In December 2022, the the Federal Trade Commission published new guidance regarding representations about the benefits and safety of health-related products: Health Products Compliance Guidance. Federal Trade Commission staff prepared the new guidance document to update and replace Dietary Supplements: An Advertising Guide for Industry, issued in 1998. Like the 1998 guidance, the new 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 health-related products, including foods, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests and health-related apps. The updated guidance 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. The new guidance also addresses claims based upon consumer testimonials or expert endorsements, mischaracterizations of FDA approval and citations to third-party literature.
While most of the examples involve dietary supplement advertising, the same legal principles apply to the marketing of any health-related product.
The updated guidance 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 updated guidance, however, does not 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 do not 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.
The Federal Trade Commission is tasked with preventing “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, along with the FTC’s policy statements on deception and advertising substantiation, are the foundation of FTC truth-inadvertising law.
There are two common-sense principles. First, advertising must be truthful and not misleading. Second, prior to disseminating an ad, advertisers must have adequate substantiation for all objective express and implied product claims conveyed 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.
“Advertising” refers to a wide variety of marketing techniques and anyone participating in deceptive marketing is potentially liable under FTC legal regulations.
The FTC and the Food and Drug Administration 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.
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.
There are key differences Between FTC and FDA legal regulations. 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” claims in labeling do not govern the FTC’s assessment of those claims in advertising. The FTC follows the same basic steps when evaluating any health-related claim regardless of whether, under FDA law, the claim would be considered a health claim, a structure/function claim, or a drug claim.
Also, 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.
The new guidance covers identifying express and implied claims, and interpreting ad meaning.
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 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 legal regulations, a marketer is equally responsible for the accuracy of claims suggested or reasonably implied in advertising.
Marketers cannot suggest benefits, safety, or other characteristics about their product indirectly that they could not 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 advertisement, marketers should not 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.
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. 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.
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.
An advertisement also can be deceptive because of what it fails to say. An advertisement 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. So, if the ad would be misleading without certain key qualifying information, that information must be disclosed.
The new guidance also discusses “clear and conspicuous” disclosures.
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 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. If it is not possible to make an effective disclosure, the claim should be modified so that a disclosure is not necessary – or the claim should not be made.
Qualifying information is information that explains or limits the applicability of an ad claim. It 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 may be 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.
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.
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
Although a clear and conspicuous disclosure might be effective to clarify an ambiguous claim that might otherwise be deceptive, it cannot directly contradict a claim.
Of course, the new guidance also devotes significant attention to 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 legal regulations, 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. Contact an FTC CID investigations lawyer with any questions about the updated guidance. 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 the type of product, the type of claim, the benefits of a truthful claim, the consequences of a false claim, and the amount of substantiation that experts in the field believe is reasonable.
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, marketers also must ensure that any assertion about the amount, type, or strength of evidence is accurate.
Even when an advertiser does not 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. 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. However, the quality of the research may be 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.
Epidemiological or observational studies can be valuable to show an association between a product or ingredient, but they do not prove a causal link. 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. FTC attorneys may accept high-quality epidemiologic evidence to substantiate a claim in those limited cases where it is considered an acceptable substitute for RCTs by experts in the field, and RCTs are not otherwise feasible.
Animal and in vitro studies may provide useful supporting or background information, but, without confirmation by human RCTs, they are not generally sufficient to substantiate health-related claims. 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 may be 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. 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 does not provide evidence of a causal relationship. Individual experiences are not a substitute for scientific research.
Additionally, advertisers should not 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 are not equivalent to a finding that there is a causal link between the recommended course of action and the health benefit. For that reason, public health recommendations alone are not 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.
In addition to the amount and type of evidence, an FTC lawyer will also 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, the quality of such evidence must be assessed.
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 some basic principles. For example, there must be a treatment group and a control group. 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. 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. To support a health-related claim, human clinical research must yield results that are statistically significant. Any statistically significant results must translate to a benefit that is clinically meaningful for consumers.
Also, studies cannot 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 should not focus only on research that supports an effect, while discounting research that does not. Studies relied on by an advertiser should be largely consistent with the surrounding body of evidence. 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.
A common problem in the substantiation of advertising claims is that an advertiser has valid studies, but the studies do not support the claim made in its advertisement. Advertisers should make sure that the research on which they rely is not 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?" "Is the ingredient or combination of ingredients in the advertised product the same as what was used in the study?" "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?" "Does the study population reflect the characteristics of the population targeted by the ad?"
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 is also important that the claims accurately reflect what the research shows. Claims that do not match the research results, no matter how sound that research is, are likely to be deceptive. So, advertisers should be careful not to exaggerate the extent, nature or permanence of the effects achieved in a study. 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.
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. First, consider what express and implied messages consumers are likely to take from advertisements. Where appropriate, carefully qualify claims - in other words, clearly explain the limited circumstances in which the advertised benefits or results apply. Second, 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.
Other issues in the context of health-related advertising covered in the new guidance 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.
With respect to the use of consumer testimonials and expert endorsements, the new guidance sets fort that 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.
An overarching principle is that advertisers should not make claims through consumer testimonials or expert endorsements that would be deceptive or could not be substantiated if the advertiser made them directly. It is not enough that a testimonial represents the honest opinion or experience of an endorser.
Under FTC legal regulations, 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.
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 would not reasonably expect is a material connection
The FTC’s new Health Products Compliance Guidance should be of interest to in-house counsel, product providers, manufacturers and digital marketers.
