Health Products 

Compliance Guidance
Health Products Compliance Guidance • 1 

Health Products

Compliance Guidance

I. Preface

Federal Trade Commission (FTC) staff has prepared this guidance document to update and 

replace Dietary Supplements: An Advertising Guide for Industry, issued in 1998. Like the 1998 

guide, this document provides guidance from FTC staff on how to ensure that claims about the 

benefits and safety of health-related products are truthful, not misleading, and supported by 

science. Since 1998, the FTC has settled or adjudicated more than 200 cases involving false or 

misleading advertising claims about the benefits or safety of dietary supplements or other healthrelated products, including foods, over-the-counter (OTC) drugs, homeopathic products, health 

equipment, diagnostic tests, and health-related apps. This update draws on the issues raised 

in those cases to illustrate how the FTC identifies the express and implied claims conveyed in 

advertising and how the agency evaluates the scientific support for those claims. While most 

of the examples involve dietary supplement advertising, the same legal principles apply to the 

marketing of any health-related product. 

This document is intended as business guidance only. It interprets and explains FTC advertising 

law pursuant to the FTC Act and as set out in case law, and Commission policy statements. 

The guide, however, doesn’t have the force or effect of law. The principles and examples are 

intended to help advertisers comply with the basic tenets of FTC law. They don’t provide a safe 

harbor from potential liability; whether a particular advertising claim is deceptive or otherwise 

violates the FTC Act will depend on the facts of the specific case.
Health Products Compliance Guidance • 2 

II. Overview of Regulatory Framework

A. FTC Authority over Advertising of Health-Related Products

The Federal Trade Commission’s broad mandate is to prevent “unfair or deceptive acts or 

practices.” That includes making sure the information marketers provide about the benefits 

and safety of dietary supplements and other health-related products is accurate so consumers 

can make informed decisions. Sections 5 and 12 of the FTC Act,1 along with the FTC’s policy 

statements on deception and advertising substantiation,

2 are the foundation of FTC truth-inadvertising law, and can be distilled down to two common-sense principles:

1. Advertising must be truthful and not misleading; and

2. Before disseminating an ad, advertisers must have adequate substantiation for all 

objective product claims conveyed, expressly or by implication, to consumers acting 

reasonably.

A deceptive ad is one that contains a material misrepresentation or omission that is likely to 

mislead consumers acting reasonably under the circumstances. The type of substantiation 

needed for a claim depends on many factors, including the product being marketed and the 

nature of the claim. As a general rule, however, claims about the health benefits or safety of 

foods, dietary supplements, drugs, and other health-related products require substantiation in the 

form of competent and reliable scientific evidence.3 

“Advertising” refers to a wide variety of marketing techniques. The term “advertising” as used 

throughout this guide refers not only to traditional TV, radio, print, and internet ads, but also more 

broadly to the variety of marketing techniques and promotion methods that marketers engage in 

to increase consumer interest in, or demand for, their products. Thus, as used here, advertising 

includes statements or depictions on packaging and labeling; in promotional materials such 

as brochures or booklets; on the internet and in other digital content; in social media and 

influencer marketing; in press releases, press interviews, or other media appearances; at trade 

shows, conferences, and seminars; and indirectly through healthcare practitioners or other 

intermediaries.4 Promotional product information distributed through any of these means must 

comply with the same truth-in-advertising principles that apply to traditional ads.5

Anyone participating in deceptive marketing is potentially liable under FTC law. Marketers of 

dietary supplements and other health-related products should ensure that anyone participating 

in marketing is familiar with basic FTC advertising principles. All parties who participate directly 

in marketing and promotion, or who have authority to control those practices, have an obligation 

to make sure that claims are presented truthfully and to check the adequacy of the support 

for those claims. The FTC has taken action not just against product marketers, but also, in 
Health Products Compliance Guidance • 3 

appropriate circumstances, against individual owners and corporate officers of the marketer, 

as well as ad agencies, distributors, retailers, catalog companies, infomercial producers, expert 

endorsers, and others engaged in deceptive marketing and promotion.6

The FTC can seek a variety of remedies for deceptive advertising. The consequences 

of deceiving consumers about the safety, efficacy, or other benefits of a product can be 

substantial. The FTC can obtain an order that stops the deceptive claims and requires that 

future marketing be truthful and substantiated. In appropriate circumstances, the FTC also 

can mandate certain disclosures or require that a marketer engage in corrective advertising to 

cure any lingering deception in the marketplace.7 In particularly egregious instances, the FTC 

has asked a court to ban a company or individual from engaging in certain marketing activities 

altogether.8 The FTC also can seek financial remedies, including, in some instances, consumer 

refunds or civil penalties. 

B. Coordination with FDA

The FTC and the Food and Drug Administration (FDA) share jurisdiction over the marketing 

of dietary supplements, foods, drugs, devices, and other health-related products. The 

agencies coordinate their enforcement and regulatory efforts pursuant to a Memorandum 

of Understanding – often called the “FDA-FTC Liaison Agreement” – that governs the basic 

division of responsibilities between them.9 The FDA has primary responsibility for claims that 

appear in labeling, including the package, product inserts, and other promotional materials 

available at point of sale. The FTC has primary responsibility for claims in all forms of 

advertising.

10 Because of this shared jurisdiction, the two agencies work closely to ensure that 

their enforcement efforts are consistent to the fullest extent feasible. Marketers should be 

aware that the FDA/FTC Liaison Agreement doesn’t limit the FTC’s jurisdiction or prohibit the 

agency from taking action against deceptive labeling claims or obtaining orders that address all 

forms of marketing, including claims that appear in labeling. 

C. Key Differences Between FTC and FDA Law

While both the FTC and the FDA require marketing of dietary supplements and other healthrelated products to be truthful and accurate, there are some key differences in the agencies’ 

legal frameworks and approaches that marketers should keep in mind.

FTC advertising law applies to all products and claims. Unlike FDA law, FTC law makes no 

bright-line distinctions between categories of health-related products or claims. For example, 

provisions in the Dietary Supplement Health and Education Act of 1994 (DSHEA) regarding 

“structure/function” claims11 in labeling don’t govern the FTC’s assessment of those claims in 

advertising.12 The FTC follows the same basic steps when evaluating any health-related claim 
Health Products Compliance Guidance • 4 

regardless of whether, under FDA law, the claim would be considered a health claim, a structure/

function claim, or a drug claim. Similarly, the FTC’s approach to advertising of health-related 

products is the same regardless of whether, under FDA law, the product is considered a food, a 

supplement, or a drug.13

The FTC doesn’t pre-approve “health” claims, as that term is defined by FDA labeling laws. 

The FTC Act doesn’t require pre-market approval of health claims in the advertising of foods, 

dietary supplements, or other products. Marketers should be aware, however, that the FTC 

gives great deference to a determination by the FDA of whether there is adequate support 

for a particular health claim in labeling. Health claims that meet the FDA “significant scientific 

agreement” standard will be presumed to be substantiated under FTC law.14 Health claims that 

do not meet the FDA’s “significant scientific agreement” standard may be deceptive unless the 

limitations or uncertainty in the supporting science are clearly communicated with qualifying 

language that is noticed and understood by consumers.15 Sections III.A.3 and III.B.5 below 

provide more detailed guidance on the clear and conspicuous disclosure of such limitations for 

claims based on emerging science. 

The FTC doesn’t require notification for “structure/function” claims. Under FDA labeling law, 

dietary supplement marketers must notify the FDA of structure/function claims and other statements 

of nutritional support that appear in labeling, but don’t need to seek FDA pre-approval. The 

FTC doesn’t have a parallel notification requirement for such claims in advertising. Despite this 

difference, both the FDA and the FTC require that marketers have prior substantiation that the 

claims are truthful and not misleading. Both agencies apply the same basic principles in assessing 

the quality and adequacy of the science substantiating those claims.16

III. Application of FTC Law to Advertising of Dietary 

Supplements and Other Health-Related Products

To determine whether advertising complies with FTC law, it is first necessary to identify all 

claims the advertising materials communicate to reasonable consumers. Once the claims are 

identified, the FTC assesses the scientific evidence upon which the company relies to determine 

whether there is adequate support for those claims. The following sections describe this twostep process with examples illustrating how the principles of ad interpretation and substantiation 

apply in the context of advertising for dietary supplements and other health-related products. 

The examples have been simplified to illustrate one or two specific points. Therefore, advertisers 

should use these examples as general guidance only.
Health Products Compliance Guidance • 5 

A. Identifying Claims and Interpreting Ad Meaning

1. IDENTIFYING EXPRESS AND IMPLIED CLAIMS

The first step in evaluating the truthfulness and accuracy of advertising and marketing materials 

is to identify all express and implied claims conveyed to consumers acting reasonably. Marketers 

must make sure that whatever they say expressly in advertising is accurate. Often, however, 

advertising conveys other claims beyond those expressly stated. Under FTC law, a marketer is 

equally responsible for the accuracy of claims suggested or reasonably implied in advertising.17 

Marketers can’t suggest benefits, safety, or other characteristics about their product indirectly 

that they couldn’t claim directly.

FTC law focuses not on the marketer’s intent, but on the consumer’s understanding. The 

determination of what claims are made in marketing is consumer-driven – in other words, what 

reasonable consumers understand the advertising or marketing materials to communicate about 

the product. When identifying the claims conveyed by an ad, marketers shouldn’t focus narrowly 

on individual phrases or statements, but rather should consider each ad as a whole, assessing 

the “net impression” conveyed by all elements of the ad, including the text, product name, and 

any charts, graphs, and other images.18 When an ad lends itself to more than one reasonable 

interpretation, the advertiser is responsible for substantiating each interpretation.

Furthermore, the FTC views advertising claims from the standpoint of the intended audience.19 

For example, terminally ill consumers might be particularly susceptible to exaggerated cure 

claims. Extrinsic evidence such as consumer surveys and copy tests can be valuable in 

determining how consumers interpret certain implied claims. In many cases, however, the claims 

conveyed are clear enough on the face of an ad, without the need for extrinsic evidence.20

Example 1:

A brochure for a weight-loss product shows images of doctors in white lab coats 

looking through microscopes, molecular structures, and a stack of medical journals. 

These images give an impression of scientific legitimacy and likely convey an implied 

claim that the product has been clinically proven to be effective for weight loss. 

Example 2:

A magazine ad for a children’s nutritional drink features an image of the straw from the 

drink box encircling a child to create a barrier as another child sneezes in her direction. 

The image used in the ad likely implies that the product can help protect children from 

catching colds or other airborne infections.
Health Products Compliance Guidance • 6 

Example 3:

An ad for a vitamin supplement claims that 90% of cardiologists regularly take the 

product. In addition to the express claim about the percentage of cardiologists who 

use the product, the ad likely conveys an implied claim that the product offers some 

benefit for the heart.

Example 4:

An ad for an infant formula states that an ingredient added to the formula can reduce 

the symptoms of colic. The ad includes an unrelated chart from a pediatric journal 

showing that, as a general principle, the length of time that colicky babies cry tends to 

decrease over the first 12 weeks of life. The graph has nothing to do with the effect of 

the infant formula on crying; it merely shows that crying decreases as a function of age. 

Using the graph in an ad for the infant formula likely implies that the formula, rather 

than the babies’ ages, causes the decrease in crying time.

Depending on how it is phrased or the context in which it is presented, a statement about a 

product’s effect on the normal “structure 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 an 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 a disease. 

Example 5:

An ad for an herbal supplement claims 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. Even without the product name 

and images, the reference to nose and throat health during the winter season likely 

conveys a cold prevention claim.

Example 6:

An ad for a topical ointment called “Arthricure” claims that the product “maintains 

joint health and mobility” into old age. A “before” picture shows an elderly woman 

using a walker. An “after” picture shows her dancing with her husband. Even without 

the product name, which implies the product can cure arthritis, the before-and-after 
Health Products Compliance Guidance • 7 

images, along with the references to joint health and mobility, likely convey a claim that 

the product can dramatically improve the symptoms of arthritis. 

2.WHEN TO DISCLOSE QUALIFYING INFORMATION

An ad also can be deceptive because of what it fails to say. Under Section 15 of the FTC Act, an 

ad is misleading if it fails to disclose information that is material in light of the claims in the ad or 

with respect to how consumers would customarily use the product.21 Thus, if the ad would be 

misleading without certain key qualifying information, that information must be disclosed. For 

example, advertisers should disclose any significant limitations on an advertised health benefit. 

Similarly, advertising that makes either an express or implied safety representation should include 

information about any significant safety risks. Even absent affirmative safety representations, 

advertisers may need to inform consumers of significant safety concerns related to the customary 

use of a product.22

Example 7:

An ad for a multi-vitamin and mineral supplement claims that the product can eliminate 

a specific mineral deficiency that results in feelings of fatigue. In fact, less than 2% 

of the general population to which the ad is targeted suffer from this deficiency. The 

advertiser should limit the claim so that consumers understand that only the small 

percentage of people who suffer from the actual mineral deficiency are likely to 

experience any reduction in fatigue from using the product.

Example 8:

The marketer of a weight-loss supplement cites a placebo-controlled, double-blind 

clinical study in an ad as demonstrating that the product resulted in an average weight 

loss of 12 pounds over an eight-week period. The weight loss for the treatment 

group was, in fact, significantly greater than for the control subjects. However, both 

the control and test subjects engaged in regular exercise and followed a restrictedcalorie diet as part of the study regimen. The ad should make clear that users of the 

supplement also will need to reduce calories and engage in regular exercise to achieve 

similar results. 

Example 9:

An ad for an herbal product claims it is a natural pain remedy “without the side effects 

of over-the-counter pain relievers.” However, there is substantial evidence that the 
Health Products Compliance Guidance • 8 

product can cause nausea in some consumers when taken regularly. Because of the 

reference to the side effects of other pain relievers, consumers would likely understand 

this ad to mean that the herbal product poses no risk of significant side effects. The 

advertiser should disclose information about the side effects of the herbal product.

Example 10:

An energy drink contains an ingredient that, when consumed daily over an extended 

period, can result in a significant increase in blood pressure. Even absent any 

representation about the product’s safety, the marketer should disclose this potentially 

serious risk. 

Example 11:

A botanical supplement is marketed as an all-natural sleep aid for “when life’s stresses 

get you down or you are just too anxious to fall asleep.” Although the botanical 

supplement doesn’t present any safety risk when used alone, the active compounds 

in the product use the same metabolic pathway as common prescription medications 

for anxiety and depression, interfering with the efficacy of those medications. This 

potential interaction should be disclosed.

3.CLEAR AND CONSPICUOUS DISCLOSURE

When the disclosure of qualifying information is necessary to prevent an ad from being 

deceptive, advertisers should present the information clearly and conspicuously, so it is difficult 

to miss (i.e., easily noticeable) and easily understandable by ordinary consumers. If the claim 

requiring a disclosure is made both visually and audibly, the disclosure should be made both 

visually and audibly; if the claim is made just visually or just audibly, the disclosure should at 

least appear the same way the claim is made, but a simultaneous visual and audible disclosure 

is more likely to be clear and conspicuous. A visual disclosure should stand out and, based on 

its size, contrast, location, the length of time it appears, and other characteristics, it should be 

easily noticed, read, and understood. An audible disclosure should be delivered in a volume, 

speed, and cadence so that it can be easily heard and understood. In social media, the internet, 

and other interactive media, the disclosure should be unavoidable; disclosures made through 
Health Products Compliance Guidance • 9 

hyperlinks are avoidable. A disclosure should not be contradicted or mitigated by, or inconsistent 

with, anything else in the ad. When an endorsement targets a specific audience, such as older 

adults or children, the effectiveness of the disclosure will be judged from the perspective of 

members of that group.

The ultimate test of whether a disclosure is effective is the net impression that consumers 

take from an ad with the disclosure. If a significant minority of consumers take a 

misleading claim from an ad despite a disclosure, the disclosure isn’t sufficient.23 If it isn’t 

possible to make an effective disclosure, the claim should be modified so that a disclosure 

isn’t necessary – or the claim shouldn’t be made.

Example 12:

A magazine ad for nasal strips claims that nightly application will reduce the sound 

of snoring. The advertiser has competent and reliable scientific evidence that the 

strips substantially reduce the sound of snoring but not that they treat sleep apnea, a 

potentially life-threatening condition for which snoring is a primary symptom. The ad 

would be deceptive if it fails to adequately disclose that the nasal strips aren’t intended 

to treat sleep apnea. A fine print disclosure of this fact at the bottom of the ad wouldn’t 

be clear and conspicuous. A disclosure immediately next to the snoring claim in the 

same font size as the claim and in black print on a white background is much more 

likely to be effective at eliminating the deception.

Qualifying information – information that explains or limits the applicability of an ad claim – 

should be sufficiently simple and clear that consumers not only notice it, but also understand its 

significance. This can be a particular challenge when explaining complicated scientific concepts 

to a general audience. For example, it is very difficult to adequately qualify a claim based on 

limited and still-emerging science to make clear to consumers the uncertain and limited nature 

of the support for the claim.24 An advertiser should make sure consumers understand both the 

extent of scientific support and the existence of any significant contrary evidence. 

Vague qualifying terms are inadequate. For example, it’s not enough to say that the product 

“may” have the claimed benefit or “helps” achieve the claimed benefit. Similarly, consumers 

are likely to interpret modifiers such as “promising,” “preliminary,” “initial,” or “pilot” as positive 

product attributes, rather than as substantial disclaimers about the state of the science behind a 

claim, particularly when the study is positively touted in the ad.25 Thus, consumers may interpret 

an ad to mean that a product will prevent or reduce the risk of a disease, even if the ad includes 

language indicating that the science supporting the effect is limited in some way.
Health Products Compliance Guidance • 10 

Example 13:

A company has results from two studies suggesting that its supplement helps to 

maintain healthy cholesterol levels. There are, however, significant limitations to each 

of the studies and a better study is necessary to confirm whether the effect is genuine. 

The company makes a claim in advertising that “promising, preliminary scientific 

studies show that our product may be effective in reducing cholesterol.” The use of 

the words “promising,” “preliminary,” and “may” is unlikely to sufficiently convey the 

limitations of the science. 

Although a clear and conspicuous disclosure might be effective to clarify an ambiguous claim that 

might otherwise be deceptive, it can’t directly contradict a claim.26

Example 14:

A smartphone app is marketed for treating acne. Its app store description says, “Better 

Skin? Get Smart. A renowned dermatologist harnessed the power of in-office acne 

treatments in a more familiar form: the Smartphone. If you have acne, these flashing 

lights will be your salvation. Rest your Smartphone against your skin’s acne-prone 

areas for 2 minutes daily to improve skin health without prescription drugs.” Just 

below the claim, in the same print size, color, and style, is the statement, “This app is 

for entertainment purposes only and is not intended for the treatment of any disease or 

medical condition.” Given the express claim that the app improves acne, the disclaimer 

that it doesn’t treat medical conditions is directly contradictory and ineffective to 

negate the acne treatment claim.

Example 15:

The marketer of an unproven weight-loss supplement, through the use of medical 

images (e.g., people dressed in lab coats, use of the Caduceus symbol) and medical 

terminology (e.g., “medical innovation” and “research center”) on its website, conveys 

a false claim that the product’s efficacy is backed by scientific proof. A fine print 

disclosure in the “Terms and Conditions” section of the website states that “no clinical 

study has been performed on the product.” The statement is inadequate to correct the 

false scientific proof claim both because it directly contradicts the claim and because it 

is not clear and conspicuous.
Health Products Compliance Guidance • 11 

B. Substantiating Claims

In addition to conveying product claims clearly and accurately, marketers need to ensure that 

there is adequate support for their claims. Under FTC law, advertisers must have a reasonable 

basis for their product claims before disseminating an ad. What constitutes a reasonable basis 

depends greatly on what claims are made, how they are presented in the context of the entire 

ad, and how they are qualified. The FTC’s substantiation standard is a rigorous one, particularly 

when claims relate to health. It is designed to ensure that consumers can have confidence in the 

accuracy of information presented in advertising. A number of factors determine the appropriate 

amount and type of substantiation required, including:27

The type of product. Generally, products related to consumer health or safety require a relatively 

high level of scientific substantiation.

The type of claim. Claims that are difficult for consumers to assess on their own– for example, 

a health benefit claim that may be subject to a placebo effect, that relates to a naturally varying 

condition, or that can’t be verified by the consumer without medical testing – are held to a more 

exacting standard.

The benefits of a truthful claim, and the cost or feasibility of developing substantiation for the 

claim. These factors are often weighed together to ensure that valuable product information 

isn’t withheld from consumers because the cost of developing substantiation is prohibitive. This 

doesn’t mean, however, that an advertiser can make any claim it wants without substantiation 

simply because the cost of research is too high. 

The consequences of a false claim. This includes both physical and economic injury. For 

example, an unsubstantiated claim about the therapeutic benefit of a product could lead a 

consumer to forgo a more effective treatment or lifestyle change, to her physical detriment. A 

consumer may suffer economic injury by purchasing an ineffective product or paying a premium 

for a product that provides no benefit over less expensive alternatives. 

The amount of substantiation that experts in the field believe is reasonable. In making this 

determination, the FTC gives great weight to accepted norms in the relevant fields of research 

and consults with experts in those fields. For a health-related claim, the FTC will rely primarily 

on experts in the particular field of health at issue and may, in addition, consult experts on a 

particular ingredient or type of product. Thus, for example, research supporting a claim about 

heart benefits would need to meet accepted norms of research in the field of cardiology. Where 

there is an existing standard for substantiation developed by a government agency such as 

the FDA or the National Institutes of Health, or another authoritative body such as the National 

Academy of Sciences, the FTC gives great deference to that standard. 
Health Products Compliance Guidance • 12 

When applied to claims about the efficacy or safety of health-related products, the factors 

described above make up the FTC’s rigorous substantiation standard of “competent and reliable 

scientific evidence.”28 The FTC has more specifically defined that standard as “tests, analyses, 

research, or studies that (1) have been conducted and evaluated in an objective manner by 

experts in the relevant disease, condition, or function to which the representation relates; and 

(2) are generally accepted in the profession to yield accurate and reliable results.”29 In addition, 

the FTC requires that the research must be “sufficient in quality and quantity based on standards 

generally accepted in the relevant scientific fields, when considered in light of the entire body of 

relevant and reliable scientific evidence, to substantiate that the representation is true.”30

The sections that follow describe various considerations that govern whether the scientific 

support for a specific health-related claim satisfies the competent and reliable scientific evidence 

standard. As a general matter, substantiation of health-related benefits will need to be in 

the form of randomized, controlled human clinical testing to meet the competent and reliable 

scientific standard.31 In evaluating the reliability of such testing, the FTC will consider several 

parameters, such as sample size, duration, and outcome measures, that will vary depending 

on the exact nature of the hypothesis being tested and accepted norms in the relevant field. 

Assessing whether a study is well-designed and well-conducted, and whether the data has 

been properly analyzed and interpreted, are tasks that should be undertaken by someone 

with appropriate expertise. Marketers of health products are encouraged to consult with an 

independent expert in the relevant field of research. Independent experts can provide unbiased 

assessments of the validity of studies, how they fit within the relevant scientific literature, and 

what conclusions can be legitimately drawn from the results. 

1. ADS THAT REFER TO A SPECIFIC LEVEL OF SUPPORT

As a starting point, marketers of health-related products must have at least the level of support 

that they claim to have. In other words, in addition to meeting the basic requirement that any 

objective claim about safety or efficacy must be substantiated, the marketer also must ensure 

that any assertion about the amount, type, or strength of evidence is accurate.32

Example 16:

An ad for a supplement includes the statement “Scientists Now Agree!” in discussing 

the product’s benefit. This statement likely conveys to consumers that the state of 

science supporting the benefit has reached the level of scientific consensus. Unless 

the advertiser possesses evidence demonstrating that scientists have reached that 

consensus, the claim is false. 
Health Products Compliance Guidance • 13 

Example 17:

An advertiser claims that its product is based on “Nobel Prize-Winning” research and 

has been “proven effective” by “$5 Million in NIH Research.” The Nobel Prize referred 

to in the ad, however, was for an unrelated use of the product’s active ingredient 

and has nothing to do with the claimed health benefits. In addition, the NIH research 

examined the safety, but not the efficacy, of the active ingredient. The specific claims 

about the level of support are deceptive even if the advertiser possesses other 

research that provides competent and reliable scientific evidence of efficacy.

Example 18:

The website for a sports drink touts a “clinically tested ingredient” for improving blood 

flow and increasing endurance. In this context, the phrase “clinically tested ingredient” 

implies not just that the ingredient was tested, but also that the test results prove a 

benefit for blood flow and endurance. The phrase also conveys a claim that the sports 

drink will provide those benefits. Because the drink also contains other ingredients, 

the marketer should consult with a qualified expert in the relevant field to determine 

whether experts in that field would generally require a clinical test of the sports drink 

itself, rather than the isolated ingredient, to confirm the blood flow and endurance 

benefits. 

2. THE AMOUNT AND TYPE OF EVIDENCE

Even when an advertiser doesn’t make a specific claim about the level of support, claims about 

the health benefits of a product must still meet the basic substantiation standard of “competent 

and reliable scientific evidence.” Randomized, controlled human clinical trials (RCTs) are 

the most reliable form of evidence and are generally the type of substantiation that experts 

would require for health benefit claims.33 Although there is no requirement for a specific 

number of RCTs, the replication of research in an independently-conducted study adds to the 

weight of the evidence. Replication in a second study by independent researchers reduces 

the chance that the results of a single RCT may be influenced by unanticipated, undetected, 

systematic biases that may occur despite the best intentions of sponsors and investigators. 

An additional, independently conducted study to corroborate findings provides much greater 

confidence in the validity of the initial results. As discussed in the next section, however, the 

quality of the research is more important than the quantity. For that reason, numerous flawed 

and inadequate studies are unlikely to add up to competent and reliable scientific evidence 

sufficient to substantiate a claim.34
Health Products Compliance Guidance • 14 

Epidemiological or observational studies can be valuable to show an association between a 

product or ingredient, but they don’t prove a causal link.35 Methodologically sound human 

clinical testing is necessary to prove causation, although there may be limited situations where 

such testing may not be feasible. In the field of nutrition, for example, it may take decades 

to determine whether there is a relationship between eating a particular food or nutrient and 

the risk of developing a disease. The FTC will accept high-quality epidemiologic evidence to 

substantiate a claim in those limited cases where: 1) it is considered an acceptable substitute for 

RCTs by experts in the field; and 2) RCTs aren’t otherwise feasible. 

Animal and in vitro studies may provide useful supporting or background information, but, 

without confirmation by human RCTs, they aren’t sufficient to substantiate health-related claims.36 

Animal studies have only limited value in predicting the effect of a product in humans, making it 

difficult to extrapolate results in animal research to benefits for humans. In vitro studies look at a 

product’s effect on isolated cells or tissues and may help identify a possible mechanism of action, 

but similarly are of limited value to predict benefits for humans. 

Anecdotal evidence about the individual experiences of consumers, including surveys of 

consumer experiences, are never sufficient to substantiate claims about the effects of a health 

product.37 Even if consumer experiences are genuine, they may be attributable to a placebo 

effect or other factors unrelated to the product. For the same reason, a healthcare practitioner’s 

observation about the effect of a health product on patients is anecdotal and doesn’t provide 

evidence of a causal relationship. Individual experiences aren’t a substitute for scientific 

research.

Finally, advertisers shouldn’t rely on public health recommendations, such as advisories from a 

medical organization, as substantiation. Public health recommendations and advisories reflect a 

judgment based on the best currently available evidence. They aren’t equivalent to a finding that 

there is a causal link between the recommended course of action and the health benefit.38 For that 

reason, public health recommendations alone aren’t sufficient to support a claim. Marketers should 

instead evaluate the strength of the scientific evidence underlying those recommendations and the 

relevance of that evidence to the marketed product and advertised claims.

Example 19:

An advertiser relies on animal and in vitro studies to support a claim that its vitamin 

supplement is more easily absorbed into the bloodstream than other forms of the 

vitamin. However, the animal research uses a species of animal that, unlike humans, 

is able to synthesize the vitamin, and the in vitro study uses a different formulation 

with a higher concentration of the compound than the product being marketed. In 

addition, in this instance, human research is feasible and is the type of research 

generally considered necessary by experts to demonstrate vitamin absorption. The 
Health Products Compliance Guidance • 15 

substantiation is inadequate because there are significant methodological problems 

and because human research is both feasible and the accepted approach in the field.

Example 20:

A company advertises its supplement as helpful in maintaining good vision into old age. 

There have been two large-scale epidemiologic studies showing a strong association 

between long-term consumption of the ingredient in the supplement and better vision 

in people over 70. Experts also have identified a plausible biological mechanism that 

likely explains the effect. A clinical intervention trial would be very difficult and costly 

to conduct and would take a minimum of 10 years. Assuming that experts in the field 

generally consider epidemiological evidence to be adequate to support the potential 

for a protective effect, and assuming the absence of contrary evidence, the claim would 

be substantiated. Because the evidence is based on long-term consumption, the claim 

shouldn’t suggest to consumers that they can expect immediate vision benefits. 

Example 21:

An ad for a supplement claims that the product will cause dramatic improvements in 

memory and describes the results of a customer satisfaction survey reporting that 

more than 75% of customers noticed memory improvement. The survey results are 

accurately described, but because the survey provides nothing more than a collection 

of anecdotal experiences, it isn’t adequate to substantiate that the supplement has any 

benefit for memory. 

Example 22:

The marketer of an online brain training program runs a radio promotion touting the 

recommendation by a well-recognized medical institution that individuals should 

engage in regular mental stimulation to improve memory and help stave off dementia. 

The recommendation is accurately reported, but it doesn’t provide substantiation for 

any express or implied claim that the marketer’s brain training program will provide 

memory benefits. The marketer must substantiate such a claim with methodologically 

sound human clinical research on its program documenting improvements in memory 

using appropriate outcome measures. 
Health Products Compliance Guidance • 16 

3. THE QUALITY OF THE EVIDENCE

In addition to the amount and type of evidence, the FTC also will examine the internal validity of 

each piece of evidence. Research should be conducted in a competent and reliable manner to 

yield meaningful results. The design, implementation, and results of each piece of research are 

important to assessing the adequacy of a marketer’s substantiation. Because, as a general 

matter, health benefit claims will require evidence in the form of human clinical testing to 

substantiate that the product provides the claimed benefit, this section focuses on assessing the 

quality of such evidence. 

The scientific community has generally accepted several basic principles as enhancing the 

validity of test results. Whether designing and conducting their own research or relying on 

research conducted by third parties, marketers should ensure that the research upon which they 

rely for any health-related claim complies with these basic principles.39 

Control Group: Human clinical studies should have both a treatment group and a control group. 

The efficacy of a product should be demonstrated by comparing the results of the treatment 

group to the results of the control group. Improvements over time in the treatment group alone 

could result from a placebo effect, spontaneous changes in subjects’ health, improvements in 

performance on a test measure purely as the result of practice or repetition (the “practice effect”), 

or other variables unrelated to the product’s benefits. An appropriately designed control (ideally 

a control using a placebo or sham treatment) helps to isolate the effects of these other variables 

from the effect of the treatment. When studies employ a cross-over design, in which subjects 

serve as their own control, they should use a sufficient wash-out period (the period during which 

subjects don’t receive the treatment) to ensure clarity as to what is causing the observed results. 

A cross-over design may not be appropriate to test some hypotheses.

Randomization: The study should use appropriate randomization or, in the alternative, careful 

matching criteria, to prevent selection bias and to assure that demographic characteristics 

and other variables are similar in the control group and the treatment group. Substantial 

differences between the control and treatment groups in age, gender, diet, health status, or other 

characteristics can undermine the validity of any findings.

Double Blinding: Both the participants in a study and the researchers should be blinded as to 

who is in the treatment group and who is in the control group. This greatly reduces the likelihood 

that either the subjects or the researchers might consciously or unconsciously take actions 
Health Products Compliance Guidance • 17 

potentially biasing the results. In the rare circumstances where a double-blind design isn’t 

feasible, the study should be blinded to the fullest extent possible and researchers should take 

steps to minimize any potential for bias.

Statistically Significant Results: To support a health-related claim, human clinical research must 

yield results that are statistically significant. A study that fails to show a statistically significant 

difference between the treatment and control groups may indicate that the measured effect is 

merely the result of placebo effect, unrelated improvement over time, or chance. Studies that 

use multiple outcome measures should report all outcomes, rather than selectively reporting 

positive outcomes. Such studies also should include a statistical adjustment to account for the 

increased likelihood that, when multiple outcomes are measured, a positive result on any one of 

the measures may be due to chance. 

In addition, a post hoc analysis of data – one that departs from the original study protocol – can 

be an indication that the researchers are engaging in data mining or “p-hacking” in an attempt 

to find some positive result to report from a study that otherwise failed to show any treatment 

effect. The more post hoc comparisons examined, the more likely the data will yield a significant 

difference that is merely the result of chance. For that reason, post hoc analysis that departs 

from the originally stated study protocol (e.g., an analysis that looks at various smaller subgroups 

of the study population) may identify areas for future exploration, but doesn’t generally provide 

reliable evidence to substantiate a claim.40

Clinically Meaningful Results: Any statistically significant results must translate to a benefit that 

is clinically meaningful for consumers. Some results that are statistically significant may be too 

small to provide real consequences for consumer health.41

Studies that fail to satisfy these basic principles are more prone to bias and other confounding 

factors, unlikely to yield reliable results, and generally won’t meet the FTC’s competent and 

reliable scientific evidence standard for substantiating health-related claims. 

In addition to these basic principles, the FTC evaluates other factors in assessing the quality of a 

study and whether the study meets accepted standards in the relevant field of research to yield 

accurate and reliable results. 

⊲ Research should begin with a clear and detailed protocol. Both the research question and 

the methodology for addressing it should be described at the outset. Primary and secondary 

outcome measures should be well-defined and specified in advance. Measures that have 

been independently validated are more reliable. 

⊲ Submission of the research protocol to an Institutional Review Board (IRB) for review and 

registration is generally accepted as a necessary step to ensure that the research is ethical 

and the safety of the subjects is protected.
Health Products Compliance Guidance • 18 

⊲ Registration of the clinical trial in a public database is a generally accepted practice in human 

research and helps to ensure that the study is conducted and analyzed in conformance with 

the protocol and that all data is fully reported. This improves transparency, enhances the 

validity of the evidence, and reduces the chance of “publication bias,” such as failing to fully 

report negative results or partially reporting only a favorable subset of results.

⊲ Inclusion and exclusion criteria for subjects should be clearly stated in the protocol and 

relevant to the population to which the product is marketed. 

⊲ Subject dropout rates, non-compliance, or concurrent changes in diet or other health-related 

behaviors should be carefully assessed to ensure they don’t undermine any findings. For 

example, researchers should conduct an “intent-to-treat” analysis that includes data from 

every subject initially assigned to the treatment and control groups, including subjects who 

dropped out during the course of the study or did not fully comply with the study protocol.

⊲ A study should be of sufficient duration, including any appropriate follow-up period, to 

demonstrate any express or implied claim that the treatment effect will persist.

⊲ In cases where product safety may be a concern, the study should be of sufficient size and 

duration to detect potential side effects.

⊲ Other aspects of the research results, such as evidence of a dose-response relationship (i.e., 

the larger the dose, the greater the effect) or a recognized biological or chemical mechanism 

to explain the effect, add weight to research findings. 

⊲ The nature and quality of the written report of the research is important. The FTC cannot 

evaluate the quality of a study from an abstract or an informal summary. A study’s write-up 

should contain sufficient detail to assess what actually took place. The FTC will evaluate 

research based in part on how closely it adheres to the protocol and how well the report 

explains any deviations. 

⊲ A rigorous, unbiased peer review process, like that required by established and reputable 

scientific journals, provides some level of assurance that the research meets accepted norms 

in the relevant field. Research that hasn’t been through a rigorous peer review process 

will be subject to greater scrutiny by the FTC. In those cases, the FTC will often require 

the marketer to provide underlying documents and raw data. The mere fact that a study 

is published, however, isn’t a guarantee of quality or proof that the product is effective for 

the advertised benefit. The rigor of peer review varies widely from journal to journal, with 

some journals accepting studies based on little more than payment of a publication fee. In 

addition, research may yield results that are of sufficient interest to the scientific community to 

warrant publication, but publication doesn’t necessarily mean that such research is conclusive 

evidence of a product’s effect.
Health Products Compliance Guidance • 19 

Example 23:

An advertiser conducts a literature search and finds several abstracts summarizing 

clinical studies about the association between a nutrient and the ability to perform 

better on memory tests. The advertiser relies on these summaries to support a claim 

that its supplement, which contains the same nutrient, aids memory. However, without 

looking carefully at the specifics of the study design, implementation, and results, there 

is no way for the advertiser to ascertain whether the research substantiates the product 

claims. (For example, did the research use a comparable formulation of the ingredient? 

Was the study adequately controlled? Did the study yield between-group results that 

are statistically significant?) Thus, the advertiser should carefully review the underlying 

science with the assistance of an expert before drafting advertising claims. 

Example 24:

An advertiser makes an unqualified claim about the anti-clotting effect of a supplement 

that contains a compound extracted from fruit. There are two human clinical studies 

supporting the effect and no contrary evidence. One study consists of subjects tested 

over a one-week period, with no control group. The second study is well-controlled 

and of longer duration, but shows only a slight effect that isn’t statistically significant. 

Because both studies have significant limitations, they don’t substantiate a claim about 

anti-clotting benefits. 

Example 25:

The marketer of an herbal supplement claims that its product promotes healthy vision 

and is approved in Germany for this purpose. The product has been used extensively 

in Europe for years and has obtained approval from the German regulators through 

their monograph process for use to improve vision in healthy people. The company 

has two abstracts of German trials that were the basis of the monograph, showing 

that the herbal supplement significantly improved the vision of healthy individuals in 

the treatment group over the placebo group. Approval of the supplement under the 

German monograph doesn’t constitute substantiation that the supplement is effective. 

The marketer should examine the underlying research to confirm that it is relevant to 

the advertiser’s product (for example, that the dosage and formulation are comparable) 

and to evaluate whether the studies are scientifically sound. The marketer also should 

examine any other research that supports or contradicts the monograph. 
Health Products Compliance Guidance • 20 

Example 26:

The marketer of a liquid protein and vitamin shake commissioned a study to evaluate 

whether the shake is effective in treating symptoms of osteoarthritis. The 200 subjects 

had all been diagnosed with mild to severe osteoarthritis. The study was randomized, 

placebo-controlled, double-blind, and used a validated measure of osteoarthritis 

symptoms, assessing subjects at regular intervals over a 90-day period. The study author 

reported that subjects using the shake showed a statistically significant improvement 

in symptoms from baseline to day 90. This result, however, doesn’t substantiate a 

marketing claim that the shake can treat symptoms of osteoarthritis because it doesn’t 

compare improvement in the treatment group to improvement in the control group. In 

fact, both groups saw some improvement on the measure over time and the treatment 

group improvement wasn’t statistically greater than that of the control group. The 

marketer then searches the data from the study for statistically significant outcomes, 

looking at comparisons that weren’t part of the original protocol. This post hoc analysis 

of the findings shows that, for a small subgroup of subjects diagnosed with the mildest 

osteoarthritis, there is a statistically greater improvement in symptoms in the treatment 

group compared to the control group. The post hoc analysis of the data doesn’t provide 

reliable evidence of a benefit for subjects with mild osteoarthritis. Further research on 

subjects with mild osteoarthritis should be conducted to verify a benefit in this population. 

Example 27:

The marketer of an at-home brain stimulation device conducts a randomized, 

controlled, double-blind study of the effects of its device on subjects with depression. 

The study uses eight validated measures to assess the impact of the device on 

symptoms of depression. Subjects show statistically greater improvement in the 

treatment group compared to the control group on one of the eight measures. The 

other seven measures reveal no difference between treatment and control group. 

The study doesn’t include any statistical correction for the use of multiple tests. The 

fact that only one outcome out of a total of eight showed statistical significance could 

be the result of chance. The higher the number of outcomes tested, the greater the 

chance of a false positive result. The marketer can’t rely on this one positive finding 

from the study to substantiate a claim about any benefit for depression. 

Example 28:

A dietary supplement is advertised to treat erectile dysfunction. The advertiser 

relies on a human clinical study that uses both a validated objective measure and an 

unvalidated subjective questionnaire. The study detects a small statistically significant 
Health Products Compliance Guidance • 21 

difference using the unvalidated questionnaire, but there is no statistically significant 

difference on the validated measure. The failure to detect a difference using the more 

reliable validated measure suggests that there wasn’t a significant effect from use of 

the product, and the claim isn’t substantiated. 

4. THE TOTALITY OF THE EVIDENCE 

Studies can’t be considered in isolation. The surrounding context of the scientific evidence is 

just as important as the internal validity of individual studies. Advertisers should consider all 

relevant well-conducted research relating to the claimed benefit and shouldn’t focus only on 

research that supports an effect, while discounting research that doesn’t. Studies relied on by an 

advertiser should be largely consistent with the surrounding body of evidence.42 Wide variations 

in outcomes of studies and inconsistent or conflicting results raise serious questions about the 

adequacy of an advertiser’s substantiation. Where there are inconsistencies in the evidence, it 

is important to examine whether there is a sound explanation for those inconsistencies. In some 

instances, for example, the differences in results are attributable to differences in dosage, the 

form of administration (e.g., oral or intravenous), the population tested, or other aspects of study 

methodology. Advertisers should assess how relevant each piece of research is to the specific 

claim they want to make, and also consider the relative strengths and weaknesses of studies. 

If a number of studies of different quality have been conducted on a specific topic, advertisers 

should look first to the results of the studies with more reliable methodologies.

The surrounding body of evidence will have a significant impact on the type, amount, and quality 

of evidence required to substantiate a claim, particularly when there is some relevant research 

that fails to support the claimed benefit. The totality of the evidence also will affect how a claim 

is presented – that is, how carefully the claim is qualified to reflect accurately the strength of the 

evidence. If a stronger body of surrounding evidence runs contrary to a claimed effect, even a 

qualified claim is likely to be deceptive.43

Example 29:

The marketer of a juice high in antioxidants claims that daily consumption of the juice 

treats erectile dysfunction. The marketer relies on a published 50-person controlled 

human clinical trial as support for its claim, while disregarding an earlier, higher quality 

unpublished 100-person study of the juice that failed to show any statistically significant 

improvement compared to the control group. The marketer commissioned both 

studies and changed the measured endpoint in the second study after reviewing the 

results of the first study. The marketer cannot selectively rely only on the favorable 

results of the second, lower quality study. The erectile dysfunction treatment claims 

are not substantiated.
Health Products Compliance Guidance • 22 

Example 30:

An advertiser wants to claim that a supplement will substantially reduce body fat. The 

advertiser has two controlled, double-blind studies showing a modest but statistically 

significant loss of fat at the end of a six-week period. However, there is an equally wellcontrolled, double-blind 12-week study showing no statistically significant difference 

between treatment and control groups. Assuming other aspects of methodology are 

similar, the studies taken together suggest that, if the product has any effect on body 

fat, it would be very small and may not persist over time. Given the totality of the 

evidence, the claim is unsubstantiated.

Example 31:

The marketer of a fruit drink claims that its product is “proven to promote 

cardiovascular health.” There is one small human clinical study finding a significant 

difference in arterial plaque build-up compared to a placebo drink. However, a 

subsequent larger study found no significant difference between the fruit drink and 

placebo on arterial plaque or other measures of cardiovascular health. A third large 

trial also found no difference in arterial plaque, although a post hoc analysis of the 

data found some benefit over placebo in a subgroup of patients with high HDL/low 

LDL cholesterol levels. Given the totality of the evidence, the claim is unsubstantiated. 

Continuing to tout the earlier small study with favorable results would be deceptive. 

Moreover, a narrow, qualified claim selectively touting the ostensibly favorable post hoc 

results of the third study, in light of the contradictory results from both that study and 

the second study, also would be deceptive.

Example 32:

An advertiser runs an ad in a magazine for retired people, claiming that its supplement 

product has been found effective in improving joint flexibility. The company sponsored 

a 12-week study, involving 100 subjects over the age of 65, to test the product’s 

effect on improving flexibility. The study was double-blind and placebo-controlled 

and has been accepted for publication in a leading medical journal. The study 

showed dramatic, statistically significant increases in joint flexibility compared to the 

placebo, based on objective measurements. In addition, European researchers have 

conducted several large independent trials using a similar formulation and dose of 

the active ingredient in the supplement. These trials also found statistically significant 

and clinically meaningful results. The advertiser retained an independent expert in 

joint flexibility who reviewed the underlying European research and confirmed that it 

meets accepted research standards. The expert also concluded that the totality of the 
Health Products Compliance Guidance • 23 

existing evidence was sufficient to substantiate the advertiser’s claim. The evidence as 

a whole likely substantiates the claim.

5.THE RELEVANCE OF THE EVIDENCE TO THE SPECIFIC PRODUCT AND CLAIM

A common problem in the substantiation of advertising claims is that an advertiser has valid 

studies, but the studies don’t support the claim made in its ad. Advertisers should make sure 

that the research on which they rely isn’t just internally valid, but also relevant to their specific 

product and to the specific advertised benefit. Therefore, advertisers should ask questions such 

as: How do the dosage and formulation of the advertised product compare to the product used 

in the study?44 Is the ingredient or combination of ingredients in the advertised product the same 

as what was used in the study?45 Is the advertised product administered in the same manner as 

the product in the study? How well do the outcomes tested in the study relate to the specific 

benefits advertised?46 Does the study population reflect the characteristics of the population 

targeted by the ad?47 If there are significant discrepancies between research conditions and the 

real-life use being promoted, advertisers must evaluate whether it is appropriate to extrapolate 

from the research to the claimed effect.

It’s also important that the claims accurately reflect what the research shows. Claims that don’t 

match the research results, no matter how sound that research is, are likely to be deceptive. 

Thus, advertisers should be careful not to exaggerate the extent, nature, or permanence of the 

effects achieved in a study.48 In addition, claims should be carefully worded to avoid overstating 

the certainty of science in areas where the science is still emerging. Although emerging science 

can sometimes be the basis for a carefully qualified claim, advertisers must make consumers 

aware of any significant limitations or inconsistencies in the scientific literature.49

Example 33:

An ad for a supplement claims that a particular nutrient helps maintain healthy 

cholesterol levels. There is a substantial body of epidemiologic evidence suggesting 

that foods high in that nutrient are associated with lower cholesterol levels. There 

are no studies, however, demonstrating a relationship between the specific nutrient 

and cholesterol, although it would be feasible to conduct such a study. The health 

effect may be attributable to other food components or to combinations of various 

components, so a claim about the cholesterol maintenance benefits of the supplement 

product isn’t substantiated by this evidence.
Health Products Compliance Guidance • 24 

Example 34:

A number of well-controlled clinical studies have been conducted to suggest that a 

tea improves mental alertness in subjects with significantly impaired blood circulation 

to the brain. A claim suggesting that the tea will improve mental alertness in healthy 

adults isn’t adequately substantiated by this evidence. Advertisers shouldn’t rely on 

research based on a specific test population for claims targeting the general population 

without first making sure it is scientifically sound to make such extrapolations.

Example 35:

An ad for brain training software shows a man trying to remember where he left his 

keys. The ad claims that the software has been “clinically proven to improve memory.” 

A clinical study employed three laboratory tasks to test working memory (the short-term 

mental manipulation of information, such as numbers). Although the study showed 

statistically significant improvements over the control group in these working memory 

tasks, these results don’t support a general memory improvement claim because there 

are other types of memory that weren’t tested. Furthermore, forgetting where one left 

one’s keys is an example of a different type of memory failure, unrelated to working 

memory, the type of memory tested.

Example 36:

An advertiser markets a drink that contains a certain strain of probiotic. Two 

independently conducted, well-controlled clinical studies on Japanese subjects, using 

a different strain of probiotic administered in time-released capsule form, show that 

the strain is an effective treatment for reducing the symptoms of Crohn’s disease. The 

marketer wants to rely upon the Japanese studies to claim that its drink will reduce the 

symptoms of Crohn’s disease. Before relying on the studies to substantiate claims for 

the drink, the advertiser should consider the relevance of the evidence to its product 

and to the population to which the product is marketed. The fact that the study used 

a different strain of probiotic, in a capsule form that may be more bioavailable than the 

drink, and administered to a population whose diet may be substantially different from 

the diet of U.S. consumers are significant differences that would affect whether the 

findings could reasonably be expected to translate to the advertised product. 
Health Products Compliance Guidance • 25 

Example 37:

An advertiser wants to claim that its energy drink helps increase alertness safely. The 

drink contains two active ingredients, each of which is known to have central nervous 

system stimulant effects. The advertiser compiles well-conducted clinical studies 

demonstrating that each of the ingredients, individually, is safe, effective, and causes no 

significant side effects in the recommended dose. Studies on the individual ingredients, 

however, may not be sufficient to substantiate a safety claim about the combination 

product because the two active ingredients together may affect the body differently than 

they do individually. The advertiser would need to have a study of the actual product if 

that is what experts in the field would generally require to substantiate the claim.

Example 38:

Several well-conducted clinical trials measuring accepted markers of immune system 

activity have been done on a specific botanical extract consistently showing that 

the extract is effective for supporting the immune system. The studied extract is a 

complex combination of several chemical constituents and the active constituents that 

may actually produce the benefit are still unknown. An advertiser wants to cite this 

research in its advertising as proof that its product will support the immune system. 

The advertiser’s product is made using a different extraction method from the same 

botanical. An analysis of the advertiser’s extract reveals that it has a significantly 

different chemical profile from the studied extract. The advertiser shouldn’t rely on 

these clinical trials alone as substantiation because the difference in extracts may result 

in significant differences in the effectiveness of the two products.

C. Other Advertising Issues

In addition to the principles of ad meaning and substantiation discussed above, a number of 

other issues commonly arise in the context of health-related advertising. These include: the 

use of consumer testimonials and expert endorsements; claims based on alternative medicine 

or traditional use; the effect of DSHEA disclaimers in advertising; claims about FDA approval or 

compliance; and the relevance to FTC advertising law of the FDA’s “third-party literature” exemption.
Health Products Compliance Guidance • 26 

1. CLAIMS BASED ON CONSUMER TESTIMONIALS OR EXPERT ENDORSEMENTS

Advertisers are liable for the misleading use of endorsements, whether in traditional advertising 

media like TV and print, on the internet, in social media, or in other forms of marketing.50 An 

overarching principle is that advertisers should not make claims through consumer testimonials 

or expert endorsements that would be deceptive or couldn’t be substantiated if the advertiser 

made them directly. It’s not enough that a testimonial represents the honest opinion or 

experience of an endorser. Under FTC law, advertisers also must have appropriate scientific 

evidence to back up the underlying implied claim that the product is effective and will work for 

buyers as it did for the endorser.51

Example 39:

A website advertising a smartphone app features testimonials from satisfied customers 

who say that, after using the app at bedtime for less than a week, their insomnia went 

away, and they slept soundly through the night. These testimonials don’t constitute 

substantiation. The advertiser must have competent and reliable scientific evidence 

that its product is effective in treating insomnia.

Example 40:

A marketer pays a blogger to use its supplement and write a review of the product 

on her blog. Although the marketer doesn’t make any specific claims about the 

supplement’s ability to cure acid reflux, the blogger writes that the supplement cures 

acid reflux and recommends the supplement to readers who suffer from this condition. 

The marketer doesn’t have any evidence that the product cures acid reflux. In this 

situation, the marketer is liable for the blogger’s misleading representation. Also, 

because the marketer is paying the blogger for the review, the blog post must include 

a clear and conspicuous disclosure of that fact so that consumers don’t mistakenly 

believe the post is unbiased.
Health Products Compliance Guidance • 27 

Testimonials that report results more dramatic than users can generally expect are likely to be 

deceptive. Moreover, attempts to disclaim dramatic results with statements like “Results not 

typical” don’t cure the deception. Those testimonials should be accompanied by a clear and 

conspicuous disclosure of the results a typical consumer can actually expect.52 

Example 41:

A magazine ad for a weight-loss supplement features before-and-after photographs 

of a woman and quotes her as saying that she lost 16 pounds in eight weeks while 

using the product. An asterisk next to the quote references a disclaimer in fine print 

at the bottom of the ad that reads, “These results are not typical. Your weight loss 

may not be the same.” The experience of the woman is accurately represented, but a 

well-conducted RCT demonstrating the efficacy of the supplement shows an average 

weight loss of only four pounds in eight weeks over placebo. The vague disclosure 

doesn’t adequately convey to consumers that their weight loss is likely to be much less. 

The placement and size of the disclaimer is also insufficiently prominent to qualify the 

claim effectively. The statement, “In an 8-week study, subjects taking the supplement 

lost an average of 5 pounds. Subjects taking a placebo lost an average of 1 pound,” 

immediately adjacent to the quote and in prominent font is likely to be effective.

When an advertiser uses an expert endorser, it should make sure that the endorser has 

appropriate qualifications to be represented as an expert and has conducted an examination or 

testing of the product generally recognized in the field as sufficient to support the endorsement. 

In addition, whenever an expert or consumer endorser is used, the advertiser should clearly 

and conspicuously disclose any material connection between the endorser and the advertiser 

of the product. A material connection is one that would affect the weight or credibility of the 

endorsement. Put another way, any personal, financial, or similar connection that consumers 

wouldn’t reasonably expect is a material connection.53

Example 42:

An infomercial for a dietary supplement features an expert referred to as a “Doctor” and a 

“leading clinician in joint health” discussing the effect of the product on the maintenance 

of healthy joints. The expert isn’t licensed to practice medicine, but has a doctoral degree 

in psychology and is a trained physical therapist who runs a sports clinic. The expert 

hasn’t conducted any review of the scientific literature on the active component of the 

supplement. In return for appearing in the infomercial, she is given a paid position as 

an officer of the company. The ad is likely to be deceptive for several reasons. First, 

her qualifications as an expert have been overstated and she hasn’t conducted an 

examination of the product sufficient to support the endorsement. In addition, her 
Health Products Compliance Guidance • 28 

connection to the company is one that consumers might not expect and that might affect 

the weight or credibility of her endorsement. Even if she were adequately qualified and 

even if she had conducted an adequate review of the product, her position as an officer 

of the company should be clearly and conspicuously disclosed.

Example 43:

A best-selling book about the benefits of a popular dietary supplement ingredient 

recommends a specific brand of the product as the highest quality, most effective 

brand on the market. The manufacturer of the brand cited in the book has an 

exclusive promotional agreement with the author and has paid her to reference 

the product by name. The manufacturer’s ad touts the fact that its product is the 

only brand recommended in the best-selling book. The ad is deceptive because 

it suggests to consumers that the endorsement is unbiased when, in fact, the 

author was paid by the manufacturer to promote the product. The book’s paid 

promotional reference to a specific brand is also advertising for the product and is 

deceptive without a clear and conspicuous disclosure of the connection between the 

manufacturer and the book’s author.

2.CLAIMS BASED ON TRADITIONAL USE

A number of health-related products, including botanical supplements, homeopathic 

medicines,54 and other alternative products, have a long history of use as traditional medicine 

in the United States or in other countries to treat certain conditions or symptoms. Under FTC 

law, claims for products based on traditional use are subject to the same requirement of 

substantiation in the form of competent and reliable scientific evidence as any other product. 

At the same time, FTC law does not prohibit advertising that is sufficiently qualified to be 

truthful and not misleading. Advertising that merely describes the traditional or historic use of 

a product and that is carefully qualified to avoid any misleading implications about the 

product’s efficacy or health benefits may be permissible.55 An advertiser who wants to 

describe a product’s historic or traditional use should take the following steps to avoid 

communicating a misleading message about the product’s efficacy or about the scientific basis 

for any health benefit:
Health Products Compliance Guidance • 29 

⊲ The advertiser should clearly identify the historic or traditional use and make sure that its 

product is consistent with that use – for example, that it contains the same ingredients and 

formulation, the same strength or dose, the same form of administration, and the same 

indications for use. If there is a significant difference between the traditional use of the 

product and the marketed product, a “traditional use” claim isn’t appropriate.

⊲ A claim that suggests a health-related benefit for which there isn’t competent and reliable 

scientific evidence must clearly communicate the lack of scientific evidence. To avoid any 

deceptive implication, a disclosure that there is no scientific basis for the traditional use 

should stand out and be in close proximity to the claim. To be effective, it may actually 

need to be incorporated into the claim. 

⊲ As with all claims, marketers shouldn’t undercut a disclosure about the lack of science with 

additional positive statements, consumer endorsements, images, or other elements of the 

ad suggesting the product is effective.

⊲ Given the inherent difficulty of discussing the traditional use of a product while also 

effectively communicating that there is no scientific basis for its efficacy, an advertiser 

should consider conducting a copy test or other consumer research to confirm that 

consumers understand the limited nature of the claim. The FTC will look closely at how 

consumers perceive a traditional use claim and whether they assume the claim means the 

product is effective and backed by more evidence than the marketers have. An ad that, 

despite a disclosure, conveys more substantiation than a marketer has, is deceptive.

Example 44:

The advertiser of an herbal tea makes the claim, “Ancient remedy used for centuries to 

aid digestion. There is no scientific evidence that it works.” The first statement about 

traditional use is accurate and the advertised product is consistent with the formulation 

of the product as traditionally used. The second statement about no scientific evidence 

is as prominent and legible as the first statement. Taken as a whole, the ad likely 

conveys the limited nature of support for the claim. If, however, the ad also includes 

a testimonial from a consumer who says the tea provides instant relief for her upset 

stomach, that testimonial detracts from and may overwhelm the qualified nature of the 

claim. In that case, the net impression the ad conveys to consumers is likely that the 

tea is effective for upset stomach or digestion – a claim that must be substantiated by 

competent and reliable scientific evidence.
Health Products Compliance Guidance • 30 

Example 45:

A supplement manufacturer markets a capsule containing a concentrated extract 

of a botanical product that has been used in its raw form in China to brew teas for 

increasing energy. The ad clearly and conspicuously conveys that the use of the 

product for boosting energy is based only on traditional use and is unsupported by 

scientific evidence. The ad may still be deceptive, however, because the concentrated 

extract isn’t consistent with the traditional use of the botanical in raw form to brew teas 

and may produce a significantly different effect.

There are certain situations where a traditional use claim, in the absence of supporting 

scientific evidence, could present a substantial risk of serious consumer injury. In such cases, 

the consequences of a false claim are greater and outweigh the benefits of allowing an 

appropriately qualified traditional use claim.56 For that reason, marketers shouldn’t make claims 

about traditional use for the treatment or cure of serious medical conditions, even if the claim 

is carefully qualified to disclose the absence of scientific support. Unlike claims about minor 

or self-limiting health conditions, or claims about supporting general health, traditional use 

claims about the treatment or cure of serious diseases, even if qualified, could put consumers at 

substantial risk of injury by encouraging self-treatment without medical supervision or by causing 

a consumer to forgo a scientifically established treatment in favor of a product that hasn’t been 

shown to be effective.57

Example 46:

An ad claims that a liquid mineral solution has been a popular American folk remedy 

for shrinking tumors since the early pioneer days. There is no scientific research that 

provides any support for this disease benefit claim. Even if the ad includes a clear and 

conspicuous disclosure that there is no scientific support, the ad is likely to convey 

to reasonable consumers that the product is an effective treatment for cancer. The 

strong effect of the claim on a potentially vulnerable consumer could overwhelm the 

disclaimer leaving a misleading net impression about the product’s efficacy. 

3. USE OF THE DSHEA DISCLAIMER IN ADVERTISING

Under DSHEA, all statements of nutritional support for dietary supplements, including “structure/

function” claims, must be accompanied by a two-part disclaimer on the product label: that the 

statement has not been evaluated by FDA and that the product is not intended to diagnose, treat, 

cure, or prevent any disease.

DSHEA did not amend and has no effect on the FTC Act and the DSHEA labeling disclaimer isn’t 

required in other forms of advertising or marketing. Many dietary supplement marketers and 
Health Products Compliance Guidance • 31 

even some marketers of other health products nevertheless include the DSHEA disclaimer or 

a similar statement in their advertising. Marketers should be aware that the DSHEA disclaimer 

or similar statements won’t cure an otherwise deceptive ad, particularly where the deception 

concerns claims about the health-related benefits of a product.58

Example 47:

An ad for an herbal supplement includes an unqualified claim that the product will 

treat diabetes. The advertiser doesn’t have adequate substantiation for this claim, 

but includes the DSHEA disclaimer prominently in the ad. The inclusion of the 

DSHEA disclaimer doesn’t negate the explicit and directly contradictory claim that 

the product treats diabetes. Given the lack of scientific support, the ad is deceptive, 

despite the disclaimer.

4. MISCHARACTERIZATIONS OF FDA APPROVAL

Advertisers should be careful not to mischaracterize the extent to which a product or claim has 

been reviewed, authorized, or approved by the FDA. For instance, compliance with the DSHEA 

notification and disclaimer provisions doesn’t constitute FDA authorization, and advertisers shouldn’t 

imply that the FDA has specifically approved any claim on that basis. Nor should advertisers 

mischaracterize or overstate any FDA assessment of the science supporting a particular claim.

Example 48:

The marketer of a nutritional shake petitions the FDA for permission to use a qualified 

health claim describing the relationship between a substance in the shake and the 

reduced risk of heart disease. After reviewing the scientific literature, the FDA issues 

a letter indicating that it will consider exercising its enforcement discretion to allow the 

marketer to make a claim in labeling that “the relationship between” the substance in 

the shake “and the reduced risk of heart disease is uncertain, because there is little 

scientific evidence for the relationship.” Ads for the shake feature a prominent banner 

stating, “Meets FDA Qualified Health Claim.” By using a technical regulatory term 

unfamiliar to most consumers, the banner mischaracterizes the FDA’s action and likely 

communicates both FDA approval of the product for heart disease and a high level of 

supporting evidence. Use of the banner in advertising is deceptive.
Health Products Compliance Guidance • 32 

Example 49:

The marketer of an electronic “ab sculpting” belt receives clearance from the FDA to 

sell the product as a Class II medical device for the intended purpose of stimulating 

and strengthening healthy muscle. The marketer airs an infomercial for the device with 

repeated references to the fact that the product is “FDA Approved,” alongside claims 

that “in just 10 minutes a day for 30 days, you can effortlessly lose two or more inches 

and 10 pounds from your waist.” The infomercial is deceptive because the juxtaposition 

of the “FDA Approved” reference and claims about weight loss and reduction in waist 

circumference gives the impression that the FDA has found the product to be effective 

for such dramatic effects. 

5.THIRD-PARTY LITERATURE

The FTC doesn’t regulate the content or accuracy of statements made in independently written 

and published books, articles, or other non-commercial literature. The FTC does, however, 

prohibit the deceptive use of such materials in the marketing of products. Marketers of dietary 

supplements and other health products should be aware that the use of newspaper articles, 

abstracts of scientific studies, or other third-party literature to promote a particular brand or 

product can have an impact on how consumers interpret an ad and on what claims the marketer 

will be responsible for substantiating.59 The determination of whether information provided 

through such materials will be subject to FTC jurisdiction turns largely on whether the materials 

have been created or are being used by a marketer specifically for the purpose of promoting its 

product.60 While each case will be fact-specific, marketers may be legally responsible for claims 

implied by their reference either directly or indirectly to third-party literature. 

Example 50:

An author publishes a book on the curative properties of an herb. The book’s title 

is “The Miracle Cancer Cure.” The book doesn’t endorse or otherwise mention any 

particular supplement brand. The author/publisher doesn’t sell the herbal supplement 

and doesn’t have a material connection to any marketers of the herb. As noncommercial speech, the book itself wouldn’t be subject to the FTC’s jurisdiction over 

advertising. However, if a marketer of the herb quotes the title of the book and uses 

excerpts to describe the anti-cancer benefits of its product, such references would be 

considered advertising. The marketer would be responsible for substantiating any 

claims about its product that are conveyed by these references. 
Health Products Compliance Guidance • 33 

Example 51:

The marketer of the herb described in Example 50 provides a link to a web page that 

in turn links to the “Miracle Cancer Cure” book. The fact that the book is “two clicks” 

away from the marketer’s own website doesn’t insulate the marketer from responsibility 

for substantiating any implied claims that consumers may take from the indirect 

reference to the book. The FTC will evaluate the marketer’s website, the description it 

provides in linking indirectly to the book, statements appearing on the linked page, and 

other elements of the marketing to determine whether the marketer is using references 

to the book to promote its product. 

Example 52:

Advertising for a weight-loss supplement includes references to what appears to be 

an independent website discussing the risks of gastric bypass surgery and referencing 

the advertiser’s supplement as a safer alternative. In fact, the advertiser created and 

owns the gastric bypass website and does not disclose that financial relationship. The 

website is not independent third-party literature. The advertiser is responsible for the 

accuracy of claims made on the site and must clearly and conspicuously disclose its 

ownership of the site.

For purposes of dietary supplement labeling, Section 5 of DSHEA provides an exemption from 

labeling requirements for scientific journal articles, books, and other publications used in the 

sale of dietary supplements, provided these materials are reprinted in their entirety, aren’t 

false or misleading, don’t promote a specific brand or manufacturer, are presented with other 

materials to create a balanced view of the scientific information, and are physically separate 

from the supplements being sold. While the DSHEA third-party literature provision doesn’t 

provide an exemption from FTC requirements for other forms of advertising, as a practical matter, 

publications and other materials that comply with the elements of the provision, particularly with 

the requirement that such materials be truthful, not misleading, and balanced, are also likely to 

comply with FTC advertising law.
Health Products Compliance Guidance • 34 

IV.Conclusion

Marketers of health-related products, including dietary supplements, should be familiar with the 

requirements under both FDA law and FTC law that labeling and advertising claims be truthful, not 

misleading, and substantiated. The FTC approach generally requires that health-related claims be 

backed by competent and reliable scientific evidence substantiating that the representations are 

true. To ensure compliance with FTC law, marketers of any health-related product should follow 

two important steps: 1) Consider what express and implied messages consumers are likely to take 

from your ads. Where appropriate, carefully qualify your claims – in other words, clearly explain 

the limited circumstances in which the advertised benefits or results apply; 2) Carefully review 

the support for each claim to make sure it is scientifically sound, adequate in the context of the 

surrounding body of evidence, and relevant to the specific product and advertising claim. 

For More Information

The FTC works to prevent fraudulent, deceptive, and unfair practices that target businesses 

and consumers. We also provide guidance at business.ftc.gov to help companies comply 

with the law. Looking for a quick take on recent cases and other initiatives? Subscribe to 

the FTC’s Business Blog at ftc.gov/news-events/stay-connected. Report scams and bad 

business practices at ReportFraud.ftc.gov. 
Health Products Compliance Guidance • 35 

Endnotes

1 Section 5 of the FTC Act prohibits “unfair or deceptive acts or practices in or affecting commerce,” and Section 

12 prohibits the dissemination of false advertisements for foods, drugs, devices, services, or cosmetics. 15 U.S.C. 

§§ 45, 52. Section 15 of the FTC Act defines “false advertisement” as “advertising that is misleading in a material 

respect[.]” 15 U.S.C. § 55(a)(1).

2 See FTC Policy Statement on Deception, appended to Cliffdale Assocs., Inc., 103 F.T.C. 110, 174 (1983), https://

www.ftc.gov/public-statements/1983/10/ftc-policy-statement-deception (“Deception Policy Statement”); FTC Policy 

Statement Regarding Advertising Substantiation, appended to Thompson Med. Co., 104 F.T.C. 648, 839 (1984), 

aff’d, 791 F.2d 189 (D.C. Cir. 1986), https://www.ftc.gov/public-statements/1983/03/ftc-policy-statement-regardingadvertising-substantiation (“Substantiation Policy Statement”).

3 See discussion at Section III.B. 

4 See, e.g., Complaint at 7, FTC v. Sunrise Nutraceuticals, Inc., No. 9:15-cv-81567 (S.D. Fla. Nov. 16, 2015) (stipulated 

final judgment) (claims made in a press release and on website); Complaint at 5-24, FTC v. NourishLife, LLC, No. 

1:15-cv-00093 (N.D. Ill. Jan. 7, 2015) (stipulated order) (claims made in social media, sponsored links, brochures, 

product packaging, emails, and websites); Complaint at 5-13, FTC v. Sensa Prods., LLC, No. 1:14-cv-00072 (N.D. Ill. 

Jan. 7, 2014) (stipulated final judgment) (claims made in a book, infomercials, print and radio ads, and email); Daniel 

Chapter One, 148 F.T.C. 832, 904-35 (2009) (initial decision) (“Daniel Chapter One Initial Decision”) (claims made in 

radio programs, newsletter, catalog, and website).

5 For a discussion of the five factors that determine whether speech is commercial, see POM Wonderful, LLC, 155 

F.T.C. 1, 74-75 (2013) (citing R.J. Reynolds Tobacco Co., 111 F.T.C. 539, 544-46 (1988)), aff’d in part, POM Wonderful 

LLC v. FTC, 777 F.3d 478, 504-05 (D.C. Cir. 2015).

6 See, e.g., FTC v. LeadClick Media, LLC, 838 F.3d 158, 167-73 (2d Cir. 2016) (affiliate advertising network); POM 

Wonderful, LLC, 155 F.T.C. at 82-84 (individual officer); FTC v. Fitness Brands, Inc., No. 1:12-cv-23065-CMA (S.D. Fla. 

Aug. 23, 2012) (stipulated final judgment) (infomercial host); Dreher, 150 F.T.C. 560 (2010) (consent order) (expert 

endorser); Campbell Mithun LLC,133 F.T.C. 702 (2002) (consent order) (ad agency); Tru-Vantage Int’l, LLC, 133 F.T.C. 

299 (2002) (consent order) (infomercial producer). 

7 See Novartis Corp. v. FTC, 223 F.3d 783, 787-88 (D.C. Cir. 2000) (corrective advertising is appropriate where 

challenged ads played a substantial role in creating or reinforcing a false belief about a product and that misbelief 

is likely to linger).

8 See, e.g., Memorandum Opinion and Order at 10, FTC v. Kevin Trudeau, No. 1:03-cv-03904 (N.D. Ill. Aug. 7, 2008) 

(imposing three-year ban on Trudeau from participating in any infomercial for any product).

9 Memorandum of Understanding Between the Fed. Trade Comm’n and the Food and Drug Admin., 36 Fed. Reg. 

18,539 (Sept. 16, 1971), www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/

DomesticMOUs/ucm115791.htm.

10 Some forms of marketing may constitute both labeling and advertising under the two agencies’ laws. For example, 

a website where a dietary supplement can be purchased would fall within the FDA’s definition of labeling in 

addition to being advertising under FTC law.

11 DSHEA amended the Federal Food, Drug, and Cosmetic Act (FDCA). Pursuant to DSHEA, “structure/function” 
Health Products Compliance Guidance • 36 

refers to an FDA regulatory term for a category of labeling claims that describe the normal structure or function 

of the human body or general well-being. Under FDA law, such claims must be truthful, not misleading and 

substantiated, but do not require prior FDA review or approval. See Structure/Function Claims, Fed. Drug Admin. 

(last updated Dec. 14, 2017), www.fda.gov/food/food-labeling-nutrition/structurefunction-claims. The term has no 

legal significance under FTC law relating to claim substantiation.

12 See Daniel Chapter One, 148 F.T.C. 832, 1086 (2009) (finding no authority that the DSHEA amendment to the 

FDCA regarding “structure/function” claims is binding on the Commission), aff’d, 405 Fed. App’x 505 (D.C. Cir. 

2010).

13 Id. at 1085-86 (rejecting Respondents’ argument that the FDCA distinctions between foods, drugs, or dietary 

supplements are binding on the FTC’s enforcement of Sections 5 and 12 of the FTC Act). See also FTC v. NPB 

Advert., Inc., 218 F. Supp. 3d 1352, 1365 n.4 (M.D. Fla. 2016) (passage of DSHEA “imposes no duty on the FTC in 

this false advertising action”); Bristol-Myers Co. v. FTC, 738 F.2d 554, 559 (2d Cir. 1984) (“FDA requirements and 

regulations . . .simply do not govern this case”).

14 See Enforcement Policy Statement on Food Advertising, 59 Fed. Reg. 28,388, 28,393-94 (June 1, 1994), www.

ftc.gov/public-statements/1994/05/enforcement-policy-statement-food-advertising (“Food Advertising Policy 

Statement”).

15 Id.

16 In 2008, the FDA issued a guidance document detailing how it evaluates substantiation for structure/function 

claims in dietary supplement labeling, stating, “The FTC has typically applied a substantiation standard of 

‘competent and reliable scientific evidence’ to claims about the benefits and safety of dietary supplements and 

other health-related products. FDA intends to apply a standard for the substantiation of dietary supplement claims 

that is consistent with the FTC approach.” Guidance for Industry: Substantiation for Dietary Supplement Claims 

Made Under Section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act, Food and Drug Admin. (Jan. 2009), 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-substantiationdietary-supplement-claims-made-under-section-403r-6-federal-food. 

17 Novartis Corp., 223 F.3d at 787; Kraft, Inc., 114 F.T.C. 40, 121-22 (1991), aff’d, 970 F.2d 311 (7th Cir. 1992).

18 Deception Policy Statement, 103 F.T.C. at 174-75, 179. See also FTC v. Roca Labs, Inc., 345 F. Supp. 3d 1375, 1385 

(M.D. Fla. 2018); FTC v. Direct Mktg. Concepts, Inc., 569 F. Supp. 2d 285, 298 (D. Mass. 2008), aff’d, 624 F.3d 1 (1st 

Cir. 2010); FTC v. Nat’l Urological Group, Inc., 645 F. Supp. 2d 1167, 1189 (N.D. Ga. 2008); Removatron Int’l Corp. v. 

FTC, 884 F.2d 1489, 1497 (1st Cir. 1989).

19 See, e.g., Telebrands Corp., 140 F.T.C. 278, 291-92 (2005), aff’d, 457 F.3d 354 (4th Cir. 2006).

20 See, e.g., POM Wonderful LLC, 155 F.T.C. at 13, 66 (noting that Commission can rely on its common sense and 

expertise to determine what claims were conveyed so long as the claims are reasonably clear); Nat’l Urological 

Grp., Inc., 645 F. Supp. 2d at 1189 (“If the advertisement explicitly states or clearly and conspicuously implies a 

claim, the court need not look to extrinsic evidence to ascertain whether the advertisement made the claim”). 

21 15 U.S.C. § 55(a)(1).

22 See, e.g., Snore Formula, Inc., 136 F.T.C. 214, 296 (2003) (consent order) (requiring that snoring treatment claims be 

accompanied by a disclosure about the dangers of sleep apnea and the need for those with certain symptoms to 

consult a physician); Formor, Inc., 132 F.T.C. 72, 101-02 (2001) (consent order) (requiring that ads and labels making 
Health Products Compliance Guidance • 37 

efficacy or performance claims for St. John’s Wort products disclose potentially dangerous drug interactions even 

when no safety claims are made); FTC v. Christopher Enters., Inc., No. 201 CV-0505ST (D. Utah Dec. 6, 2001) 

(stipulated final order) (requiring disclosure of risks from certain uses of comfrey regardless of whether safety 

claims are made); Consumer Direct, Inc., 113 F.T.C. 923, 925-26 (1990) (consent order) (challenging the failure to 

disclose the risk of injury from exercise device’s spring snapping or breaking). 

23 The Commission has found percentages ranging from 10% to 22% to be sufficient to constitute a significant 

minority. ECM Biofilms, Inc., 160 F.T.C. 652, 667-68 (citing Firestone Tire & Rubber Co. v. FTC, 481 F.2d 246, 249 

(6th Cir. 1973); Telebrands Corp., 140 F.T.C. at 325), aff’d ECM Biofilms, Inc. v. FTC, 851 F.3d 599, 611 (6th Cir. 2017) 

(“We have previously expressed unwillingness ‘to overturn the deception findings of the Commission’ where an ad 

misleads ‘15% (or 10%) of the buying public.’”).

24 See, e.g., Nestlé HealthCare Nutr., Inc., 151 F.T.C. 1, 20 (2011) (consent order) (analysis to aid public comment noting 

that Commission “experience and research show that it is very difficult to adequately qualify a disease riskreduction claim in advertising to indicate that the science supporting the claimed effect is limited”). 

25 See, e.g., POM Wonderful LLC, 155 F.T.C. at 22-23 & nn.13-14 (use of adjectives such as “promising” or “preliminary” 

does not alter the net impression of the efficacy claims, “especially when the chosen adjectives . . . provide a 

positive spin on the studies, rather than a substantive disclaimer”) (Commissioner Ohlhausen concurring but 

finding that certain POM ads warranted extrinsic evidence to determine impact of such qualifiers on establishment 

claims).

26 Deception Policy Statement, 103 F.T.C. at 180 (“pro forma statements or disclaimers may not cure otherwise 

deceptive messages”); see also Section III.C.3, discussing misuse of the DSHEA disclaimer in advertising to negate 

an express or implied disease claim. 

27 Substantiation Policy Statement, 104 F.T.C. at 839. These factors are known as the Pfizer factors, after the 1972 

case in which they were first enunciated. Pfizer, Inc., 81 F.T.C. 23 (1972).

28 See Roca Labs, Inc., 345 F. Supp. 3d at 1387 (competent and reliable scientific evidence required to support 

health-related claims, including weight-loss claims); see also POM Wonderful LLC v. FTC, 777 F.3d 478, 495-97 

(D.C. Cir. 2015) (affirming Commission’s competent and reliable scientific evidence standard for disease-related 

claims about food products); Direct Mktg. Concepts, Inc., 569 F. Supp. 2d at 300 (“because those are nonestablishment health-related efficacy claims, the defendants must be able to point to ‘competent and reliable 

scientific evidence’ as substantiation”) (citing Removatron Int’l Corp., 884 F.2d at 1498 (1st Cir. 1989)); Nat’l 

Urological Grp., Inc., 645 F. Supp. 2d at 1190 (applying same standard to weight loss and erectile dysfunction 

claims for dietary supplements); FTC v. QT, Inc., 448 F. Supp. 2d 908, 961 (N.D. Ill. 2006) (applying same standard 

to pain-related claims for “ionized” bracelet) , aff’d, 512 F.3d 858 (7th Cir. 2008).

29 See, e.g., FTC v. Roca Labs, Inc., No. 8:15-cv-2231-MSS-CPT, at 12-13 (M.D. Fla. Jan. 29, 2019) (final judgment and 

order involving weight-loss supplement) (“Roca Labs Final Order”); see also POM Wonderful LLC, 155 F.T.C. at 56, 

193; Telebrands Corp., 140 F.T.C. at 347. 

30 See, e.g., Roca Labs Final Order at 12-13; FTC v. Sunrise Nutraceuticals, No. 9:15-cv-81567-DMM (S.D. Fla. 

2016) (final stipulated judgment involving supplement purported to eliminate symptoms of opiate withdrawal); 

Lumos Labs, Inc., No. 3:16-cv-00001-sk (N.D. Cal. 2016) (final stipulated judgment involving online brain training 

games purported to provide cognitive benefits); FTC v. Keyview Labs, Inc., No. 8:15-cv-1047 (C.D. Cal. 2015) (final 

stipulated judgment involving supplement purported to improve memory). 

31 See, e.g., Roca Labs, Inc., 345 F. Supp. 3d at 1387 (requiring a randomized controlled human clinical trial (“RCT”) to 
Health Products Compliance Guidance • 38 

substantiate weight-loss claims). The court in Roca Labs rejected defendants’ reliance on U.S. v. Bayer, No. 07-01 

(JLL), 2015 WL 5822595 (D.N.J. Sept. 24, 2015), as authority that RCTs should not be required. Roca Labs, Inc., 

345 F. Supp. 3d at 1387. The court ruled that Bayer was “inapposite both procedurally and factually,” because it 

turned on a narrow question of whether Bayer had violated an existing FTC consent decree. It reasoned that the 

Bayer court’s refusal to read an RCT requirement into the language of a specific FTC decree provision did not 

preclude the FTC from “requiring RCTs or challenging claims for lack of an RCT” in the case before it. Id.

The case law both before and after Bayer has consistently applied an RCT standard in cases challenging healthrelated advertising claims as unsubstantiated. See, e.g., FTC v. Nat’l Urological Grp., Inc., No. 1:04-CV-3294-CAgP, 

2017 U.S. Dist. LEXIS 182256 at *49-51 (N.D. Ga. Oct. 10, 2017) (applying an RCT substantiation standard to weightloss claims and distinguishing Bayer as a case with a “noticeably different” procedural posture), aff’d, 786 F. 

App’x 947 (11th Cir. 2019); POM Wonderful LLC, 777 F.3d at 504-05 (affirming Commission holding that competent 

and reliable scientific evidence consisting of RCTs 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. Coorga Nutraceuticals 

Corp., 201 F. Supp. 3d 1300 (D. Wyo. 2016) (final judgment and order requiring human clinical testing for claims 

that product reverses or prevents formation of gray hair); Nat’l Urological Grp., Inc., 645 F. Supp. 2d at 1202-03 

(accepting undisputed expert testimony that erectile dysfunction claims require well-designed, placebo-controlled, 

randomized, double-blind clinical trials for substantiation); Direct Mktg. Concepts, Inc., 569 F. Supp. 2d at 303 (“[I]

t 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, 1498 (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 human clinical testing 

for disease treatment and prevention claims.  See, e.g., FTC v. Sunrise Nutraceuticals, No. 9:15-cv-81567-DMM 

(S.D. Fla. 2016) (stipulated final judgment requiring human clinical testing for claims that a product can alleviate 

symptoms of drug addiction withdrawal or increase likelihood of successful withdrawal); Brown, 152 F.T.C. 466, 

481-82 (2011) (consent order); Nestlé HealthCare Nutr., Inc., 151 F.T.C. at 13 (consent order); Viral Response Sys., 

Inc., 115 F.T.C. 676, 691 (1992) (consent order).

32 See, e.g., POM Wonderful LLC, 777 F.3d at 491; Removatron Int’l Corp., 111 F.T.C. at 297-98, 306.

33 See supra note 31.

34 See, e.g., QT, Inc., 448 F. Supp. 2d at 940-44, 965 (multiple studies, each with significant flaws, failed to 

substantiate pain relief claims for “Q-ray” bracelet).

35 See, e.g., POM Wonderful LLC, 777 F.3d at 495 (citing expert testimony that observational research is insufficient 

to establish a causal link between a food or nutrient and a reduction in disease risk).

36 See, e.g., Nat’l Urological Grp., Inc., 2017 U.S. Dist. LEXIS 182256 at *95-98 (“only human studies can confirm that 

a specific substance actually has an effect in humans and extrapolating data obtained from animal studies and in 

vitro studies to humans has significant limitations”); FTC v. SlimAmerica, Inc., 77 F. Supp. 2d 1263, 1274 (S.D. Fla. 

1999) (stating animal and in vitro studies “cannot be characterized as serious scientific research” without medical 

proof that effects would be the same in humans).

37 FTC v. QT, Inc., 512 F.3d 858, 862 (7th Cir. 2008) (testimonials “are not a form of proof because most testimonials 

represent a logical fallacy: post hoc ergo propter hoc,” i.e., “[a] person who experiences a reduction in pain after 

donning the bracelet may have enjoyed the same reduction without it.”).

38 See, e.g., POM Wonderful LLC, 777 F.3d at 495 (citing expert’s acknowledgement that health recommendations 
Health Products Compliance Guidance • 39 

are made when the data is not supported by RCTs, based on “best available evidence” which is “not the same as 

stating that a causal link has been established.”)

39 See POM Wonderful LLC, 155 F.T.C. at 36-39 (setting out essential elements of RCT substantiating disease claims 

including control, randomization, validated measures, statistical significance between groups, and doubleblinding when feasible); see also Nat’l Urological Grp., Inc., 2017 U.S. Dist. LEXIS 182256 at *98-106 (describing 

the rationale for requiring that human clinical studies substantiating a claim must have placebo controls, double 

blinding, randomization, be of sufficient size and duration, use appropriate endpoints, and show statistically 

significant results between treatment and control group).

40 See, e.g., POM Wonderful LLC, 777 F.3d at 485 (noting that authors of cardiac study emphasized that subgroup 

findings were based on “post hoc exploratory analyses” which should be interpreted “with caution” because of 

an increased risk of “type I errors” or false positives). See also id. at 494 (citing Commission opinion that POM’s 

“selective touting of ostensibly favorable results and nondisclosure of contrary indications from the same or a later 

study” were deceptive omissions of material facts).

41 See, e.g., POM Wonderful LLC, 155 F.T.C. at 51 (accepting expert opinion that RCTs producing both statistically 

significant and clinically significant results needed to support erectile dysfunction claims); Thompson Med. Co., 104 

F.T.C. at 724 (initial decision) (results of clinical trials should be both statistically significant and clinically important). 

42 See Food Advertising Policy Statement, supra note 14 at Section IV.A. 

43 Id.

44 See, e.g., NBTY, Inc., 151 F.T.C. 201, 205 (2011) (consent order) (settling charges that claims that 100 mg of DHA 

promotes healthy brain and eye development in children are deceptive for a supplement containing only 100 mcg 

of DHA); Gen. Nutr., Inc., 113 F.T.C. 146, 175 (1986) (initial decision) (studies involving the anti-cancer benefits of 

vegetables do not support claims for tablets containing equivalent of 1/16 serving of vegetables).

45 See, e.g., Nat’l Urological Grp., Inc., 645 F. Supp. 2d at 1202 (accepting undisputed expert testimony that study 

on different dose or different combination of active ingredients would not be sufficient to substantiate efficacy 

claim); see also FTC v. Wellness Support Network, Inc., No. 3:10-cv-04879 (N.D. Cal. Feb. 19, 2014) (order granting 

FTC summary judgment) (accepting expert requirement that RCTs for diabetes supplement should be on the same 

dosage and formulation rather than on individual ingredients because “there may be interactions between the 

ingredients that affect their physiological actions”).

46 See, e.g., Nat’l Urological Grp., Inc., 2017 U.S. Dist. LEXIS 182256 at *105-106 (determining whether a product 

causes weight loss requires a study evaluating change in weight as an endpoint; a study examining metabolic 

endpoints cannot determine whether weight loss will also occur).

47 See, e.g., POM Wonderful LLC, 155 F.T.C. at 38 (“the population from which the groups draw must be appropriate 

for the purposes of the study . . . in a prostate cancer prevention trial the appropriate population would involve 

healthy men having no sign of prostate cancer, whereas in a prostate cancer treatment trial, the appropriate 

sample population would depend on the stage of the disease targeted by the study”). 

48 See, e.g., Quigley Corp., 129 F.T.C. 406 (2000) (consent order) (challenged claims that zinc lozenge could prevent 

colds and pneumonia went beyond research on reducing severity of colds). 

49 See also Section III.A.3 discussing disclosures about the limited nature of supporting science for a claim. 

50 The FTC has provided detailed guidance on this subject in its Guides Concerning Use of Endorsements and 
Health Products Compliance Guidance • 40 

Testimonials in Advertising, 16 C.F.R. § 255 (2022), http://www.ecfr.gov/cgi-bin/text-idx?SID=de10601c673ac6ac750

0291dbfecca38&mc=true&node=pt16.1.255&rgn=div5 (“Endorsement Guides”).

51 Id. § 255.2(a); see also Daniel Chapter One Initial Decision, 148 F.T.C. at 993; FTC v. Bronson Partners, LLC, 564 F. 

Supp. 2d 119, 125 (D. Conn. 2008), aff’d, 654 F.3d 359 (2d Cir. 2011). 

52 Endorsement Guides, supra note 50, § 255.2(b).

53 Id. § 255.5.

54 Enforcement Policy Statement on Marketing Claims for OTC Homeopathic Drugs, 81 Fed. Reg. 90,122 (Dec. 13, 

2016) (“Homeopathic Drugs Policy Statement”).

55 Id. at 90,123.

56 See also discussion at Section III.B of factors the FTC considers in determining the amount and type of evidence 

required to substantiate a claim.

57 Cf. Homeopathic Drugs Policy Statement, supra note 54 at 90,122 & n.1 (limiting application of policy statement to 

the treatment of disease conditions that resolve spontaneously with or without specific treatment).

58 See, e.g., Daniel Chapter One Initial Decision, 148 F.T.C at 944-45 (DSHEA disclosure did not alter the overall net 

impression from the advertisements that the challenged products prevent, treat, or cure cancer); Direct Mktg. 

Concepts, 624 F.3d at 12 n.9 (disclaimers that products were not intended to diagnose, treat, or cure any disease, 

in light of statement that studies prove disease cure, “leaves an overall impression of nonsense, not clarity”); 

Spencer, 132 F.T.C. 174, 179-189, 191 (2001) (consent order) (challenging disease treatment and cure claims for 

colloidal silver despite presence of DSHEA disclosures).

59 See POM Wonderful LLC, 155 F.T.C. at 21, 103 (citation to clinical studies can contribute to a clinically proven claim).

60 Id. at 74-75.
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