FTC HEALTH PRODUCTS COMPLIANCE GUIDANCE

In December 2022, the Federal Trade Commission published its Health Product Compliance Guidance, replacing the 1998 dietary supplement advertising guidelines.

The new and updated guidance prohibits false and deceptive advertising representations for all health-related products (the FTC shares jurisdiction with the US Food and Drug Administration which regulates labeling), including dietary supplements, over-the-counter medicine, foods, homeopathic products, health-related apps, health equipment and diagnostic tests.

What Does the Health Product Compliance Guidance Say About Claim Substantiation Standards?

The FTC Health Product Compliand Guidance discusses what is new - and what is not.

 The Guidance states that the FTC will aggressively enforce the advertising claim substantion required in order to ensure that advertisers possesses “competent and reliable scientific evidence” for any health-related claims.  According to the Commission, "generally competent and reliable evidence for health-related claims consists of “randomized, controlled human clinical testing” conducted by appropriate  experts that are required to assess studies in order to ensure that they are well designed and properly analyzed.  The FTC expects companies to support health-related claims with high quality, randomized, controlled human clinical trials (RCTs).

While the FTC does not require a hard number of reliable RCTs, the quality of data is a significant factor in the FTC's analysis.

What About Animal and In Vitro Studies?

The new Guidance states that animal and in vitro studies alone are insufficient to substantiate health related representations.  "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.  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."

Studies Should be Consistent With the Surrounding Body of Evidence

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 shouldn’t 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, 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.

What Constitutes Competent and Reliable Scientific 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.

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 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: (i) a control group; (ii) double blinding; (iii) statistically significant results; and (iv) clinically meaningful results,

What are "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 and easily understandable by reasonable, 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 advertisements.  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 is insufficient.  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.

What About Claims Based Upon 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.  As a general rule, 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 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.  Moreover, attempts to disclaim dramatic results with statements like “Results not typical” do not cure the deception.  Those testimonials should be accompanied by a clear and conspicuous disclosure of the results a typical consumer can actually expect.

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.

Are Claims for Products Based on Traditional Use Subject to the Same Substantiation Requirements?

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

An advertiser that 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: (i) clearly identify the historic or traditional use and make sure that its product is consistent with that use (e.g., it contains the same ingredients and formulation, the same strength or dose, the same form of administration, and the same indications for use); (ii) a claim that suggests a health-related benefit for which there is not 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); (iii) do not "undercut" a disclosure about the lack of science with additional positive statements, consumer endorsements, images, or other elements of the advertisement suggesting the product is effective; and (iv) 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 advertisement that, despite a disclosure, conveys more substantiation than a marketer has, is deceptive).

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 those cases, the consequences of a false claim are greater and outweigh the benefits of allowing an appropriately qualified traditional use claim.

As a result, marketers should not 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 has not been
shown to be effective.

Can Use of Third Party Literature to Promote a Product Can Have an Impact on Consumer Perception of Advertising Representations?

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 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.  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.

For purposes of dietary supplement labeling, Section 5 of the Dietary Supplement Health and Education Act of 1994 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, are not false or misleading, do not 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 does not 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.

Takeaway

Health-related claims remain a key area of focus for the FTC.  Advertisers that market health-related products should consult with an experienced FTC compliance attorney defense lawyer before disseminating promotional materials.