[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 90122-90123]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29770]



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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  

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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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    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