The Federal Trade Commission updated its 24-year-old Dietary Supplements Advertising Guide to apply to all health-related claims.

In announcing the new Health Products Compliance Guidance, the FTC noted that “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. 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.”

The guidance noted that its “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.”

The guidance said advertising refers to a wide variety of marketing techniques, not only traditional TV, radio, print, and internet ads, but also to “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. Promotional product information distributed through any of these means must comply with the same truth-in-advertising principles that apply to traditional ads,” the guidance said.

The revisions and expansions in the new guidance include:

• The “clear and conspicuous” standard and qualified claims;
• The “competent and reliable scientific evidence” standard;
• Testing methodology;
• Consumer testimonials and expert endorsements;
• Traditional use claims;
• FDA approval claims; and
• Third-party literature.

Marketers Need To Identify Express and Implied Claims

The guidance said 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 can’t suggest benefits, safety, or other characteristics about their product indirectly that they couldn’t claim directly,” the guidance said. “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.”

The guidance advised that 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. When an ad lends itself to more than one reasonable interpretation, the advertiser is responsible for substantiating each interpretation.”

The FTC also said an ad can be deceptive because of what it fails to say. “If the ad would be misleading without certain key qualifying information, that information must be disclosed,” the guidance said. “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.”

Clear and Conspicuous Disclosure Detailed

As to clear and conspicuous disclosure, the guidance said that “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.”

The guidance noted that 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,” the guidance said.

In social media, the Internet, and other interactive media, “the disclosure should be unavoidable,” the guidance said, noting “disclosures made through hyperlinks are avoidable.” In addition, “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,” the FTC said. “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,” the guidance concluded.

Qualifying 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,” the guidance noted.

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. 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,” the guidance said, noting “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. 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.”

How to Present Substantiating Claims

The guidance noted 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.”

Several factors determine the appropriate amount and type of substantiation required, including:

• 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, which 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 guidance cautioned.
• 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 his/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,” the guidance said. 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. “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.”

In addition, the FTC has more specifically defined that standard as “tests, analyses, research, or studies that have been conducted and evaluated in an objective manner by experts in the relevant disease, condition, or function to which the representation relates; and are generally accepted in the profession to yield accurate and reliable results.”

The FTC also 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,” the guidance said.

“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,” the guidance said. “In evaluating the reliability of such testing, the FTC will consider several parameters, such as sample size, duration, and outcome measures, which 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.”

The guidance added 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,” the FTC said.

Amount and Type of Evidence Discussed

First, marketers of health-related products must have at least the level of support that they claim to have. “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,” the guidance said.

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.”

The guidance noted that “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.”

There is no requirement for a specific number of RCTs, the guidance said. “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 is more important than the quantity,” the guidance said. “Numerous flawed and inadequate studies are unlikely to add up to competent and reliable scientific evidence sufficient to substantiate a claim.”

The guidance noted “epidemiological or observational studies can be valuable to show an association between a product or ingredient, but they don’t 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.”

The FTC will accept high-quality epidemiologic evidence to substantiate a claim in limited cases where: it is considered an acceptable substitute for RCTs by experts in the field; and RCTs are not otherwise feasible. In addition, 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,” the guidance said. In vitro studies also 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,” the FTC said. “Even if consumer experiences are genuine, they may be attributable to a placebo effect or other factors unrelated to the product.”

A healthcare practitioner’s observation about the effect of a health product on patients also is anecdotal and doesn’t provide evidence of a causal relationship. “Individual experiences aren’t a substitute for scientific research,” the guidance said.

“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,” the guidance said. “They aren’t 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 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,” the FTC said.

Quality of Evidence Is Key

The FTC examines 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,” the guidance said.

The FTC noted science has accepted several basic principles to enhance 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”[RL1] :

• 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, 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 do not 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,” the guidance said.
• 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,” the guidance said.
• Double Blinding – both study subjects and 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 potentially biasing the results,” the guidance said. “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 – “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,” the guidance said. “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 may identify areas for future exploration, but doesn’t generally provide reliable evidence to substantiate a claim.”
• Clinically Meaningful Results – any statistically significant results must translate to a benefit that is clinically meaningful for consumers, the FTC said. “Some results that are statistically significant may be too small to provide real consequences for consumer health.”

The guidance noted that “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.”

Additional Factors Considered

In addition, 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 is a necessary step to ensure the research is ethical and the safety of the subjects is protected.
• Registration of the clinical trial in a public database is needed 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,” the guidance said.
• 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 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,” the guidance said. “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 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,” the guidance said. “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.”

Totality of Evidence Needed

The guidance noted that studies cannot be considered in isolation. “The surrounding context of the scientific evidence is just as important as the internal validity of individual studies,” the guidance said. “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. 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,” the guidance said, noting that in some instances, the differences in results are attributable to differences in dosage, the form of administration, 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 guidance said. “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.”

The guidance noted that “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.”

The FTC advised advertisers to 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,” the guidance said. “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.”

In addition, claims should be carefully worded to avoid overstating the certainty of science in areas where the science is still emerging, the guidance said. “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.”

Other Advertising Issues Detailed

The guidance also discussed several other issues that arise in health-related advertising, including:

• the use of consumer testimonials and expert endorsements;
• claims about FDA approval or compliance; and
• the relevance to FTC advertising law of the FDA’s “third-party literature” exemption.

The guidance noted that advertisers are liable for the misleading use of endorsements. “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,” the guidance said. “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.”

“Testimonials that report results more dramatic than users can generally expect are likely to be deceptive,” the FTC said. “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.”

In addition, 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. “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,” the guidance said. “Any personal, financial, or similar connection that consumers wouldn’t reasonably expect is a material connection.”

Advertisers also should be careful not to mischaracterize the extent to which a product or claim has been reviewed, authorized or approved by the FDA. “Nor should advertisers mischaracterize or overstate any FDA assessment of the science supporting a particular claim,” the guidance said.

While the FTC does not regulate the content or accuracy of statements made in independently written and published books, articles or other non-commercial literature, the agency does prohibit the deceptive use of such materials in the marketing of products. “[Marketers] 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. 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. 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,” the guidance said.