Richard B. Newman provides litigation and counseling services, with a particular focus on advertising law matters and consumer protection defense. Among other work, he represents clients in advertising substantiation proceedings and investigations conducted by the Federal Trade Commission (FTC) and state Attorneys General (AG).
The Federal Trade Commission requires advertisers to possess a reasonable basis for advertising and marketing claims. The process of demonstrating that reasonable basis is called claim substantiation. Substantiation of express and implied claims is a key enforcement priority that affects advertisers and marketers.
The FTC’s truth-in-advertising law can be boiled down to two common-sense propositions. First, advertising must be truthful and not misleading. Second, before disseminating an ad, whether it is via the Internet, television or radio, advertisers must have adequate substantiation for all express and implied claims.
A deceptive ad is one that contains a misrepresentation or omission that is likely to mislead consumers acting reasonably under the circumstances to their detriment. The FTC’s substantiation standard is a flexible one that depends on many factors. For example, when evaluating claims about the efficacy and safety of foods, dietary programs, supplements and drugs, the FTC has typically applied a substantiation standard of competent and reliable scientific evidence.
To determine whether an advertisement complies with FTC law, it is first necessary to identify all express and implied claims that the advertisement conveys to consumers. Once the claims are identified, the scientific evidence is assessed to determine whether there is adequate support for those claims.
When identifying claims, advertisers should not focus just upon individual phrases or statements, but rather should consider the advertisements as a whole, assessing the objective “net impression” conveyed by all elements of the advertisement, including the text, product name, and depictions. When an advertisement lends itself to more than one reasonable interpretation, the FTC will expect the advertiser to be able to substantiate each interpretation.
An advertisement can also be deceptive because of what it fails to say. The FTC Act requires disclosure of material information, including qualifying information, if an advertisement would be misleading in its absence.
In addition to advertising claim substantiation, compliance reviews of advertising collateral include, without limitation:
- Truth in Claims;
- Dot Com Disclosure Requirements;
- Claim Substantiation and “Competent and Reliable Scientific Evidence;”
- Endorsements, Testimonials and Before/After Photos;
- Negative Options/Continuity Programs; and
- Third-Party Intellectual Property.
An experienced advertising law attorney can help you understand that current state of advertising law and regulation, and the baseline requirements for online advertising as it pertains to your particular product or service.
Many consumer class actions, regulatory investigations and enforcement actions are initiated due to an inability to substantiate representations regarding the efficacy or a product. Marketers must always have evidence to substantiate the representations in ad copy.
The type of evidence necessary to substantiate claims depends upon the nature of the claims. Pursuant to FTC guidance, the relevant standard for truthful and not misleading health-related claims for dietary supplements is “competent and reliable scientific evidence.”
The FTC defines “competent and reliable scientific evidence” as “tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”
Consider the following:
- If there is no data or inconsistent data, it must be disclosed;
- Do not expressly or impliedly misrepresent that independent tests demonstrate the effectiveness of product on ad copy;
- Do not misrepresent any material aspect of the performance, efficacy or characteristics of a product;
- To the extent that photos/videos reflect a claim of what the product will deliver (e.g., a visualization of less wrinkles, younger skin, etc.), this can be considered a representation as to the efficacy thereof and marketers must possess some way to substantiate the claim;
- Create and maintain a file of peer-reviewed scientific studies that support express and implied claims; and
- Only utilize truthful testimonials from verified consumers and disclose when they are compensated.
Qualifying “wiggle” terms (e.g., that the product “may” have the claimed benefit or “helps” achieve the claimed benefit) are unlikely to be adequate. Furthermore, advertisers should not make qualified claims where the studies they relied upon are contrary to a stronger body of evidence. In such instance, even a qualified claim could mislead consumers.
Example: A company has results from two studies suggesting that the main ingredient in its supplement helps to maintain healthy cholesterol levels. There are, however, significant limitations to each of the studies and a better controlled study is necessary to confirm whether the effect is genuine. The company makes a claim in advertising that “scientific studies show that our product may be effective in reducing cholesterol.” The use of the word “may” is not likely to be a sufficient disclaimer to convey the limitations of the science. A disclosure that clearly describes the limitations of the research, in language consumers can easily understand, and states directly and unambiguously that additional research is necessary to confirm the preliminary results is more likely to be effective. The extent to which studies support an unqualified claim will depend largely on what experts in the relevant field would consider to be adequate support.
Also, establishment claims that characterize the amount of science possessed must be backed by that actual amount.
Evaluation of CRSE
When evaluating what “competent and reliable scientific evidence” to use for health-related dietary supplement claims, and how to use it, consider the following:
- Studies and claims must reflect and be consistent with the body of evidence;
- Longer-term studies are better than short-term studies;
- Results must always be statistically and clinically significant;
- The nature and quality of the written report is critical;
- Studies published in reputable peer-reviewed scientific journals are perceived more favorably than non-published studies;
- Studies not published in peer-reviewed journals may be used to substantiate claims if they would be considered properly designed and controlled by experts in the field;
- Always consider the test subjects, dose, dosage form, route of administration, formulation, total length of exposure, frequency of exposure, study population and results when making representations and disclosures;
- Studies should test the same amount of ingredient as is found in the advertised product;
- Wiggle language like “designed to” or “may” to qualify performance benefits will not serve to reduce the substantiation burden;
- The target audience of the ads should be the test population in third-party studies (e.g., if you market to healthy women, testing on unhealthy males will not suffice);
- Animal or in vitro studies alone will typically not be sufficient;
- Independent studies are much more convincing than studies done by someone in a position to benefit from sales of the product or from the company’s success;
- Analyze the studies themselves, not just abstracts;
- Foreign research, as a general matter, is acceptable, however you must note that differences between populations, such as differences in diet, general health, or patterns of use, could confound results and should be properly disclosed; and
- If aspects of studies are unclear, you should obtain the written opinion of an expert in the field.
Always be prepared to explain your substantiating evidence and where it fits within the larger body of science.
What Your Studies Really Show
When relying upon clinical studies, avoid taking logical leaps in an attempt to substantiate claims. For example, the study you want to rely on shows that the product does X. You know that X is associated with Y. That does not mean that you can necessarily claim that the product does Y. Marketers must pay close attention to whether the studies relied upon match your product advertised in terms of dosage and/or route of administration. Were the studies conducted on the final product formulation or just one ingredient? As always, disclosures are critical but they cannot undo an otherwise deceptive representation.
Marketers should prevent giving an unsupported message that a product had been tested. Always make it clear that claims are based on individual ingredient studies. And note that some ingredients when combined can have a synergistic or additive effect together but others can diminish in efficacy when combined. This may also create safety concerns which should be evaluated by an expert. The foregoing are favorite and fertile areas for the FTC when initiating investigations and enforcement actions.
Flexible “Reasonable Basis” Standard
The changing regulatory landscape has brought with it the potential for a return to more flexible enforcement policies, including a reasonable basis substantiation standard.
FTC guidance does not require randomized clinical trials of dietary supplements and notes that “competent and reliable scientific evidence” is a “flexible” standard, and that there is “no fixed formula for the number or type of studies required.” Relevant guidance also states that the “standard for evaluating substantiation is sufficiently flexible to ensure that consumers have access to information about emerging areas of science.”
The FTC has recently noted that “adopting a one-size-fits-all approach to substantiation by imposing such rigorous and possibly costly requirements for such a broad category of health and disease-related claims may, in many instances, prevent useful information from reaching consumers in the marketplace and ultimately make consumers worse off.”
While randomly controlled trials may indeed constitute solid support for dietary supplement and nutraceutical advertising claims, two double-blind, placebo-controlled clinical studies may not always necessarily be required. In fact, numerous federal courts have stated that the standard of what constitutes CRSE is a question of fact that requires careful consideration of, without limitation, experts in the field and appropriate statistical methods to assess ‘outcomes.
Related claims may only require an assessment of the body of relevant scientific information to determine if advertising claims are substantiated. Of course, RCTs are generally considered to be the gold standard of support for advertising claims. When there exists double-blind placebo controlled studies that experts agree substantiate express and implied claims, courts will also likely conclude that claims are substantiated. Be certain to consult with advertising compliance counsel prior to launching your advertising campaign.
Other general health-related claims, representations are subject to the traditional competent and reliable scientific evidence standard. Here, competent and reliable scientific evidence means tests, analyses, research or studies that have been conducted and evaluated in an objective manner by qualified persons and are generally accepted in the profession to yield accurate and reliable results. Such evidence must be based upon standards generally accepted in the relevant scientific field, when considered in light of the entire body of relevant and reliable scientific evidence to substantiate that the representation is true.
For example, the FTC and the New York Office of the Attorney General have recently taken action against the developers of mobile health applications. With regard to the former, the FTC recently settled a matter with the marketers of app-supported smartphone accessories that purported to accurately measure consumers’ blood alcohol content. According to the Commission, the marketers failed to test the accuracy or the app and to notify users that the app did not accurately reflect blood alcohol levels. Previously, the FTC settled with the marketers of a blood pressure app that purportedly lacked reliable testing. In both cases, the FTC expressed concern about the potential safety issues from the lack of proper testing.
The NY OAG’s investigation revealed that two app developers claimed that their apps accurately measured heart rate after vigorous exercise using only a smartphone camera and sensors. A third developer claimed that its app transformed a smartphone into a fetal heart monitor and therefore could be used to play an unborn baby’s heart rate, even though the app was not an FDA-approved fetal heart monitor. According to the OAG, the developers initially marketed these apps without possessing sufficient information to back up their marketing claims.
Substantiation for health and safety-related advertising claims are watched with a critical eye by regulatory agencies.
Know Compliance Basics
Substantiating advertising claims is not always a straightforward endeavor. Advertisers must know how to identify claims in their advertising, determine which claims require substantiation and understand the FTC’s criteria. Certain specific claims, such as health or environmental claims may require additional actions.
Objective assertions about a product or service require substantiation (e.g., “cleans better”). Claims that appear in marketing and advertising materials, on product packaging and on the product itself are covered. Claims requiring substantiation can be express or implied. Subjective claims generally do not require substantiation, provided it is clear to the consumer that the claim is subjective (e.g., “looks cleaner”).
There are numerous factors for establishing the existence of a reasonable basis for claim, including, but not limited to, the following:
- Type of product or service;
- Type of claim;
- Consumer benefit from a truthful claim;
- Ease of developing substantiation for the claim;
- Consequences of a false claim; and
- Amount of substantiation experts in the relevant field believe is reasonable.
Some claims are easier to substantiate than others. If a claim cannot be substantiated, advertisers should revise the claim or conduct additional research (e.g., consumer surveys, scientific studies, market surveys, etc.).
When testing a claim, advertisers should conduct and evaluate the test in an objective manner, with independent, qualified persons using procedures generally accepted in the scientific community. Always consider whether the average consumer would reasonably be expected to achieve the touted results when using the product as instructed under normal use conditions.
If a claim could potentially be misinterpreted by consumers, advertisers may need to include disclosures to qualify the claim. Disclosures must always be clear and conspicuous, prominent, in close proximity to the claim it is qualifying and be reasonably understandable. See here for additional information advertising disclosure requirements.
Lastly, specific types of advertising claims may require specific kinds of substantiation. Without limitation, health claims should be supported by competent and reliable scientific evidence. Comparative advertisements should be substantiated with appropriate evidence, be based upon current versions or features of the products being compared, and be based upon independent, head-to-head testing. Environmental marketing claims are often difficult to substantiate because consumers may interpret claims about a product’s green, eco-friendly, or environmentally friendly qualities broadly. Environmental marketing claims may need to be properly qualified in order to avoid misleading consumers. U.S. origin claims and price comparisons must also be substantiated.