accordingly, marketing claims that such homeopathic 
products have a therapeutic effect lack a reasonable basis and are 
likely misleading in violation of Sections 5 and 12 of the FTC Act.\14\ 
However, the FTC has long recognized that marketing claims may include 
additional explanatory information in order to prevent the claims from 
being misleading. Accordingly, the promotion of an OTC homeopathic 
product for an indication that is not substantiated by competent and 
reliable scientific evidence may not be deceptive if that promotion 
effectively communicates to consumers that: (1) There is no scientific 
evidence that the product works and (2) the product's claims are based 
only on theories of homeopathy from the 1700s that are not accepted by 
most modern medical experts.\15\ To be non-misleading, the product and 
the claims must also comply with requirements for homeopathic products 
and traditional homeopathic principles. Of course, adequately 
substantiated claims for homeopathic products would not require 
additional explanation.
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    \14\ Although this Policy Statement is limited to OTC 
homeopathic products for the treatment of self-limiting disease 
conditions (ones that resolve spontaneously with or without specific 
treatment) amenable to self-diagnosis, marketing claims about the 
efficacy of homeopathic products not covered by this Policy 
Statement also are subject to the requirements to Sections 5 and 12.
    \15\ A statement that a product is based on traditional 
homeopathic theories might put some consumers on notice as to the 
basis of the product's efficacy claims. However, because many 
consumers do not understand what homeopathy is, the Commission does 
not believe that such a statement alone would adequately put 
consumers on notice that a product's efficacy claims are not backed 
by scientific evidence, and could, in fact, enhance the perceived 
credibility of the claim. Similarly, the Commission believes that a 
statement that a product's efficacy ``has not been evaluated by the 
Food and Drug Administration'' does not adequately address the 
potential lack of substantiation for a product's efficacy claims; 
dietary supplements bear a similar disclosure but FDA does require 
that dietary supplement label claims be supported by competent and 
reliable scientific evidence. Finally, the Commission believes that 
a simple statement that a product's efficacy is not supported by 
scientific evidence does not convey the truly limited basis for the 
efficacy claim and that, to avoid deceiving consumers, it is likely 
necessary to explain that it is not accepted by modern medicine.
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    Perfunctory disclaimers are unlikely to successfully communicate 
the information necessary to make claims for OTC homeopathic drugs non-
misleading. The Commission notes:
     Any disclosure should stand out and be in close proximity 
to the efficacy message; to be effective, it may actually need to be 
incorporated into the efficacy message.
     Marketers should not undercut such qualifications with 
additional positive statements or consumer endorsements reinforcing a 
product's efficacy.
     In light of the inherent contradiction in asserting that a 
product is effective and also disclosing that there is no scientific 
evidence for such an assertion, it is possible that depending on how 
they are presented many of these disclosures will be insufficient to 
prevent consumer deception. Marketers are advised to develop extrinsic 
evidence, such as consumer surveys, to determine the net impressions 
communicated by their marketing materials.
     The Commission will carefully scrutinize the net 
impression of OTC homeopathic advertising or other marketing employing 
disclosures to ensure that it adequately conveys the extremely limited 
nature of the health claim being asserted. If, despite a marketer's 
disclosures, an ad conveys more substantiation than the marketer has, 
the marketer will be in violation of the FTC Act.
    In summary, there is no basis under the FTC Act to treat OTC 
homeopathic drugs differently than other health products. Accordingly, 
unqualified disease claims made for homeopathic drugs must be 
substantiated by competent and reliable scientific evidence. 
Nevertheless, truthful, non-misleading, effective disclosure of the 
basis for an efficacy claim may be possible. The approach outlined in 
this Policy Statement is therefore consistent with the First Amendment, 
and neither limits consumer access to OTC homeopathic products nor 
conflicts with the FDA's regulatory scheme. It would allow a marketer 
to include an indication for use that is not supported by scientific 
evidence so long as the marketer effectively communicates the limited 
basis for the claim in the manner discussed above.

    By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2016-29770 Filed 12-12-16; 8:45 am]
 BILLING CODE 6750-01-P



                                                   90122                       Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices

                                                   FEDERAL TRADE COMMISSION                                  or affecting commerce, such as the                       Commission announced in 1972 that
                                                                                                             deceptive advertising or labeling of OTC                 objective product claims must be
                                                   Enforcement Policy Statement on                           drugs.3 Section 12 prohibits the                         substantiated,9 the FTC has rarely
                                                   Marketing Claims for OTC                                  dissemination of false advertisements in                 challenged misleading claims for
                                                   Homeopathic Drugs                                         or affecting commerce of food, drugs,                    products that were homeopathic or
                                                   AGENCY:    Federal Trade Commission.                      devices, services, or cosmetics.4 Under                  purportedly homeopathic.10
                                                                                                             these provisions, companies must have                       Efficacy and safety claims for
                                                   ACTION:   Commission policy statement.                    a reasonable basis for making objective                  homeopathic drugs are held to the same
                                                   SUMMARY:   The Federal Trade                              product claims, including claims that a                  standards as similar claims for non-
                                                   Commission has issued an Enforcement                      product can treat specific conditions,                   homeopathic drugs. As articulated in
                                                   Policy Statement on Marketing Claims                      before those claims are made.5                           the Advertising Substantiation Policy
                                                   for OTC Homeopathic Drugs. The                               Homeopathy, which dates back to the                   Statement, advertisers must have ‘‘at
                                                   Statement describes the level of                          late-eighteenth century, is based on the                 least the advertised level of
                                                   substantiation that the Commission                        view that disease symptoms can be                        substantiation.’’ Absent express or
                                                   expects for marketing claims for over-                    treated by minute doses of substances                    implied reference to a particular level of
                                                   the-counter (OTC) homeopathic drugs. It                   that produce similar symptoms when                       support, the Commission, in evaluating
                                                   also recognizes that marketing claims                     provided in larger doses to healthy                      the types of evidence necessary to
                                                   for OTC homeopathic products for an                       people. Many homeopathic products are                    substantiate a claim, considers ‘‘the type
                                                   unsubstantiated indication might be                       diluted to such an extent that they no                   of claim, the product, the consequences
                                                   made non-deceptive by the inclusion of                    longer contain detectable levels of the                  of a false claim, the benefits of a truthful
                                                   additional explanatory information that                   initial substance. In general,                           claim, the cost of developing
                                                   effectively communicates to consumers                     homeopathic product claims are not                       substantiation for the claim, and the
                                                   that there is no scientific evidence that                 based on modern scientific methods and                   amount of substantiation experts believe
                                                   the product works and that the                            are not accepted by modern medical                       is reasonable.’’ 11 For health, safety, or
                                                   product’s claims are based only on                        experts, but homeopathy nevertheless                     efficacy claims, the FTC has generally
                                                   theories of homeopathy from the 1700s                     has many adherents.6                                     required that advertisers possess
                                                   that are not accepted by most modern                         In 1988, the Food & Drug                              ‘‘competent and reliable scientific
                                                   medical experts.                                          Administration (FDA) issued a                            evidence,’’ defined as ‘‘tests, analyses,
                                                                                                             Compliance Policy Guide (CPG) entitled                   research, or studies that have been
                                                   DATES: The Commission announced the
                                                                                                             ‘‘Conditions Under Which Homeopathic                     conducted and evaluated in an objective
                                                   issuance of the Statement on November
                                                                                                             Drugs May be Marketed,’’ which                           manner by qualified persons and [that]
                                                   15, 2016.
                                                                                                             permitted marketers to distribute OTC                    are generally accepted in the profession
                                                   FOR FURTHER INFORMATION CONTACT:
                                                                                                             homeopathic products without                             to yield accurate and reliable results.’’ 12
                                                   Michael Ostheimer (202–326–2699) or                       demonstrating their efficacy.7 Under the
                                                   Richard Cleland (202–326–3088),                                                                                    In general, for health benefit claims,
                                                                                                             CPG, only homeopathic products                           particularly claims that a product can
                                                   Bureau of Consumer Protection, 600                        intended solely for self-limiting disease
                                                   Pennsylvania Avenue NW., Washington,                                                                               treat or prevent a disease or its
                                                                                                             conditions amenable to self-diagnosis of                 symptoms, the substantiation required
                                                   DC 20580.                                                 symptoms and treatment may be                            has been well-designed human clinical
                                                   SUPPLEMENTARY INFORMATION:                                marketed OTC. The CPG requires that                      testing.13
                                                   Enforcement Policy Statement on                           OTC homeopathic drugs be labeled as
                                                   Marketing Claims for OTC                                  homeopathic and that their labeling                        9 See  Pfizer, Inc., 81 F.T.C. 23, 62–64 (1972).
                                                   Homeopathic Drugs                                         display at least one major OTC                             10 See,  e.g., Complaint, FTC v. HCG Diet Direct,
                                                                                                             indication for use.                                      LLC, No. 2:14–cv–00015–NVW (D. Ariz. Jan. 7,
                                                      The Federal Trade Commission (FTC)                        The FTC Act does not exempt                           2014) (stipulated judgment) (challenging weight-
                                                   is issuing this Policy Statement to                       homeopathic products from the general
                                                                                                                                                                      loss claims for purported homeopathic products);
                                                   provide guidance regarding its                                                                                     Complaint, FTC v. Iovate Health Scis. USA, Inc.,
                                                                                                             requirement that objective product                       No. 10–CV–587 (W.D.N.Y. July 14, 2010) (stipulated
                                                   enforcement policy with respect to                        claims be truthful and substantiated.8                   judgment) (challenging claims that purported
                                                   marketing claims for over-the-counter                     Nevertheless, in the decades since the                   allergy-relieving product was homeopathic and
                                                   (OTC) homeopathic drugs. It applies                                                                                effective); Quigley Corp., No. C–3926, 2000 FTC
                                                   only to OTC products intended solely                                                                               LEXIS 24 (Feb. 10, 2000) (consent order)
                                                                                                                3 Federal Trade Commission Act, 15 U.S.C.
                                                                                                                                                                      (challenging cold treatment and prevention claims
                                                   for self-limiting disease conditions 1                    45(a)(2).                                                for homeopathic products); Levey, 116 F.T.C. 885
                                                   amenable to self-diagnosis of symptoms                       4 Federal Trade Commission Act, 15 U.S.C. 52.
                                                                                                                                                                      (1993) (consent order) (challenging weight-loss and
                                                   and treatment.2 The Commission                               5 See Advertising Substantiation Policy               impotency treatment claims for purported
                                                   believes this Policy Statement is                         Statement, appended to Thompson Medical Co.,             homeopathic products).
                                                                                                             104 F.T.C. 648, 839 (1984), aff’d, 791 F.2d 189 (D.C.       11 Advertising Substantiation Policy Statement,
                                                   appropriate in light of the burgeoning                    Cir. 1986) (‘‘Advertising Substantiation Policy          104 F.T.C. at 840. These factors are known as the
                                                   mainstream marketing of OTC                               Statement’’).                                            Pfizer factors, after the 1972 case, supra note 9, in
                                                   homeopathic products alongside other                         6 FTC Staff Report on the Homeopathic Medicine        which they were first enunciated.
                                                   OTC drugs.                                                & Advertising Workshop (Nov. 2016).                         12 See, e.g., POM Wonderful LLC, 155 F.T.C. 56,
                                                                                                                7 See CPG Sec. 400.400 Conditions Under Which         193 (2013), aff’d in part, 777 F.3d 478, 504–05 (D.C.
                                                      The FTC’s authority over disease and
                                                                                                             Homeopathic Drugs May be Marketed (revised Mar.          Cir. 2015), cert. denied, No. 15–525, 2016 U.S.
                                                   other health-related claims comes from                    1995), http://www.fda.gov/iceci/                         LEXIS 2991 (May 2, 2016); Telebrands Corp., 140
                                                   Sections 5 and 12 of the FTC Act.                         compliancemanuals/                                       F.T.C. 278, 347 (2005), aff’d, 457 F.3d 354 (4th Cir.
                                                   Section 5, which applies to both
mstockstill on DSK3G9T082PROD with NOTICES2




                                                                                                             compliancepolicyguidancemanual/                          2006); Novartis Corp., 127 F.T.C. 580, 725 (1999),
                                                   advertising and labeling, prohibits                       ucm074360.htm.                                           aff’d, 223 F.3d 783 (D.C. Cir. 2000); Brake Guard
                                                                                                                8 ‘‘[A] product that contemporary technology does     Prods., Inc., 125 F.T.C. 138, 256 (1998).
                                                   unfair or deceptive acts or practices in                  not understand must establish that this ‘magic’             13 See, e.g., POM Wonderful LLC, 155 F.T.C. at 5–

                                                                                                             actually works. Proof is what separates an effect        6 (requiring well-designed, well-conducted, double-
                                                      1 A self-limiting disease condition is one that
                                                                                                             new to science from a swindle . . . . [I]f a condition   blind, randomized controlled clinical testing to
                                                   resolves spontaneously with or without specific           responds to treatment, then selling a placebo as if      substantiate heart disease, prostate cancer, and
                                                   treatment.                                                it had therapeutic effect directly injures the           erectile dysfunction prevention and treatment
                                                      2 This Policy Statement does not apply to the          consumer.’’ FTC v. QT, Inc., 512 F.3d 858, 862–63        claims; also imposing such a requirement for all
                                                   practice of medicine.                                     (7th Cir. 2008).                                         future disease claims), aff’d in part, 777 F.3d at



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                                                                               Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices                                                  90123

                                                      For the vast majority of OTC                          evidence may not be deceptive if that                   is effective and also disclosing that there
                                                   homeopathic drugs, the case for efficacy                 promotion effectively communicates to                   is no scientific evidence for such an
                                                   is based solely on traditional                           consumers that: (1) There is no                         assertion, it is possible that depending
                                                   homeopathic theories and there are no                    scientific evidence that the product                    on how they are presented many of
                                                   valid studies using current scientific                   works and (2) the product’s claims are                  these disclosures will be insufficient to
                                                   methods showing the product’s efficacy.                  based only on theories of homeopathy                    prevent consumer deception. Marketers
                                                   Accordingly, marketing claims that such                  from the 1700s that are not accepted by                 are advised to develop extrinsic
                                                   homeopathic products have a                              most modern medical experts.15 To be                    evidence, such as consumer surveys, to
                                                   therapeutic effect lack a reasonable basis               non-misleading, the product and the                     determine the net impressions
                                                   and are likely misleading in violation of                claims must also comply with                            communicated by their marketing
                                                   Sections 5 and 12 of the FTC Act.14                      requirements for homeopathic products                   materials.
                                                   However, the FTC has long recognized                     and traditional homeopathic principles.
                                                   that marketing claims may include                        Of course, adequately substantiated                        • The Commission will carefully
                                                   additional explanatory information in                    claims for homeopathic products would                   scrutinize the net impression of OTC
                                                   order to prevent the claims from being                   not require additional explanation.                     homeopathic advertising or other
                                                   misleading. Accordingly, the promotion                     Perfunctory disclaimers are unlikely                  marketing employing disclosures to
                                                   of an OTC homeopathic product for an                     to successfully communicate the                         ensure that it adequately conveys the
                                                   indication that is not substantiated by                  information necessary to make claims                    extremely limited nature of the health
                                                   competent and reliable scientific                        for OTC homeopathic drugs non-                          claim being asserted. If, despite a
                                                                                                            misleading. The Commission notes:                       marketer’s disclosures, an ad conveys
                                                   504–05 (affirming Commission holding that                  • Any disclosure should stand out                     more substantiation than the marketer
                                                   competent and reliable scientific evidence               and be in close proximity to the efficacy               has, the marketer will be in violation of
                                                   consisting of randomized, well-controlled human          message; to be effective, it may actually               the FTC Act.
                                                   clinical testing is needed for disease-related claims
                                                   but finding fencing-in order requirement of two          need to be incorporated into the efficacy                  In summary, there is no basis under
                                                   such tests was not justified in this instance); see      message.                                                the FTC Act to treat OTC homeopathic
                                                   also FTC v. Nat’l Urological Group, Inc., 645 F.           • Marketers should not undercut such                  drugs differently than other health
                                                   Supp. 2d 1167, 1202–03 (N.D. Ga. 2008) (accepting        qualifications with additional positive
                                                   undisputed expert testimony that erectile                                                                        products. Accordingly, unqualified
                                                   dysfunction claims require well-designed, placebo-
                                                                                                            statements or consumer endorsements                     disease claims made for homeopathic
                                                   controlled, randomized, double-blind clinical trials     reinforcing a product’s efficacy.                       drugs must be substantiated by
                                                   for substantiation); FTC v. Direct Mktg. Concepts,         • In light of the inherent
                                                   Inc., 569 F. Supp. 2d 285, 303 (D. Mass. 2008), aff’d,                                                           competent and reliable scientific
                                                                                                            contradiction in asserting that a product
                                                   624 F.3d 1 (1st Cir. 2010) (‘‘it seems well-accepted                                                             evidence. Nevertheless, truthful, non-
                                                   that double-blind, placebo-controlled studies are
                                                                                                               15 A statement that a product is based on
                                                                                                                                                                    misleading, effective disclosure of the
                                                   necessary to substantiate health-related efficacy                                                                basis for an efficacy claim may be
                                                   claims’’); Removatron Int’l Corp., 111 F.T.C. 206        traditional homeopathic theories might put some
                                                   (1988), aff’d, 884 F.2d 1489 (1st Cir. 1989)             consumers on notice as to the basis of the product’s    possible. The approach outlined in this
                                                   (requiring ‘‘adequate and well-controlled clinical       efficacy claims. However, because many consumers        Policy Statement is therefore consistent
                                                   testing’’ to substantiate claims for hair removal        do not understand what homeopathy is, the
                                                                                                            Commission does not believe that such a statement       with the First Amendment, and neither
                                                   product); Thompson Med. Co., 104 F.T.C. at 826
                                                   (requiring well-controlled clinical studies to
                                                                                                            alone would adequately put consumers on notice          limits consumer access to OTC
                                                                                                            that a product’s efficacy claims are not backed by      homeopathic products nor conflicts
                                                   substantiate certain analgesic drug claims). The
                                                                                                            scientific evidence, and could, in fact, enhance the
                                                   Commission has also accepted numerous
                                                                                                            perceived credibility of the claim. Similarly, the
                                                                                                                                                                    with the FDA’s regulatory scheme. It
                                                   settlements that required randomized controlled                                                                  would allow a marketer to include an
                                                                                                            Commission believes that a statement that a
                                                   clinical testing for disease treatment and prevention
                                                   claims. See, e.g., Brown, 152 F.T.C. 466, 481–82
                                                                                                            product’s efficacy ‘‘has not been evaluated by the      indication for use that is not supported
                                                                                                            Food and Drug Administration’’ does not                 by scientific evidence so long as the
                                                   (2011) (consent order); Nestlé HealthCare Nutrition,    adequately address the potential lack of
                                                   Inc., 151 F.T.C. 1, 13 (2011) (consent order); Viral     substantiation for a product’s efficacy claims;         marketer effectively communicates the
                                                   Response Sys., Inc., 115 F.T.C. 676, 691 (1992)          dietary supplements bear a similar disclosure but       limited basis for the claim in the
                                                   (consent order).                                         FDA does require that dietary supplement label
                                                      14 Although this Policy Statement is limited to
                                                                                                                                                                    manner discussed above.
                                                                                                            claims be supported by competent and reliable
                                                   OTC homeopathic products for the treatment of            scientific evidence. Finally, the Commission              By direction of the Commission.
                                                   self-limiting disease conditions (ones that resolve      believes that a simple statement that a product’s
                                                   spontaneously with or without specific treatment)        efficacy is not supported by scientific evidence does   Donald S. Clark,
                                                   amenable to self-diagnosis, marketing claims about       not convey the truly limited basis for the efficacy     Secretary.
                                                   the efficacy of homeopathic products not covered         claim and that, to avoid deceiving consumers, it is
                                                                                                                                                                    [FR Doc. 2016–29770 Filed 12–12–16; 8:45 am]
                                                   by this Policy Statement also are subject to the         likely necessary to explain that it is not accepted
                                                   requirements to Sections 5 and 12.                       by modern medicine.                                     BILLING CODE 6750–01–P
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Document Created: 2016-12-13 02:44:51
Document Modified: 2016-12-13 02:44:51
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionCommission policy statement.
DatesThe Commission announced the issuance of the Statement on November 15, 2016.
ContactMichael Ostheimer (202-326-2699) or Richard Cleland (202-326-3088), Bureau of Consumer Protection, 600 Pennsylvania Avenue NW., Washington, DC 20580.
FR Citation81 FR 90122 

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