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

1A self-limiting disease condition is one that 

resolves spontaneously with or without specific 

treatment. 

2This Policy Statement does not apply to the 

practice of medicine. 

3Federal Trade Commission Act, 15 U.S.C. 

45(a)(2). 

4Federal Trade Commission Act, 15 U.S.C. 52. 

5See 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’’). 

6FTC Staff Report on the Homeopathic Medicine 

& Advertising Workshop (Nov. 2016). 

7See CPG Sec. 400.400 Conditions Under Which 

Homeopathic Drugs May be Marketed (revised Mar. 

1995), http://www.fda.gov/iceci/ 

compliancemanuals/ 

compliancepolicyguidancemanual/ 

ucm074360.htm. 

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). 

9See Pfizer, Inc., 81 F.T.C. 23, 62–64 (1972). 

10See, e.g., Complaint, FTC v. HCG Diet Direct, 

LLC, No. 2:14–cv–00015–NVW (D. Ariz. Jan. 7, 

2014) (stipulated judgment) (challenging weightloss 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). 

11Advertising 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. 

12See, 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). 

13See, e.g., POM Wonderful LLC, 155 F.T.C. at 5– 

6 (requiring well-designed, well-conducted, doubleblind, 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 

FEDERAL TRADE COMMISSION 

Enforcement Policy Statement on 

Marketing Claims for OTC 

Homeopathic Drugs 

AGENCY: Federal Trade Commission. 

ACTION: Commission policy statement. 

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 overthe-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. 

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

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

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. 

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

Efficacy and safety claims for 

homeopathic drugs are held to the same 

standards as similar claims for nonhomeopathic 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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Federal Register / Vol. 81, No. 239 / Tuesday, December 13, 2016 / Notices 90123 

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, placebocontrolled, 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); Nestle ́ 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). 

14Although 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. 

15A 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. 

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. 

Perfunctory disclaimers are unlikely 

to successfully communicate the 

information necessary to make claims 

for OTC homeopathic drugs nonmisleading. 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, nonmisleading, 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 

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