The viewpoints expressed in this article are those of the author and do not necessarily reflect those of any Competent Authority or respective company. The purpose of this article is to guide and inform the reader. The reader is encouraged to verify any opinions and facts the author presents. 

In December 2022 there were two significant announcements. The US Food and Drug Administration (FDA) issued the long anticipated and highly-publicized Modernization of Cosmetic Regulations Act of 2022 (a.k.a., MoCRA). A less publicized announcement from Federal Trade Commission (FTC) was the publication of the revised advertising guidance, Health Products Compliance Guidance, addressing food, dietary supplements, OTC drugs and cosmetics that are advertised or promoted for any health-related benefits.

This new FTC guidance replaced the 1998 Dietary Supplements: An Advertising Guide for Industry. It is important to note that the FTC guidance applies not only to dietary supplements but to all products making health-related claims including OTC drugs, cosmetics, dietary supplements, food, OTC diagnostics and health-related mobile apps. What’s more, what is discussed may be extrapolated to all claims. This article highlights the 2022 FTC guidance document. Although the guidance is specifically on “health related claims,” the implied lessons are true for all claims.

Government Claim Jurisdiction

It is best to start by answering the question: “What is a claim?” Claims are the most important and basic ways of communicating with consumers. Any communication about one’s product that consumers are likely to understand as a representation of one’s product is a claim—a representation of fact that can be demonstrated. This holds true for communications appearing in any media such as on package label, brand website, other internet or digital content, promotional material, store banners, TV, radio, social media, influencer marketing, press interviews, any media appearances, trade shows, conferences, seminars, healthcare practitioners or other intermediaries, and even the metaverse.

In general, claims must be truthful, accurate in what they claim, must not mislead and finally, must be adequately substantiated. A marketer must substantiate all reasonable interpretations of a claim that are both expressed and implied. All claims must be taken in the context they are presented. Lastly, a claim is not what marketers think a claim means but what consumers think a claim means. Worse yet, what authorities and lawyers—aka, “bounty hunters”—think it means.

In the US, claims are regulated by government agencies including FDA through the Federal Food Drug and Cosmetic Act (FDCA) and the Fair Packaging and Labeling Act (FPLA) and through FTC and its “Act.” FDCA 602 bans false or misleading claims that render a brand “misbranded.” If a product has such a claim, it will be considered “misbranded.” FDA also bans marketing drugs as cosmetics. FTC Act, sect. 5, prohibits unfair or deceptive acts or practices. Sect. 12, prohibits false advertising for cosmetics. In brief, there is a clear distinction in regulating claims between FDA and FTC. FDA regulates labeling claims and FTC regulates advertising claims. Unlike FDA, whose scope is generally limited to on package label claims, inserts and other promotional material available at the point of sale for food, drugs, cosmetics and medical devices, FTC has jurisdiction on just about all products and all forms of advertising; i.e., stating of claims, in all media. FTC may not directly act on label claims, but it will make sure FDA does through a Memorandum of Understanding known as the “FDA-FTC Liaison Agreement.”

If you are in the cosmetic sector, FDA is always on your mind—you rarely think of FTC. But FTC, in many respects, will have more of an impact on your business; therefore, it behooves you to know a little more about it. As such, the rest of the discussion is on FTC and the guidance they recently provided to the industry.

FTC Health-Related Claims Guidance

FTC’s broad advertising mandate is to prevent “unfair or deceptive acts or practices” so consumers can make informed decisions. Sections 5 and 12 of the FTC Act, along with FTC’s policy statements on deception and advertising substantiation, are the foundation of FTC truth-in advertising law and can be distilled to two common-sense principles:

• Advertising must be truthful and not misleading; and
• Before disseminating an ad, advertisers must have adequate substantiation for all objective product claims conveyed, expressly or by implication, to reasonable consumers.

Anyone participating in deceptive marketing is potentially liable under FTC law. FTC can take a variety of actions to remedy deceptive advertising. It may obtain an order that stops the deceptive claims; mandate certain disclosures or require that a marketer engage in corrective advertising to cure any lingering deception in the marketplace; ask a court to ban a company or individual from engaging in certain marketing activities altogether; seek financial remedies, including, in some instances, consumer refunds or civil penalties; and if need be, coordinate with FDA through its memorandum of understanding.

The 2022 FTC Health Products Compliance Guidance in discussion here was prepared and released to the industry to update and replace the previous “Dietary Supplements: An Advertising Guide for Industry,” issued in 1998. Like its predecessor, the current guidance ensures that claims about the benefits and safety of health-related products are truthful, not misleading and supported by science. It interprets and explains FTC advertising law pursuant to the FTC Act and as set out in case law, and Commission policy statements. Unlike the previous one, however, the current guidance is “tried and true” because it is built by learnings of more than 200 cases settled or adjudicated by FTC involving false or misleading advertising claims since 1998. These were cases about the benefits or safety of dietary supplements, foods, OTC drugs, homeopathic products, health equipment, diagnostic tests and health-related apps. But since it is a guide, it doesn’t have the force or effect of law. It is intended as business guidance only.

Whether a particular advertising claim is deceptive or otherwise violates the FTC Act will depend on all the facts of the specific case. Although this guidance is specific to health-related claims, its messages extend far beyond. The contents of the guidance that are briefly discussed in this article are:

• Application of FTC law to health-related products;
• Identifying express and implied claims;
• When to disclose qualifying information;
• Clear and conspicuous disclosure; and
• Substantiating claims: 

—The amount and type of evidence;
—The quality of the evidence;
—The totality of the evidence;
—The relevance of the evidence to the specific product and claim;
—Claims based on consumer testimonials or expert endorsements;
—Claims based on traditional use;
—Use of the DSHEA disclaimer in advertising;
—Mischaracterizations of FDA approval; and
—Third-party literature.

As the reader can see from the above content list, a large portion of the guidance is devoted to and pertains to, claims substantiation.

Application of FTC Law to Health-Related Products. FTC views advertising claims from the standpoint of the intended audience; therefore, marketers should see things through the customer’s eyes.

In other words, FTC law focuses not on the marketer’s intent, but on the consumer’s understanding. Marketers are equally responsible for the accuracy of claims suggested or reasonably implied in advertising. Don’t suggest anything about your product indirectly that you cannot claim directly. Furthermore, consider each ad in its entirety, assessing the “net impression” conveyed by all elements of the ad, including the text, product name, and any charts, graphs, and other graphics—don’t just focus narrowly on individual phrases or statements that may be true on their own but not so in the entire ad. When an ad lends itself to more than one reasonable interpretation, the advertiser is responsible for substantiating each of those interpretations.

Identifying Expressed and Implied Claims. This is best accomplished by examples.

Example 1: An ad for a vitamin supplement claims that 90% of cardiologists regularly take the product. The expressed claim that 90% of cardiologists taking the supplement may be true, but the fact that the ad specifically mentioned cardiologist it implies that the product offers some heart benefit which may not be true.

Example 2: A brochure for a weight-loss product shows images of doctors in white lab coats looking through microscopes; there are depictions of molecular structures, and a stack of medical journals. Collectively, they imply scientific legitimacy and that the product has been clinically proven to be effective for weight loss. If there is no clinical proof, the ad is deceptive.

Example 3: 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 if one disregards the product name, which implies the product can cure arthritis, the before-and-after images (along with the references to joint health and mobility) imply that the product can dramatically improve arthritis symptoms. One would need considerable clinical testing that is both statistically and clinically significant as detailed below.

When to Disclose Qualifying Information. An ad can be deceptive not only on what it claims, but also because of what it fails to say. Also, if a product is intended for a specific subset of consumers, it will be deceptive if it did not disclose that only a subset of consumers will benefit. Finally, if claims testing was on a regiment of products, and thus the results and what you are claiming are based on that regiment, you must say so.

Clear and Conspicuous Disclosure. Firstly, claims should be modified so that disclosures are not necessary. If one must use qualifying statements/information in order to prevent a claim from being deceptive, advertisers should present the information clearly and conspicuously, so it is not difficult to miss and be easily understood by ordinary consumers. A visual disclosure should stand out and, based on its size, contrast, location, the length of time it appears, it should be easily noticed, read and understood. It holds true for an audible disclosure. It 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, disclosures should be unavoidable. A disclosure should not be contradictory or inconsistent with anything else in the ad. If it isn’t possible to make an effective disclosure, the claim should not be made. Advertisers should make sure consumers understand both the extent of scientific support and the existence of any significant contrary evidence.

Vague qualifying terms are inadequate and should be avoided. For example, it’s not enough to say that the product “may” have a claimed benefit or “helps” achieve a claimed benefit. Also, consumers are likely to interpret modifiers such as “promising,” “preliminary,” “initial” or “pilot” as positive product attributes.

Substantiating 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 the claims made, how they appear in the context of the entire ad, and how they are qualified. In other words, a brand owner must ensure there is adequate support for the claims. FTC will consider several parameters when considering adequate support, such as sample size, duration and outcome measures. Parameters will vary depending on the exact nature of the hypothesis being tested and accepted norms in the relevant field. Furthermore, products related to consumer health or safety require a relatively high level of scientific substantiation. Several factors determine the appropriate amount and type of substantiation required, such as the type of product, the type of claim, cost and/or feasibility of developing substantiation for the claim, the consequences of making a false claim if it leads to a physical or economic injury, and the amount of substantiation that experts in the field believe is reasonable. Regarding the latter, FTC gives great weight to accepted norms in the relevant fields of research and likes to consult with experts in those fields. FTC also regards existing standards for substantiation developed by government agencies or other authoritative bodies. The cost of substantiating a claim is not an excuse for not having a reasonable basis for the claim.

The final advice in developing claims is to consult independent experts to 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 rest of this article pertains to specific aspects of claim substantiation.

Ads/Claims That Refer to a Specific Level of Support. If you claim something like, “Scientists Now Agree!” in discussing the product’s benefits, you must possess evidence demonstrating that scientists reached that consensus. A claim that is often made is “clinically tested” as it pertains to ingredients or product. If you make such a claim—YES—it must be true that it was clinically tested but that is not enough. The results must also show a benefit.

The Amount and Type of Evidence. For health claims, randomized, controlled human clinical trials (RCTs) are the most reliable form of evidence and are generally the type of substantiation that experts would require, and FTC would highly consider. There is no specific requirement for how many RCTs should be conducted, but replication in a second independently conducted study adds to the weight of the evidence. However, the quality of the research is more important than the quantity.

Epidemiological or observational studies can be valuable to show an association between a product or ingredient, but they don’t prove a causal link and should not be relied on to make direct claims.
Animal and in vitro studies may provide useful supporting or background information, but they aren’t sufficient to substantiate health-related claims.

Anecdotal evidence about individual experiences of consumers, including surveys of consumer experiences, are never sufficient to substantiate claims about the effects of a health product. Likewise for a healthcare practitioner’s observation—it is anecdotal and doesn’t provide evidence of a causal relationship. Bottom line, individual experiences are no substitute for scientific research. Also, public health recommendations and advisories aren’t equivalent to a causal link.

The Quality of the Evidence. The scientific community has generally accepted several basic principles as enhancing the validity of test results. Human clinical studies should have both a treatment group and a control group. Ideally a control using a placebo or sham treatment. Cross-over design, in which subjects serve as their own control, is also acceptable—provided subjects use a sufficient wash-out period; e.g., subjects don’t receive the treatment so they can come to the baseline before testing begun. A study should use appropriate randomization or, as an alternative, careful matching criteria, to prevent selection bias and to assure that demographics and other variables are similar in the control group and the treatment group. Substantial differences between them, for example in age, gender, diet, health status or other characteristics, can challenge the validity of findings. Study subjects and researchers should be blinded as to who is in the treatment group and who is in the control group. The next two quality criteria—statistical and clinical significance—are key because they are often used but very much misunderstood. To support a health-related claim, human clinical research must yield results that are statistically significant. However, statistically significant results must translate to a benefit that is clinically meaningful for consumers. Some significant results may be too small to provide real consequences for consumers.

The Totality of the Evidence. Studies should not be considered in isolation. Considering all existing scientific evidence is just as important as the internal validity of individual studies. When considering external scientific evidence, don’t ignore those that do not support your hypothesis/claim. Studies relied on by an advertiser should be largely consistent with the surrounding body of evidence. The totality of the evidence should affect how a claim is presented. Bottom line, don’t just rely on your internal data. Ask yourself if what you see is in harmony with what others see.

The Relevance of the Evidence to the Specific Product and Claim. Make sure that your product’s formula, advertising and use instructions accurately reflect your studies of substantiation. The dosage of your active or protagonist ingredient and formulation of the advertised product should compare to the product used in the study. Your formula for the advertised product should be the same as what was used in the study.

The product’s use instructions should reflect the same manner of administration as the product in the study. The outcomes tested in the study should relate to the specific benefits advertised. The study population should reflect the characteristics of the population targeted by the ad.

Caution should be used in extrapolating from the research to the claimed effect. Evaluate whether it is appropriate to do so and be careful not to promote significant discrepancies. Claims must accurately reflect what the research shows and claims that don’t match the research results, no matter how sound that research, are likely to be deceptive. Also, be careful not to exaggerate the extent nature, or permanence of the effects achieved in a study.

Claims Based on Consumer Testimonials or Expert Endorsements. As noted, advertisers are liable for the misleading use of endorsements in all advertising media. It’s not enough that a testimonial represents the honest opinion or experience of an endorser. 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. Under FTC law, advertisers must have appropriate scientific evidence to back up the underlying implied claim that the product will work for buyers as it did for the endorser.

Claims Based on Traditional Use. Botanicals, homeopathic medicines and other alternative products, may have a long history of use as traditional medicines, but under FTC law, product claims based on traditional use are subject to the same requirement of substantiation as any other product. That is, must have competent and reliable scientific evidence. The reader should not misunderstand. Advertising that merely describes the traditional or historic use of a product is OK provided it does not communicate a misleading message.

This is best demonstrated with the following claims example: “Traditional remedy used for centuries to XYZ. There is no scientific evidence that it works.”

The first part of the statement is accurate, provided the advertised product is consistent with the formulation of the product as traditionally used. The second part of the statement is as prominent and legible as the first statement, and it is not positioned as a qualifier detached from the first part of the statement—so that’s good. Therefore, taken as a whole, the ad conveys the limited nature of support for the claim. The entire claim statement is truthful and not misleading. But if the ad also includes a testimonial from a consumer who says the product provides instant XYZ, that testimonial gives the impression that it works and therefore detracts from, and may overwhelm, the qualified nature of the claim of being substantiated by competent and reliable scientific evidence—in which in this case it clearly states is not.

DSHEA Caveats

DSHEA stands for Dietary Supplement Health & Education Act of 1994. 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 such as: “XYZ has not been evaluated by FDA and that the product is not intended to diagnose, treat, cure, or prevent any disease.”

DSHEA has no effect on the FTC Act and the DSHEA labeling disclaimer is not required in other forms of advertising or marketing except on the product label. Still, some include the DSHEA disclaimer or a similar statement in other advertising—non-package label. The point here is that the DSHEA disclaimer or a similar statement will not legitimize a deceptive ad.

Mischaracterizations of FDA Approval. One should not mischaracterize the extent to which a product or claim has been reviewed, authorized or approved by FDA. Advertisers should not imply that FDA has specifically approved any claim nor should mischaracterize or overstate any FDA assessment of the science supporting a particular claim. Simply, FDA does not approve claims.

Use of Third-Party Literature. Ones should not base claims on third party literature solely, but one can use it to strengthen one’s claim substantiation.

Other Considerations

In addition to regulatory scrutiny, health-related claims are a focus of class action activity. For example, there have been challenges:

• Alleging that beverages are falsely advertised as healthy, despite a high sugar content;
• Alleging that food and beverage products are advertised as “no added sugar” when products in that category do not normally contain added sugar;
• Overstating the importance of an ingredient in the product, when the ingredient is present in an insignificant amount; and
• Claiming that products are advertised as “natural,” despite the present of artificial ingredients or additives.
• In addition, challenges to health-related advertising may be brought in the National Advertising Division. NAD generally follows FTC guidance, and found, for example, that:
• Health-related efficacy claims must be supported by competent and reliable scientific evidence. Generally, for health-related claims, competent and reliable scientific evidence are human clinical trials that are methodologically sound and statistically significant to the 95% confidence level with results that translate into meaningful benefits for consumers who relate directly to the performance attributes promised by advertising.
• The most reliable form of evidence to support health-related advertising claims is randomized controlled trials which compare results from using the product at issue to a control.
• Animal studies alone are usually insufficient to support health-related advertising claims for products marketed for use by humans.
• Claims like “#1 proven effective” convey the message that the advertised product has been the subject of the highest number of studies showing clinical efficacy over a range of conditions.

Epilogue

The objective of this article is to familiarize the reader with FTC as it relates to claims and advertising and specifically to summarize the recently released guidance. A manufacturer should be familiar with the requirements under both FDA and FTC law. To sum up, for both institutions, labeling and advertising claims must not mislead, be truthful 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:

• Consider what express and implied messages consumers are likely to take from your ads;
• 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.

If you are involved in making and substantiating claims and advertising, you should download and refer to the Dec. 20, 2022, FTC guidance on health-related claims document: https://www.ftc.gov/system/files/ftc_gov/pdf/Health-Guidance-508.pdf.